2023/0132(COD) | [ParlTrack]

Proposal for a directive
Article 83 – paragraph 3

3. Where the Agency adopts scientific guidelines for the application of this Article it shall consult the Commission and the authorities or bodies as well as the stakeholders referred to in Article 162 of [revised Regulation (EC) No 726/2004].

Amendment 1209 #

Proposal for a directive
Article 83 – paragraph 3

Amendment 1210 #

Proposal for a directive
Article 84 – paragraph 1 – introductory part

1. A regulatory data protection period of ~~four~~two years shall be granted for a medicinal product with respect to a new and previously unknown therapeutic indication not previously authorised in the Union, provided that:

Amendment 1211 #

Proposal for a directive
Article 84 – paragraph 1 – introductory part

1. A regulatory data protection period of ~~four~~two years shall be granted for a medicinal product with respect to a new therapeutic indication not previously authorised in the Union, provided that:

Amendment 1212 #

Proposal for a directive
Article 84 – paragraph 1 – introductory part

1. A regulatory data protection period of ~~four~~two and a half years shall be granted for a medicinal product with respect to a new therapeutic indication not previously authorised in the Union, provided that:

Amendment 1213 #

Proposal for a directive
Article 84 – paragraph 1 – introductory part

1. A regulatory data protection period of ~~four~~one years shall be granted for a medicinal product with respect to a new therapeutic indication not previously authorised in the Union, provided that:

Amendment 1214 #

Dolors MONTSERRAT, Nathalie COLIN-OESTERLÉ, Stelios KYMPOUROPOULOS

Proposal for a directive
Article 84 – paragraph 1 – introductory part

1. A non-cumulative period of regulatory data protection ~~period~~ of four years shall be granted for a medicinal product with respect to a ~~new therapeutic indication~~a new therapeutic option, including new therapeutic indication, posology, pharmaceutical form, method or route of administration or any other way in which the medicinal product may be used, not previously authorised in the Union, provided that:

Amendment 1215 #

Proposal for a directive
Article 84 – paragraph 1 – introductory part

1. A non-cumulative period of regulatory data protection ~~period~~ of four years shall be granted for a medicinal product with respect to a new therapeutic ~~indication~~option, including a new indication, posology, pharmaceutical form, method or route of administration or any other way in which the medicinal product may be used, not previously authorised in the Union, provided that:

Amendment 1216 #

Adam JARUBAS, Ewa KOPACZ, Elżbieta Katarzyna ŁUKACIJEWSKA

Proposal for a directive
Article 84 – paragraph 1 – introductory part

Amendment 1217 #

Proposal for a directive
Article 84 – paragraph 1 – introductory part

Amendment 1218 #

Proposal for a directive
Article 84 – paragraph 1 – introductory part

1. A non-cumulative period of regulatory data protection ~~period~~ of four years shall be granted for a medicinal product with respect to a new therapeutic ~~indication~~option, including a new indication, posology, pharmaceutical form, method or route of administration or any other way in which the medical product may be used, not previously authorised in the Union, provided that:

Amendment 1219 #

Proposal for a directive
Article 84 – paragraph 1 – introductory part

1. A non-cumulative period of regulatory data protection period of four years shall be granted for a medicinal product with respect to a new therapeutic ~~indication~~option, incuding a new indication, posology, pharmaceutical form, method or route of administration or any other way in which the medicinal product may be used, not previously authorised in the Union, provided that:

Amendment 1220 #

Proposal for a directive
Article 84 – paragraph 1 – introductory part

1. A non-cumulative period of regulatory data protection period of four years shall be granted for a medicinal product with respect to a new therapeutic indication not previously authorised in the Union, provided that:

Amendment 1221 #

Adam JARUBAS, Ewa KOPACZ, Elżbieta Katarzyna ŁUKACIJEWSKA

Proposal for a directive
Article 84 – paragraph 1 – point a

(a) adequate ~~non-clinical or~~ clinical studies w~~ere carried out~~ith an active-comparator were carried out by the marketing authorisation holder in relation to the therapeutic indication demonstrating that it is of significant clinical benefit, and

Amendment 1222 #

Proposal for a directive
Article 84 – paragraph 1 – point a

(a) adequate non-clinical or clinical ~~studies were carried out~~evidence was provided in relation to the therapeutic ~~indica~~option demonstrating that it is of significant ~~clinical~~ benefit, and

Amendment 1223 #

Proposal for a directive
Article 84 – paragraph 1 – point a

Amendment 1224 #

Dolors MONTSERRAT, Nathalie COLIN-OESTERLÉ, Stelios KYMPOUROPOULOS

Proposal for a directive
Article 84 – paragraph 1 – point a

Amendment 1225 #

Proposal for a directive
Article 84 – paragraph 1 – point a

Amendment 1226 #

Proposal for a directive
Article 84 – paragraph 1 – point a

Amendment 1227 #

Proposal for a directive
Article 84 – paragraph 1 – point a

(a) adequate non-clinical or clinical studies were carried out by the marketing authorisation applicant in relation to the therapeutic indication demonstrating that it is of significant clinical benefit, and

Amendment 1228 #

Proposal for a directive
Article 84 – paragraph 1 – point a

Amendment 1229 #

Adam JARUBAS, Ewa KOPACZ, Elżbieta Katarzyna ŁUKACIJEWSKA

Proposal for a directive
Article 84 – paragraph 1 – point b

(b) the medicinal product is authorised in accordance with Articles 9 to 12 and has not previously benefitted from data protection, or 2516 years have passed since the granting of the initial marketing authorisation of the medicinal product concerned.

Amendment 1230 #

Proposal for a directive
Article 84 – paragraph 1 – point b

(b) the medicinal product is authorised in accordance with Articles 9 to 12 and ~~has not~~does not fall in the same global marketing authorization as a medicinal product that has previously benefitted from data protection or market exclusivity, or 25 years have passed since the granting of the initial marketing authorisation of the medicinal product concerned.

Amendment 1231 #

Proposal for a directive
Article 84 – paragraph 1 – point b

Amendment 1232 #

Dolors MONTSERRAT, Nathalie COLIN-OESTERLÉ, Stelios KYMPOUROPOULOS

Proposal for a directive
Article 84 – paragraph 1 – point b

Amendment 1233 #

Proposal for a directive
Article 84 – paragraph 1 – point b

Amendment 1234 #

Proposal for a directive
Article 84 – paragraph 1 – point b

Amendment 1235 #

Proposal for a directive
Article 84 – paragraph 1 – point b

(b) the medicinal product is authorised in accordance with Articles 9 to 12 and ~~has not~~does not fall in the same global marketing authorisation as a medical product that has previously benefitted from data protection or market exclusivity, or 25 years have passed since the granting of the initial marketing authorisation of the medicinal product concerned.

Amendment 1236 #

Proposal for a directive
Article 84 – paragraph 2

~~2. The data protection period referred to in paragraph 1 may only be granted once for any given medicinal product.~~deleted

Amendment 1237 #

Proposal for a directive
Article 84 – paragraph 2

2. The data protection period referred to in paragraph 1 may only be granted once for any given medicinal product and provided that an established medicinal product continues to be available to patients during treatment without direct or indirect unreasonable changes in price or conditions.

Amendment 1238 #

Proposal for a directive
Article 84 – paragraph 3

3. During the data protection period referred to in paragraph 1, the m~~arketing authorisation shall indicate that the medicinal product is an existing medicinal product authorised in the Union that has been authorised with an additional therapeutic indication~~edicinal product shall be appointed as a value added medicinal product.

Amendment 1239 #

Proposal for a directive
Article 84 – paragraph 3

Amendment 1240 #

Dolors MONTSERRAT, Nathalie COLIN-OESTERLÉ, Stelios KYMPOUROPOULOS

Proposal for a directive
Article 84 – paragraph 3

Amendment 1241 #

Proposal for a directive
Article 84 – paragraph 3

3. During the data protection period referred to in paragraph 1, the m~~arketing authorisation shall indicate that the medicinal product is an existing medicinal product authorised in the Union that has been authorised with an additional therapeutic indication~~edicinal product should be designated as a value added medicinal product.

Amendment 1242 #

Proposal for a directive
Article 84 a (new)

Article84a Reporting of research and development costs from the marketing authorisation holder 1. Where the marketing authorisation holder benefits from data and market protection granted under this Directive it shall: (a) Upon request, submit to the Commission and/or the competent authorities of the Member States responsible for pricing and reimbursement an electronic report with detailed information on their expenditure in research and development activities related to the medicinal product; (b) make the report available within 30 days from the receipt of the request; (c) publish a summary of the report on the same webpage where the information described in Article 57 will be published. The link should be communicated to the competent authority of the Member State granting the marketing authorisation or, where appropriate, to the Agency; (d) ensure that the electronic report and lay summary are accurate and have been audited by an independent external auditor. 2. The Commission shall promote transparency and data sharing mechanisms regarding reimbursement prices of medicinal products by the Member States. 3. The Commission shall adopt delegated acts to lay down the methodology and format in which the information should be reported and published pursuant to paragraph 1.

Amendment 1243 #

Proposal for a directive
Article 84 a (new)

Article84a Reporting of research and development costs from the marketing authorisation holder 1. Where the marketing authorisation holder benefits from data and market protection granted under this Directive it shall: (a) Upon request, submit to the Commission and the competent authorities of the Member States responsible for pricing and reimbursement a report with detailed information on their actual costs and expenditure in research and development activities related to the medicinal product; (b) make the report available within 30 days from the receipt of the request; (c) publish a summary of the report on the same webpage where the information described in Article 57 will be published. The link should be communicated to the competent authority of the Member State granting the marketing authorisation or, where appropriate, to the Agency; (d) ensure that the electronic report and lay summary are accurate and have been audited by an independent external auditor. 2.The Commission shall adopt implementing in acts to lay down the methodology and format in which the information should be reported and published pursuant to paragraph 1.

Amendment 1244 #

Proposal for a directive
Article 84 a (new)

Article84a Reporting of research and development costs from the marketing authorisation holder 1. Where the marketing authorisation holder benefits from data and market protection granted under this Directive it shall: (a) Upon request, submit to the Commission and/or the competent authorities of the Member States responsible for pricing and reimbursement an electronic report with detailed information on their expenditure in research and development activities related to the medicinal product; (b) make the report available within 30 days from the receipt of the request; (c) publish a summary of the report on the same webpage where the information described in Article 57 will be published. The link should be communicated to the competent authority of the Member State granting the marketing authorisation or, where appropriate, to the Agency; (d) ensure that the electronic report and lay summary are accurate and have been audited by an independent external auditor. 2.The Commission shall adopt implementing in acts to lay down the methodology and format in which the information should be reported and published pursuant to paragraph 1.

Amendment 1245 #

Adam JARUBAS, Ewa KOPACZ, Elżbieta Katarzyna ŁUKACIJEWSKA

Proposal for a directive
Article 85 – paragraph 1 – introductory part

Patent rights, or supplementary protection certificates under the [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted] shall not be regarded as infringed when ~~a reference medicinal product is used~~studies, trials and other activities are conducted and the subsequent practical requirements associated with such activities, for the purposes of:

Amendment 1246 #

Proposal for a directive
Article 85 – paragraph 1 – introductory part

Patent rights, or supplementary protection certificates under the [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted] shall not be regarded as infringed when ~~a reference medicinal product is used~~necessary studies, trials and other activities are conducted exclusively for the purposes of:

Amendment 1247 #

Proposal for a directive
Article 85 – paragraph 1 – introductory part

Patent rights, or supplementary protection certificates under the [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted] shall not be regarded as infringed when ~~a reference medicinal product is us~~studies, trials and other activities are conducted for the purposes of:

Amendment 1248 #

Proposal for a directive
Article 85 – paragraph 1 – introductory part

Patent rights, or supplementary protection certificates under the [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted] shall not be regarded as infringed when ~~a reference medicinal product is us~~studies, trials and other activities are conducted for the purposes of:

Amendment 1249 #

Proposal for a directive
Article 85 – paragraph 1 – introductory part

Patent rights, or supplementary protection certificates under the [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted] shall not be regarded as infringed when ~~a reference medicinal product is us~~studies, trials and other activities are conducted for the purposes of:

Amendment 1250 #

Proposal for a directive
Article 85 – paragraph 1 – introductory part

Patent rights, or supplementary protection certificates under the [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted] shall not be regarded as infringed when ~~a reference medicinal product is us~~studies, trials and other activities are conducted for the purposes of:

Amendment 1251 #

Proposal for a directive
Article 85 – paragraph 1 – introductory part

Amendment 1252 #

Proposal for a directive
Article 85 – paragraph 1 – introductory part

Amendment 1253 #

Proposal for a directive
Article 85 – paragraph 1 – introductory part

Amendment 1254 #

Proposal for a directive
Article 85 – paragraph 1 – introductory part

Amendment 1255 #

Proposal for a directive
Article 85 – paragraph 1 – introductory part

Amendment 1256 #

Dolors MONTSERRAT, Massimiliano SALINI, Nathalie COLIN-OESTERLÉ

Proposal for a directive
Article 85 – paragraph 1 – point a

(a) studies, trials and other activities conducted to generate data for an application, for: (i) a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinal products and for subsequent variations; (ii) health technology assessment as defined in Regulation (EU) 2021/2282; (iii) pricing and reimbursement.deleted

Amendment 1257 #

Proposal for a directive
Article 85 – paragraph 1 – point a – introductory part

(a) studies, trials and other activities are conducted to generate data for ~~an application, for:~~the purpose of: (i) obtaining a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinal products and for subsequent variations; (ii) conducting a health technology assessment as defined in Regulation (EU) 2021/2282; (iii) obtaining pricing and reimbursement approval; (iv) complying with any other regulatory or administrative requirement in the Union or elsewhere; and the subsequent practical requirements associated with such activities.

Amendment 1258 #

Proposal for a directive
Article 85 – paragraph 1 – point a – introductory part

(a) ~~studies, trials and other activities conducted to generate data for an application, for:~~(i) obtaining for a marketing authorisation and subsequent variations; (ii) conducting a health technology assessment as defined in Regulation (EU) 2021/2282; (iii) obtaining for pricing and reimbursement approval; (iv) enabling public and private procurement of medicinal products after expiry of the relevant patents or supplementary protection certificate; (v) complying with any other regulatory or administrative requirement in the Union or elsewhere; and the subsequent practical requirements associated with such activities.

Amendment 1259 #

Proposal for a directive
Article 85 – paragraph 1 – point a – introductory part

(a) ~~studies, trials and other activities conducted~~applying to a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinal products and for subsequent variation facilitating health technology assessment as defined in Regulation (EU) 2021/2282; filing for pricing and reimbursement; participating in a tender to gen~~erate data for an application, for:~~ able market entry of generic and biosimilar products as soon as the relevant patents or supplementary protection certificates expire.

Amendment 1260 #

Proposal for a directive
Article 85 – paragraph 1 – point a – introductory part

(a) ~~studies, trials and other activities conducted to generate data for an application, for:~~deletion

Amendment 1261 #

Adam JARUBAS, Ewa KOPACZ, Elżbieta Katarzyna ŁUKACIJEWSKA

Proposal for a directive
Article 85 – paragraph 1 – point a – introductory part

(a) studies, trials and other activities are conducted ~~to generate data for an application, for~~for the purpose of:

Amendment 1262 #

(a) ~~studies, trials and other activities conducted to generate data for an application, for:~~obtaining a marketing authorisation and subsequent variations;

Amendment 1263 #

Proposal for a directive
Article 85 – paragraph 1 – point a – introductory part

(a) studies, trials and other activities ~~conducted to generate data for an application, for~~are undertaken in order to:

Amendment 1264 #

Proposal for a directive
Article 85 – paragraph 1 – point a – introductory part

(a) studies, and trials ~~and other activities conduct~~needed to generate data for an application, for:

Amendment 1265 #

Proposal for a directive
Article 85 – paragraph 1 – point a – introductory part

(a) studies, trials and other activities conducted ~~to generate data for an application, for~~for the purpose of :

Amendment 1266 #

Proposal for a directive
Article 85 – paragraph 1 – point a – introductory part

(a) studies, trials and other activities are conducted ~~to generate data for an application, for~~for the purpose of:

Amendment 1267 #

Adam JARUBAS, Ewa KOPACZ, Elżbieta Katarzyna ŁUKACIJEWSKA

Proposal for a directive
Article 85 – paragraph 1 – point a – point i

~~(i) a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinal products and for subsequent variations;~~deleted

Amendment 1268 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point i

~~(i) a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinal products and for subsequent variations;~~deleted

Amendment 1269 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point i

~~(i) a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinal products and for subsequent variations;~~deleted

Amendment 1270 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point i

(i) ~~a marketing~~medical authoriszation ~~of generic, biosimilar, hybrid or bio-hybrid medi~~for comercinal ~~products and for subsequent var~~izations;

Amendment 1271 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point i

(i) obtaining a marketing authorisation ~~of generic, biosimilar, hybrid or bio-hybrid medicinal products and for~~and subsequent variations;

Amendment 1272 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point i

(i) obtaining a marketing authorisation ~~of generic, biosimilar, hybrid or bio-hybrid medicinal products and for~~and subsequent variations;

Amendment 1273 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point i

(i) obtain a marketing authorisation ~~of generic, biosimilar, hybrid or bio-hybrid medicinal products and for~~and its subsequent variations;

Amendment 1274 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point i

(i) obtaining a marketing authorisation ~~of generic, biosimilar, hybrid or bio-hybrid medicinal~~for products and ~~for~~ subsequent variations;

Amendment 1275 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point i

(i) applying to a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinal products and for subsequent variations;

Amendment 1276 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point i

(i) applying for a marketing authorisation ~~of generic, biosimilar, hybrid or bio-hybrid medicinal products and for~~and subsequent variations;

Amendment 1277 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point i

(i) obtaining a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinal products and for subsequent variations;

Amendment 1278 #

Adam JARUBAS, Ewa KOPACZ, Elżbieta Katarzyna ŁUKACIJEWSKA

Proposal for a directive
Article 85 – paragraph 1 – point a – point ii

~~(ii) health technology assessment as defined in Regulation (EU) 2021/2282;~~deleted

Amendment 1279 #

~~(ii) health technology assessment as defined in Regulation (EU) 2021/2282;~~deleted

Amendment 1280 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point ii

~~(ii) health technology assessment as defined in Regulation (EU) 2021/2282;~~deleted

Amendment 1281 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point ii

(ii) undertake health technology assessment as defined in Regulation (EU) 2021/2282;

Amendment 1282 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point ii

(ii) conducting a health technology assessment as defined in Regulation (EU) 2021/2282;

Amendment 1283 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point ii

(ii) facilitating health technology assessment as defined in Regulation (EU) 2021/2282;

Amendment 1284 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point ii

(ii) conducting a health technology assessment as defined in Regulation (EU) 2021/2282;

Amendment 1285 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point ii

(ii) conducting health technology assessment as defined in Regulation (EU) 2021/2282;

Amendment 1286 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point ii

(ii) conducting a health technology assessment as defined in Regulation (EU) 2021/2282;

Amendment 1287 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point ii

(ii) conducting a health technology assessment as defined in Regulation (EU) 2021/2282;

Amendment 1288 #

Adam JARUBAS, Ewa KOPACZ, Elżbieta Katarzyna ŁUKACIJEWSKA

Proposal for a directive
Article 85 – paragraph 1 – point a – point iii

~~(iii) pricing and reimbursement.~~deleted

Amendment 1289 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point iii

~~(iii) pricing and reimbursement.~~deleted

Amendment 1290 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point iii

~~(iii) pricing and reimbursement.~~deleted

Amendment 1291 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point iii

~~(iii) pricing and reimbursement.~~deleted

Amendment 1292 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point iii

(iii) obtaining pricing and reimbursement. approval;

Amendment 1293 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point iii

(iii) obtaining pricing and reimbursement approval.

Amendment 1294 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point iii

(iii) obtaining pricing and reimbursement. approval;

Amendment 1295 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point iii

(iii) obtain pricing and reimbursement. listing;

Amendment 1296 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point iii

(iii) filing for pricing and reimbursement.

Amendment 1297 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point iii

(iii) obtaining pricing and reimbursement. approval;

Amendment 1298 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point iii

(iii) obtaining pricing and reimbursement. approval;

Amendment 1299 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point iii a (new)

(iii a) participating in public and private procurement tenders of medicinal products for which the fulfillment of the obligations laid out in the tender will commence after the expiry of the relevant patents or supplementary protection certificates;

Amendment 1300 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point iii a (new)

(iii a) participating in a tender to enable market entry of generic and biosimilar products as soon as the relevant patents or supplementary protection certificates expire.

Amendment 1301 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point iii a (new)

(iii a) enabling public and private procurement of medicinal products after expiry of the relevant patents or supplementary protection certificate;

Amendment 1302 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point iii a (new)

(iii a) enabling public and private procurement of medicinal products after expiry of the relevant patents or supplementary protection certificate;

Amendment 1303 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point iii a (new)

(iii a) enabling public and private procurement of medicinal products after expiry of the relevant patents or supplementary protection certificate;

Amendment 1304 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point iii a (new)

(iii a) enabling public and private procurement of medicinal products after expiry of the relevant patents or supplementary protection certificate

Amendment 1305 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point iii a (new)

(iii a) comply with all other regulatory or administrative requirement in the Union or in third countries;

Amendment 1306 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point iii a (new)

(iii a) Bolar examption for pre- production of products

Amendment 1307 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point iii b (new)

(iii b) complying with any other regulatory or administrative requirements necessary for the purpose of placing the medicinal product on the Union market or for export in third countries markets, after expiration of the patent or supplementary protection certificate.

Amendment 1308 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point iii b (new)

(iii b) complying with any other regulatory or administrative requirement in the Union or elsewhere; and the subsequent practical requirements associated with such activities.

Amendment 1309 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point iii b (new)

(iii b) complying with any other regulatory or administrative requirement in the Union or elsewhere and the subsequent practical requirements associated with such activities.

Amendment 1310 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point iii b (new)

(iii b) enable public and private procurement of medicinal products for the supply after expiry of the relevant patents or supplementary protection certificate;

Amendment 1311 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point iii b (new)

(iii b) complying with any other regulatory or administrative requirement in the Union or elsewhere;

Amendment 1312 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point iii c (new)

(iii c) complying with any other regulatory or administrative requirement in the Union or elsewhere;

Amendment 1313 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point iii c (new)

(iii c) and the subsequent practical requirements associated with such activities.

Amendment 1314 #

(a a) the subsequent practical requirements linked to such activities.

Amendment 1315 #

Adam JARUBAS, Ewa KOPACZ, Elżbieta Katarzyna ŁUKACIJEWSKA

Proposal for a directive
Article 85 – paragraph 1 – point b

(b) the activities conducted exclusively for the purposes set out in point (a), may cover the submission of the application for a marketing authorisation and the offer, manufacture, sale, supply, storage, import, use and purchase of patented medicinal products or processes, including by third party suppliers and service providers.deleted

Amendment 1316 #

Proposal for a directive
Article 85 – paragraph 1 – point b

Amendment 1317 #

Dolors MONTSERRAT, Nathalie COLIN-OESTERLÉ, Massimiliano SALINI

Proposal for a directive
Article 85 – paragraph 1 – point b

(b) the activities conducted exclusively for the purposes set out in point (a)~~, may cover~~ include the submission of the application for a marketing authorisation and the offering, manufacture, sale, supply, storage, import, export, use and purchase of ~~patented medicinal~~ products or processes, including by third party suppliers and service providers. This exception shall not cover the placing on the market in a Member State, while relevant patent rights or supplementary protection certificates are in force in that Member State, of the medicinal products purposes.

Amendment 1318 #

Proposal for a directive
Article 85 – paragraph 1 – point b

(b) the activities conducted exclusively for the purposes set out in point (a), may cover the submission of relevant documents to competent authorities, including the application for a marketing authorisation and the offer, health technology assessment, manufacture, sale, supply, storage, import, export, use and purchase of patented medicinal products or processes, including by third party suppliers and service providers.

Amendment 1319 #

Proposal for a directive
Article 85 – paragraph 1 – point b

(b) tThe activities ~~conducted exclusively for the purposes set out in point (a), may cover the submission of the application for a marketing authorisation and~~falling within the first subparagraph include the offering, manufacture, sale, supply, storage, import, export, use and purchase of ~~patented medicinal~~ products or processes, including by third party suppliers and service providers.

Amendment 1320 #

Proposal for a directive
Article 85 – paragraph 1 – point b

Amendment 1321 #

Proposal for a directive
Article 85 – paragraph 1 – point b

Amendment 1322 #

Proposal for a directive
Article 85 – paragraph 1 – point b

(b) thThose activities ~~conducted exclusively for the purposes set out in point (a), may cover the submission of the application for a marketing authorisation and~~falling within the first subparagraph include the offering, manufacture, sale, supply, storage, import, export, use and purchase of ~~patented medicinal~~ products or processes, including by third party suppliers and service providers.

Amendment 1323 #

Proposal for a directive
Article 85 – paragraph 1 – point b

(b) the activities conducted ~~exclusively~~ for the purposes set out in point (a), ~~may cover the submission of the application for a marketing authorisation and~~include the offering, manufacture, sale, supply, storage, import, export, use and purchase of ~~patented medicinal~~ products or processes, including by third party suppliers and service providers.

Amendment 1324 #

Proposal for a directive
Article 85 – paragraph 1 – point b

(b) the activities conducted exclusively for the purposes set out in point (a), ~~may~~shall cover the ~~submission of the application for a marketing authorisation and the~~ offering, manufacture, sale, supply, storage, import, export, use and purchase of ~~patented medicinal~~ products or processes, including by third party suppliers and service providers.

Amendment 1325 #

Proposal for a directive
Article 85 – paragraph 1 – point b

(b) the activities conducted exclusively for the purposes set out in point (a), may cover ~~the submission of the application for a marketing authorisation and the offer,~~ manufacture, sale, supply, storage, import, use and purchase of patented medicinal products or processes, including by third party suppliers and service providers.

Amendment 1326 #

Proposal for a directive
Article 85 – paragraph 1 – point b

(b) the activities ~~conducted exclusively for the purposes set out in point (a), may cover the submission of the application for a marketing authorisation and~~falling under the first subparagraph include the submission of the relevant files to the competent authorities or bodies for their assessment, the offer, manufacture, sale, supply, storage, import, export, use and purchase of ~~patented medicinal~~ products or processes, including by third party suppliers and service providers.

Amendment 1327 #

Adam JARUBAS, Ewa KOPACZ, Elżbieta Katarzyna ŁUKACIJEWSKA

Proposal for a directive
Article 85 – paragraph 1 – point b

Amendment 1328 #

Proposal for a directive
Article 85 – paragraph 1 – point b a (new)

(b a) obtaining pricing and reimbursement approval;

Amendment 1329 #

Adam JARUBAS, Ewa KOPACZ, Elżbieta Katarzyna ŁUKACIJEWSKA

Proposal for a directive
Article 85 – paragraph 1 – point b b (new)

(b b) enabling public and private procurement of medicinal products after expiry of the relevant patents or supplementary protection certificate;

Amendment 1330 #

Adam JARUBAS, Ewa KOPACZ, Elżbieta Katarzyna ŁUKACIJEWSKA

Proposal for a directive
Article 85 – paragraph 1 – point b c (new)

(b c) complying with any other regulatory or administrative requirement in the Union or elsewhere;

Amendment 1331 #

Adam JARUBAS, Ewa KOPACZ, Elżbieta Katarzyna ŁUKACIJEWSKA

Proposal for a directive
Article 85 – paragraph 1 a (new)

The activities falling within the first subparagraph include the offering, manufacturing, selling, suppling, storing, importing, exporting, using and purchasing of products or processes, including by third party suppliers and service providers.

Amendment 1332 #

Proposal for a directive
Article 85 – paragraph 1 a (new)

The activities falling within the first subparagraph may include the offering, manufacture, sale, supply, storage, import, export, use and purchase of products or processes, including by third party suppliers and service providers.

Amendment 1333 #

Proposal for a directive
Article 85 – paragraph 2

This exception shall not cover the placing on the market in a Member State of the medicinal products ~~resulting from such activities~~manufactured for the purposes mentioned above, while the relevant patent rights or supplementary protection certificates are in force in that Member State.

Amendment 1334 #

Proposal for a directive
Article 85 – paragraph 2

This exception shall not cover the placing on the market ~~of the medicinal products resulting from such activiti~~in a Member State, while relevant patent rights or supplementary protection certificates are in force in that Member State, of the medicinal products manufactured for the aforementioned purposes.

Amendment 1335 #

Proposal for a directive
Article 85 – paragraph 2

Amendment 1336 #

Proposal for a directive
Article 85 – paragraph 2

Amendment 1337 #

Adam JARUBAS, Ewa KOPACZ, Elżbieta Katarzyna ŁUKACIJEWSKA

Proposal for a directive
Article 85 – paragraph 2

Amendment 1338 #

Proposal for a directive
Article 85 – paragraph 2

Amendment 1339 #

Proposal for a directive
Article 85 – paragraph 2

Amendment 1340 #

Proposal for a directive
Article 85 – paragraph 2

This exception shall not cover the placing on the market of the medicinal products resulting from such activities before expiry of relevant patent or supplementary protection certificates.

Amendment 1341 #

Adam JARUBAS, Ewa KOPACZ, Elżbieta Katarzyna ŁUKACIJEWSKA

Proposal for a directive
Article 85 a (new)

Article 85a Ban of patent linkage 1. Applications, decision-making procedures and decisions to regulate marketing authorizations or the prices of medicinal products or to determine their inclusion within the scope of public health insurance systems or the public and private procurement of medicinal products shall be considered by Member States as regulatory or administrative procedures which, as such, are independent from the enforcement of intellectual property rights. 2. The protection of intellectual property rights shall not be a valid ground to refuse, suspend, delay, withdraw or revoke decisions relating to marketing authorisations, the price of a medicinal product or its inclusion within the public health insurance system, or the public and private procurement of medicinal products. 3. The applications, decision-making procedures and decisions referred to in paragraph 1 shall not be subject to conditions which expose applicants to a risk of infringement of the intellectual property rights. 4. Paragraphs 1, 2 and 3 shall apply without prejudice to the Union and national legislation relating to the protection of intellectual property.

Amendment 1342 #

Proposal for a directive
Article 85 a (new)

Article85a 1. Applications, decision-making procedures and decisions to regulate marketing authorizations or the prices of medicinal products or to determine their inclusion within the scope of public health insurance systems or the public and private procurement of medicinal products shall be considered by Member States as regulatory or administrative procedures which, as such, are independent from the enforcement of intellectual property rights. 2. The protection of intellectual property rights shall not be a valid ground to refuse, suspend, delay, withdraw or revoke decisions relating to marketing authorisations, the price of a medicinal product or its inclusion within the public health insurance system, or the public and private procurement of medicinal products if all market protection periods are respected. 3. The applications, decision-making procedures and decisions referred to in paragraph 1 shall not be subject to conditions which expose applicants to a risk of infringement of the intellectual property rights. 4. Paragraphs 1, 2 and 3 shall apply without prejudice to the Union and national legislation relating to the protection of intellectual property.

Amendment 1343 #

Proposal for a directive
Article 85 a (new)

Article 85a 1. Applications, decision-making procedures and decisions to regulate marketing authorizations or the prices of medicinal products or to determine their inclusion within the scope of public health insurance systems or the public and private procurement of medicinal products shall be considered by Member States as regulatory or administrative procedures which, as such, are independent from the enforcement of intellectual property rights. 2. The protection of intellectual property rights shall not be a valid ground to refuse, suspend, delay, withdraw or revoke decisions relating to marketing authorisations, the price of a medicinal product or its inclusion within the public health insurance system, or the public and private procurement of medicinal products. 3. The applications, decision-making procedures and decisions referred to in paragraph 1 shall not be subject to conditions which expose applicants to a risk of infringement of the intellectual property rights. 4. Paragraphs 1, 2 and 3 shall apply without prejudice to the Union and national legislation relating to the protection of intellectual property.

Amendment 1344 #

Proposal for a directive
Article 85 a (new)

Article 85a 1. Applications, decision-making procedures and decisions to regulate marketing authorizations or the prices of medicinal products or to determine their inclusion within the scope of public health insurance systems or the public and private procurement of medicinal products shall be considered by Member States as regulatory or administrative procedures which, as such, are independent from the enforcement of intellectual property rights. 2. The protection of intellectual property rights shall not be a valid ground to refuse, suspend, delay, withdraw or revoke decisions relating to marketing authorisations, the price of a medicinal product or its inclusion within the public health insurance system, or the public and private procurement of medicinal products. 3. The applications, decision-making procedures and decisions referred to in paragraph 1 shall not be subject to conditions which expose applicants to a risk of infringement of the intellectual property rights. 4. Paragraphs 1, 2 and 3 shall apply without prejudice to the Union and national legislation relating to the protection of intellectual property.

Amendment 1345 #

Dolors MONTSERRAT, Massimiliano SALINI, Nathalie COLIN-OESTERLÉ, Tomislav SOKOL

Proposal for a directive
Article 85 a (new)

Article85a 1. Applications, decision-making procedures and decisions to regulate marketing authorizations or the prices of medicinal products or to determine their inclusion within the scope of public health insurance systems or the public and private procurement of medicinal products shall be considered by Member States as regulatory or administrative procedures which, as such, are independent from the enforcement of intellectual property rights. 2. The protection of intellectual property rights shall not be a valid ground to refuse, suspend, delay, withdraw or revoke decisions relating to marketing authorisations, the price of a medicinal product or its inclusion within the public health insurance system, or the public and private procurement of medicinal products. 3. The applications, decision-making procedures and decisions referred to in paragraph 1 shall not be subject to conditions exposing applicants to risks of infringement of the intellectual property rights. 4. Paragraphs 1, 2 and 3 shall apply without prejudice to the Union and national legislation relating to the protection of intellectual property.

Amendment 1346 #

Proposal for a directive
Article 85 a (new)

Article85a 1. Applications, decision-making procedures and decisions to regulate marketing authorizations or the prices of generics, biosimilars, hibryds and biohibrids or to determine their inclusion within the scope of public health insurance system of medicinal products shall be considered by Member States as regulatory or administrative procedures which, as such, are independent from the enforcement of intellectual property rights. 2. The protection of intellectual property rights shall not be a valid ground to refuse, suspend, delay, withdraw or revoke decisions relating to marketing authorisations, the price of generics, biosimilars, hibryds and biohibrids or its inclusion within the public health insurance system. 3. The applications, decision-making procedures and decisions referred to in paragraph 1 shall not be subject to conditions which expose applicants to a risk of infringement of the intellectual property rights. Paragraphs 1, 2 and 3 shall apply without prejudice to the Union and national legislation relating to the protection of intellectual property.

Amendment 1347 #

Proposal for a directive
Article 85 a (new)

Article 85a 1. Applications, procedures, and decisions to regulate marketing authorisations, the prices of medicinal products, or to decide on their inclusion within the scope of public helath insurance or public and private precurement, shall be considered by the Member States as administrative or regulatory precedures independent from the enforcement of intellectual propoerty (IP) rights. 2. The protection of IP rights shall not be used unjustifiably as a reason to refuse, suspend, delay, withdraw, or revoke decisions on the regulatory or administatives procedures outlined in paragraph 1. 3. The applications, decisions, and procedures reffered to in paragraph 1 shall not be subject to conditions which expose applicants to a risk of infringement of the IP rights. 4. All paragraphs of this article shall apply without prejudice to the Union and national law relating to the protection of IP.

Amendment 1348 #

Proposal for a directive
Article 85 a (new)

Article85a Prohibition on patent linkage 1. Member States shall not, when conducting regulatory or administrative procedures in regards to activities carried out in accordance with Article 85, enforce intellectual property rights as a valid ground for refusal, suspension, delay, withdrawal or revocation of marketing authorisation, pricing and reimbursement decisions or tender bids in regards to public and private procurement of medicinal products. 2. If the market authorization holder ceases to commercialise a medicinal product in the Union, the Commission shall have a public purchase option for all related intellectual property rights.

Amendment 1349 #

Proposal for a directive
Article 86 – paragraph 1 – subparagraph 1

Where an application for marketing authorisation, includes the results of all studies conducted in compliance with an agreed paediatric investigation plan, the holder of the patent or supplementary protection certificate shall be entitled to a six-month extension of the period referred to in Article 13, paragraphs 1 and 2 of [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted]. Where the agreed paediatric investigation plan is conducted in relation to a disease that is different from the one for which the medicinal product is intended in the adult population, the holder of the patent or supplementary protection certificate shall be entitled to a 12-month extension of the period.

Amendment 1350 #

Proposal for a directive
Article 86 – paragraph 1 – subparagraph 1

Where an application for marketing authorisation, includes the results of all studies conducted in compliance with an agreed paediatric investigation plan, or the supplementary evidence based on extrapolation and/or from the appropriately designed post-marketing long-term studies in pediatric patients receiving the drug, the holder of the patent or supplementary protection certificate shall be entitled to a six-month extension of the period referred to in Article 13, paragraphs 1 and 2 of [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted].

Amendment 1351 #

Proposal for a directive
Article 86 – paragraph 1 – subparagraph 1 a (new)

The periods of extension referred to in paragraph 1 shall not apply to orphan medicinal products which have elected for and benefited from the extension of market exclusivity provided in Article 72(3) of [revised Regulation 726/2004].

Amendment 1352 #

Proposal for a directive
Article 86 a (new)

Article86a Measuring pharmaceutical access within the EU 1.The Commission, in collaboration with Member States, shall develop objective and specific indicators to measure pharmaceutical access within the EU. The indicators related to pharmaceutical access should include but not be limited to availability, health system and patient affordability and accesibility of medicines. (a) The Commission shall ensure that these indicators are evidence-based, measurable, and regularly reviewed to reflect the evolving healthcare landscape within the EU. Additionally, the Commission shall ensure that confidentiality of pricing and reimbursement data is overcome to avoid distorsion estimates. (b) The Commission, in collaboration with Member States, shall produce a quinquennial report on the state of pharmaceutical access within the Union. This report shall comprehensively analyse the indicators defined in paragraph 1, evaluating their effectiveness in gauging access to medicines. The Commission shall also establish a public database for annual update of paramenters defined in the quinquennial report.

Amendment 1353 #

Proposal for a directive
Article 87 – paragraph 1 – subparagraph 1 – introductory part

At the time of or after the granting of a marketing authorisation, the competent authority of the Member State may impose an obligation on the marketing authorisation holder:

Amendment 1354 #

Proposal for a directive
Article 87 – paragraph 1 – subparagraph 1 – point a

(a) to conduct a post-authorisation safety study if there are concerns about the risks of an authorised medicinal product to public health or environment. If the same concerns apply to more than one medicinal product, the competent authority of the Member State shall, following consultation with the Pharmacovigilance Risk Assessment Committee, encourage the marketing authorisation holders concerned to conduct a joint post- authorisation safety study;

Amendment 1355 #

Proposal for a directive
Article 87 – paragraph 1 – subparagraph 1 – point b a (new)

(b a) to conduct a post-authorisation safety and efficacy long-term study in children receiving the drug “of the label” because the paediatric investigation plan could not be accomplished due to failure to timely complete paediatric clinical studies.

Amendment 1356 #

Proposal for a directive
Article 87 – paragraph 1 – subparagraph 1 – point c – paragraph 1

to conduct a post-authorisation environmental risk assessment study, collection of monitoring data or information on use, if there are concerns about the risks to the environment ~~or public health, including antimicrobial~~and/or antibiotic resistance, due to an authorised medicinal product, or related active substance. Such measures may be imposed at both initial marketing authorisations and as response to a review where a risk to the environment has been identified.

Amendment 1357 #

Amendment 1358 #

Proposal for a directive
Article 87 – paragraph 1 – subparagraph 1 – point c – paragraph 1

Amendment 1359 #

Proposal for a directive
Article 87 – paragraph 1 – subparagraph 1 – point c – paragraph 1

Amendment 1360 #

Proposal for a directive
Article 87 – paragraph 1 – subparagraph 1 – point c – paragraph 1 a (new)

Where the application concerns an antimicrobial medicinal product, the competent authority or the Member States shall require the marketing authorisation holder to conduct post-authorisation studies as outline in Article 87(1c) in order to ensure that the benefit-risk balance remains positive with a view to the possible development of antimicrobial resistance.

Amendment 1361 #

Proposal for a directive
Article 87 – paragraph 1 – subparagraph 1 – point c – paragraph 1 b (new)

Under the provisions of Article 87 (1d) Member States shall; (a) collect relevant and comparable data on the volume of sales and on the use of antimicrobial medicinal products used, to enable in particular the direct or indirect evaluation of the use of such products with the aim to monitor the development of antimicrobial resistances; (b) send collated data on the volume of sales and the use per types of antimicrobial medicinal products to the Agency. The Agency shall cooperate with Member States and with other Union agencies to analyse those data and shall publish an annual report. The Agency shall take into account those data when adopting any relevant guidelines and recommendations.

Amendment 1362 #

Proposal for a directive
Article 87 – paragraph 1 – subparagraph 2

The imposition of such an obligation shall be duly justified, notified in writing, and shall include the objectives and timeframe for submission and conduct of the study. Information on imposed post- authorisation studies shall be noted in the product’s European Public Assessment Report, package leaflet and a medicine repository of the competent authority

Amendment 1363 #

Proposal for a directive
Article 87 a (new)

Article 87a Amendment and Integration of Antimicrobial Usage and Data Collection in Veterinary Medicine The Commission shall if approrpiate propose an amendment of (EU) 2019/6 on veterinary medicinal products. The proposal shall, if possible, contain the following provisions in line with the provisions of this Directive: 1. A prescription for antibiotic products shall: (a) be limited to the amount required for the treatment or therapy concerned; (b) only be prescribed for a limited duration to cover the period of risk, in particular when used as metaphlylaxis or prophylaxis; (c) require a justification through diagnostic testing in accordance with Article 87a (2c) point i; (d) not be influenced by any form of economic incentive provided directly or indirectly to persons who prescribe veterinary medicinal products, given the risks associated with antimicrobial resistance. (i) Prior to the prescription of an antibiotic product, the person qualified to prescribe is required to examine the sensitivity of the bacterial pathogens causing the illness (antibiogram). The antibiogram shall be conducted: (a) in the case of treatments with antibiotics; or (b) when changing the antibiotic product during a course of treatment; or (c) in the case of combined adminsitration of antibiotics for one indication, except for authorised ready-made products containing a combination of antibiotic active substances; (ii )By derogation from point i of this article, an antibiogram is not required: (a) if the collection of samples would involve a risk of additional impairment to the health status of the patient to be treated; or (b) if there is no suitable method available for the determination of the sensitivity of the pathogen; If, due to the derogations set out in (2c), point ii, an antibiogram cannot be performed, an appropriate rapid test must be conducted. 2. The amendment of (EU) 2019/6 of the European Parliament and of the Council shall also ensure the inclusion of priority antimicrobials in the list reserved for the treatment of certain infections in humans. The Commission shall incorporate priority antimicrobials into the designated list in alignment with the WHO recommendations on priority antimicrobials. 3. The amendment of (EU) 2019/6 of the European Parliament and of the Council shall utilize relevant and comparable data on the volume of sales and the use of antimicrobial medicinal products in animals, as collected in accordance with Article 57 of Regulation (EU) 2019/6. A system of benchmarks for the use of antimicrobial medicinal products shall be introduced, including the establishment of official controls for enterprises significantly exceeding these benchmarks.

Amendment 1364 #

Proposal for a directive
Article 87 b (new)

Article 87b Integration of Antimicrobial Usage Data in Human Medicine In accordance with Article 87 of this Directive, upon the completion of data collection and appropriate analysis, the Commission shall, if appropriate, propose the setting of benchmarks and the establishment of suitable reduction targets. These targets shall consider the specific circumstances of different medical specialties, focusing on the prudent use of antimicrobial medicinal products in human medicine.

Amendment 1365 #

Proposal for a directive
Article 89 – paragraph 1

1. The marketing authorisation holder shall incorporate any safety or efficacy conditions referred to in Articles 44~~, 45~~ and 87 in the risk management system.

Amendment 1366 #

Proposal for a directive
Article 89 – paragraph 2

2. The Member States shall inform the Agency of the marketing authorisations that they have granted subject to conditions pursuant to Article~~s 44,~~ 45 and of any obligations imposed in accordance with Article 87.

Amendment 1367 #

Proposal for a directive
Article 92 – paragraph 3

3. The procedures for examination of applications for variations shall be proportionate to the risk and impact involved. Those procedures shall range from procedures that allow implementation only after approval based on a complete scientific assessment to procedures that allow immediate implementation and subsequent notification by the marketing authorisation holder to the competent authority. Such procedures may also include updates by the marketing authorisation holder of their information held in a database. Accelerated assessment procedures shall also be foreseen for variations which are of major interest from the point of view of public health and in particular from the viewpoint of therapeutic innovation.

Amendment 1368 #

Member States shall operate a pharmacovigilance system for the fulfilment of their pharmacovigilance tasks and their participation in the Union pharmacovigilance activities including the pharmacovigilance over the post- authorization safety and efficacy long- term studies in children using the drug off label, because of the failed marketing authorization for reasons such as failure to timely complete paediatric clinical studies.

Amendment 1369 #

Proposal for a directive
Article 97 – paragraph 1 – point e a (new)

(e a) Facilitate harm reduction from adverse events through developing and implementing corrective patient safety plans for safe medicinal product administration and handling which can include the deployment of digital medication safety systems in hospitals and ambulatory care settings.

Amendment 1370 #

Proposal for a directive
Article 97 – paragraph 1 – point e a (new)

(e a) facilitate harm reduction from adverse events through developing and implementing corrective patient safety plans for safe medicinal product administration and handling which can include the deployment of digital medication safety systems in hospitals and ambulatory care settings.

Amendment 1371 #

Proposal for a directive
Article 101 – paragraph 2

2. Paragraph 1 shall not preclude the competent authorities of the Member States from charging fees to marketing authorisation holders for performing pharmacovigilance activities on the condition that the independence in the performance of those pharmacovigilance activities is strictly guaranteed and in accordance with provisions laid down in Article 208.

Amendment 1372 #

Proposal for a directive
Article 102 – paragraph 1 – point b a (new)

(b a) where applicable, documentation related to received scientific advice;

Amendment 1373 #

Proposal for a directive
Article 102 – paragraph 1 – point b b (new)

(b b) environmental risk assessment reports;

Amendment 1374 #

Proposal for a directive
Article 102 – paragraph 1 – point b c (new)

(b c) conditions imposed on marketing authorisation holder pursuant to Article 44;

Amendment 1375 #

Proposal for a directive
Article 102 – paragraph 1 – point d a (new)

(d a) periodic safety update reports;

Amendment 1376 #

Proposal for a directive
Article 102 – paragraph 1 – point d b (new)

(d b) information related to antimicrobials referred to in Article 17 and the awareness card, where relevant;

Amendment 1377 #

Proposal for a directive
Article 102 – paragraph 1 – point d c (new)

(d c) information on the shortage status of medicinal products as referred to in Article 121(1)(b) of [revised Regulation (EC) No 726/2004];

Amendment 1378 #

Proposal for a directive
Article 102 – paragraph 1 – point d d (new)

(d d) dates of expiry of IP and regulatory data and market protection periods.

Amendment 1379 #

Proposal for a directive
Article 104 – paragraph 2

2. The marketing authorisation holder shall ensure that information to the public is presented objectively and is not misleading, and it is presented in a clear and adjusted language.

Amendment 1380 #

Proposal for a directive
Article 105 – paragraph 2

2. Marketing authorisation holders shall not refuse to consider reports of suspected adverse reactions received electronically or by any other appropriate means from patients, carers or other relevant persons, such as family members, or healthcare professionals.

Amendment 1381 #

Proposal for a directive
Article 105 – paragraph 2

Amendment 1382 #

Proposal for a directive
Article 105 – paragraph 2

Amendment 1383 #

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ, Erik POULSEN, Ondřej KNOTEK

Proposal for a directive
Article 105 – paragraph 2

Amendment 1384 #

Proposal for a directive
Article 105 – paragraph 2

Amendment 1385 #

Proposal for a directive
Article 106 – paragraph 1 – subparagraph 1

Each Member State shall record all suspected adverse reactions that occur in its territory and that are brought to its attention from healthcare professionals and patients. This shall include all authorised medicinal products and medicinal products used in accordance with Article 3, paragraphs 1 or 2. Member States shall involve patients and healthcare professionals, as appropriate, in the follow- up of any reports they receive in order to comply with Article 97(1), points (c) and (e) and shall seek to inform directly those stakeholders that reported a suspected adverse drug reaction on decisions taken in relation to the safety of the medicinal product.

Amendment 1386 #

Each Member State shall record all suspected adverse reactions that occur in its territory and that are brought to its attention from healthcare professionals and patients. This shall include all authorised medicinal products and medicinal products used in accordance with Article 3, paragraphs 1 or 2. Member States shall involve patients and healthcare professionals, as appropriate, in the follow- up of any reports they receive in order to comply with Article 97(1), points (c) and (e), and shall seek to inform directly those stakeholders that reported a suspected adverse drug reaction on decisions taken in relation to the safety of the medicinal product.

Amendment 1387 #

Proposal for a directive
Article 106 – paragraph 1 – subparagraph 1 a (new)

Member States shall ensure that patients and healthcare professionals who report adverse reactions shall be able to opt in for an automated notifications shall there be any update on the safety profile of the product.

Amendment 1388 #

Proposal for a directive
Article 106 – paragraph 5

5. Member States shall ensure that reports of suspected adverse reactions arising from an error, including those associated with the use, administration, and dispensation of a medicinal product, by professionals, that are brought to their attention are made available to the Eudravigilance database and to any authorities, bodies, organisations or institutions, responsible for patient safety within that Member State concerned. They shall also ensure that the authorities responsible for medicinal products within that Member State are informed of any suspected adverse reactions brought to the attention of any other authority within that Member State. These reports shall be appropriately identified in the forms referred to in Article 102 of [revised Regulation (EC) No 726/2004].

Amendment 1389 #

Proposal for a directive
Article 106 – paragraph 5

Amendment 1390 #

Proposal for a directive
Article 106 – paragraph 5 a (new)

5 a. Competent Authorities of the Member States, members of the Pharmacovigilance Risk Assessment Committee, the Committee for Medicinal Products for Human Use and the coordination group by means of a repository referred to in Article in 104 of [revised Regulation (EC) No726/2004) shall ensure that reports of adverse reactions arising from medication errors associated with the incorrect administration and dispensation of a medicinal product available in the Eudravigilance database are included in periodic safety update reports, and cooperate with healthcare professionals to define, if needed, corrective action to achieve high standards of medication safety in healthcare settings, such as the implementation of digital medication safety systems.

Amendment 1391 #

Proposal for a directive
Article 107 – paragraph 3 a (new)

3 a. The Agency shall make publicly available the reports referred to in paragraph 1 points (a) and (b).

Amendment 1392 #

Proposal for a directive
Article 107 – paragraph 4 – subparagraph 1 – point a

(a) where such obligation has been laid down as a condition in the marketing authorisation in accordance with Articles 44 ~~or 45~~; or

Amendment 1393 #

Proposal for a directive
Article 107 – paragraph 4 a (new)

4 a. The Agency and Member States shall cooperate to achieve high standards of safety in public health delivery, including in the prescribing, administration and monitoring of medicinal products, by supporting the digital transition of health systems in cooperation with healthcare professionals and service providers.

Amendment 1394 #

Proposal for a directive
Article 108 – paragraph 6 a (new)

6 a. The Agency and the Member States shall work together to achieve high standards of safety in public health delivery, by supporting the digital transition of health systems together with healthcare professionals and service providers.

Amendment 1395 #

Proposal for a directive
Article 112 – paragraph 1 – point 1 (new)

(1) Upon receipt of a periodic assessment report that records adverse reactions arising from a medication error decide whether any corrective action is required to achieve high standards of medication safety in hospitals and ambulatory care settings.

Amendment 1396 #

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ

Proposal for a directive
Article 112 – paragraph 2 a (new)

2 a. Upon receipt of a periodic assessment report that records adverse reactions arising from a medication error decide whether any corrective action is required to achieve high standards of medication safety in hospitals and ambulatory care settings.

Amendment 1397 #

Proposal for a directive
Article 112 a (new)

Article112a Medicines under additional monitoring 1. The Agency shall, in collaboration with the Member States, set up, maintain and make public a list of medicinal products that are subject to additional monitoring. That list shall include the international non-proprietary names and active substances of: (a) medicinal products authorised in the Union that contain a new active substance which was not contained in any medicinal product authorised in the Union; (b) any biological medicinal product not covered by point (a) that was authorised after [date of implementation]; (c) medicinal products that are authorised pursuant to this Regulation, subject to the conditions referred to in point (f) of Article 12(4), point (a) of Article 20(1) or Articles 18, 19, 30 or 113; (d) medicinal products that are authorised pursuant to [revised Directive 2001/83/EC], subject to the conditions referred to in points (b) and (c) of the first paragraph of Article 44, Article 45, or point (a) of the first subparagraph of Article 87(1) thereof. At the request of the Commission, following consultation with the Pharmacovigilance Risk Assessment Committee, medicinal products that are authorised pursuant to this Regulation subject to the conditions referred to in points (d), (e) or (g) of Article 12(4), point (b) of Article 20 (1) or Article 46(2), may also be included in the list referred to in paragraph 1 of this Article. At the request of a national competent authority, following consultation with the Pharmacovigilance Risk Assessment Committee, medicinal products that are authorised pursuant to [revised Directive 2001/83/EC] subject to the conditions referred to in points (a), (d) or (f) of the first paragraph of Article 44, point (b) of the first subparagraph of Article 87 or Article 100(2) thereof, may also be included in the list referred to in paragraph 1 of this Article. 2. The list referred to in paragraph 1 shall include an electronic link to the product information and to the summary of the risk management plan. 3. In the cases referred to in points (a) and (b) of paragraph 1 of this Article, the Agency shall remove a medicinal product from the list five years after the Union reference date referred to in Article 108(5) of [revised Directive 2001/83/EC]. In the cases referred to in points (c) and (d) of paragraph 1 of this Article, the Agency shall remove a medicinal product from the list once the conditions have been fulfilled. 4. For medicinal products included in the list referred to in paragraph 1, the summary of product characteristics and the package leaflet shall include the statement ‘This medicinal product is subject to additional monitoring’. The statement shall be preceded by an inverted black triangle, and shall be followed by a standardised explanatory sentence. 5. The Agency shall, in cooperation with the competent authorities, develop and conduct awareness campaigns on the promotion of information about medicines under additional monitoring. Those campaigns shall be intended to raise awareness amongst healthcare professionals, patients, consumers and the general public of the pharmacovigilance system and the additional monitoring of medicines.

Amendment 1398 #

Proposal for a directive
Article 117 – paragraph 4

4. Payments to healthcare professionals for participating in non- interventional post-authorisation safety studies shall be transparent and restricted to the compensation for time and expenses incurred.

Amendment 1399 #

Proposal for a directive
Article 120 – paragraph 1

1. Upon completion of the study, a final study report shall be submitted to the competent authority of the Member State or the Pharmacovigilance Risk Assessment Committee within 12 months of the end of data collection unless a written waiver has been granted by the competent authority of the Member State or the Pharmacovigilance Risk Assessment Committee, ~~as appropriate~~in duly justified cases.

Amendment 1400 #

Proposal for a directive
Article 123 – title

Guidance to facilitate the performance of pharmacovigilance activities

Amendment 1401 #

Proposal for a directive
Article 123 – paragraph 1 – introductory part

The Agency shall, in cooperation with competent authorities of the Member States and other interested parties, in particularly those referred to in Article 162 of [reviesed Regulation (EC) No 726/2004], draw up:

Amendment 1402 #

Proposal for a directive
Article 123 – paragraph 1 – point a a (new)

(a a) guidance for national competent authorities and marketing authorisation holders on the effective inclusion of patients, consumers and healthcare professionals in the data collection and communication of the risks of medicinal products within the pharmacovigilance systems referred to in Articles 96 and 99;

Amendment 1403 #

Proposal for a directive
Article 123 – paragraph 1 – point b

(b) scientific guidance on post- authorisation efficacy studies in accordance with the consultation process laid down under Article 162 of revised Regulation (EU) No 726/2004.

Amendment 1404 #

Proposal for a directive
Article 123 – paragraph 1 – point b

(b) scientific guidance on post- authorisation efficacy studies, following the consultation process established under Article 162 of the [revised Regulation (EU) 726/2004].

Amendment 1405 #

Proposal for a directive
Article 123 – paragraph 1 – point b a (new)

(b a) scientific guidance on post- authorisation treatment optimisation studies.

Amendment 1406 #

Proposal for a directive
Article 123 – paragraph 1 – point b a (new)

(b a) scientific guidance on post- authorisation treatment optimisation studies.

Amendment 1407 #

Proposal for a directive
Chapter X – title

X ~~Homeopathic medicinal products and t~~Traditional herbal medicinal products

Amendment 1408 #

Proposal for a directive
Chapter X – Section 1

~~[...]~~deleted

Amendment 1409 #

Proposal for a directive
Article 125

Registration or authorisation of homeopathic medicinal products 1. Member States shall ensure that homeopathic medicinal products manufactured and placed on the market in the Union are registered in accordance with Articles 126 and 127 or authorised in accordance with Article 133(1), except where such homeopathic medicinal products are covered by a registration or authorisation granted in accordance with national legislation on or before 31 December 1993. In case of registrations, Chapter III, Sections 3 and 4, and Article 38, paragraphs 1, 2 and 3 shall apply. 2. Member States shall establish a simplified registration procedure referred to in Article 126 for the homeopathic medicinal products.5 deleted

Amendment 1410 #

Proposal for a directive
Article 126

Simplified registration procedure for homeopathic medicinal products 1. Homeopathic medicinal products that satisfy all of the following conditions may be subject to a simplified registration procedure: (a) they are administered orally or externally; (b) no specific therapeutic indication appears on the labelling of the medicinal product or in any information relating thereto; (c) there is a sufficient degree of dilution to guarantee the safety of the medicinal product. For the purposes of point (c), the medicinal product may not contain either more than one part per 10000 of the mother tincture or more than 1/100th of the smallest dose used in allopathy with regard to active substances whose presence in an allopathic medicinal product results in the obligation to submit a doctor’s prescription. The Commission is empowered to adopt delegated acts in accordance with Article 215 to amend the first subparagph, point (c), in order to take account of scientific progress. At the time of registration, Member States shall determine the prescription status for the dispensing of the homeopathic medicinal product. 2. The criteria and rules of procedure provided for in Article 1(10), point (c), Article 30, Chapter III, Section 6, Articles 191, 195 and 204 shall apply by analogy to the simplified registration procedure for homeopathic medicinal products, with the exception of the proof of therapeutic efficacy.Article 126 deleted

Amendment 1411 #

Proposal for a directive
Article 127

Application requirements for simplified An application a simplified registration may cover a series of homeopathic medicinal products derived from the same homeopathic stock or stocks. The following shall be included with the application in order to demonstrate, in particular, the pharmaceutical quality and the batch-to-batch homogeneity of the homeopathic medicinal products concerned: (a) the scientific name or other name given in a pharmacopoeia of the homeopathic stock or stocks, together with a statement of the various routes of administration, pharmaceutical forms and degree of dilution to be registered; (b) a dossier describing how the homeopathic stock or stocks are obtained and controlled, and justifying their homeopathic use, on the basis of an adequate bibliography; (c) the manufacturing and control file for each pharmaceutical form and a description of the method of dilution and potentisation; (d) the manufacturing authorisation for the homeopathic medicinal product concerned; (e) the copies of any registrations or authorisations obtained for the same homeopathic medicinal product in other Member States; (f) one or more mock-ups of the outer packaging and the immediate packaging of the homeopathic medicinal products to be registered; (g) the data concerning the stability of the homeopathic medicinal product.Article 127 deleted registration

Amendment 1412 #

Proposal for a directive
Article 128

Application of decentralised and mutual recognition procedures to homeopathic 1. Article 38, paragraphs 4 and 6, Articles 39 to 42 and 95 shall not apply to the homeopathic medicinal products referred to in Article 126. 2. Chapter III, Sections 3 to 5, shall not apply to the homeopathic medicinal products referred to in Article 133(2).rticle 128 deleted medicinal products

Amendment 1413 #

Proposal for a directive
Article 129

Homeopathic medicinal products, with the exception those referred to in Article 126(1), shall be labelled in accordance with the provisions of Chapter VI and shall be identified by a reference on their labels, in clear and legible form, to their homeopathic nature.Article 129 deleted Labelling of homeopathic medicinal products

Amendment 1414 #

Proposal for a directive
Article 130

Specific requirements for labelling of certain homeopathic medicinal products 1. The labelling and, where appropriate, the package insert for homeopathic medicinal products referred to in Article 126(1) in addition to the clear mention of the words ‘homeopathic medicinal product’, shall bear the following, and no other, information: (a) the scientific name of the stock or stocks followed by the degree of dilution, making use of the symbols of the pharmacopoeia used in accordance with Article 4(62); (b) name and address of the registration holder and, where appropriate, of the manufacturer; (c) method of administration and, if necessary, route of administration; (d) pharmaceutical form; (e) expiry date, in clear terms (month, year); (f) contents of the sales presentation; (g) special storage precautions, if any; (h) a special warning if necessary for the medicinal product; (i) manufacturer's batch number; (j) registration number; (k) ‘homeopathic medicinal product without approved therapeutic indications’; (l) a warning advising the user to consult a doctor if the symptoms persist. As regards the first subparagraph, point (a), if the homeopathic medicinal product is composed of two or more stocks, the scientific names of the stocks on the labelling may be supplemented by an invented name. 2. Notwithstanding paragraph 1, Member States may require the use of certain types of labelling in order to show: (a) the price of the homeopathic medicinal product; (b) the conditions for refunds by social security bodies.Article 130 deleted

Amendment 1415 #

Proposal for a directive
Article 131

1. Chapter XIII shall apply to homeopathic medicinal products. 2. By derogation from paragraph 1, Article 176(1) shall not apply to medicinal products referred to in Article 126(1). However, only the information specified in Article 130(1) may be used in the aArticle 131 deleted Advertising of ~~such~~ homeopathic medicinal products.

Amendment 1416 #

Exchange of information on homeopathic Member States shall communicate to each other all the information necessary to guarantee the quality and safety of homeopathic medicinal products manufactured and marketed within the Union, and in particular the information referred to in Articles 202 and 203.Article 132 deleted medicinal products

Amendment 1417 #

Proposal for a directive
Article 133

Other requirements for homeopathic 1. Homeopathic medicinal products other than those referred to in Article 126(1) shall be granted a marketing authorisation in accordance with Articles 6 and 9 to 14 and labelled in accordance with Chapter VI. 2. A Member State may introduce or retain in its territory specific rules for the non- clinical tests and clinical studies of homeopathic medicinal products other than those referred to in Article 126(1), in accordance with the principles and characteristics of homeopathy as practised in that Member State. In this case, the Member State concerned shall notify the Commission of the specific rules in force. 3. Chapter IX shall apply to homeopathic medicinal products, with the exception of those referred to in Article 126(1). Chapter XI, Chapter XII, Section 1, and Chapter XIV shall apply to homeopathicArticle 133 deleted medicinal products.

Amendment 1418 #

Proposal for a directive
Article 134 – paragraph 1 – subparagraph 1 – point a

(a) they have therapeutic indications exclusively appropriate to traditional herbal medicinal products that, by virtue of their composition and purpose, are intended and designed for use ~~without the supervision of a medical practitioner~~ for diagnostic purposes or for prescription or monitoring of treatment;

Amendment 1419 #

Proposal for a directive
Article 134 – paragraph 1 – subparagraph 1 – point a a (new)

(a a) they are composed of plants with a known natural therapeutic properties;

Amendment 1420 #

Proposal for a directive
Article 134 – paragraph 1 – subparagraph 1 – point b

(b) they are exclusively for administration in accordance with a specified strength and posology that do not present risks for human health;

Amendment 1421 #

Proposal for a directive
Article 134 – paragraph 3

3. However, in cases where the competent authorities judge that a herbal medicinal product that fulfils the conditions laid down in paragraph 1 (‘traditional herbal medicinal product’) fulfils the criteria for a national marketing authorisation in accordance with Article 5 ~~or for a simplified registration in accordance with Article 126,~~ the provisions of this Section shall not apply.

Amendment 1422 #

Proposal for a directive
Article 139 – paragraph 1

1. The Commission shall adopt ~~implementing~~delegated acts to establish a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products, taking into account the draft list prepared by the herbal medicinal products working group. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 214(2). The list shall contain, with regard to each herbal substance, the therapeutic indication, the specified strength and the posology, the route of administration, the adverse effects, the confirmed and potential interactions with other medicinal products, foods or traditional herbal medicinal products, the contraindications and any other information necessary for the safe use of the herbal substance as a traditional herbal medicinal product.

Amendment 1423 #

Proposal for a directive
Article 140 – paragraph 1

1. Article 1(5), points (a) and (b) and Article 1(10), point (c), Articles 6 to 8, 29, 30, 44, 46, 90, 97, 155, Article 188, paragraphs 1 and 11, Articles 191, 195, 196, 198, 199(2), 202, 203 and 204 and Chapters IX and XI of this Directive as well as Commission Directive 2003/94/EC77[1] shall apply, mutadis mutandis, to traditional-use registrations granted under this Section. _________________ 77 Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (OJ L 262, 14.10.2003, p. 22).

Amendment 1424 #

Proposal for a directive
Article 140 – paragraph 2 – subparagraph 1 – point a

(a) the product is a traditional herbal medicinal product for use in specified therapeutic indication(s) exclusively based upon long-standing use; and with possible adverse effects;

Amendment 1425 #

Proposal for a directive
Article 140 – paragraph 2 – subparagraph 1 – point b

(b) the user should consult a doctor or a qualified healthcare practitioner if the symptoms persist during the use of the traditional herbal medicinal product or if adverse effects ~~not~~ mentioned or not in the package leaflet occur.; and

Amendment 1426 #

Proposal for a directive
Article 140 – paragraph 2 – subparagraph 1 – point b a (new)

(b a) herbal medicinal products may be contraindicated in some people and may produce pharmacological interactions with other medications, altering their safety and efficacy. Consult a doctor or a qualified healthcare practitioner.

Amendment 1427 #

Proposal for a directive
Article 140 – paragraph 3

3. In addition to the requirements set out in Chapter XIII, any advertisement for a traditional herbal medicinal product registered under this Section shall contain the following statement: Traditional herbal medicinal product for use in specified therapeutic indication(s) exclusively based upon long-standing use, with possible adverse effects, contraindications and interactions with other medicines. For more information, consult a healthcare professional.

Amendment 1428 #

Proposal for a directive
Article 141 – paragraph 2 a (new)

2 a. Invited experts shall provide their declaration of interest ahead of the meeting to the Agency.

Amendment 1429 #

Rosanna CONTE, Annalisa TARDINO

Proposal for a directive
Article 141 – paragraph 5

5. The herbal medicinal products working group shall draft its rules of procedure, including regarding provisions laid down in Article 208 and Article 147 of [revised Regulation (EC) No 726/2004].

Amendment 143 #

Proposal for a directive
Recital 2

(2) The most recent comprehensive revision took place between 2001 and 2004 while targeted revisions on post- authorisation monitoring (pharmacovigilance) and on falsified medicines were adopted subsequently. In the almost 20 years since the last comprehensive revision, the pharmaceutical sector has changed and has become more globalised, both in terms of development and manufacture. Moreover, science and technology have evolved at a rapid pace. However, there continues to be unmet medical needs, i.e. diseases without or only with suboptimal ~~treatments~~or highly burdensome treatments, or with treatments targeting only sub-populations of a disease. Moreover, some patients may not benefit from innovation because medicines may be unaffordable or not placed on the market in the Member State concerned. There is also a greater awareness of the environmental impact of medicines. More recently, the COVID-19 pandemic has stress tested the framework.

Amendment 1430 #

Proposal for a directive
Article 142 – paragraph 3 – point a

(a) preparation, dividing up, changes in packaging or presentation where these processes are carried out, solely for retail and hospital supply, by pharmacists in dispensing pharmacies or by persons legally authorised in the Member States to carry out such processes; or

Amendment 1431 #

Proposal for a directive
Article 143 – paragraph 1 – subparagraph 2 – point a a (new)

(a a) environmental impact assessment of the product’s manufacturing process;

Amendment 1432 #

Proposal for a directive
Article 143 – paragraph 1 – subparagraph 2 – point b a (new)

(b a) proof that the product’s supply chain is diversified, identifying alternatives for each component;

Amendment 1433 #

Proposal for a directive
Article 147 – paragraph 1 – subparagraph 1 – point j a (new)

(j a) comply with the risk mitigating measures in accordance with Article 22(4). In this regard, they shall comply and permit representatives of competent authorities of Member States to access their manufacturing premises, sites, and any outdoor facilities and effluents at any time. This obligation shall also apply where decentralised manufacturing or testing takes place.

Amendment 1434 #

Proposal for a directive
Article 147 – paragraph 1 – subparagraph 1 – point j a (new)

(j a) comply with risk mitigation measures identified and considered in accordance with Article 22(4).

Amendment 1435 #

Proposal for a directive
Article 148 – paragraph 8 – introductory part

8. TIn order to ensure the smooth functioning of the decentralised sites with activities relevant for other Union legal frameworks, the competent authority of the Member State supervising the decentralised site pursuant to paragraph 4 shall coo~~perate~~rdinate their activities and supervisory tasks with the relevant authorities responsible for the supervision of the manufacturing or testing activities under other Union acts as regards the following:

Amendment 1436 #

Proposal for a directive
Article 148 – paragraph 8 a (new)

8 a. The competent authorities referred to paragraph 8 shall guarantee that the modalitities of coordination shall not adversely affect the preparation of SoHO therapies on a Member State level.

Amendment 1437 #

Proposal for a directive
Article 148 – paragraph 9

9. Where relevant, competent authorities of the Member State supervising the central and decentralised sites ~~may~~shall liaise with the competent authority of the Member State responsible for the supervision of the marketing authorisation.

Amendment 1438 #

Proposal for a directive
Article 159 – paragraph 1 – subparagraph 1

At the request of a third country, the Commission shall assess whether that country’s regulatory framework applicable to active substances exported to the Union and the respective control and enforcement activities ensure a level of protection of public ~~health~~and worker’s health and environment equivalent to that of the Union.

Amendment 1439 #

Billy KELLEHER, Catherine AMALRIC, Ondřej KNOTEK

Proposal for a directive
Article 159 – paragraph 2 – subparagraph 2 – point a

(a) the country’s rules for good manufacturing practice, including local environmental manufacturing standards, occupational health and labour rights standards;

Amendment 144 #

Proposal for a directive
Recital 2

(2) The most recent comprehensive revision took place between 2001 and 2004 while targeted revisions on post- authorisation monitoring (pharmacovigilance) and on falsified medicines were adopted subsequently. In the almost 20 years since the last comprehensive revision, the pharmaceutical sector has changed and has become more globalised, both in terms of development and manufacture. Moreover, science and technology have evolved at a rapid pace. However, there continues to be unmet medical needs, i.e. diseases without or only with suboptimal ~~treatments~~, inappropriate or highly burdensome treatments or treatments addressing subpopulations of a disease only. Moreover, some patients may not benefit from innovation because medicines may be unaffordable or not placed on the market in the Member State concerned. There is also a greater awareness of the environmental impact of medicines. More recently, the COVID-19 pandemic has stress tested the framework.

Amendment 1440 #

Proposal for a directive
Article 160 – paragraph 1 – introductory part

The Commission ~~may~~shall adopt implementing acts in accordance with Article 214(2) to supplement this Directive by specifying:

Amendment 1441 #

Proposal for a directive
Article 160 – paragraph 1 – introductory part

The Commission may adopt ~~implementing~~delegated acts in accordance with Article 21~~4(2)~~5 to supplement this Directive by specifying:

Amendment 1442 #

Proposal for a directive
Article 160 – paragraph 1 – point b a (new)

(b a) the principles and measures on reducing the environmental impact of medicinal products and active substances in manufacturing and distribution

Amendment 1443 #

Proposal for a directive
Article 160 – paragraph 1 – point b a (new)

(b a) measures to reduce the negative impact on the environment posed by the development, manufacturing, use and disposal of medicinal product.

Amendment 1444 #

Proposal for a directive
Article 160 – paragraph 2

Where relevant, these principles shall be ~~specified in coherence~~aligned with with any principles of good practices established under any other Union legal framework.

Amendment 1445 #

Proposal for a directive
Article 160 – paragraph 2 a (new)

2. The Commission is empowered to adopt delegated acts in order to supplement this Directive by establishing, within good manufacturing practices for medicinal products and active substances, principles, guidelines and detailed guidelines to ensure that water pollution , soil and air linked to their manufacture are reduced as much as possible, in accordance with the state of scientific knowledge. The obligations created by the delegated acts will first have been the subject of a feasibility study including at least an assessment of their impacts in terms of environmental risk management and security of supply for the European market.

Amendment 1446 #

Proposal for a directive
Article 166 – paragraph 1 – point c

(c) obtain, including by financial transactions, (except in the case of financial transactions within the same corporate group their supplies of medicinal products only from persons who are themselves in possession of a wholesale distribution authorisation in the Union or a manufacturing authorisation referred to in Article 163(3);

Amendment 1447 #

Proposal for a directive
Article 166 – paragraph 1 – point d

(d) supply, including by financial transaction (except in the case of financial transactions within the same corporate group) , medicinal products only to persons who are themselves wholesale distribution authorisation holders or who are authorised or entitled to supply medicinal products to the public;

Amendment 1448 #

Proposal for a directive
Article 166 – paragraph 1 – point l

(l) ~~continuously guarante~~appoint full-line wholesalers, who shall, pursuant to Article 56 (3) continuously ensure the appropriate and continued supply of an adequate range of medicinal products to meet the requirements of a specific geographical area, and deliver the supplies requested over the whole of the area in question, within a reasonable timeframe, which shall be defined in the national legislation;

Amendment 1449 #

Proposal for a directive
Article 166 – paragraph 1 – point l

(l) continuously guarantee the appropriate and continued supply of an adequate range and the necessary quantity of medicinal products to meet the requirements of a specific geographical area, and deliver the supplies requested over the whole of the area in question, within a reasonable timeframe, which shall be defined in the national legislation;

Amendment 145 #

Proposal for a directive
Recital 2 a (new)

(2 a) This Directive should contribute to the implementation of the One Health Approach, stressing the well-established interconnectedness between human, animal, and ecosystem health and the need to include those three dimensions when addressing public health threats. The loss of biodiversity, changes in land use, deforestation, urbanisation, agricultural expansion and intensification, poor air quality, wildlife trafficking and consumption patterns and transmissions of diseases between humans and animals are all factors that have contributed to the increasing disease burden. In addition, pollution from active pharmaceutical ingredients negatively affects the quality of waters and ecosystems, posing risks to public health globally.

Amendment 1450 #

Proposal for a directive
Article 166 – paragraph 1 – point m

(m) cooperate with marketing authorisation holders and competent authorities of the Member States on the security of supply., according to the principels of Public Service Obligations;

Amendment 1451 #

Proposal for a directive
Article 166 – paragraph 1 – point m a (new)

(m a) comply with the provisions of Public Service Obligations.

Amendment 1452 #

Proposal for a directive
Article 167 – paragraph 1

1. With regard to the supply of medicinal products to pharmacists and persons authorised or entitled to supply medicinal products to the public, Member States shall not impose upon the wholesale distribution authorisation holder that has been granted by another Member State any obligation, in particular public service obligations, more stringent than those they impose on persons whom they have themselves authorised to engage in equivalent activities. Member States shall rely on the information contained in the repositories system to ensure wholesale distributors comply with their supply obligations.

Amendment 1453 #

Dolors MONTSERRAT, Nathalie COLIN-OESTERLÉ, Tomislav SOKOL

Proposal for a directive
Article 167 – paragraph 2

2. The wholesale distributors of a medicinal product placed on the market in a Member State shall~~, within the limits of their responsibilities,~~ ensure appropriate and continued supplies of that medicinal product to pharmacies and persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered.

Amendment 1454 #

Proposal for a directive
Article 167 – paragraph 2

2. The wholesale distributors of a medicinal product placed on the market in a Member State shall, within the limits of their responsibilities, ensure appropriate and continued supplies of that medicinal product to pharmacies and persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered. Member States shall rely on the information contained in the repositories system referred to in Article 67, paragraph 2, second sub-paragraph, point (e) to ensure wholesale distributors comply with their supply obligations.

Amendment 1455 #

Proposal for a directive
Article 167 – paragraph 2

Amendment 1456 #

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ

Proposal for a directive
Article 167 – paragraph 2

2. The wholesale distributors of a medicinal product placed on the market in a Member State shall, within the limits of their contractual responsibilities, ensure appropriate and continued supplies of that medicinal product to pharmacies and persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered.

Amendment 1457 #

Proposal for a directive
Article 167 – paragraph 3 a (new)

3 a. To ensure continued supply to patients, the wholesale distributors shall not be authorised to supply medicinal products in another Member State should this, in any way, prevent them from covering the needs of the patients in the Member States concerned.

Amendment 1458 #

Proposal for a directive
Article 168 – paragraph 1 – introductory part

1. For all supplies of medicinal products to a person authorised or entitled to supply medicinal products to the public in the Member State concerned, the authorised wholesaler must ~~enclos~~provide a document, which may be submitted in electronic format, that makes it possible to ascertain the following:

Amendment 1459 #

Proposal for a directive
Article 172 – paragraph 1 – introductory part

1. ~~Without prejudice to national legislation prohibiting the offer for sale at a distance of prescription medicinal products to the public by means of information society services,~~ Member States shall ensure that medicinal products are offered for sale at a distance after prescription to the public by means of services as defined in Directive (EU) 2015/1535 of the European Parliament and of the Council78 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services under the following conditions: _________________ 78 Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1).

Amendment 146 #

Proposal for a directive
Recital 3

(3) This revision is part of the implementation of the Pharmaceutical strategy for Europe and aims to ~~promote innovation, in particular for unmet medical needs, while reducing regulatory burden and the environmental impact of medicines; ensure access to innovative and est~~ensure access to innovative and established medicines for patients and improve affordabili~~shed medicines for patient~~ty of these medicines, with special attention to enhancing security of supply and addressing risks of shortages, taking into account the challenges of the smaller markets of the Union; promote innovation, in particular for unmet medical needs, while reducing regulatory burden and the environmental impact of medicines; and create a balanced and competitive system that keeps medicines affordable for health systems ~~while~~and patients while particularly rewarding targeted innovation that improves access to medicinal products in all Member States, where they address unmet medical needs and where preclincial studies and development has taken place in the Union, reinforcing our industrial ecosystems.

Amendment 1460 #

Proposal for a directive
Article 172 – paragraph 1 – point a

(a) the natural or legal person offering the medicinal products is authorised or entitled to supply medicinal products to the public, also at a distance, in accordance with national legislation of the Member State in which that person is established and in accordance with national legislation of the Member State to which the products are supplied;

Amendment 1461 #

Proposal for a directive
Chapter XII a (new)

XII a Chapter XII(a) Health claims made on non-medicinal products Article 174(a) Non-medicinal products 1.Only products authorised though the procedures described on this Directive and in [revised Regulation 2023/0131(COD)] shall be considered as medicinal products.Products that can not prove pharmacological activity, efficacy, safety and quality or that have not been evaluated though the described procedures shall not be considered as medicinal products. 2.Products authorised for human use that are intended to be administered to the human body (i.e. oral, parenteral or topical administration) that are not considered medicinal products shall be regulated under other legislations of Member States and the Union, inter alia, legislations laying down the rules for food and cosmetics, where applicable.These shall include all the provisions related to safety and quality controls and to the limitation of health claims. Article 174(b) Consumer awareness and protection measures 1.Where a Member State has serious grounds for considering that a non- medicinal product´s health claims exceed the legal limits for which the product is authorised, including claims related to therapeutic activity and health benefits, that Member State may temporaly suspend the authorisation of the product.It shall inform the other Member States and the Commission and give reasons for the suspension. 2.Where the Commission has serious grounds for considering that a non medicinal product in a Member State makes health claims that exceed legal limits for which the product is authorised, including claims related to therapeutic and health benefits, they shall immediately notify the relevant authorities of the Member State in question that shall reply within 2 months and take the necessary corrective measures. 3.Member States shall actively monitor non substantiated health claims of non medicinal products, specially those posing high risk for individuals and public health (including the risk of pharmacological treatment abandonment) and apply corrective mesasures where necessary, in favor of individual and public health. 4.By one year after the entry into force of this Directive the Commission shall establish a list of non medicinal products in the Union that exceed legal limits for health claims for which the product is authorised.Member States shall, on the basis of the list created at Union level, apply corrective action in accordance with Union and national law. 5.By two years after the entry into force of this Directive, the Commission shall make publicly available the list of non medicinal products referred to in paragraph 3 and accompany information, conclusions and corrective actions taken at Union and Member State level to address non substantiated health claims.The Commission shall regularly update this list in consultation with Member States, who at national level are responsible for monitoring non substantiated health claims of non medicinal products.Where relevant, the Commission may also consult relevant stakeholders including health professionals, consumer organisations, and academics. 6.The Commission shall cooperate with Member States in order to establish national education programmes and awareness raising campaigns related to health literacy and the risks associated with non medicinal products making non substantiated health claims. 7.Member States shall at national level create dedicated channels for the reporting of non medicinal products claiming therapeutic and health benefits whereby national authorities shall investigate these claims, and where relevant apply corrective measures.These channels shall be easily available for health professionals, consumers and patient associations and citizens.In cases of corrective measures applied at national level, the authorities shall report to the Commission on the findings and measures applied. 8.The Commission shall adobt delegated acts with specific requirements for consumer awareness and protection measures related to therapeutic and health benefit claims of non-medicinal products.

Amendment 1462 #

Proposal for a directive
Article 175 – paragraph 1 – subparagraph 2 – point e

(e) the provision of inducements to prescribe or supply medicinal products by the gift, offer or promise of any benefit or bonus, whether in money or in kind, ~~except when their intrinsic value is minimal;~~

Amendment 1463 #

Proposal for a directive
Article 175 – paragraph 1 – subparagraph 2 – point e

Amendment 1464 #

Proposal for a directive
Article 175 – paragraph 2 – point d a (new)

(d a) clear, impartial and independent information from an accredited health professional to the public about a medicinal product and its correct use, provided that it does not fall within the circumstances referred to in the preceding subparagraph and meets the conditions laid down in the legislation of each Member State.

Amendment 1465 #

Proposal for a directive
Article 175 – paragraph 2 – point d a (new)

(da) clear, impartial and independent information imparted to the general public by an accredited healthcare professional on a medicinal product and its correct use, provided that it is not covered by the circumstances provided for in the previous paragraph and that it complies with the conditions laid down in each Member State's own legislation.

Amendment 1466 #

Proposal for a directive
Article 176 – paragraph 3 – point a

(a) shall ~~encourag~~promote the rational use of the medicinal product, by presenting it objectively and without exaggerating its properties;

Amendment 1467 #

Proposal for a directive
Article 176 – paragraph 3 – point b

(b) shall be accurate, verifiable, based on strict scientific evidence and data and not be misleading.

Amendment 1468 #

Proposal for a directive
Article 176 – paragraph 3 – point b

(b) shall be accurate, verifiable ~~and~~, not be misleading. or omit any key information without which could be mislead;

Amendment 1469 #

Proposal for a directive
Article 176 – paragraph 3 – point b a (new)

(b a) shall not induce to an excesive or abusive use of the medicinal product.

Amendment 147 #

Proposal for a directive
Recital 3

(3) This revision is part of the implementation of the Pharmaceutical strategy for Europe and aims to promote innovation, in particular for unmet medical needs, and establishes a conducive environment for the research, development, and manufacturing of pharmaceuticals within the Union while reducing regulatory burden and the environmental impact of medicines; ensure access to innovative and established medicines for patients, with special attention to enhancing security of supply and addressing risks of shortages, taking into account the challenges of the smaller markets of the Union; and create a balanced and competitive system that keeps medicines affordable for health systems while rewarding innovation.

Amendment 1470 #

Proposal for a directive
Article 176 – paragraph 4

4. Any form of advertising that aims to highlight negatively another medicinal product shall be prohibited. Advertising that suggests that a medicinal product is safer or more effective than another medicinal product shall also be prohibited~~, unless demonstrated and supported by the summary of product characteristics~~.

Amendment 1471 #

Proposal for a directive
Article 176 – paragraph 4

Amendment 1472 #

Proposal for a directive
Article 176 – paragraph 4

Amendment 1473 #

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ, Erik POULSEN

Proposal for a directive
Article 176 – paragraph 4

Amendment 1474 #

Proposal for a directive
Article 177 – paragraph 1 – subparagraph 1 (new)

Member States shall monitor the digital market services or products, websites, applications likely to broadcast advertising for prescription medicinal products for which advertising is prohibited according to article 177, paragraph 1.

Amendment 1475 #

Proposal for a directive
Article 177 – paragraph 1 – point b a (new)

(b a) contain substances listed in Annex X of Directive 2000/60/EC, individual priority substances in Annex I to Directive 2008/105/EC or substances in Annex I of Directive 2006/118/EC;

Amendment 1476 #

Proposal for a directive
Article 177 – paragraph 1 – point b a (new)

(b a) contain substances listed as individual priority substances in Annex I to Directive 2008/105/EC [Environmental Quality Standards Directive].

Amendment 1477 #

Proposal for a directive
Article 177 – paragraph 1 – point b a (new)

(b a) contain substances that are known to produce adictive behaviours;

Amendment 1478 #

Margarita DE LA PISA CARRIÓN, Joanna KOPCIŃSKA

Proposal for a directive
Article 177 – paragraph 1 – point b a (new)

(b a) contains substances that might generate addiction.

Amendment 1479 #

Proposal for a directive
Article 177 – paragraph 1 – point b a (new)

(b a) are antibiotics.

Amendment 148 #

Rosanna CONTE, Annalisa TARDINO

Proposal for a directive
Recital 3

(3) This revision is part of the implementation of the Pharmaceutical strategy for Europe and aims to promote innovation, in particular for unmet medical needs, while reducing regulatory burden and the environmental impact of medicines; ensure access to innovative and established medicines ~~for~~under equal conditions for all patients, with special attention to enhancing security of supply and addressing risks of shortages, taking into account the challenges of the smaller markets of the Union; and create a balanced and competitive system that keeps medicines affordable for health systems while rewarding innovation.

Amendment 1480 #

Proposal for a directive
Article 177 – paragraph 1 – point b a (new)

(ba) are antibiotics;

Amendment 1481 #

Proposal for a directive
Article 177 – paragraph 1 – point b a (new)

(b a) are antibiotics

Amendment 1482 #

Proposal for a directive
Article 177 – paragraph 1 – point b b (new)

(b b) contain hazardous substances during pregnancy;

Amendment 1483 #

Proposal for a directive
Article 177 – paragraph 1 – point b b (new)

(b b) are an antimicrobial.

Amendment 1484 #

Proposal for a directive
Article 177 – paragraph 1 – point b c (new)

(b c) contain substances affected by potential or actual shortage.

Amendment 1485 #

Proposal for a directive
Article 177 – paragraph 2

2. Medicinal products may be advertised to the general public where, by virtue of their composition and purpose, they are intended and designed for use without the obligatory intervention of a medical practitioner for diagnostic purposes or for the prescription or monitoring of treatment, with the advice of ~~the~~a medical practitioner or a pharmacist, if necessary.

Amendment 1486 #

Proposal for a directive
Article 177 – paragraph 2

2. Medicinal products may be advertised to the general public where, by virtue of their composition and purpose, they are intended and designed for use without the intervention of a ~~medical practit~~healthcare professioneral for diagnostic purposes or for the prescription or monitoring of treatment, with the advice of the pharmacist, if necessary.

Amendment 1487 #

Proposal for a directive
Article 177 – paragraph 2

2. Medicinal products may be advertised to the general public where, by virtue of their composition and purpose, they are intended and designed for use without the intervention of a ~~medical practit~~health professioneral for diagnostic purposes or for the prescription or monitoring of treatment, with the advice of the pharmacist~~, if necessary~~.

Amendment 1488 #

Proposal for a directive
Article 177 – paragraph 2

2. Medicinal products may be advertised to the general public where, by virtue of their composition and purpose, they are intended and designed for use without the intervention of a ~~medical practit~~health professioneral for diagnostic purposes or for the prescription or monitoring of treatment, with the advice of the pharmacist~~, if necessary~~.

Amendment 1489 #

Proposal for a directive
Article 177 – paragraph 2

2. Medicinal products may be advertised to the general public where, by virtue of their composition and purpose, they are intended and designed for use without the intervention of a medical practitioner for diagnostic purposes or for the prescription or monitoring of treatment, with the advice of the pharmacist~~, if necessary~~.

Amendment 149 #

Proposal for a directive
Recital 3

(3) This revision is part of the implementation of the Pharmaceutical strategy for Europe and aims to promote innovation, in particular for unmet medical needs, while reducing regulatory burden and the environmental impact of medicines; ensure equal access to innovative and established medicines for all patients, with special attention to enhancing security of supply and addressing risks of shortages, taking into account the challenges of the smaller markets of the Union; and create a balanced and competitive system that keeps medicines affordable for health systems while rewarding innovation.

Amendment 1490 #

Proposal for a directive
Article 177 – paragraph 2 a (new)

2 a. products for which there is no scientifically based proof of efficacy, such as homeopatic or traditional medicinal products, shall not be advertised as valid alternatives to science based therapies and medicinal products, and their advertisement shall clearly inform the public regardig the lack of scientific base for their effects and therapeutic efficacy;

Amendment 1491 #

Proposal for a directive
Article 177 – paragraph 3

3. Member States shall be entitled to ban, anytime on their territory, advertising to the general public of any medicinal products ~~the cost of which may be reimbursed.~~, particularly for public health reasons and to prevent overuse and misuse of such products;

Amendment 1492 #

Proposal for a directive
Article 177 – paragraph 3

3. Member States shall be entitled to ban, anytime on their territory, advertising to the general public of medicinal products othe ~~cost of which may be reimbursed~~r than those referred to in paragraph 1.

Amendment 1493 #

Proposal for a directive
Article 177 – paragraph 3

3. Member States shall be entitled to ban, on their territory, advertising to the general public of medicinal products othe ~~cost of which may be reimbursed~~r than those referred to in paragraph 1.

Amendment 1494 #

Proposal for a directive
Article 177 – paragraph 3

Amendment 1495 #

Proposal for a directive
Article 177 – paragraph 4

4. The prohibition contained in paragraph 1 shall not apply to vaccination campaigns ~~carried out by the industry and~~ approved by the competent authorities of the Member States.

Amendment 1496 #

Proposal for a directive
Article 177 – paragraph 4

4. The prohibition contained in paragraph 1 shall not apply to vaccination campaigns ~~carried out by the industry and~~ approved by the competent authorities of the Member States.

Amendment 1497 #

Proposal for a directive
Article 177 – paragraph 4

4. The prohibition contained in paragraph 1 shall not apply to vaccination campaigns ~~carried out by the industry and~~ approved by the competent authorities of the Member States.

Amendment 1498 #

Proposal for a directive
Article 177 – paragraph 4

4. The prohibition contained in paragraph 1 shall not apply to vaccination campaigns ~~carried out by the industry and~~ approved by the competent authorities of the Member States.

Amendment 1499 #

Billy KELLEHER, Catherine AMALRIC, Ondřej KNOTEK

Proposal for a directive
Article 177 – paragraph 4

4. The prohibition contained in paragraph 1 shall not apply to vaccination campaigns ~~carried out by the industry and~~ approved by the competent authorities of the Member States.

Amendment 150 #

Proposal for a directive
Recital 3

(3) This revision is part of the implementation of the Pharmaceutical strategy for Europe and aims to promote innovation, in particular for unmet medical needs, while reducing regulatory burden and the environmental impact of medicines; ensure access to innovative and established medicines for all patients, with special attention to enhancing security of supply and addressing risks of shortages, taking into account the challenges of the smaller markets of the Union; and create a balanced and competitive system that keeps medicines affordable for health systems while rewarding innovation.

Amendment 1500 #

Proposal for a directive
Article 178 – paragraph 1 – point a a (new)

(a a) an explicit reminder of the potential risks associated to self medication together with the request to keep the family doctor informed about the use of any medicinal product;

Amendment 1501 #

Proposal for a directive
Article 178 – paragraph 1 – point b – point i

(i) the name of the medicinal product, ~~as well as the common name if the medicinal product contains only one active substanc~~international non-propriety name, as well as the common name;

Amendment 1502 #

Proposal for a directive
Article 178 – paragraph 1 – point b – point ii

(ii) the information necessary for correct use and disposal of the medicinal product;

Amendment 1503 #

Proposal for a directive
Article 178 – paragraph 1 – point b – point iii

(iii) an express, legible invitation to read carefully the instructions on the package leaflet or on the outer packaging, as the case may be, and to consult a medical practitioner or a pharmacist for extended information.

Amendment 1504 #

Proposal for a directive
Article 178 – paragraph 1 a (new)

1 a. Any indirect advertising included, whether intentional or not, in any type of communication whose objective is not expressely and obviously advertising shall be prohibited. This includes any mention to specific medicinal products in i.e. social media, television programms or media platforms.

Amendment 1505 #

Proposal for a directive
Article 178 – paragraph 2 a (new)

2 a. The European Commission shall adopt implementing acts with specific requirements in relation to the advertising of medicinal products through social media, and consumers’ exposure to such type of content in that platform.

Amendment 1506 #

Proposal for a directive
Article 178 – paragraph 2 a (new)

Amendment 1507 #

Proposal for a directive
Article 178 – paragraph 2 a (new)

2 a. The Commission shall adopt delegated acts with specific requirements in relation to the advertising of medicinal products through social media, and consumers’ exposure to such type of content in that platform.

Amendment 1508 #

Proposal for a directive
Article 179 – paragraph 1 – point h

(h) suggests that the safety or efficacy of the medicinal product is due to the fact that it is natural and/or not chemical;

Amendment 1509 #

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ

Proposal for a directive
Article 180 – paragraph 2 a (new)

2 a. The Commission shall adopt a delegated act, in accordance with Article 215, regarding restrictions and obligations related to advertising of medicinal products on social media, including on the involvement of celebrities and influencers in the promotion of medicinal products online.

Amendment 151 #

Proposal for a directive
Recital 3 a (new)

(3 a) In parallel of this revision, the Union should build a new European pharmaceutical ecosystem to accelerate research and development of a new medicinal product and support innovation through the establishment of public- private partnerships, the multiplication of University Hospital Institutes, centres of excellence and bioclusters.

Amendment 1510 #

Proposal for a directive
Article 183 – paragraph 1

1. Where medicinal products are being promoted to persons qualified to prescribe or supply them, no gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to such persons ~~unless they are inexpensive and relevant to the practice of medicine or pharmacy~~.

Amendment 1511 #

Proposal for a directive
Article 183 – paragraph 1

1. Where medicinal products are being promoted to persons qualified to prescribe or supply them, no gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to such persons unless they are ~~inexpensive and~~ relevant to the practice of medicine or pharmacy.

Amendment 1512 #

Proposal for a directive
Article 185 – paragraph 1 – point g

(g) no samples of medicinal products containing substances classified as psychotropic or narcotic within the meaning of international conventions, or those known to produce adictive behaviours, may be supplied.

Amendment 1513 #

Proposal for a directive
Article 185 – paragraph 1 – point g

(g) no samples of medicinal products containing substances classified as antibiotic, psychotropic or narcotic within the meaning of international conventions may be supplied.

Amendment 1514 #

Proposal for a directive
Article 185 – paragraph 1 – point g

(g) no samples of medicinal products containing substances classified as antibiotic, psychotropic or narcotic within the meaning of international conventions may be supplied.

Amendment 1515 #

Proposal for a directive
Article 185 – paragraph 1 – point g

(g) no samples of medicinal products containing substances classified as antibiotic, psychotropic or narcotic within the meaning of international conventions may be supplied.

Amendment 1516 #

Proposal for a directive
Article 185 – paragraph 1 – point g – point i (new)

i) no samples of medicinal products classified as antimicrobial may be supplied.

Amendment 1517 #

Proposal for a directive
Article 186 – paragraph 1

1. Member States shall ensure that there are adequate and effective methods to monitor the advertising of medicinal products. Such methods, which ~~may~~shall be based on a system of prior vetting especially when advertising is targeted at the general public, shall in any event include legal provisions under which persons or organisations regarded under national law as having a legitimate interest in prohibiting any advertisement inconsistent with this Chapter, may take legal action against such advertisement, or bring such advertisement before the competent authority of the Member State either to decide on complaints or to initiate appropriate legal proceedings.

Amendment 1518 #

Proposal for a directive
Article 186 – paragraph 1

1. Member States shall ensure that there are adequate and effective methods to monitor the advertising of medicinal products. Such methods, which ~~may~~shall be based on a system of prior vetting, at least for advertisements to the general public, shall in any event include legal provisions under which persons or organisations regarded under national law as having a legitimate interest in prohibiting any advertisement inconsistent with this Chapter, may take legal action against such advertisement, or bring such advertisement before the competent authority of the Member State either to decide on complaints or to initiate appropriate legal proceedings.

Amendment 1519 #

Proposal for a directive
Article 186 – paragraph 1

1. Member States shall ensure that there are adequate and effective methods to monitor the advertising of medicinal products. Such methods, which ~~may~~shall be based on a system of prior vetting at least for advertisements to the general public, shall in any event include legal provisions under which persons or organisations regarded under national law as having a legitimate interest in prohibiting any advertisement inconsistent with this Chapter, may take legal action against such advertisement, or bring such advertisement before the competent authority of the Member State either to decide on complaints or to initiate appropriate legal proceedings.

Amendment 152 #

Proposal for a directive
Recital 3 a (new)

(3 a) In the interest of public health and for the wellfunctioning EU regulatory framework, the innovative medicinal product should be understood as one that meets a previously unmet or inadequately met, substantive health need and offers enhanced effectiveness or other incremental benefit relative to existing therapeutic alternatives.

Amendment 1520 #

Proposal for a directive
Article 186 – paragraph 4 a (new)

4 a. Member State shall set up and maintain a national transparency register of transfers of value regarding the advertising activities referred to in Articles 175, 177, 180, 182, 183, 184 and 185, targeting persons qualified to prescribe medicinal products. The Commission shall on its website publish a listing referring to all national registries.

Amendment 1521 #

Proposal for a directive
Article 186 – paragraph 4 b (new)

4 b. The national registries referred to in paragraph 4a shall include at least the following information: (a) the name of the marketing authorisation holder; (b) the name of a person qualified to prescribe medicinal products; (c) medicinal product concerned; (d) type of advertising activity, referred to in Article 175 paragraph 1 points (b) to (g) and Article 184; (e) monetary value.

Amendment 1522 #

Proposal for a directive
Article 186 – paragraph 4 c (new)

4 c. Marketing authorisation holders shall use the national transparency register referred to in paragraph 4a to submit information referred to in paragraph 4b in relation to each person qualified to prescribe medicinal products in respective Member State where such activity takes place.

Amendment 1523 #

Proposal for a directive
Article 186 – paragraph 5

5. The paragraphs 1 to 4c shall not exclude the voluntary control of advertising of medicinal products by self- regulatory bodies ~~and recourse to such bodies, if proceedings before such bodies are possible in addition to the judicial or administrative proceedings referred to in paragraph 1~~.

Amendment 1524 #

Proposal for a directive
Article 187 – paragraph 2 – point d a (new)

(d a) report activities in national registries, as laid down in Article 186 (4c).

Amendment 1525 #

Proposal for a directive
Article 188 – paragraph 1 – subparagraph 1

The competent authority of the Member State concerned, namely the supervisory authority, shall, in cooperation with the Agency and where relevant, other Member States, ensure compliance with the rules of this Directive, namely the principles of good manufacturing practice and good distribution practices referred to in Articles 160 and 161.

Amendment 1526 #

Proposal for a directive
Article 188 – paragraph 3 – introductory part

3. The competent authority of the Member State, namely the supervisory authority, shall ensure that the measures referred to in paragraph 1, second subparagraph, are carried out by the official representatives of the competent authority of the Member State concerned:

Amendment 1527 #

Proposal for a directive
Article 188 – paragraph 5 – introductory part

5. Where the competent authority of the Member State, namely the supervisory authority, considers it necessary, in particular where there are grounds for suspecting non-compliance with the rules of this Directive, including with the principles of good manufacturing practice and good distribution practices, referred to in Articles 160 and 161, or based on a risk assesment, it may have its official representatives carry out the measures referred to in paragraph 1, second subparagraph at the premises or on the activities of:

Amendment 1528 #

Proposal for a directive
Article 188 – paragraph 5 – point d

(d) distributors of medicinal products or manufacturers or distributors of active substances located in third countries;

Amendment 1529 #

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Ondřej KNOTEK

Proposal for a directive
Article 188 – paragraph 7 – point a a (new)

(a a) Examine any documents and records to verify compliance with the particulars of this Directive , and obtain evidence, such as copies of documents, photographs or videos.

Amendment 153 #

Proposal for a directive
Recital 3 b (new)

(3 b) With the financial support from the Horizon Europe programme, the Union should participate to the establishment of a sustainable network of centres of excellence complementing each other to enable transnational research in ATMPs or other related innovative therapeutic modalities relevant to the future treatment of any diseases. These scientific and technical centres are expected to provide access and advance translatable, quality-controled technologies, share data, and build capacity to assist industrial and academic developers of ATMPs. They are also expected to explore the establishment of connections with clinical networks.

Amendment 1530 #

Proposal for a directive
Article 189 – paragraph 1 – subparagraph 1

Upon request by one or more competent authorities of the Member States, inspections referred to in Article 188, paragraphs 3 and 5, may be carried out by official representatives from more than one Member State, together with the inspectors of the Agency, if specifically requested by the aforementioned competent authorities, in accordance with Article 52(2), point (a) of [revised Regulation (EC) 726/2004] (‘the joint inspection’).

Amendment 1531 #

Proposal for a directive
Article 189 – paragraph 1 – subparagraph 2 – point a

(a) it is demonstrated, or there are reasonable ground for suspecting, that the activities carried out on the territory of the Member State receiving the request pose a risk to the safety and quality in the Member State of the competent authority requesting the joint inspection, and the supervisory authority receiving the request has not performed an inspection to verify these suspects;

Amendment 1532 #

Proposal for a directive
Article 189 – paragraph 1 – subparagraph 2 – point c

(c) the competent authority of the Member State receiving the request agrees that there are other reasonable grounds such as training of inspectors, sharing of good practice, for ~~for~~ conducting a joint inspection.

Amendment 1533 #

Proposal for a directive
Article 189 – paragraph 2 – point b

(b) the roles of the participating inspectors during and following the inspection, including the designation of an authority leading the inspection, if the supervisory authority refuses to lead the inspection;

Amendment 1534 #

Proposal for a directive
Article 192 – paragraph 1

For the purpose of implementing Article 191, Member States may require manufacturers of immunological products and of medicinal products derived from substances of human origin to submit to a competent authority of the Member States copies of all the control reports signed by the qualified person in accordance with Article 153.

Amendment 1535 #

Proposal for a directive
Article 193 – paragraph 1 – subparagraph 1

to submit samples from each batch of the bulk and/or the medicinal product for examination by an Official Medicines Control Laboratory or a laboratory that a Member State has designated for that purpose before release on to the market unless the competent authority of another Member State has previously examined the batch in question and declared it to be in conformity with the approved specifications. In such a case the declaration of conformity issued by another Member States shall be ~~directly~~ recognised. Member States shall ensure that any such examination is completed within 360 days of the receipt of the samples and documentation of the controls carried out by the marketing authorisation holder in accordance with article 191.

Amendment 1536 #

Proposal for a directive
Article 193 – paragraph 1 – subparagraph 1

to submit samples from each batch of the bulk or the medicinal product for examination by an Official Medicines Control Laboratory or a laboratory that a Member State has designated for that purpose before release on to the market unless the competent authority of another Member State has previously examined the batch in question and declared it to be in conformity with the approved specifications. In such a case the declaration of conformity issued by another Member States shall be directly recognised. Member States shall ensure that any such examination is completed within 360 days of the receipt of the samples.

Amendment 1537 #

Proposal for a directive
Article 193 – paragraph 2

2. Where, in the interests of public health, the laws of a Member State so provide, the competent authorities of the Member State may require the marketing authorisation holder for medicinal products derived from human blood or human plasma to submit samples from each batch of the bulk and/or the medicinal product for testing by an Official Medicines Control Laboratory or a laboratory that a Member State has designated for that purpose before being released ~~into free circulation~~to the market, unless the competent authorities of another Member State have previously examined the batch in question and declared it to be in conformity with the approved specifications. In such a case the declaration of conformity issued by another Member State shall be recognised. Member States shall ensure that any such examination is completed within 60 calendar days of the receipt of the samples and documentation of the controls carried out by the marketing authorisation holder in accordance with article 191.

Amendment 1538 #

Proposal for a directive
Article 194 – title

Processes for the preparation of medicinal products derived from ~~human blood or~~substances of human ~~plasma~~origin

Amendment 1539 #

Proposal for a directive
Article 194 – paragraph 1

1. Member States shall take all necessary measures to ensure that the manufacturing and purifying processes used in the preparation of medicinal products derived from ~~human blood or~~substances of human ~~plasma~~origin are properly validated, attain batch-to-batch consistency and guarantee, insofar as the state of technology permits, the absence of ~~specific viral~~risks for the human health, including contaminations..

Amendment 154 #

Proposal for a directive
Recital 4

(4) This revision focuses on provisions relevant to achieve its specific objectives; therefore it covers all but provisions concerning falsified medicines~~, homeopathic~~ and traditional herbal medicines. Nevertheless, for the sake of clarity, it is necessary to replace Directive 2001/83/EC of the European Parliament and of the Council38[1] with a new Directive. The provisions on falsified ~~medicines, homeopathic~~ medicines and traditional herbal medicines are therefore maintained in this Directive without changing their substance compared to previous harmonisations. However, in view of the changes in the governance of the Agency, the Herbal Committee is replaced by a working group. _________________ 38 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).

Amendment 1540 #

Proposal for a directive
Article 194 – paragraph 1

1. Member States shall take all necessary measures to ensure that the manufacturing and purifying processes used in the preparation of medicinal products derived from human blood or human plasma are properly validated, attain batch-to-batch consistency and guarantee~~, insofar as the state of technology permits,~~ the absence of specific ~~viral~~ contamination that may pose a risk to patients.

Amendment 1541 #

Proposal for a directive
Article 194 – paragraph 2

2. To this end manufacturers shall notify the competent authorities of the Member States of the methods used to ~~reduce or eliminate pathogenic viruses liable to be transmitted by medicinal product~~ensure the quality and safety of the substances of human origin, as descrivbed ~~from human blood or human plasma~~in Regulation (EU) No [SoHO Regulation]. The competent authority of the Member State may submit samples of the bulk and/or the medicinal product for testing by a State laboratory or a laboratory designated for that purpose, either during the examination of the application pursuant to Article 29, or after a marketing authorisation has been granted.

Amendment 1542 #

Proposal for a directive
Article 195 – paragraph 2

2. The competent authorities of the Member States or, in the case of centralised marketing authorisation, the Commission may suspend~~, revoke~~ for 3 months or vary a marketing authorisation if a serious risk to the environment or public health has been identified and not sufficiently addressed by the marketing authorisation holder. If, after the 3 months suspension, the serious risk to the environment or public health has not been sufficiently addressed by the marketing authorisation holder, the competent authorities of the Member States or, in the case of centralised marketing authorisation, the Commission may revoke the marketing authorisation.

Amendment 1543 #

Proposal for a directive
Article 195 – paragraph 2

2. The competent authorities of the Member States or, in the case of centralised marketing authorisation, the Commission may suspend~~, revoke~~ or vary a marketing authorisation if a serious risk to the environment or, including public health, has been identified and not sufficiently addressed by the marketing authorisation holder. Should the environmental risks, which also encompass public health dangers, surpass the therapeutic benefits for the intended patients and if these risks are not adequately reducible, the relevant Member State authorities or the Commission may revoke the marketing authorization of the holder.

Amendment 1544 #

Proposal for a directive
Article 195 – paragraph 2

2. The competent authorities of the Member States or, in the case of centralised marketing authorisation, the Commission may suspend, revoke or vary a marketing authorisation if a serious risk to the environment or public health has been identified and not sufficiently addressed by the marketing authorisation holder. The responsible authority must clearly consider whether this suspension is proportionate to the loss for the affected patients and should first consider further steps to reduce the risk.

Amendment 1545 #

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ, Erik POULSEN, Andreas GLÜCK, Ondřej KNOTEK

Proposal for a directive
Article 195 – paragraph 2

2. The competent authorities of the Member States or, in the case of centralised marketing authorisation, the Commission may suspend, revoke or vary a marketing authorisation if a serious risk to the environment or public health has been identified and not sufficiently addressed by the marketing authorisation holder, with the exception of medicinal products authorised before 30 october 2005 to avoid restricting patients' access to existing treatments.

Amendment 1546 #

Proposal for a directive
Article 195 – paragraph 2

2. The competent authorities of the Member States or, in the case of centralised marketing authorisation, the Commission may suspend, revoke or vary a marketing authorisation if a serious risk to the environment or public health has been identified and not sufficiently addressed by the marketing authorisation holder with clear prioritatization of public health over risk to environment.

Amendment 1547 #

Proposal for a directive
Article 195 – paragraph 2

2. The competent authorities of the Member States or, in the case of centralised marketing authorisation, the Commission may suspend, ~~revoke~~ or vary a marketing authorisation if a serious risk to the environment or public health has been identified and not sufficiently addressed by the marketing authorisation holder via conditions laid out in Articles 44(h) or 87(c). .

Amendment 1548 #

Proposal for a directive
Article 195 – paragraph 2

Amendment 1549 #

Proposal for a directive
Article 195 – paragraph 2

Amendment 155 #

Proposal for a directive
Recital 4 a (new)

(4 a) This revision should align with the EU's ambitions in industry, digitalization, and trade, acknowledging the critical role of the European life sciences sector, especially the pharmaceutical industry, in upholding the EU's competitive edge. Bolstering robust European research and development is crucial for European sovereignty within the ambit of a globally competitive geopolitical landscape. The pharmaceutical legislative framework should be attuned to the broader EU industrial strategy, echoing the Council's emphasis from 23 March 2023 on amplifying incentives for investment in innovation and the 2016 Council's guidance that any amendments, including those affecting the incentive system, should not hinder the creation of drugs for rare disease treatment. Advancements in innovation are pivotal for enhancing patient health outcomes and the wider public health sector.

Amendment 1550 #

2. The competent authorities of the Member States or, in the case of centralised marketing authorisation, the Commission ~~may~~shall suspend, revoke or vary a marketing authorisation if a serious risk to the environment or public health has been identified and not sufficiently addressed by the marketing authorisation holder.

Amendment 1551 #

Proposal for a directive
Article 195 – paragraph 2

Amendment 1552 #

Proposal for a directive
Article 195 – paragraph 2

Amendment 1553 #

Proposal for a directive
Article 195 – paragraph 3

3. A marketing authorisation may also be suspended, revoked or varied where the particulars supporting the application as provided for in Articles 6, 9 to 14 or Annexes I to V are incorrect or have not been amended in accordance with Article 90, or where any conditions referred to in Articles 44~~, 45~~ and 87 have not been fulfilled or where the controls referred to in Article 191 have not been carried out.

Amendment 1554 #

Annalisa TARDINO

Proposal for a directive
Article 195 – paragraph 3

3. A marketing authorisation may also be suspended~~, revoked~~ or varied where the particulars supporting the application as provided for in Articles 6, 9 to 14 or Annexes I to V are incorrect or have not been amended in accordance with Article 90, or where any conditions referred to in Articles 44, 45 and 87 have not been fulfilled or where the controls referred to in Article 191 have not been carried out.

Amendment 1555 #

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ, Erik POULSEN, Ondřej KNOTEK

Proposal for a directive
Article 196 – paragraph 1 – point f

(f) a serious risk to the environment or to public health via the environment has been identified and not sufficiently addressed by the marketing authorisation holder, with the exception of medicinal products authorised before 30 october 2005 to avoid restricting patients’ access to existing treatments.

Amendment 1556 #

Proposal for a directive
Article 196 – paragraph 1 – point f

(f) a serious risk to the environment or to public health via the environment has been identified and not sufficiently addressed by the marketing authorisation holder, within 3 months since the serious risk to the environment or to public health via the environment has been identified.

Amendment 1557 #

Proposal for a directive
Article 196 – paragraph 1 – point f

(f) a serious risk to the environment or to public health via the environment has been identified and not sufficiently addressed by the marketing authorisation holder via conditions specified in Articles 44(h) or 87(c).

Amendment 1558 #

Proposal for a directive
Article 196 – paragraph 1 – point f

(f) a serious risk to the environment ~~or to public health via the environment~~ has been identified and not sufficiently addressed by the marketing authorisation holder via conditions laid out in Articles 44(h) or 87(c).

Amendment 1559 #

Proposal for a directive
Article 196 – paragraph 1 – point f

Amendment 156 #

Proposal for a directive
Recital 4 b (new)

(4 b) This Directive should acknowledge that fostering a competitive pharmaceutical industry within the EU, bolstering EU-based clinical trials, and localizing the manufacture of active pharmaceutical ingredients are complementary objectives that enhance the Union's strategic health autonomy while increasing the affordability, accessibility, and availability of medicinal products, thereby supporting a more resilient and sustainable European health ecosystem.

Amendment 1560 #

Proposal for a directive
Article 196 – paragraph 1 – point f

(~~f) a serious risk to the environment or to public health via the environment has been identified and not sufficiently addressed by the marketing authorisation holder.~~Does not affect the English version.)

Amendment 1561 #

Proposal for a directive
Article 197 – paragraph 3

3. If the medicinal product in question is suspected of presenting a serious risk to public health or to environment, the competent authority of the Member State in which that product was first identified shall, without undue delay, transmit a rapid alert notification to all Member States and all actors in the supply chain in that Member State. In the event of such medicinal products being deemed to have reached patients, urgent public announcements shall be issued within 24 hours in order to recall those medicinal products from the patients. Those announcements shall contain sufficient information on the suspected quality defect or falsification and the risks involved.

Amendment 1562 #

Proposal for a directive
Article 200 – paragraph 2

2. Member States shall ensure that adequate financial resources are available to provide the staff and other resources, including appropriate digital infrastructure, necessary for the competent authorities to carry out the activities required by this Directive and [revised Regulation (EC) No 726/2004].

Amendment 1563 #

Proposal for a directive
Article 200 – paragraph 3

3. The competent authorities of the Member States shall cooperate with each other and with the Agency and the Commission in the performance of their tasks under this Directive and [revised Regulation (EC) No 726/2004] to ensure proper application and due enforcement. The competent authorities of the Member States shall transmit to each other and to the Agency all necessary information.

Amendment 1564 #

Proposal for a directive
Article 200 – paragraph 4 – subparagraph 1

The competent authority of the Member State may process personal health data from sources other than clinical studies including the Eudravigilance database, electronic health data obtained pursuant to the applicable rules of the European Health Data Space to support their public health tasks and, in particular, the evaluation and monitoring to medicinal products, for the purpose of improving the robustness of the scientific assessment or verifying claims of the applicant or marketing authorisation holder. The competent authorities must put in place sufficient, effective and specific technical and organisational measures to safeguard the fundamental rights and interests of data subjects in line with Regulation (EU) 2016/679 and Regulation (EU) 2018/1725, including but not limited to clear and targeted data retention and deletion policies, state-of-the-art anonymisation and pseudonymisation requirements and techniques, confidentiality and data security measures, and access control mechanisms.

Amendment 1565 #

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ, Erik POULSEN, Andreas GLÜCK, Ondřej KNOTEK

Proposal for a directive
Article 200 – paragraph 4 – subparagraph 1

The competent authority of the Member State may process personal health data from sources other than clinical studies, including real world data, to support their public health tasks and, in particular, the evaluation and monitoring to medicinal products, for the purpose of improving the robustness of the scientific assessment or verifying claims of the applicant or marketing authorisation holder.

Amendment 1566 #

Proposal for a directive
Article 201 – paragraph 1

1. Member States, in applying this Directive, shall ensure that when questions arise with regard to the regulatory status of a medicinal product, in relation to their link to substances of human origin as referred to in Regulation (EU) No [SoHO Regulation], the competent authorities of the Member States shall consult the Agency and the relevant authorities established under that Regulation. The Agency shall coordinate the review and outcomes of the questions and will publish relevant details after deletion of any information of a commercially confidential nature.

Amendment 1567 #

Proposal for a directive
Article 201 – paragraph 1

1. Member States, in applying this Directive, shall ensure that when questions arise with regard to the regulatory status of a medicinal product, in relation to their link to substances of human origin as referred to in Regulation (EU) No [SoHO Regulation], the competent authorities of the Member States shall consult the Agency and the relevant authorities established under that Regulation. The Agency shall oversee the examination and results of inquiries and disclose pertinent information, ensuring any commercially sensitive data is removed prior to publication.

Amendment 1568 #

Proposal for a directive
Article 201 – paragraph 1 a (new)

1 a. Member States shall ensure a consultation process between national competent authorities for medicinal products and other relevant authorities or bodies for the exchange of information and pooling of expertise related to provisions laid down in this Directive, including, as appropriate, notified bodies under Regulation (EU) 2017/745 and Regulation (EU) 2017/746, bodies responsible for health technology assessment as referred to in Regulation (EU) 2021/2282 and national bodies responsible for pricing and reimbursement.

Amendment 1569 #

Proposal for a directive
Article 201 – paragraph 2 a (new)

2 a. The Commission, in applying this Directive, in order to improve regulatory certainty and cross-sectoral cooperation it shall on an annual basis, or more frequently where deemed necessary, organise joint meetings between the Agency and the relevant advisory and regulatory bodies established under other Union legislation to assess emergeing trends and questions on the regulatory status of products and to find agreement on common regulatory status principles. The summaries and conclusions of these joint meetings shall be made publicly available, including the opinions and conclusions of each of the respective bodies.

Amendment 157 #

Proposal for a directive
Recital 6

(6) The regulatory framework for medicinal products use should also take into account the needs of the undertakings in the pharmaceutical sector and trade in medicinal products within the Union, without jeopardising the quality, safety and efficacy of medicinal products products and without jeopardising patients` access to medicines.

Amendment 1570 #

Proposal for a directive
Article 206 – paragraph 1 – subparagraph 1

Member States shall lay down the rules on penalties applicable to infringements of national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. The penalties must be effective, proportionate and dissuasive. Member States shall, without delay, and taking into consideration the provision in paragraph 4, notify the Commission of those rules and of those measures and shall notify without delay of any subsequent amendment affecting them.

Amendment 1571 #

Proposal for a directive
Article 206 – paragraph 1 – subparagraph 1

Amendment 1572 #

Proposal for a directive
Article 206 – paragraph 1 a (new)

1 a. When deciding on the amount of the penalty in each individual case, all relevant circumstances of the specific situation shall be taken into account and due regard shall be given to the following: (a) the nature, gravity and duration of the infringement and of its consequences, taking into account the nature, scope as well as the number of persons affected and the level of damage suffered by them; (b) whether penalties have been already applied by other competent authorities to the same infringing party; (c) the size and market share of the entity committing the infringement; (d) the intentional or negligent character of the infringement; (e) any action taken by the infringing party to mitigate the damage of the infringement; (f) the degree of responsibility of the infringing party taking into account technical and organisational measures implemented to prevent the infringement; (g) the degree of cooperation with the competent authorities, in order to remedy the infringement and mitigate the possible adverse effects of the infringement; (h) the manner in which the infringement became known to the competent authorities, in particular whether, and if so to what extent, the infringing party notified the infringement; (i) the risk to public health presented by the falsification of medicinal products.

Amendment 1573 #

Proposal for a directive
Article 206 – paragraph 1 b (new)

1 b. The non-compliance of an entity with any requirements or obligations under this Directive, including the supply of incorrect, incomplete or misleading information to national competent authorities, shall be subject to penalties of up to 20 000 000 EUR or, or in the case of an undertaking, up to 5% of its total worldwide annual turnover for the preceding financial year, whichever is higher. In case of ongoing non- compliance, the national competent authority may fine the entity with fines for each day of delay, which shall be transparent and proportionate. The amount of the fines shall be established by the competent authority pursuant to criteria laid down in paragraph 1a.

Amendment 1574 #

Proposal for a directive
Article 206 – paragraph 2 – point d

(d) non-compliance with the provisions laid down in this Directive on pharmacovigilance, and the provisions laid down in paragraph 2 of Article 17 in relation to the stewardship plan for antimicrobials, and in Article 44 on national marketing authorisations subject to conditions;

Amendment 1575 #

Proposal for a directive
Article 206 – paragraph 2 – point d a (new)

(d a) non-compliance with the provisions laid down in this Directive on obligations imposed by national competent authorities, including related to product’s efficacy, safety and environmental impact, including antimicrobial resistance;

Amendment 1576 #

Proposal for a directive
Article 206 – paragraph 2 – point d b (new)

(d b) non-compliance with the provisions related to supply obligation;

Amendment 1577 #

Proposal for a directive
Article 206 – paragraph 2 – point d c (new)

(d c) non-compliance with launches of products in Member States, as laid down in article 58a;

Amendment 1578 #

Proposal for a directive
Article 206 – paragraph 2 – point e a (new)

(e a) non-compliance with the obligations laid down in this Directive in Chapter V.

Amendment 1579 #

Proposal for a directive
Article 206 – paragraph 3

~~3. Where relevant, the penalties shall take into account the risk to public health presented by the falsification of medicinal products.~~deleted

Amendment 158 #

Proposal for a directive
Recital 6

(6) The regulatory framework for medicinal products for human use should also take into account the needs of the undertakings in the pharmaceutical sector and trade in medicinal products within the Union, without jeopardising the quality, safety and efficacy of medicinal products.

Amendment 1580 #

Proposal for a directive
Article 206 – paragraph 3 a (new)

3 a. 4. The European Commission shall lay down criteria for establishing the penalties, taking into account paragraphs 1, 2 and 3, and the highest penalties laid down amongst Member States before the application of this Directive

Amendment 1581 #

Proposal for a directive
Article 206 – paragraph 3 a (new)

3 a. The European Commission shall lay down criteria for establishing the penalties, taking into account paragraphs 1, 2 and 3, and the highest penalties laid down amongst Member States before the application of this Directive.

Amendment 1582 #

Dolors MONTSERRAT, Nathalie COLIN-OESTERLÉ, Stelios KYMPOUROPOULOS

Proposal for a directive
Article 207 – paragraph 1

Member States shall ensure that appropriate collection systems are in place for medicinal products that are unused or have expired and that the medicinal products gathered are managed appropriately, preventing any technically preventable environmental leakage.

Amendment 1583 #

Proposal for a directive
Article 207 – paragraph 1

Member States shall ensure that appropriate collection systems are in place for medicinal products that are unused or have expired and that the collected medicinal products are managed properly without any technically avoidable leakage to the environment.

Amendment 1584 #

Proposal for a directive
Article 207 – paragraph 1

Member States shall ensure that appropriate collection systems are in place for medicinal products that are unused or have expired. and that the collected medicinal products are managed properly without any technically avoidable leakage to the environment

Amendment 1585 #

Proposal for a directive
Article 207 – paragraph 1

Member States shall ensure that appropriate collection systems are in place for medicinal products that are unused or have expired, and that the collected medicinal products are managed properly without any technically avoidable leakage to the environment.

Amendment 1586 #

Proposal for a directive
Article 207 – paragraph 1

Member States shall ensure that appropriate collection and disposal systems are in place for medicinal products that are unused or have expired.

Amendment 1587 #

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ, Erik POULSEN

Proposal for a directive
Article 207 – paragraph 1 – point 1 (new)

(1) By ... [18 months after the date of entry into force of this Directive], Member States shall draw up national plans including measures designed to: (a) monitor the rates of correct and incorrect disposal of unused and expired medicinal products; (b) inform the general public about the environmental risks associated with incorrect disposal of medicinal products, in particular those that contain substances referred to in Article 22(2); (c) inform healthcare professionals about the environmental risks associated with incorrect disposal of unused or expired medicinal products, in particular those that contain substances referred to in Article 22(2); (d) increase the rate of correct disposal of unused or expired medicinal products;and (e) designate public and private actors responsible for the collection systems referred to in paragraph 1.

Amendment 1588 #

Proposal for a directive
Article 207 – paragraph 1 – subparagraph 1 (new)

Member States shall promote awareness- raising and educational campaigns for the general public on the environmental risks of pharmaceuticals and on how to improve disposal practices.

Amendment 1589 #

Proposal for a directive
Article 208 – paragraph 1

1. In order to guarantee independence and transparency, the Member States shall ensure that members of staff of the competent authority responsible for granting authorisations, rapporteurs and experts concerned with the authorisation and post-authorisation surveillance of medicinal products have no direct or indirect financial or other interests in the pharmaceutical industry that could affect their impartiality. These persons shall make an annual declaration of their financial interests which shall be made publicly available on the authority’s website.

Amendment 159 #

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ, Dacian CIOLOŞ

Proposal for a directive
Recital 8

(8) This revision maintains the level of harmonisation that has been achieved. Where necessary and appropriate, it further reduces the remaining disparities, by laying down rules on the supervision and control of medicinal products and the rights and duties incumbent upon the competent authorities of the Member States with a view to ensuring compliance with legal requirements. In the light of experience gained on the application of the Union pharmaceutical legislation and the evaluation of its functioning, the regulatory framework need to be adapted to scientific and technological progress, the current market conditions and economic reality within the Union. Scientific and technological developments induce innovation and development of medicinal products, including for therapeutic areas where there is still unmet medical need and of medicinal products with less harmful impacts on environment. To harness these developments, the Union pharmaceutical framework should be adapted to meet scientific developments such as genomics, accommodate cutting edge medicinal products, e.g. personalised medicinal products and technological transformation such as data analytics, digital tools and the use of artificial intelligence. These adaptations also contribute to competitiveness of the Union pharmaceutical industry.

Amendment 1590 #

Proposal for a directive
Article 208 – paragraph 1

1. In order to guarantee independence and transparency, the Member States shall ensure that members of staff of the competent authority responsible for granting authorisations, rapporteurs and experts concerned with the authorisation and surveillance of medicinal products have no financial or other interests in the pharmaceutical industry that could affect their impartiality and their independance. These persons shall make an annual declaration of their financial interests and update them annually and whenever necessary.

Amendment 1591 #

Proposal for a directive
Article 208 – paragraph 1

1. In order to guarantee independence and transparency, the Member States shall ensure that members of staff of the competent authority responsible for granting authorisations, rapporteurs and experts concerned with the authorisation and surveillance of medicinal products have no financial or other interests in the pharmaceutical industry that could affect their impartiality. These persons shall make an annual declaration of their financial interests which shall be made publicly available.

Amendment 1592 #

Proposal for a directive
Article 208 – paragraph 1

1. In order to guarantee independence and transparency, the Member States shall ensure that members of staff of the competent authority responsible for granting authorisations, rapporteurs and experts concerned with the authorisation and surveillance of medicinal products have no financial or other interests in the pharmaceutical industry that could affect their impartiality. These persons shall make an annual declaration of their financial interests, which shall be made publicly available.

Amendment 1593 #

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ, Dacian CIOLOŞ

Proposal for a directive
Article 208 – paragraph 2

2. In addition, the Member States shall ensure that the competent authority makes publicly available its rules of procedure and those of its committees, including their working groups and expert groups, agendas for its meetings and records of its meetings, accompanied by decisions taken, details of votes and explanations of votes, including minority opinions.

Amendment 1594 #

Proposal for a directive
Article 208 – paragraph 2 a (new)

2 a. 3. The multidisciplinarity of experts may constitute a guarantee of the independence and impartiality of their work.

Amendment 1595 #

Proposal for a directive
Article 214 – paragraph 3

3. Where the opinion of the Committee is to be obtained by written procedure and reference is made to this paragraph, that procedure shall be terminated without result only when, within the time limit for delivery of the opinion, the chair of the Committee so decides.deleted

Amendment 1596 #

Proposal for a directive
Article 214 – paragraph 4

4. The rules of procedure of, meeting agenda and minutes with detailed records including information on decisions taken, details and explanation of votes, including minority opinions shall be made publicly available. Names of members and other national experts participating in the Standing Committee on Medicinal Products shall be made publicly available. on the Commission’s website.

Amendment 1597 #

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ, Erik POULSEN

Proposal for a directive
Article 214 – paragraph 4 a (new)

4 a. Members and experts participating in the Committee shall act in an independent manner and shall have no direct or indirect financial or other interests in the pharmaceutical industry that could affect their impartiality. They shall submit their conflict of interest declaration to the Chair of the Committee ahead of each meeting.

Amendment 1598 #

Proposal for a directive
Article 216 – paragraph 1

By [OP please insert the date = 10 years following 18 months after the date of entering into force of this Directive], the Commission shall present a report to the European Parliament and the Council on the application of this Directive, including an assessment of the fulfilment of its objectives and the resources required to implement it, in particular regarding the prolongation of data protection period to take into account the evolution of scientific knowledge and innovation.

Amendment 1599 #

Proposal for a directive
Article 216 – paragraph 1

By [OP please insert the date = 107 years following 18 months after the date of entering into force of this Directive], the Commission shall present a report to the European Parliament and the Council on the application of this Directive, including an assessment of the fulfilment of its objectives and the resources required to implement it.

Amendment 160 #

Proposal for a directive
Recital 8

(8) This revision maintains the level of harmonisation that has been achieved. Where necessary and appropriate, it further reduces the remaining disparities, by laying down rules on the supervision and control of medicinal products and the rights and duties incumbent upon the competent authorities of the Member States with a view to ensuring compliance with legal requirements. In the light of experience gained on the application of the Union pharmaceutical legislation and the evaluation of its functioning, the regulatory framework need to be adapted to scientific and technological progress, the current market conditions and economic reality within the Union. Scientific and technological developments induce innovation and development of medicinal products, including for therapeutic areas where there is still unmet medical need. To harness these developments, the Union pharmaceutical framework should be adapted to meet scientific developments such as genomics, accommodate cutting edge medicinal products, e.g. personalised medicinal products, novel health treatments and technological transformation such as data analytics, digital tools and the use of artificial intelligence. These adaptations also contribute to competitiveness of the Union pharmaceutical industry.

Amendment 1600 #

Proposal for a directive
Article 217 – paragraph 2

~~2. Directive 2009/35/EC is repealed with effect from [OP please insert the date = 18 months after the date of entering into force of this Directive].~~deleted

Amendment 1601 #

Proposal for a directive
Article 218 – paragraph 1

1. The procedures concerning the applications for marketing authorisations for medicinal products validated in accordance with Article 19 of Directive 2001/83/EC before [OP please insert the date = 18 months after the date of entering into force of this Directive] and that were pending on [OP please insert the date = the day before 18 months after the date of entering into force of this Directive] shall be completed in accordance with ~~Article 29~~Directive 2001/83/EC.

Amendment 1602 #

Proposal for a directive
Article 218 – paragraph 6

6. By way of derogation from paragraph 3, the reporting obligations as referred to in Article 57 and 57a, shall not apply with regards to medicinal products authorised in accordance with Directive 2001/83/EC before [OP please insert the date = 18 months after the date of entering into force of this Directive].

Amendment 1603 #

Proposal for a directive
Article 219 – paragraph 1

1. Member States shall bring into force the laws, regulations and administrative provisions to comply with this Directive by [1824 months after the date of entering into force of this Directive]. They shall immediately communicate the text of those measures to the Commission.

Amendment 1604 #

Proposal for a directive
Annex I – point 13 a (new)

(13 a) Patient experience data in accordance with article 22a (new).

Amendment 1605 #

Proposal for a directive
Annex I – point 21 – point a – introductory part

a) an antimicrobial ~~stewardship~~resistance mitigation plan which shall in particular outline:

Amendment 1606 #

Proposal for a directive
Annex I – point 21 – point a – introductory part

a) an antimicrobial stewardship and access plan which shall in particular outline:

Amendment 1607 #

Proposal for a directive
Annex I – point 21 – point a – point i

(i) ~~information about risk mitigation~~risk mitigation strategy outlining measures to limit antimicrobial resistance development related to the use, prescription and administration of the medicinal product;

Amendment 1608 #

Proposal for a directive
Annex I – point 21 – point a – point ii

(ii) how the marketing authorisation holder intends to monitor and report to the competent authority the resistance to the antimicrobial medicinal product.;

Amendment 1609 #

Proposal for a directive
Annex I – point 21 – point a – point ii a (new)

(ii a) strategy to ensure access, including proposed production chain with sufficient capacity, supply systems, approach to product labelling, and the approach to overcome economic barriers to access;

Amendment 161 #

Proposal for a directive
Recital 9

(9) Medicinal products for rare diseases and for children, should be subject to the same conditions as any other medicinal product concerning their quality, safety and efficacy, for example for what concerns the marketing authorisation procedures, quality and the pharmacovigilance requirements. However, specific requirements also apply to them considering their unique characteristics, and encountered problems such as failure to timely accomplish the paediatric clinical studies and obtain data required for marketing authorization, which results in significant delay of approval in children compared to adults. Such requirements, which are currently defined in separate legislations, should be integrated in general pharmaceutical legal framework in order to ensure clarity and coherency of all the measures applicable to these medicinal products. Furthermore, as some medicinal products authorised for use in children are authorised by the Member States, specific provisions should be integrated in this Directive.

Amendment 1610 #

Proposal for a directive
Annex I – point 21 – point a – point ii b (new)

(ii b) obstacles and constraints to stewardship and access;

Amendment 1611 #

Proposal for a directive
Annex I – point 21 – point a – point ii c (new)

(ii c) exploitation strategy for IP rights, including whether it is planned for the IP rights to be transferred to a third party for non-prioritised territories; exploitation strategy for IP rights, including whether it is planned for the IP rights to be transferred to a third party for non- prioritised territories;

Amendment 1612 #

Proposal for a directive
Annex I – point 21 – point a – point ii d (new)

(ii d) strategy to ensure marketing approvals are received for key territories in a timely manner; and

Amendment 1613 #

Proposal for a directive
Annex I – point 21 – point a – point ii e (new)

(ii e) strategy and methodology for monitoring effectiveness of stewardship and access, including proposed metrics to measure success.

Amendment 1614 #

Proposal for a directive
Annex I – point 21 – point a a (new)

a a) The stewardship and access plan should be made publicly available by the EMA when market authorization has been granted.

Amendment 1615 #

Proposal for a directive
Annex I – point 23 a (new)

(23 a) A summary of the applicant’s expected market launch plans in the EU.

Amendment 1616 #

Proposal for a directive
Annex II – Part I – point 5 – point 5.2 – point 5.2.5 – point 5.2.5.1 – paragraph 1 – introductory part

In general, clinical trials shall include patients who are representative of the population to be treated with the new medicinal product, use clinically meaningful endpoints, and be done as ‘controlled clinical trials’ ~~if possible,~~ randomised and ~~as appropria~~versus the best proven inte rve~~rsus~~ntion; placebo ~~and versus~~control may be used in addition if necessary and e~~stablished medicinal product of proven therapeutic value; any other design shall be justified. The treatment of the control groups will vary from case to case and also will depen~~thical. The Agency shall adopt scientific guidelines on criteria for identifying the best proven intervention(s) taking into account the outcome of the consultation with the Commission, and with the stakeholders involved oin eth~~ical~~e cons~~ider~~ultations and therapeutic area; thus it may, in some instances, be more pertinent to compare the efficacy of a new medicinal product with that of an established medicinal product of proven therapeutic value rather than with the effect of a placebo mechanism referred to in Article 162 of [revised Regulation (EC) 726/2004]. Any study design other than that referred to in the first subparagraph shall be duly justified; the grounds for any exceptions and conditions shall be laid down in a guideline developed by the Agency following the same consultation process described in the second subparagraph. The scientific guidelines adopted by the Agency shall observe the principles of the Declaration of Helsinki.

Amendment 1617 #

Proposal for a directive
Annex II – Part I – point 5 – point 5.2 – point 5.2.5 – point 5.2.5.1 – paragraph 1 – introductory part

~~In general, c~~Clinical trials shall be done as ‘controlled clinical trials’ ~~if possible,~~ randomised and as appropriate versus placebo and versus an established medicinal product of proven therapeutic value; any other design shall be duly justified providing ethical and clinical reasons. The treatment of the control groups will vary from case to case and also will depend on ethical considerations and therapeutic area; thus it may, in some instances, be more pertinent to compare the efficacy of a new medicinal product with that of an established medicinal product of proven therapeutic value rather than with the effect of a placebo.

Amendment 1618 #

Proposal for a directive
Annex III – point 2

2. The qualified person shall have acquired practical full-time experience over at least two years, in one or more undertakings that are authorised manufacturers, obtaining sufficient knowledge of manufacture, testing, supply chains, good manufacturing practice and pharmaceutical quality systems as well as regulatory processes and dossier content for ensuring the quality of medicinal products. The length of practical experience required may be reduced by one year where the university course was longer than five years, and by one and a half years where the university course was longer than six years.

Amendment 1619 #

Proposal for a directive
Annex III – point 4

4. The qualified person shall have acquired practical experience over at least two years, in one or more undertakings or not-for-profit entities that are authorised to manufacture medicinal products, in the activities of qualitative analysis of medicinal products, of quantitative analysis of active substances and of the testing and checking necessary to ensure the quality of medicinal products. The length of practical experience required may be reduced by one year where the university course was longer than five years, and by one and a half years where the university course was longer than six years.

Amendment 162 #

Proposal for a directive
Recital 9

(9) Medicinal products for rare diseases and for children, should be subject to the same conditions as any other medicinal product concerning their quality, safety ~~and~~, efficacy and environmental risk, for example for what concerns the marketing authorisation procedures, quality and the pharmacovigilance requirements. However, specific requirements also apply to them considering their unique characteristics. Such requirements, which are currently defined in separate legislations, should be integrated in general pharmaceutical legal framework in order to ensure clarity and coherency of all the measures applicable to these medicinal products. Furthermore, as some medicinal products authorised for use in children are authorised by the Member States, specific provisions should be integrated in this Directive.

Amendment 1620 #

Proposal for a directive
Annex IV – paragraph 1 – point a

(a) the name of the medicinal product, including in Braille, followed by its strength and pharmaceutical form, and, if appropriate, whether it is intended for babies, children or adults; ~~where the medicinal product contains up to three active substances,~~ the international non- proprietary name(s) (INN) shall be included, or, if one does not exist, the common name;

Amendment 1621 #

Proposal for a directive
Annex IV – paragraph 1 – point g a (new)

(g a) for antimicrobials, a pictogram and a warning that improper use and disposal of the medicinal product contributes to antimicrobial resistance;

Amendment 1622 #

Proposal for a directive
Annex IV – paragraph 1 – point j

(j) specific precautions relating to the disposal of unused medicinal products or waste derived from medicinal products~~, where appropriate,~~ as well as reference to any appropriate collection system in place;

Amendment 1623 #

Proposal for a directive
Annex IV – paragraph 1 – point j

(j) specific precautions relating to the disposal of unused medicinal products or waste derived from medicinal products, ~~where appropriate,~~ as well as reference to any appropriate collection system in place;

Amendment 1624 #

Proposal for a directive
Annex V – paragraph 1 – point 4 – point a a (new)

(a a) efficacy-related information and risk-benefit assessment, including information on remaining uncertainty about the medicine’s efficacy and safety profile;

Amendment 1625 #

Proposal for a directive
Annex V – paragraph 1 – point 4 – point b

(b) posology and method of administration for adults and, where necessary for children, and where relevant, a comprehensive and accurate illustrated description of the measuring and/or delivery device,

Amendment 1626 #

Proposal for a directive
Annex V – paragraph 1 – point 6 – point f

(f) special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product~~, if appropriate~~. In case of antimicrobial medicinal products in addition to the precautions a warning that inappropriate disposal of the medicinal product contributes to antimicrobial resistance.;

Amendment 1627 #

Proposal for a directive
Annex V – paragraph 1 – point 6 – point f a (new)

(f a) for products containing substances classified based on Annex I of Regulation (EC) No 1272/2008 as persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), persistent, mobile and toxic (PMT), very persistent and very mobile (vPvM) or are endocrine active agents, a warning that improper use and disposal of the medicinal product, inter alia through toilets, contributes to deteriorating the aquatic environment;

Amendment 1628 #

Proposal for a directive
Annex V – paragraph 1 – point 6 – point f b (new)

(f b) summary of environmental impact assessment.

Amendment 1629 #

Proposal for a directive
Annex VI – paragraph 1 – point 2

(2) the therapeutic indications and efficacy-related information;

Amendment 163 #

Proposal for a directive
Recital 9 a (new)

(9 a) Member States should form and take part to an EU-wide Rare Medicines Fund where each Member State should invest 5% of its average costs resulting from medicinal expenses that is the share of rare diseases. The Fund should negotiate, jointly for all Member States, the prices of medicines and medicinal products for rare diseases, and the Member States should commit to the purchase of these medicines by public procurement to respond to the needs of their citizens.

Amendment 1630 #

Proposal for a directive
Annex VI – paragraph 1 – point 2 a (new)

(2 a) a key information section reflecting the results of consultations with target patients’ organisations to ensure that it is legible, clear and easy to use;

Amendment 1631 #

Proposal for a directive
Annex VI – paragraph 1 – point 2 a (new)

(2 a) efficacy-related information per therapeutic indication;

Amendment 1632 #

Proposal for a directive
Annex VI – paragraph 1 – point 4 – point b

(b) the method and, if necessary, route of administration; where relevant, a comprehensive and accurate illustrated description of the measuring and/or delivery device, including all the different steps of medicine preparation and administration;

Amendment 1633 #

Proposal for a directive
Annex VI – paragraph 1 – point 6 a (new)

(6 a) a list of pending post-authorisation studies and other obligations;

Amendment 1634 #

Proposal for a directive
Annex VI – paragraph 1 – point 8 a (new)

Amendment 1635 #

Proposal for a directive
Annex VI – paragraph 1 – point 8 a (new)

(8a) Further to the measures provided for in Article 64(2a), for medicinal products included in the list referred to in Article 112a of [Regulation (EC) No 726/2004 as amended], the following additional statement shall be added: ‘This medicinal product is subject to additional monitoring.’ This statement shall be preceded by the symbol referred to in Article 112 of [Regulation (EC) No 726/2004 as amended] and followed by an appropriate standardised explanatory sentence.

Amendment 1636 #

Proposal for a directive
Annex VI – paragraph 1 – point 8 a (new)

(8 a) for products containing substances listed in Article 22 paragraph 2 of this Directive, a warning that improper use and disposal of the medicinal product, inter alia through toilets, contributes to deteriorating the aquatic environment.

Amendment 164 #

Proposal for a directive
Recital 11

(11) The Directive should work in synergy with the Regulation to enable innovation and promote competitiveness of the ~~Union~~EU's pharmaceutical industry, in particular of SMEs. Furthermore, it should aim to prioritize the expansion of EU-based clinical trials and the local production of active pharmaceutical ingredients, thereby reinforcing the strategic autonomy of the European health ecosystem. In this respect a balanced system of incentives is proposed that rewards innovation especially in areas of unmet medical need, EU-based innovation and innovation that reaches patients and improves access across the Union. To make the regulatory system more efficient and innovation- friendly the Directive also aims at reducing administrative burden and simplifying procedures for undertakings.

Amendment 165 #

Proposal for a directive
Recital 11

(11) The Directive should work in synergy with the Regulation to enable innovation and promote competitiveness of the Union pharmaceutical industry, in particular SMEs and to ensure an increased access to innovative, quality medicines. In this respect a balanced system of incentives is proposed that rewards innovation especially in areas of unmet medical need and innovation that reaches patients and improves access across the Union. To make the regulatory system more efficient and innovation- friendly the Directive also aims at reducing administrative burden and simplifying procedures for undertakings.

Amendment 166 #

Proposal for a directive
Recital 11

(11) The Directive should work in synergy with the Regulation to enable innovation and promote competitiveness of the Union pharmaceutical industry, in particular SMEs. In this respect a balanced system of incentives is proposed that rewards innovation especially in areas of unmet medical need ~~and~~, innovation that reaches patients and improves access across the Union and innovation that stems from preclinical studies developed in the Union. To make the regulatory system more efficient and innovation- friendly the Directive also aims at reducing administrative burden and simplifying procedures for undertakings.

Amendment 167 #

Dolors MONTSERRAT, Nathalie COLIN-OESTERLÉ, Tomislav SOKOL

Proposal for a directive
Recital 11 a (new)

(11 a) It is however, difficult to establish a direct link between incentives offered nowadays at Union level and Union competitiveness in the pharmaceutical sphere vis-à-vis third country based companies. While incentives can make the EU a more attractive market for industry, they remain agnostic to medicines´ geographical origin. Medicines originating from third country based companies are eligible to all EU incentives. Equally, EU based innovative companies can benefit from incentives elsewhere if they sell their products in these markets. Therefore a reduction in the regulatory data protection period should not harm EU companies vis-à-vis non EU companies coming to the EU market in terms of competitiveness.

Amendment 168 #

Proposal for a directive
Recital 11 a (new)

(11 a) This Directive should be in line with the EU’s industrial, digital and trade aspirations. The European life sciences sector, and the pharmaceutical industry in particular, are essential in ensuring EU’s competitiveness. Maintaining and strengthening robust R&D sectors are key pillars of the shared European sovereignty in an increasingly competitive geopolitical context.

Amendment 169 #

Dolors MONTSERRAT, Nathalie COLIN-OESTERLÉ, Tomislav SOKOL

Proposal for a directive
Recital 11 b (new)

(11 b) However, to improve research and development in the pharmaceutical sphere stemming from the Union, as well as contributing to open EU strategic autonomy, it could be beneficial to establish a direct link between preclinical studies conducted in the Union and an incentive pronlonging data protection for a medicinal product. Therefore, an incentive to extend the data protection period is proposed where a company can demonstrate this.

Amendment 170 #

Proposal for a directive
Recital 11 b (new)

(11 b) This Directive should recognize that there is no trade-off between maintaining a competitive pharmaceutical industry in the EU and ensuring the affordability, accessibility, and availability of medicinal products in the EU.

Amendment 171 #

Proposal for a directive
Recital 12

(12) The definitions and scope of Directive 2001/83/EC should be clarified in order to achieve high standards for the quality, safety and efficacy of medicinal products and to address potential regulatory gaps, without changing the overall scope or affecting national competences in this regard, such as for pricing and reimbursement procedures, due to scientific and technological developments, e.g. low- volume products, bedside-manufacturing or personalised medicinal products that do not involve an industrial manufacturing process.

Amendment 172 #

Proposal for a directive
Recital 13

(13) To avoid the duplication of requirements for medicinal products in this Directive and in the Regulation, the general standards in regards to quality, safety ~~and~~, efficacy and environmental risk of medicinal products laid down in this Directive shall be applicable to medicinal products covered by national marketing authorisation and also to medicinal products covered by centralised marketing authorisation. Therefore, the requirements for an application for medicinal product are valid for both, also the rules on prescription status, product information, regulatory protection and rules on manufacturing, supply, advertising, supervision and other national requirements shall be applicable to medicinal products covered by centralised marketing authorisation.

Amendment 173 #

Proposal for a directive
Recital 13 a (new)

(13 a) The Commission should create a process to prioritize less environmentally harmful medicines by enabling Member States to withdraw the marketing authorisation of medicines where a less environmentally harmful, equivalent alternative exists for the medicine. Life- saving medicines or medicines responding to unmet medical needs should be excluded from this process. Member States should equally fund capacities that facilitate the development of enviromentally less harmful medicines.

Amendment 174 #

Proposal for a directive
Recital 15

(15) In order to take account both of the emergence of new therapies and of the growing number of so-called ‘borderline’ products between the medicinal product sector and other sectors, certain definitions and derogations should be modified, so as to avoid any doubt as to the applicable legislation. With the same objective of clarifying situations when a product fully falls within the definition of a medicinal product and also meet the definition of other regulated products, the ~~rules for medicinal products under this Directive apply~~Agency and the advisory and regulatory bodies established in other Union legislation, as relevant, should engage in consultations, in order to find consensus on the regulatory status of the product or the application of Union law to the borderline product in question. Where necessary, the Commission should be empowered to take the decision on the regulatory status or applicability of legal rules to the borderline product,the assessment and conclusions of which should be made publicly available. Furthermore, for transparency purposes, the respective opinions and conclusions of the Agency and the other advisory and regulatory bodies established in other Union legislation should be made publicly available. Furthermore, to ensure the clarity of applicable rules, it is also appropriate to improve the consistency of the terminology of the pharmaceutical legislation and clearly indicate the products excluded from the scope of this Directive.

Amendment 175 #

Proposal for a directive
Recital 15 a (new)

(15 a) It would be valuable to map terms used in ICD 11 an MedDRA, to clearly identify indications and to harmonise terminology used in other healthcare systems.

Amendment 176 #

Proposal for a directive
Recital 16

(16) The new definition for a substance of human origin (SOHO) by the [SoHO Regulation] covers any substance collected from the human body in whatever manner, whether it contains cells or not and regardless of whether it meets the definition of ‘blood’, ‘tissue’ or ‘cell’, for example human breast milk, intestinal microbiota and any other SoHO that may be applied to humans in the future. Such substances of human origin, other than tissues and cells, may become SoHO derived medicinal products, other than ATMPs, when the SoHO is subject to an industrial process involving systematisation, reproducibility and operations performed on a routine basis or batch-wise resulting in a product of standardised consistency. When a process concerns extraction of an active ingredient from the SoHO, other than tissues and cells, or a transformation of a SoHO, other than tissues and cells, by changing its inherent properties, this should also be considered a SoHO derived medicinal product. When a process concerns ~~concentrat~~pooling, separating or isolating elements in the preparation of ~~blood components~~SoHO, as well as methods to reduce, inactivate or eliminate microbes to enhance micro-biological quality, this should not be considered as changing their inherent properties.

Amendment 177 #

Proposal for a directive
Recital 16

(16) The new definition for a substance of human origin (SOHO) by the [SoHO Regulation] covers any substance collected from the human body in whatever manner, whether it contains cells or not and regardless of whether it meets the definition of ‘blood’, ‘tissue’ or ‘cell’, for example human breast milk, intestinal microbiota and any other SoHO that may be applied to humans in the future. Such substances of human origin, other than tissues and cells, may become SoHO derived medicinal products, other than ATMPs, when the SoHO is subject to an industrial process involving systematisation, reproducibility and operations performed on a routine basis or batch-wise resulting in a product of standardised consistency. When a process concerns extraction of an active ingredient from the SoHO, other than tissues and cells, or a transformation of a SoHO, other than tissues and cells, by changing its inherent properties, this should also be considered a SoHO derived medicinal product. When a process concerns pooling, concentrating, separating or isolating elements in the preparation of ~~blood components~~SoHO, as well as methods that increase micro- biological quality, this should not be considered as changing their inherent properties.

Amendment 178 #

Proposal for a directive
Recital 17 a (new)

(17 a) For SoHO derived medicinal products, each Member State shoud ensure through public service obligations that those manufacturers provide an appropriate and continuous supply of SoHO derived medicinal products to patients in their territory. Member States should negotiate fair and transparent prices for SoHO derived medicinal products that are derived from altruistic and unpaid donations. Member States should also ensure that affordable SoHO derived medicinal products are available to patients in their territory. In this regard, manufacturers of these products should report annually to authorities on the quantities prepared and the amount supplied for public use.

Amendment 179 #

Proposal for a directive
Recital 17 a (new)

(17 a) Member States should take measures to promote the availability of medicinal products derived from substances of human origin and together with the Commission strengthen EU open strategic autonomy with regard to plasma for fractionation intended for plasma- derived medicinal products.

Amendment 180 #

Proposal for a directive
Recital 18

(18) Advanced therapy medicinal products that are prepared incidentally and exceptionally on a non-routine basis according to specific quality standards, and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product for an individual patient, should be excluded from the scope of this Directive whilst at the same time ensuring that relevant Union rules related to quality and safety are not undermined (‘hospital exemption’). Hospital exemptions should be granted strictly when there is neither a certified medicinal alternative available, nor an appropriate clinical trial or compassionate use program that aligns with the therapeutic needs for an Advanced Therapy Medicinal Product (ATMP) for which the patient is qualified within the European jurisdiction, provided that the production of such therapy is a singular event and not part of a standard manufacturing cycle. The system for granting marketing authorizations is underpinned by the evidence from clinical trials, which is essential for confirming product safety and effectiveness. Therefore, it is crucial to ensure that the hospital exemption does not deplete the pool of clinical trial participants or jeopardize the reliability of the marketing authorization process for ATMPs. Experience has shown that there are great differences in the application of hospital exemption among Member States. To improve the application of hospital exemption this Directive introduces measures for collection, reporting of data as well as review of these data yearly by the competent authorities and their publication by the Agency in a repository. Furthermore, the Agency should provide a report on the implementation of hospital exemption on the basis of contributions from Member States in order to ~~examine whether an adapted framework should be established for certain less complex ATMPs that have been developed and used under the hospital exemption~~assist in the overall surveillance of the products’ quality, safety, and effectiveness.. When an authorisation for the manufacturing and use of an ATMP under hospital exemption is revoked because of safety concerns, the relevant competent authorities shall inform the competent authorities of other Member States.

Amendment 181 #

Proposal for a directive
Recital 18

(18) Advanced therapy medicinal products that are prepared incidentally and exceptionally on a non-routine basis according to specific quality standards, and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a product custom-made ~~product for~~to meet the special needs of an individual patient, should be excluded from the scope of this Directive whilst at the same time ensuring that relevant Union rules related to quality and safety are not undermined (‘hospital exemption’). The use of hospital exemption should apply only where there is neither a centrally authorised medicinal product nor a relevant clinical trial or compassionate use program for the same indication with an advanced therapy medicinal product for which the patient is eligible in the Union. The manufacturing of such products should not result in any one of the following conditions over the course a year: (i) standardised process; (ii) repetitive process; (iii) process involving pre-planning other than that which is required for an urgent ad-hoc situation. Experience has shown that there are great differences in the application of hospital exemption among Member States. To improve the application of hospital exemption this Directive introduces measures for collection, reporting of data as well as review of these data yearly by the competent authorities and their publication by the Agency in a repository. Furthermore, the Agency should provide a report on the implementation of hospital exemption on the basis of contributions from ~~Member States in order to examine whether an adapted framework should be established for certain less complex ATMPs that have been developed and used under the hospital exemption~~all stakeholders. When an authorisation for the manufacturing and use of an ATMP under hospital exemption is revoked because of safety concerns, the relevant competent authorities shall inform the competent authorities of other Member States.

Amendment 182 #

Proposal for a directive
Recital 18

(18) Advanced therapy medicinal products that are prepared on a non-routine basis according to specific quality standards, and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product for an individual patient, should be excluded from the general scope of this Directive ~~whilst at the same time ensuring that relevant Union rules related to quality and safety are not undermined (‘hospital exemption’)~~(‘hospital exemption’). This should remain incidental and exceptional to meet the special needs of an individual patient and under conditions that avoid that the marketing authorisation system and relevant Union rules related to quality and safety are not undermined (‘hospital exemption’). The marketing authorisation system also relies on the outcomes of clinical trials and provides the best guarantee for demonstrating the safety and efficacy of the products. In that light, it is important to avoid that hospital exemption may result in a shortage of patients for clinical trials or that it would undermine the predictability of securing a marketing authorisation for ATMPs. Experience has shown that there are great differences in the application of hospital exemption among Member States. To improve the application of hospital exemption this Directive introduces measures for collection, reporting of data as well as review of these data yearly by the competent authorities and their publication by the Agency in a repository. Furthermore, the Agency should provide a report on the implementation of hospital exemption on the basis of contributions from Member States in order to ~~examine whether an adapted framework should be established for certain less complex ATMPs that have been developed and used under the hospital exemption~~help a general monitoring of the quality, safety and efficacy of the products used. When an authorisation for the manufacturing and use of an ATMP under hospital exemption is revoked because of safety concerns, the relevant competent authorities shall inform the competent authorities of other Member States.

Amendment 183 #

Proposal for a directive
Recital 18

(18) Advanced therapy medicinal products that are prepared on a non-routine basis according to specific quality standards, and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a product custom-made ~~product for an individual patient~~to meet the special needs of an individual patient where there is neither an authorised medicinal product available, a compassionate use programme nor a relevant clinical trial for the same indication with an advanced therapy medicinal product for which the patient is eligible in the Union, should be excluded from the scope of this Directive whilst at the same time ensuring that relevant Union rules related to quality and safety are not undermined (‘hospital exemption’). Experience has shown that there are great differences in the application of hospital exemption among Member States. To improve the application of hospital exemption this Directive introduces measures for collection, reporting of data as well as review of these data yearly by the competent authorities and their publication by the Agency in a repository. Furthermore, the Agency should provide a report on the implementation of hospital exemption on the basis of contributions from ~~Member States in order to examine whether an adapted framework should be established for certain less complex ATMPs that have been developed and used under the hospital exemption~~all stakeholders. When an authorisation for the manufacturing and use of an ATMP under hospital exemption is revoked because of safety concerns, the relevant competent authorities shall inform the competent authorities of other Member States.

Amendment 184 #

Proposal for a directive
Recital 18

(18) Advanced therapy medicinal products that are prepared on a non-routine basis according to specific quality standards, and used within the same Member State in a hospital under the ~~exclusive~~ professional responsibility of a medical practitioner and hospital pharmacist, in order to comply with an individual medical prescription for a custom-made product for an individual patient, should be excluded from the scope of this Directive whilst at the same time ensuring that relevant Union rules related to quality and safety are not undermined (‘hospital exemption’). Experience has shown that there are great differences in the application of hospital exemption among Member States. To improve the application of hospital exemption this Directive introduces measures for collection, reporting of data as well as review of these data yearly by the competent authorities and their publication by the Agency in a repository. Furthermore, the Agency should provide a report on the implementation of hospital exemption on the basis of contributions from Member States in order to examine whether an adapted framework should be established for certain less complex ATMPs that have been developed and used under the hospital exemption. In case of unmet medical need, Member States may allow for mutual recognition and cross- border exchange of advanced therapy medicinal products prepared under hospital exemption. When an authorisation for the manufacturing and use of an ATMP under hospital exemption is revoked because of safety concerns, the relevant competent authorities shall inform the competent authorities of other Member States.

Amendment 185 #

Proposal for a directive
Recital 18

(18) Advanced therapy medicinal products that are prepared ~~on a non- routine basis~~ according to specific quality standards, and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product for an individual patient, should be excluded from the scope of this Directive whilst at the same time ensuring that relevant Union rules related to quality and safety are not undermined (‘hospital exemption’). Experience has shown that there are great differences in the application of hospital exemption among Member States. To improve the application of hospital exemption this Directive introduces measures for collection, reporting of data as well as review of these data yearly by the competent authorities and their publication by the Agency in a repository. Furthermore, the Agency should provide a report on the implementation of hospital exemption on the basis of contributions from Member States in order to examine whether an adapted framework should be established for certain less complex ATMPs that have been developed and used under the hospital exemption. When an authorisation for the manufacturing and use of an ATMP under hospital exemption is revoked because of safety concerns, the relevant competent authorities shall inform the competent authorities of other Member States.

Amendment 186 #

Proposal for a directive
Recital 18 a (new)

(18 a) Hospital exemption pathway is a crucial way of providing patients with access to innovative and affordable treatments that may not be available through other channels. Any limitations to this pathway should avoided, but only based on efficacy, quality and safety criteria, without time restrictions or restrictions on quantities. Competent authorities should guarantee that the authorisation of other products through the centralized procedure does not adversely affect the activities and responsibilities of developers functioning under the hospital exemption. The Agency, as well as competent authorities at the national level, should support academic institutions and other non-profit entities through the requirements of the hospital exemption clause and, when adequate, should provide guidance through centralised marketing authorisation procedure.

Amendment 187 #

Proposal for a directive
Recital 18 a (new)

(18 a) The Agency should also establish support programmes to help guiding academic and other not-for-profit entities through the centralised marketing authorisation procedure. This could build on the EMA pilot program for enhanced support to academic and non-profit developers of advanced therapy medicinal products, started in September 2022 and take into account experience with hospital exemption uses.

Amendment 188 #

Proposal for a directive
Recital 18 a (new)

(18 a) The Agency should create a program aimed at assisting academic institutions and non-profit organizations in navigating the centralized marketing authorization process. This initiative should be informed by insights from the EMA's pilot program that began in September 2022, which provided specialized support to academic and non- profit developers of advanced therapy medicinal products.

Amendment 189 #

Proposal for a directive
Recital 20

(20) In the interest of public health, a medicinal product should only be allowed to be placed on the market in the Union when the marketing authorisation has been granted to the medicinal product, and its quality, safety ~~and~~, efficacy and environmental risk have been demonstrated. However, exemption should be provided from this requirement in situations characterised by an urgent need to administer a medicinal product to address the specific needs of a patient, or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation that could cause harm. In particular, to fulfil special needs, Member States should be allowed to exclude from the provisions of this Directive medicinal products supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications of an authorised healthcare professional and for use by an individual patient under their direct personal responsibility. Member States should be also allowed to temporarily authorise the distribution of an unauthorised medicinal product in response to a suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation any of which could cause harm.

Amendment 190 #

Proposal for a directive
Recital 21

(21) Marketing authorisation decisions should be taken on the basis of the objective scientific criteria of quality, safety and efficacy of the medicinal product concerned, to the exclusion of economic or any other considerations including the status of intellectual property rights. . However, Member States should be able exceptionally to prohibit the use in their territory of medicinal products.

Amendment 191 #

Proposal for a directive
Recital 22

(22) The particulars and documentations that are to accompany an application for marketing authorisation for a medicinal product demonstrate that the therapeutic efficacy of the product overweight potential risks. The benefit-risk balance of all medicinal products will be assessed when they are placed on the market, five years after market approval, except for generics, and at any other time the competent authority deems appropriate.

Amendment 192 #

Proposal for a directive
Recital 22 a (new)

(22 a) As a general rule, marketing authorisation should be granted based on comparative clinical trials on patients who are representative of the population to be treated with the product. To this end, placebo controlled trials should only be accepted where duly justified, necessary and ethical. In addition, patient-reported outcome measures (PROMs) and patient- reported experience measures (PREMs) should be an integral part of clinical data submitted with the marketing authorisation application in order to assess the quality of care and the impact of the treatments on patients. Particular attention should be given to the gender balance of clinical trials so that women can fully and safely benefit from medicines throughout their life-course.

Amendment 193 #

Proposal for a directive
Recital 23 a (new)

(23a) Patent protection creates a legal framework, which is important for pharmaceutical innovation as it provides companies with financial incentives to cover the research and development (R&D) costs of new medicinal products. The research-based pharmaceutical industry is an essential sector and contributor to ensuring quality manufacturing and supply of medicinal products, to ensuring future innovation to address outstanding, unmet needs, and to supporting the resilience, responsiveness and readiness of healthcare systems to address future challenges, including pandemics.

Amendment 194 #

Proposal for a directive
Recital 24

(24) It is therefore necessary to introduce a requirement for new medicinal products or when developing paediatric indications of already authorised products covered by a patent or a supplementary protection certificate to present either the results of studies in the paediatric population in accordance with an agreed paediatric investigation plan or proof of having obtained a waiver or deferral, at the time of filing a marketing authorisation application or an application for a new therapeutic indication, new pharmaceutical form or new route of administration. However, in order to avoid exposing children to unnecessary clinical trials or due to the nature of the medicinal products, that requirement should not apply to generics or similar biological medicinal products and medicinal products authorised through the well-established medicinal use procedure, ~~nor to homeopathic medicinal products~~ and traditional herbal medicinal products authorised through the simplified registration procedures of this Directive.

Amendment 195 #

Proposal for a directive
Recital 27

(27) Certain particulars and documentation that are normally to be submitted with an application for a marketing authorisation should not be required if a medicinal product is a generic medicinal product or a similar biological medicinal product (biosimilar) that is authorised or has been authorised in the Union. Both generic and biosimilar medicinal products are important to ensure access of medicinal products to a wider patient population at more affordable prices and create a competitive internal market . In a joint statement authorities of the Member States confirmed that the experience with approved biosimilar medicinal products over the past 15 years has shown that in terms of efficacy, safety and immunogenicity they are comparable to their reference medicinal product and are therefore interchangeable and can be used instead of its reference product (or vice versa) or replaced by another biosimilar of the same reference product.

Amendment 196 #

Proposal for a directive
Recital 30

(30) Regulatory decision-making on the development, authorisation and supervision of medicines may be supported by access and analysis of health data, including real world data i.e. health data generated outside of clinical studies, where appropriate, and/or data generated via in silico methods, such as computational modelling and simulation, molecular modelling, mechanistic modelling, digital twin and artificial intelligence (AI). The competent authorities should be able to use such data, including via the European Health Data Space interoperable infrastructure.

Amendment 197 #

Proposal for a directive
Recital 31

(31) Directive 2010/63/EU of the European Parliament and of the Council43[1] lays down provisions on the protection of animals used for scientific purposes based on the principles of replacement, reduction and refinement. Any study involving the use of animals, which provides essential information on the quality, safety and efficacy of a medicinal product, should take into account those principles of replacement, reduction and refinement, where they concern the care and use of live animals for scientific purposes, and should be undertaken as a last resort and be optimised in order to provide the most satisfactory results whilst using the minimum number of animals. The marketing authorisation applicant should not carry out animal tests in case scientifically satisfactory non-animal testing methods are available. Where scientifically satisfactory non-animal testing methods are not available, applicants that use animal testing should ensure that the principle of replacement, reduction and refinement of animal testing for scientific purposes has been with regard to any animal study conducted for the purpose of supporting the application. The procedures of such testing should be designed to avoid causing pain, suffering, distress or lasting harm to animals and should follow the available EMA and ICH guidelines. In particular, the marketing authorisation applicant and the marketing authorisation holder should take into account the principles laid down in Directive 2010/63/EU, including, where possible, use new approach methodologies in place of animal testing. These can include but are not limited to: in vitro models, such as microphysiological systems including organ-on-chips, (2D and 3D-) cell culture models, organoids and human stem cells-based models; in silico tools or read-across models. ~~_________________ 43~~[1] Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).

Amendment 198 #

Proposal for a directive
Recital 31

(31) Directive 2010/63/EU of the European Parliament and of the Council43[1] lays down provisions on the protection of animals used for scientific purposes based on the principles of replacement, reduction and refinement. Any study involving the use of animals, which provides essential information on the quality, safety and efficacy of a medicinal product, should take into account those principles of replacement, reduction and refinement, where they concern the care and use of live animals for scientific purposes, and should be optimised in order to provide the most satisfactory results whilst using the minimum number of animals. The procedures of such testing should be designed to avoid causing pain, suffering, distress or, lasting harm or death to animals and should follow the available EMA and ICH guidelines. In particular, the marketing authorisation applicant and the marketing authorisation holder should take into account the principles laid down in Directive 2010/63/EU, including, where possible, use new approach methodologies in place of animal testing. These can include but are not limited to: These can include but are not limited to: in vitro models, such as microphysiological systems including organ-on-chips, (2D and 3D-) cell culture models, organoids and human stem cells-based models; in silico tools or read-across models. ~~_________________ 43~~[1] Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).

Amendment 199 #

Proposal for a directive
Recital 31

(31) Directive 2010/63/EU of the European Parliament and of the Council43[1] lays down provisions on the protection of animals used for scientific purposes based on the principles of replacement, reduction and refinement. Ultimately, efforts should be made to fully replace procedures on live animals for scientific purposes. Any study involving the use of animals, which provides essential information on the quality, safety and efficacy of a medicinal product, should take into account those principles of replacement, reduction and refinement, where they concern the care and use of live animals for scientific purposes, and should be optimised in order to provide the most satisfactory results whilst using the minimum number of animals. The procedures of such testing should be designed to avoid causing pain, suffering, distress or lasting harm to animals and should follow the available EMA and ICH guidelines. In particular, the marketing authorisation applicant and the marketing authorisation holder should take into account the principles laid down in Directive 2010/63/EU, including, where possible, use new approach methodologies (NAMs) in place of animal testing. These can include but are not limited to: in vitro models, such as microphysiological systems including organ-on-chips, (2D and 3D-) cell culture models, organoids and human stem cells-based models; in silico tools or read-across models. _________________ 43 Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33)grouping and read-across, aquatic egg models as well as invertebrate species.

Amendment 200 #

Proposal for a directive
Recital 31

(31) Directive 2010/63/EU of the European Parliament and of the Council43 lays down provisions on the protection of animals used for scientific purposes based on the principles of replacement, reduction and refinement. Any study involving the use of animals, which provides essential information on the quality, safety and efficacy of a medicinal product, should take into account those principles of replacement, reduction and refinement, where they concern the care and use of live animals for scientific purposes, and should be optimised in order to provide the most satisfactory results whilst using the minimum number of animals. The procedures of such testing should be designed to avoid causing pain, suffering, distress or lasting harm to animals and should follow the available EMA and ICH guidelines. In particular, the marketing authorisation applicant and the marketing authorisation holder should take into account the principles laid down in Directive 2010/63/EU, including, where possible, use new approach methodologies in place of animal testing. These can include but are not limited to: in vitro models, such as microphysiological systems including organ-on-chips, (2D and 3D-) cell culture models, organoids and human stem cells-based models; in silico ~~tools~~methods, or read-across models. _________________ 43 Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).

Amendment 201 #

Proposal for a directive
Recital 32

(32) Procedures should be in place to facilitate joint animal testing, wherever possible, in order to avoid unnecessary ~~duplication of~~ testing using live animals covered by Directive 2010/63/EU. Marketing authorisation applicants and marketing authorisation holders should make all efforts to reuse animal study results and make the results obtained from animal studies publicly available. For abridged applications marketing authorisation applicants should refer to the relevant studies conducted for the reference medicinal product.

Amendment 202 #

Proposal for a directive
Recital 34

(34) There is the possibility under certain duly justified circumstances for marketing authorisations to be granted, subject to specific obligations or conditions, on a conditional basis or under exceptional circumstances. The legislation should allow under similar circumstances for medicinal products with a standard marketing authorisation for new therapeutic indications to be authorised on a conditional basis or, in case of centrally- authorised products, under exceptional circumstances. The products authorised on a conditional basis or under exceptional circumstances should in principle satisfy the requirements for a standard marketing authorisation with the exception of the specific derogations or conditions outlined in the relevant conditional or exceptional marketing authorisation and shall be subject to specific review of the fulfilment of the imposed specific conditions or obligations. The grounds for refusal of a marketing authorisation should apply mutatis mutandis for such cases.

Amendment 203 #

Proposal for a directive
Recital 39

(39) In the interest of as broad as possible access to medicinal products, a Member State that has an interest in receiving access to a particular medicinal product undergoing authorisation through the decentralised and mutual recognition procedures should be able to opt-into that procedure. A Member State who did not join the initital application for the decentralised procedure within 30 days of the sumission of the application should still have a second opportunity to opt into the procedure at a later point, in this case they should immeditately inform the applicant and the competent authority of the reference Member State for the decentralised procedure.

Amendment 204 #

Proposal for a directive
Recital 39

Amendment 205 #

Proposal for a directive
Recital 41

(41) In the case of products with well- known molecules, generic medicinal products of which the reference medicinal product has been granted a marketing authorisation under the centralised procedure, hybrid medicinal products, well established and products with fixed dose combinations of known molecules, applicants seeking marketing authorisation should be able to choose either of the two procedures, on certain conditions. Similarly, the mutual- recognition or decentralised procedure should remain available as an option for certain medicinal products, even if they represent a therapeutic innovation or are of benefit to society or to patients. Since generic medicines account for a major part of the market in medicinal products, their access to the Union market should be facilitated in the light of the experience acquired, therefore, the procedures to include other Member States concerned to such procedure should be further simplified.

Amendment 206 #

Proposal for a directive
Recital 42

(42) The simplification of procedures should not have an impact on standards or the quality of scientific evaluation of medicinal products to guarantee the quality, safety ~~and~~, efficacy and environmetal risk and therefore, the scientific evaluation period should remain. However, the reduction of overall period for marketing authorisation procedure from 210 days to 180 days is foreseen.

Amendment 207 #

Proposal for a directive
Recital 44

(44) As regards access to medicinal products, previous amendments to the Union pharmaceutical legislation have addressed this issue by providing for accelerated assessment of marketing authorisation applications or by allowing conditional marketing authorisation for medicinal products for unmet medical need. While these measures accelerated the authorisation of innovative and promising therapies, these medicinal products do not always reach the patient and patients in the Union still have different levels of access to medicinal products. Patient access to medicinal products depends on many factors. Marketing authorisation holders are not obliged to market a medicinal product in all Member States; they may decide not to market their medicinal products in, or withdraw them from, one or more Member States. National pricing and reimbursement policies, the size of the population, the organisation of health systems and national administrative procedures are other factors influencing market launch and patient access. In addition, complex regulatory environment and associated administrative burden may prevent SMEs, research institutes and academic institutions developing promising innovative treatments from applying for conditional market authorization.

Amendment 208 #

Proposal for a directive
Recital 44

(44) As regards access to medicinal products, previous amendments to the Union pharmaceutical legislation have addressed this issue by providing for accelerated assessment of marketing authorisation applications or by allowing conditional marketing authorisation for medicinal products for unmet medical need. While these measures accelerated the authorisation of innovative and promising therapies, in some areas, there still exist many public health priorities unaddressed and these medicinal products do not always reach the patient and patients in the Union still have different levels of access to medicinal products. Patient access to medicinal products depends on many factors. Marketing authorisation holders are not obliged to market a medicinal product in all Member States; they may decide not to market their medicinal products in, or withdraw them from, one or more Member States. National pricing and reimbursement policies, the size of the population, the organisation of health systems and national administrative procedures and often high prices of innovative medicines are other factors influencing market launch and patient access.

Amendment 209 #

Proposal for a directive
Recital 44

(44) As regards access to medicinal products, previous amendments to the Union pharmaceutical legislation have addressed this issue by providing for accelerated assessment of marketing authorisation applications or by allowing conditional marketing authorisation for medicinal products for unmet medical need. While these measures accelerated the authorisation of innovative and promising therapies, these medicinal products do not always reach the patient and patients in the Union still have different levels of access to medicinal products. Patient access to medicinal products depends on many factors. Marketing authorisation holders are not obliged to market a medicinal product in all Member States; they may decide not to market their medicinal products in, or withdraw them from, one or more Member States, often due to profitability considerations. National pricing and reimbursement policies, the size of the population, the organisation of health systems, and national administrative procedures are other factors influencing market launch and patient access.

Amendment 210 #

Proposal for a directive
Recital 44 a (new)

(44 a) In order to increase the availability of medicines and contribute to reducing of access inequalities within the Union, the marketing authorisation holders of medicinal products other than generics should submit an application for pricing and reimbursement in Member States upon request. In addition, the Agency should include in its medicine database information on the actual placing on the market and reimbursement status for all centrally authorised medicines.

Amendment 211 #

Proposal for a directive
Recital 45

(45) Addressing unequal patient access and affordability of medicinal products has become a key priority of the Pharmaceutical Strategy for Europe, as also highlighted by Council conclusions45[1] and a resolution of the European Parliament46 [2]. Member States called for revised mechanisms and incentives for development of medicinal products tailored to the level of unmet medical need, while ensuring health system sustainability, patient access and availability of affordable medicinal products in all Member States. _________________ 45 Council conclusions on strengthening the balance in the pharmaceutical systems in the EU and its Member States, (OJ C, C/269, 23.07.2016, p. 31). Council Conclusions on Access to medicines and medical devices for a Stronger and Resilient EU, (2021/C 269 I/02). 46 European Parliament resolution of 2 March 2017 on EU options for improving access to medicine (2016/2057(INI)) Shortages of medicines, 2020/2071(INI)Putting in place tolls to evaluate access to medicines at a Union level is key to follow-up on the results achieved through incentives.

Amendment 212 #

Proposal for a directive
Recital 45 a (new)

(45 a) Given the unmet needs in the area of mental health, the revision should also support early access to novel treatments for patients who need them most through means like compassionate use programmes and conditional marketing authorisation. These programs should play a pivotal role in providing treatment experience for providers and generating valuable real-world data to inform safety policies and future product labelling.

Amendment 213 #

Proposal for a directive
Recital 45 b (new)

(45 b) Use of early access pilot programs to treat a diverse set of patients with complex comorbidities who are often excluded from clinical trials focused on novel mental health treatments should be supported. Allowing this would support gathering critical additional data on the safety and efficacy of these treatments in a broader population. Furthermore, these programs should explore different treatment protocols, such as group therapy and peer support specialists, to find the optimal balance of safety, efficacy, affordability, and equitable access.

Amendment 214 #

Proposal for a directive
Recital 45 c (new)

(45 c) The revision should aim to support innovative mental health care treatments that combine pharmacological, and psychological aspects. Moreover, generation of empirical evidence for the quality and safety of novel mental health treatments should be further explored and supported. This includes understanding the interactions between the pharmacological substances and the psychotherapy as well as assistive technologies that can assist to patient preparation, monitoring or treatment integration.

Amendment 215 #

Proposal for a directive
Recital 45 d (new)

(45 d) Mental health disorders also represent an area of unmet medical need, where only a moderate progress has been achieved during the past decades, especially in addressing the treatment resistant depression, treatment-resistant PTSD as well as regarding the neurodegenerative diseases. At the same time the mental health disorders pose a substantial burden on individuals, healthcare systems, caregivers, and economies.

Amendment 216 #

Proposal for a directive
Recital 46

(46) Access also comprises affordability. In this regard, the Union pharmaceutical legislation respects the competence of the Member States in terms of pricing and reimbursement. In a complementary manner, it aims to have a positive impact on affordability and sustainability of health systems with measures that support competition from generic and biosimilar medicinal products. The competition from generic and biosimilar medicinal products should also, in turn, increase patient access to medicinal products.

Amendment 217 #

Proposal for a directive
Recital 47

(47) To ensure dialogue among all actors in the medicines lifecycle, ~~discussions on policy issues related to the application of the rules related to prolongation of regulatory data protection for market launch shall take place in the Pharmaceutical Committee. T~~the Commission may invite bodies responsible for health technology assessment as referred to in Regulation (EU) 2021/2282 or national bodies responsible for pricing and reimbursement, as required, to participate in the deliberations of the Pharmaceutical Committee.

Amendment 218 #

Proposal for a directive
Recital 47

(47) To ensure dialogue among all actors in the medicines lifecycle, discussions on policy issues related to the application of the rules related to prolongation of regulatory data protection ~~for market launch~~ shall take place in the Pharmaceutical Committee. The Commission may invite bodies responsible for health technology assessment as referred to in Regulation (EU) 2021/2282 or national bodies responsible for pricing and reimbursement, as required, to participate in the deliberations of the Pharmaceutical Committee.

Amendment 219 #

Proposal for a directive
Recital 47

(47) To ensure dialogue among all actors in the medicines lifecycle, discussions on policy issues related to the application of the rules related to prolongation of regulatory ~~data~~market protection ~~for market launch~~ shall take place in the Pharmaceutical Committee. The Commission may invite bodies responsible for health technology assessment as referred to in Regulation (EU) 2021/2282 or national bodies responsible for pricing and reimbursement, as required, to participate in the deliberations of the Pharmaceutical Committee.

Amendment 220 #

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ, Erik POULSEN, Dacian CIOLOŞ

Proposal for a directive
Recital 48

(48) While pricing and reimbursement decisions are a Member State competence, cooperation in this area is essential in order to avoid that decisions in one Member State create shortages in other Member States. For this reason, the Pharmaceutical Strategy for Europe announced actions to support cooperation of Member States to improve affordability. While the price paid within a given Member State reflects the preference of a national health system, more coordination on pricing and procurement could contribute to more equal and timely access to medicines, including for Member States with lower purchasing power. The Commission may support joint price negotiation with pharmaceutical companies, as per the Beneluxa Initiative on Pharmaceutical Policy and the Valletta Declaration. The Commission has transformed the group of National Competent Authorities on Pricing and Reimbursement and public healthcare payers (NCAPR) from an ad- hoc forum to a continuous voluntary cooperation with the aim to exchange information and best practices on pricing, payment and procurement policies to improve the affordability and cost- effectiveness of medicines and health system’s sustainability. The Commission is committed to stepping up this cooperation and further supporting information exchange among national authorities, including on national pricing, reimbursment and public procurement of medicines, while fully respecting the competences of Member States in this area. The Commission may also invite NCAPR members to participate in deliberations of the Pharmaceutical Committee on topics that may have an impact on pricing or reimbursement policies, such as the market launch incentive.

Amendment 221 #

Erik POULSEN, Catherine AMALRIC, Asger CHRISTENSEN, Morten LØKKEGAARD

(48) While pricing and reimbursement decisions are a Member State competence, the Pharmaceutical Strategy for Europe announced actions to support cooperation of Member States to improve affordability. The Commission has transformed the group of National Competent Authorities on Pricing and Reimbursement and public healthcare payers (NCAPR) from an ad- hoc forum to a continuous voluntary cooperation with the aim to exchange information and best practices on pricing, payment and procurement policies to improve the affordability and cost- effectiveness of medicines and health system’s sustainability. The Commission is committed to stepping up this cooperation and further supporting information exchange among national authorities, including on public procurement of medicines, while fully respecting the competences of Member States in this area. Such procurement efforts should be based on the principle of the ‘most economically advantageous tender’ (‘MEAT’ criteria), which aims to ensure the best value for money rather than most economically advantageous product. Such an approach could also help in defining adequate supply in relation to critical medicines and, thereby, compensate and incentivise industry, and support the application of these criteria in a coordinated way, at EU level. Predictability of supply would also be helped by medium-term contractual incentives to diversify and attract the next generation of manufacturing investments in Europe. The Commission may also invite NCAPR members to participate in deliberations of the Pharmaceutical Committee on topics that may have an impact on pricing or reimbursement policies, such as the market launch incentive.

Amendment 222 #

Proposal for a directive
Recital 48

(48) While pricing and reimbursement decisions are a Member State competence, tcooperation and dialogue with all stakeholders in this areas could help to avoid that decisions in one Member State contribute to unavailability in other Member States. The Pharmaceutical Strategy for Europe announced actions to support cooperation of Member States to improve affordability. The Commission has transformed the group of National Competent Authorities on Pricing and Reimbursement and public healthcare payers (NCAPR) from an ad- hoc forum to a continuous voluntary cooperation with the aim to exchange information and best practices on pricing, payment and procurement policies to improve the affordability and cost- effectiveness of medicines and health system’s sustainability. The Commission is committed to stepping up this cooperation and further supporting information exchange among national authorities, including on public procurement of medicines, while fully respecting the competences of Member States in this area. The Commission may also invite NCAPR members to participate in deliberations of the Pharmaceutical Committee on topics that may have an impact on pricing or reimbursement policies, such as the market launch incentive.

Amendment 223 #

Proposal for a directive
Recital 48

Amendment 224 #

Proposal for a directive
Recital 49

(49) Joint procurement, whether within a country or across countries, can improve access, affordability, and security of supply of medicines, in particular for smaller countries. Member States interested in joint procurement of medicines can make use of Directive 2014/24/EU47 , which sets out purchasing procedures for public buyers, the Joint Procurement Agreement48 and the proposed revised Financial Regulation49 . Upon request from the Member States the Commission may support interested Member States by facilitating coordination to enable access to medicines for patients in the Union as well as information exchange, in particular for medicines for rare and chronic diseases. Joint procurement should not have detrimental impact on access to medicines for countries not taking part in the procurement. _________________ 47 Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65). 48 Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU. 49 COM/2022/223 final.

Amendment 225 #

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ, Erik POULSEN, Ondřej KNOTEK

Proposal for a directive
Recital 49

(49) Joint procurement, whether within a country or across countries, can improve access, affordability, and security of supply of medicines, in particular for smaller countries. Member States interested in joint procurement of medicines can make use of Directive 2014/24/EU47 , which sets out purchasing procedures for public buyers, the Joint Procurement Agreement48 and the proposed revised Financial Regulation49 . Upon request from the Member States the Commission may support interested Member States by facilitating coordination to enable access to medicines for patients in the Union as well as information exchange, in particular for medicines for rare and chronic diseases, antibiotics and generic and biosimilar medicinal products. _________________ 47 Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65). 48 Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU. 49 COM/2022/223 final.

Amendment 226 #

Proposal for a directive
Recital 49

(49) Joint procurement, whether within a country or across countries, can improve access, affordability, and security of supply of medicines, in particular for smaller countries. Member States interested in joint procurement of medicines can make use of Directive 2014/24/EU47 , which sets out purchasing procedures for public buyers, the Joint Procurement Agreement48 and the proposed revised Financial Regulation49 . Upon request from the Member States the Commission may support interested Member States by facilitating coordination to enable access to medicines for patients in the Union as well as information exchange, in particular for medicines linked to public health emergencies and for rare and chronic diseases. . _________________ 47 Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65). 48 Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU. 49 COM/2022/223 final.

Amendment 227 #

Proposal for a directive
Recital 49

(49) Joint procurement, whether within a country or across countries, can improve access, affordability, and security of supply of medicines, in particular for smaller countries. Member States ~~interested in~~ joint procurement of medicines ~~can~~should make use of Directive 2014/24/EU47 , which sets out purchasing procedures for public buyers, the Joint Procurement Agreement48 and the proposed revised Financial Regulation49 . Upon request from the Member States the Commission may support ~~interested~~ Member States by facilitating coordination to enable access to medicines for patients in the Union as well as information exchange, in particular for medicines for rare and chronic diseases. _________________ 47 Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65). 48 Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU. 49 COM/2022/223 final.

Amendment 228 #

Proposal for a directive
Recital 49 a (new)

(49 a) Practices in procurement procedures for medicines differ between Member States and long-term availability is rarely a primary consideration. The 2014 Procurement Directive encourages a more strategic approach through award criteria, including criteria beyond price. Using the lowest price as the main selection criterion may reduce incentives for the industry to build for long-term supply in the EU. At the same time, vulnerability may be increased when public procurement procedures award contracts to a single company. Where challenges with access to a critical medicine and related affordability may be an issue, Member States can work together to increase buying power. Joint procurement between Member States can act as a powerful tool to improve access, affordability and security of supply, of particular benefit in smaller EU markets. This can improve the negotiating position of Member States to incentivise production capacities, as well as diversifying supply chains. In specific cases, those instruments could also support enhanced predictability through multi-annual contracts. The joint procurement of medicines or on Member States’ behalf in the case of the COVID- 19 pandemic, for example, provided a powerful tool to improve access, affordability, and security of supply, was of particular benefit to smaller EU Member States with less economic power.

Amendment 229 #

Proposal for a directive
Recital 49 a (new)

(49 a) Member States should develop a Joint Pharmaceuticals Development Body that would consist of 15 members from research, industry, Member States and the Commission. The Body should come up with joint solutions in ensuring access to up-to-date and best available medicinal care for Europeans. The purpose of the Body shoudl be to guarantee competitiveness and innovational capacity of the Union regarding pharmaceutical innovation and manufacturing, as well as the strategic autonomy of the Union when it comes to medicines, drawing from the joint actions and cooperation within the Union and between Member States during the COVID-19 pandemic.

Amendment 230 #

Proposal for a directive
Recital 50

Amendment 231 #

Rosanna CONTE, Annalisa TARDINO

Proposal for a directive
Recital 50

(50) The establishment of a criteria- based definition of ‘unmet medical need’ is required to incentivise the development of medicinal products in therapeutic areas that lack effective treatments or where only less-than-ideal therapies exist, with the aim of spurring pharmaceutical research and development that genuinely meets patient requirements.that are currently underserved. To ensure that the concept of unmet medical need reflects scientific and technological developments and current knowledge in underserved diseases, the Commission should specify and update using implementing acts, the criteria of satisfactory method of diagnosis, prevention or treatment, ‘remaining ~~high~~ morbidity or mortality’, ‘relevant patient population’ ~~following scientific assessment by the Agency. The Agency~~, ‘quality of life’, ‘burden of administration’, ‘appropriate standard of care’, ‘significant added therapeutic value’, ‘patient experience data’ following scientific assessment by the Agency. The Agency should include patient representatives in its decision-making processes, will seek input from a broad range of authorities or bodies active along the lifecycle of medicinal products in the framework of the consultation process established under the [revised Regulation (EC) No 726/2004] and also take into account scientific initiatives at EU level or between Member States related to analysing unmet medical needs, burden of disease and priority setting for research and development. ~~The criteria for ‘unmet medical need’ can be subsequently used by Member States to identify specific therapeutic areas of interest.~~ Given that chronic diseases account for 86% of all deaths in the EU, the assessment of disease burden should not be limited to mortality and morbidity metrics alone but ought to incorporate relevant data on patient experiences, including aspects related to quality of life. The inclusion of new therapeutic indications to an authorised medicinal products should contribute to the access of patients to additional therapies and therefore should be incentivised.

Amendment 232 #

Proposal for a directive
Recital 50

(50) The establishment of a criteria- based definition of ‘unmet medical need’ is required to incentivise the development of medicinal products in therapeutic areas that are currently underserved. To ensure that the concept of unmet medical need reflects scientific and technological developments and current knowledge in underserved diseases, as well as the manifold aspects it encompasses, such as the potential of medicines to improve quality of life, ease the burden of care and take into account the scope (addressing only a sub- population of a disease) of therapies, where they exist, the Commission should specify and update using implementing acts, the criteria of satisfactory method of diagnosis, prevention or treatment, ‘remaining high morbidity or mortality’, ‘'quality of life', relevant patient population’', 'access and scope (e.g. addressing only a sub-population of a disease) and ease of use of existing treatments' and 'severity of illness', following scientific assessment by the Agency. The Agency will seek input from a broad range of authorities or bodies – including relevant patient populations – active along the lifecycle of medicinal products in the framework of the consultation process established under the [revised Regulation (EC) No 726/2004] and also take into account scientific initiatives at EU level or between Member States related to analysing unmet medical needs, taking into account their complex nature and including all relevant aspects that determine the level of unmet medical need as listed above, burden of disease and priority setting for research and development. The criteria for ‘unmet medical need’ should be holistic, inclusive and take into account the many complex factors involved, and can be subsequently used by Member States to identify specific therapeutic areas of interest.

Amendment 233 #

Proposal for a directive
Recital 50

(50) The establishment of a criteria- based definition of ‘unmet medical need’ is ~~required to~~necessary to ensure incentiv~~ise~~es for the development of medicinal products in therapeutic areas that are currently underserved. To ensure that the concept of unmet medical need reflects scientific and technological developments and current knowledge in underserved diseases, the Commission should specify and update using implementing acts, the criteria of satisfactory method of diagnosis, prevention or treatment, ‘remaining high morbidity or mortality’, ‘relevant patient population’ following scientific assessment by the Agency. The Agency will seek input from a broad range of authorities or bodies active along the lifecycle of medicinal products in the framework of the consultation process established under the [revised Regulation (EC) No 726/2004] and also take into account scientific initiatives at EU level or between Member States related to analysing unmet medical needs, burden of disease and priority setting for research and development are appropriately allocated and to prevent unintended extensions of data protection based on unclear interpretation of unmet medical need. The criteria for ‘unmet medical need’ can be subsequently used by Member States to identify specific therapeutic areas of interest.

Amendment 234 #

Billy KELLEHER

Proposal for a directive
Recital 50

(50) The establishment of a criteria- based definition of ‘unmet medical need’ is required to incentivise the development of medicinal products in therapeutic areas that are currently underserved. To ensure that the concept of unmet medical need reflects scientific and technological developments ~~and~~, current knowledge in underserved diseases, as well as the many aspects that it embodies – e.g. the potential of medicines to improve quality of life, ease the burden of treatment and take account of the scope (addressing a subpopulation of a disease only) of treatments where they exist - the Commission should specify and update using implementing acts, the criteria of satisfactory method of diagnosis, prevention or treatment, ‘remaining high morbidity or mortality’, ‘relevant patient population’ following scientific assessment by the Agency. The Agency will seek input from a broad range of authorities and other relevant stakeholders such as relevant patient populations or bodies active along the lifecycle of medicinal products in the framework of the consultation process established under the [revised Regulation (EC) No 726/2004] and also take into account scientific initiatives at EU level or between Member States related to analysing unmet medical needs, – taking into account the impact, scope, ease of access and use as well as availability and appropiateness of treatments where they exist, and the potential of innovation to improve quality of life for patients and their families - burden of disease and priority setting for research and development. The criteria for ‘unmet medical need’ should be holistic, inclusive and take account of its many complex factors - can be subsequently used by Member States to identify specific therapeutic areas of interest.

Amendment 235 #

Ondřej KNOTEK, Billy KELLEHER, Susana SOLÍS PÉREZ

Proposal for a directive
Recital 50

(50) The establishment of a criteria- based definition of ‘unmet medical need’ is required to incentivise the development of medicinal products in therapeutic areas ~~that are currently underserved~~for which no or only suboptimal treatments are available and to encourage pharmaceutical research and development that truly addresses the needs of patients. To ensure that the concept of unmet medical need reflects scientific and technological developments and current knowledge ~~in underserved diseases~~, the Commission should specify and update using implementing acts, the criteria of ~~satisfactory method of diagnosis, prevention or treatment,~~ ‘remaining high morbidity or mortality’, ‘relevant patient population~~’ following scientific assessment by the Agency. The Agency will~~ or subpopulation’, ‘burden of disease’, ‘appropriate standard of care’, ‘significant added therapeutic value’, ‘patient experience data’ following scientific assessment by the Agency. The Agency shall involve patient representatives in its decision- making, seek input from a broad range of authorities or bodies active along the lifecycle of medicinal products in the framework of the consultation process established under the [revised Regulation (EC) No 726/2004] and also take into account scientific initiatives at EU level or between Member States related to analysing unmet medical needs, burden of disease and priority setting for research and development. ~~The criteria for ‘unmet medical need’ can be subsequently used by Member States to identify specific therapeutic areas of interest~~As chronic diseases represent 86% of all deaths in the EU, the burden of diseases cannot solely be assessed by measuring mortality and morbidity, but should include relevant patient experience data, including quality of life.

Amendment 236 #

Proposal for a directive
Recital 50

(50) The establishment of a criteria- based definition of ‘unmet medical need’ is required to incentivise the development of medicinal products in therapeutic areas that are currently underserved. To ensure that the concept of unmet medical need reflects scientific and technological developments and current knowledge in underserved diseases, the Commission should specify and update using implementing acts, the criteria of satisfactory method of diagnosis, prevention or treatment, ‘remaining high morbidity or mortality’, ‘relevant patient population’ and 'quality of life' following scientific assessment by the Agency. The Agency will seek input from a broad range of authorities or bodies active along the lifecycle of medicinal products in the framework of the consultation process established under the [revised Regulation (EC) No 726/2004], consult relevant stakeholders including representatives from patient's organisations, healthcare professionals and industry and also take into account scientific initiatives at EU level or between Member States related to analysing unmet medical needs, burden of disease and priority setting for research and development. The criteria for ‘unmet medical need’ can be subsequently used by Member States to identify specific therapeutic areas of interest.

Amendment 237 #

Proposal for a directive
Recital 50

Amendment 238 #

Proposal for a directive
Recital 50

Amendment 239 #

Proposal for a directive
Recital 50

Amendment 240 #

Proposal for a directive
Recital 50 a (new)

(50 a) Advancing treatments in neglected therapeutic areas can significantly enhance patient lives, particularly by considering the management of side effects, daily functioning, pain, and co- existing illnesses. Enhancements in patient quality of life should be able to lead to their re-engagement in work or education, benefiting both the individual and society by reducing economic burdens. Additionally, new treatments can lessen the load on caregivers, with wider social benefits. Defining these therapeutic areas and unmet needs should involve consultation with stakeholders like patients, healthcare providers, and industry experts.

Amendment 241 #

Dolors MONTSERRAT, Nathalie COLIN-OESTERLÉ, Stelios KYMPOUROPOULOS

Proposal for a directive
Recital 50 a (new)

Amendment 242 #

Proposal for a directive
Recital 51 a (new)

(51 a) Repurposing of off-patent medicines to develop new therapeutic options should also be incentivised as it can expand access in an affordable manner, providing significant benefits to patients;

Amendment 243 #

Proposal for a directive
Recital 51 a (new)

(51 a) Repurposing of off-patent medicines to develop new therapeutic options should also be incentivised as it can expand access in an affordable manner, providing significant benefits to patients.

Amendment 244 #

Proposal for a directive
Recital 51 a (new)

(51 a) Repurposing of off-patent medicines to develop new therapeutic options should also be incentivised as it can expand access in an affordable manner, providing significant benefits to patients.

Amendment 245 #

Proposal for a directive
Recital 51 a (new)

(51 a) Repurposing of off-patent medicines to develop new therapeutic options should also be incentived as it can expand access to patients and reduce health inequalities.

Amendment 246 #

Proposal for a directive
Recital 52

(52) For the initial marketing authorisation application for medicinal products containing a new active substance, the submission of clinical trials that include as a comparator an evidence- based existing treatment should be incentivised, in order to foster the generation of comparative clinical evidence that is relevant and can accordingly support subsequent health technology assessments and decisions on pricing and reimbursement by Member States.deleted

Amendment 247 #

Proposal for a directive
Recital 52

Amendment 248 #

Proposal for a directive
Recital 52

(52) For the initial marketing authorisation application for medicinal products containing a new active substance, the submission of clinical trials that include as a comparator an evidence- based existing treatment or an undertaking to generate real world evidence, including patient reported outcomes that compare the new active substance to the existing treatment, should be incentivised, in order to foster the generation of comparative clinical evidence that is relevant and can accordingly support subsequent health technology assessments and decisions on pricing and reimbursement by Member States.

Amendment 249 #

Proposal for a directive
Recital 52

(52) For the initial marketing authorisation application for medicinal products containing a new active substance, the submission of clinical trials that include as a comparator an evidence- based existing treatment should be ~~incentivised~~recommended, especially in regards to medicines for non rare diseases, in order to foster the generation of comparative clinical evidence that is relevant and can accordingly support subsequent health technology assessments and decisions on pricing and reimbursement by Member States.

Amendment 250 #

Proposal for a directive
Recital 53

(53) A marketing authorisation holder should, within its responsibilities, ensure the appropriate and continuous supply of a medicinal product throughout its lifetime irrespective of whether that medicinal product is covered by a supply incentive or not.

Amendment 251 #

Proposal for a directive
Recital 53 a (new)

(53 a) During negotiations, developers and Member States should imperatively respect and adhere to the timelines set out by Directive 89/105/EEC, to accelerate and widen the availability of innovative therapies to patients.

Amendment 252 #

Proposal for a directive
Recital 54

(54) Micro, small and medium-sized enterprises (‘SMEs’), not-for-profit entities or entities with limited experience in the Union system should benefit from additional time to ~~market~~submit an application for pricing and reimbursement for a medicinal product in the Member States where a Member State has requested it and the marketing authorisation is valid for the purposes of receiving additional regulatory data protection.

Amendment 253 #

Proposal for a directive
Recital 54

(54) Micro, small and medium-sized enterprises (‘SMEs’), not-for-profit entities or entities with limited experience in the Union system should benefit from additional time to market a medicinal product in the Member States where the marketing authorisation is valid ~~for the purposes of receiving additional regulatory data protection~~.

Amendment 254 #

Proposal for a directive
Recital 54

(54) Micro, small and medium-sized enterprises (‘SMEs’), not-for-profit entities or entities with limited experience in the Union system should benefit from additional time to market a medicinal product in the Member States where the marketing authorisation is valid for the purposes of receiving additional regulatory ~~data~~market protection.

Amendment 255 #

Proposal for a directive
Recital 55

(55) ~~When applying the provisions on market launch incentives, m~~Marketing authorisation holders and Member States should do their utmost to achieve a mutually agreed supply of medicinal products in accordance with the needs of the Member State concerned, without unduly delaying or hindering the other party from enjoying its rights under this Directive.

Amendment 256 #

Proposal for a directive
Recital 55

Amendment 257 #

Proposal for a directive
Recital 56

(56) Member States have the possibility to waive the condition of launch in their territory for the purpose of the prolongation of data protection for market launch. This can be done through a statement of non-objection to prolong the period of regulatory data protection. This is expected to be the case particularly in situations where launch in a particular Member State is materially impossible or because there are special reasons why a Member State wishes that launch take place later. In the case where a Member State does not react to the application by the marketing authorisation holder within the deadline provided, it should be considered that a statement of non objection has been provided and the condition in that Member State should be waived. The Commission should ensure that marketing authorisation holders are not unduly prevented from receiving the incentives for actions beyond their control.

Amendment 258 #

(56) Member States have the possibility to ~~waive the condition of launch in their territor~~request a market launch of centrally for the purpose of the prolongation of data protection for market launch. This can be done through a statement of non-objection to prolong the period of regulatory data protection. This is expected to be the case particularly in situations where launch in a particular Member State is materially impossible or because there are special reasons why a Member State wishes that launch take place ldecentrally approved product at any time after the marketing authorisation is valid in the Member State. Subsequently, marketing authorisation holders have nine months to apply for a pricing and reimbursement in that Member State, 18 months where the marketing authorisation holder is an SME, an entity not engaged in economic activity or an entity with a limited experience in the Union system. Alternative timelines may be agreed between the Member State and the marketing authorisation holder. Marketing authorisation holders have the right to launch a product in a Member State before being proactively approached by that Member Stater.

Amendment 259 #

Proposal for a directive
Recital 56

(56) Member States have the possibility to waive the condition of launch in their territory for the purpose of the prolongation of ~~data~~market protection for market launch. This can be done through a statement of non-objection to prolong the period of regulatory ~~data~~market protection. This is expected to be the case particularly in situations where launch in a particular Member State is materially impossible or because there are special reasons why a Member State wishes that launch take place later.

Amendment 260 #

Proposal for a directive
Recital 57

(57) The ~~issuing of documentation from the Member States as regards the prolongation of data protection for the purpose of supply of medicinal products~~application for pricing and reimbursement in ~~all~~the Member States ~~where a marketing authorisation is valid, in particular the waiver to the conditions for such prolongation,~~ does not affect at any time the powers of the Member States as regards the supply, setting of prices for medicinal products or their inclusion in the scope of national health insurance schemes. ~~Member States do not waive the possibility to request release or supply of the product concerned at any time before, during or after the prolongation of the data protection period.~~

Amendment 261 #

Ondřej KNOTEK, Catherine AMALRIC, Billy KELLEHER, Susana SOLÍS PÉREZ

Proposal for a directive
Recital 57

(57) The issuing of documentation from the Member States as regards the prolongation of ~~data~~market protection for the purpose of supply of medicinal products in all Member States where a marketing authorisation is valid, in particular the waiver to the conditions for such prolongation, does not affect at any time the powers of the Member States as regards the supply, setting of prices for medicinal products or their inclusion in the scope of national health insurance schemes. Member States do not waive the possibility to request release or supply of the product concerned at any time before, during or after the prolongation of the ~~data~~market protection period.

Amendment 262 #

Proposal for a directive
Recital 58

(58) An alternative way of demonstrating supply relates to the inclusion of medicinal products in a positive list of medicinal products covered by the national health insurance system in accordance with Directive 89/105/EEC. The related negotiations between companies and the Member State should be conducted in good faith. In addition, the timelines set by Directive 89/105/EEC should be respected during the negotiations between Member States and marketing authoriation holder to ensure a fast and timely patient's access to medicines.

Amendment 263 #

Dolors MONTSERRAT, Nathalie COLIN-OESTERLÉ, Stelios KYMPOUROPOULOS, Tomislav SOKOL

Proposal for a directive
Recital 58

Amendment 264 #

Proposal for a directive
Recital 58 a (new)

(58 a) Small patient populations, especially paediatric or rare disease ones, are often the most disadvantaged when it comes to access to medicines. In this regard, Directive 2011/24/EU should be considered as an alternative pathway of making available medicinal products to patients, who need paediatric, orphan medicinal products or advanced therapy medicinal products. The medicines can be administered via a center of excellence, early access or compassionate use programs, or other cross-border healthcare services.

Amendment 265 #

Proposal for a directive
Recital 58 a (new)

Amendment 266 #

Proposal for a directive
Recital 58 a (new)

(58 a) Supply assurance can also be achieved through national strategies that facilitate patient access, such as programs for named patients, tailored individual patient initiatives, and the uptake and optimization of cross-border healthcare options, as stipulated in Directive 2011/24/EU. It is crucial to bolster cross- border healthcare, especially for treatments that require specialized infrastructure or technical expertise that may be lacking in certain Member States.

Amendment 267 #

Proposal for a directive
Recital 59

(59) A Member State that considers that the conditions of supply have not been met for its territory should provide a reasoned statement of non-compliance at the latest in the Standing Committee on Medicinal Products for Human Use procedure of the variation linked to the provision of the relevant incentive.deleted

Amendment 268 #

Proposal for a directive
Recital 59 a (new)

(59 a) If negotiations between Member States and developers are conducted sincerely but fail to result in an agreement on the distribution and ongoing supply of a therapy, the introduction of a mediation process should be warranted. This mechanism, overseen by the Commission, should safeguard developers from unfairly missing out on incentives due to factors beyond their influence.

Amendment 269 #

Proposal for a directive
Recital 60

(60) The Commission and Member States shall continuously monitor any data and learnings from the application of the incentives system in order to improve~~, including through implementing acts,~~ how these provisions are applied. The Commission shall establish a list of national contact points in this regard.

Amendment 270 #

Proposal for a directive
Recital 61

(61) When a compulsory licence has been granted by a relevant authority in the Union to tackle a public health emergency, regulatory data protection may, if still in force, prevent the effective use of the compulsory licence as they impede the authorisation of generic medicinal products, and thus access to the medicinal products needed to address the crisis. For this reason, data and market protection should be suspended when a compulsory licence has been issued to tackle a public health emergency. Such a suspension of the regulatory data protection should be allowed only in relation to the compulsory licence granted and its beneficiary. The suspension shall comply with the objective, the territorial scope, the duration and the subject matter of the granted compulsory licence.deleted

Amendment 271 #

Proposal for a directive
Recital 61

(61) When a compulsory licence has been granted by a relevant authority in the ~~Union to tackle a public health emergency, regulatory data protection~~, regulatory data protection, market protection and market exclusivity may, if still in force, prevent the effective use of the compulsory licence as they impede the authorisation of generic medicinal products, and thus access to the medicinal products needed ~~to address the crisis~~. For this reason, data and market protection and exclusivity should be suspended when a compulsory licence has been issued ~~to tackle a public health emergency~~. Such a suspension of the regulatory data protection, market protection and market exclusivity should be allowed only in relation to the compulsory licence granted and its beneficiary. The suspension shall comply with the objective, the territorial scope, the duration and the subject matter of the granted compulsory licence. Where necessary to safeguard public health, national competent authorities should be able to also reduce the duration of market and data protection and market exclusivity for medicinal products that are not protected by a patent or a supplementary protection certificate.

Amendment 272 #

Proposal for a directive
Recital 61

(61) When a compulsory licence has been granted by a relevant authority in the Union to ~~tackle a~~safeguard public health ~~emergency,~~,[A1] regulatory data protection may, if still in force, prevent the effective use of the compulsory licence as they impede the authorisation of generic medicinal products, and thus access to the medicinal products needed to address ~~the~~a crisis or safeguard public health interests as determined on a Member State level. For this reason, data and market protection should be suspended when a compulsory licence has been issued to ~~tackle a~~safeguard public health ~~emergency~~.. Such a suspension of the regulatory data protection should be allowed only in relation to the compulsory licence granted and its beneficiary. The suspension shall comply with the objective, the territorial scope, the duration and the subject matter of the granted compulsory licence.

Amendment 273 #

Proposal for a directive
Recital 61 a (new)

(61 a) The WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) provides for a possibility, under conditions, to issue compulsory licences. This provides governments the authority to grant the use of a patented invention without the consent of the patent owner. The Doha Declaration on the TRIPS Agreement and Public Health provides that each WTO Member has not only the right to grant compulsory licences, but also the freedom to determine the grounds upon which such licences are granted.

Amendment 274 #

Proposal for a directive
Recital 62

(62) The suspension of the regulatory data protection should be granted only for the duration of the compulsory licence. A ‘suspension‘ of data and market protection in cases of public health emergency shall mean that data and market protection shall produce no effect in relation to the particular licensee of the compulsory licence while that compulsory licence is in effect. When the compulsory licence ends, the data and market protection shall resume their effect. The suspension should not result in an extension of the original duration.deleted

Amendment 275 #

Proposal for a directive
Recital 62

(62) The suspension of the regulatory data protection should be granted only for the duration of the compulsory licence. A ‘suspension‘ of data and market protection ~~in cases of public health emergenc~~and market exclusivity shall mean that data and market protection and market exclusivity shall produce no effect in relation to the particular licensee of the compulsory licence while that compulsory licence is in effect. When the compulsory licence ends, the data and market protection shall resume their effect. The suspension should not result in an extension of the original duration.

Amendment 276 #

Proposal for a directive
Recital 62

(62) The suspension of the regulatory data protection should be granted only for the duration of the compulsory licence. A ‘suspension‘ of data and market protection ~~in cases of~~to safeguard public health ~~emergency~~ shall mean that data and market protection shall produce no effect in relation to the particular licensee of the compulsory licence while that compulsory licence is in effect. When the compulsory licence ends, the data and market protection shall resume their effect. The suspension should not result in an extension of the original duration.

Amendment 277 #

Proposal for a directive
Recital 63

(63) It is currently possible for applicants for marketing authorisation of ~~generic, biosimilar, hybrid and bio-hybrid~~ medicinal products to conduct studies, trials and the subsequent practical requirements necessary to obtain and vary regulatory approvals for those medicinal products during the term of protection of the patent or Supplementary Protection Certificate (SPC) of the reference medicinal relevant product, without this being considered patent or Supplementary Protection Certificate (SPC) infringement. The application of this limited exemption is however fragmented across the Union and ithe objective of enabling a day-one entry of generic and biosimilar medicinal products has not been fully achieved. The timely entry of generic and biosimilar medicinal products into the Union market is important in order to increase competition, reduce prices, ensure that national healthcare systems are sustainable and improve patients’ access to affordable medicines. It is considered necessary, in order to facilitate the market entry of medicinal products, in particular generic, biosimilar, hybrid and bio-hybrid medicinal products ~~that rel~~, on day one a ~~reference medicinal product,~~fter loss of the patent or SPC protection to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The exemption must be confined to conducting studies ~~and~~, trials and other activities needed for the regulatory approval process or administrative purposes, health technology assessment ~~and~~s, obtaining pricing and reimbursement ~~request~~, the public and private procurement of medicinal products to be supplied immediately after expiry of the relevant patents or SPC and complying with other regulatory or administrative requirements, including after a marketing authorisation has been granted, even though this may require substantial amounts of test production to demonstrate reliable manufacturing, both by the applicants and by third party suppliers or service providers. During the term of protection in a Member Stateof the patent or SPC of, for the re~~ference medicinal product, there can be no commercial us~~levant product or process, there can be placing on the market (within the meaning of the Commission Notice – The ‘Blue Guide’ on the implementation of EU product rules 2022 2022/C 247/01) in that Member State of the resulting final medicinal products obtained for the purposes of the regulatory approval process.

Amendment 278 #

Dolors MONTSERRAT, Massimiliano SALINI, Nathalie COLIN-OESTERLÉ, Stelios KYMPOUROPOULOS, Tomislav SOKOL

Proposal for a directive
Recital 63

(63) It is currently possible for applicants for marketing authorisation of ~~generic, biosimilar, hybrid and bio-hybrid~~ medicinal products to conduct studies, trials and the subsequent practical requirements necessary to obtain and vary regulatory approvals for those medicinal products ~~during the term of protection of the~~, without this being considered patent or Supplementary Protection Certificate ( SPC~~) of the reference medicinal product, without this being considered patent or SPC infringement. The application of th~~ infringement. The application of this limited exemption is however fragmented across the Union and the objective of enabling a day one entry of generic and biosimilar medicinal products has not been fully achieved. The timely entry of generic and biosimilar medicinal products into the Union market is lim~~ited exemption is however fragmented across the Union and i~~portant in order to increase competition, reduce pr ices, ensure that national healthcare systems are sustainable and improve patients’ access to affordable medicines. It is considered necessary, in order to facilitate the market entry of medicinal products, in particular generic, biosimilar, hybrid and bio- hybrid medicinal products ~~that rel~~, on day one a ~~reference medicinal product~~fter loss of the patent or SPC protection , to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The exemption must be confined to conducting studies ~~and~~, trials and other activities needed for the regulatory approval process or administrative purposes , health technology assessment ~~and~~s, obtaining pricing and reimbursement ~~request~~, the public and private procurement of medicinal products to be supplied immediately after expiry of the relevant patents or SPC and complying with other regulatory or administrative requirements, including after a marketing authorisation has been granted, even though this may require substantial amounts of test production to demonstrate reliable manufacturing, both by the applicants and by third party suppliers or service providers. During the term of protection in a Member State of the patent or SPC of, for the re~~ference medicinal product, there can be no commercial us~~levant product or process , there can be no placing on the market (within the meaning of the Commission Notice – The ‘Blue Guide’ on the implementation of EU product rules 2022 2022/C 247/01) in that Member State of the resulting final medicinal products obtained for the purposes of the regulatory approval process.

Amendment 279 #

Proposal for a directive
Recital 63

(63) It is currently possible for applicants for marketing authorisation of generic, biosimilar, hybrid and bio-hybrid medicinal products to conduct studies, trials and the subsequent practical requirements necessary to obtain and vary regulatory approvals for those medicinal products during the term of protection of the patent or Supplementary Protection Certificate (SPC) of the reference medicinal product, without this being considered patent or SPC infringement. The application of this limited exemption is however fragmented across the Union and ithe objective of enabling a day-one entry of generic and biosimilar medicinal products has not been fully achieved. The timely entry of generic and biosimilar medicinal products into the Union market is important in order to increase competition, reduce prices, ensure that national healthcare systems are sustainable and improve patients’ access to affordable medicines. It is considered necessary, in order to facilitate the market entry of medicinal products, in particular generic, biosimilar, hybrid and bio-hybrid medicinal products ~~that rel~~, on day one a ~~reference medicinal product~~fter loss of the patent or SPC protection, to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The exemption must be confined to conducting studies ~~and~~, trials and other activities needed for the regulatory approval process or administrative purposes, health technology assessment ~~and~~s, obtaining pricing and reimbursement ~~request~~, and complying with other regulatory or administrative requirements, including after a marketing authorisation has been granted, even though this may require substantial amounts of test production to demonstrate reliable manufacturing, both by the applicants and by third party suppliers or service providers. During the term of protection in a Member State of the patent or SPC of the reference medicinal ~~product, there can be no commercial us~~relevant product or process, there can be no placing on the market (within the meaning of the Commission Notice – The ‘Blue Guide’ on the implementation of EU product rules 2022 2022/C 247/01) in that Member State of the resulting final medicinal products obtained for the purposes of the regulatory approval process.

Amendment 280 #

Adam JARUBAS, Ewa KOPACZ, Elżbieta Katarzyna ŁUKACIJEWSKA

Proposal for a directive
Recital 63

(63) It is currently possible for applicants for marketing authorisation of ~~generic, biosimilar, hybrid and bio-hybrid~~ medicinal products to conduct studies, trials and the subsequent practical requirements necessary to obtain and vary regulatory approvals for those medicinal products ~~during the term of protection of the~~without this being considered patent or Supplementary Protection Certificate (SPC) ~~of the reference medicinal product, without this being considered patent or SPC infringement. The application of th~~infringement. The application of this limited exemption is however fragmented across the Union and the objective of enabling a day one entry of generic and biosimilar medicinal products has not been fully achieved. The timely entry of generic and biosimilar medicinal products into the Union market is lim~~ited exemption is however fragmented across the Union and i~~portant in order to increase competition, reduce prices, ensure that national healthcare systems are sustainable and improve patients’ access to affordable medicines. It is considered necessary, in order to facilitate the market entry of medicinal products, in particular generic, biosimilar, hybrid and bio-hybrid medicinal product~~s that rel~~ on day one a ~~reference medicinal product~~fter loss of the patent or SPC protection, to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The exemption must be confined to conduct studies and trials and other activities needed for the regulatory approval process or administrative purposes, health technology assessment ~~and~~, obtaining pricing and reimbursement ~~request~~decisions, the public and private procurement of medicinal products to be supplied immediately after ex piry of the relevant patents or SPC and complying with other regulatory or administrative requirements, including after a marketing authorisation has been granted, even though this may require substantial amounts of test production to demonstrate reliable manufacturing, both by the applicants and by third party suppliers or service providers. During the term of protection in a Member State of the patent or SPC ofor the re~~ference medicinal product, there can be no commercial us~~levant product or or process, there can be no placing on the market in that Member State of the resulting final medicinal products obtained for the purposes of the regulatory approval process (within the meaning of the Commission Notice – The ‘Blue Guide’ on the implementation of EU product rules 2022 2022/C 247/01).

Amendment 281 #

Proposal for a directive
Recital 63

(63) It is currently possible for applicants for marketing authorisation of ~~generic, biosimilar, hybrid and bio-hybrid~~ medicinal products to conduct studies, trials and the subsequent practical requirements necessary to obtain and vary regulatory approvals for those medicinal products ~~during the term of protection of the~~, without this being considered patent or Supplementary Protection Certificate (SPC) ~~of the reference medicinal product, without this being considered patent or SPC infringement. The application of th~~infringement. The application of this limited exemption is however fragmented across the Union and the objective of enabling a day-one entry of generic and biosimilar medicinal products has not been fully achieved. The timely entry of generic and biosimilar medicinal products into the Union market is lim~~ited exemption is however fragmented across the Union and i~~portant in order to increase competition, reduce prices, ensure that national healthcare systems are sustainable and improve patients’ access to affordable medicines. It is considered necessary, in order to facilitate the market entry of medicinal products, in particular of generic, biosimilar, hybrid and bio- hybrid medicinal products ~~that rel~~on day one a ~~reference medicinal product~~fter after the loss of the patent or SPC protection, to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The exemption must be confined to conducting studies ~~and~~, trials and other activities needed for the regulatory approval process or administrative purposes, health technology assessment ~~and pricing reimbursement request~~s, pricing and reimbursement, the public and private procurement of medicinal products to be supplied immediately after expiry of the relevant patents or SPC and complying with other regulatory or administrative requirements, including after a marketing authorisation has been granted, even though this may require substantial amounts of test production to demonstrate reliable manufacturing, both by the applicants and by third party suppliers or service providers. During the term of protection in a Member Stat of the patent or SPC ofor the re~~ference medicinal product, there can be no commercial us~~levant product or process, there can be no placing on the market (within the meaning of the Commission Notice – The ‘Blue Guide’ on the implementation of EU product rules 2022 2022/C 247/01) in that Member State of the resulting final medicinal products obtained for the purposes of the regulatory approval process.

Amendment 282 #

Proposal for a directive
Recital 63

(63) It is currently possible for applicants for marketing authorisation of ~~generic, biosimilar, hybrid and bio-hybrid~~ medicinal products to conduct studies, trials and the subsequent practical requirements necessary to obtain and vary regulatory approvals for those medicinal products ~~during the term of protection of the~~without this being considered patent or Supplementary Protection Certificate (SPC) ~~of the reference medicinal product, without this being considered patent or SPC infringement. The application of th~~infringement. The application of this limited exemption is however fragmented across the Union and the objective of enabling a day-one entry of generic and biosimilar medicinal products has not been fully achieved. The timely entry of generic and biosimilar medicinal products into the Union market is lim~~ited exemption is however fragmented across the Union and i~~portant in order to increase competition, reduce prices, ensure that national healthcare systems are sustainable and improve patients’ access to affordable medicines. It is considered necessary, in order to facilitate the market entry of medicinal products, in particular generic, biosimilar, hybrid and bio-hybrid medicinal products ~~that rel~~on day one a ~~reference medicinal product,~~fter loss of the patent or SPC protection to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The exemption must be confined to conducting studies ~~and~~, trials and other activities needed for the regulatory approval process or administrative purposes, health technology assessment ~~and~~, obtaining pricing and reimbursement ~~request~~, the public and private procurement of medicinal products to be supplied immediately after expiry of the relevant patents or SPC and complying with other regulatory or administrative requirements, including after a marketing authorisation has been granted, even though this may require substantial amounts of test production to demonstrate reliable manufacturing, both by the applicants and by third party suppliers or service providers. During the term of protection in a Member State of the patent or SPC of, for the re~~ference medicinal product, there can be no commercial us~~levant product or process, there can be no placing on the market (within the meaning of the Commission Notice – The ‘Blue Guide’ on the implementation of EU product rules 2022 2022/C 247/01) in that Member State of the resulting final medicinal products obtained for the purposes of the regulatory approval process.

Amendment 283 #

Proposal for a directive
Recital 63

(63) It is currently possible for applicants for marketing authorisation of ~~generic, biosimilar, hybrid and bio-hybrid~~ medicinal products to conduct studies, trials and the subsequent practical requirements necessary to obtain and vary regulatory approvals for those medicinal products during the term of protection of the patent or Supplementary Protection Certificate (SPC) of the reference medicinal product, without this being considered patent or SPC infringement. The application of thwithout this being considered patent or SPC infringement. The application of this limited exemption is however fragmented across the Union and the objective of enabling a day-one entry of generic and biosimilar medicinal products has not been fully achieved. The timely entry of generic and biosimilar medicinal products into the Union market is lim~~ited exemption is however fragmented across the Union and i~~portant in order to increase competition, reduce prices, ensure that national healthcare systems are sustainable and improve patients’ access to affordable medicines. It is considered necessary, in order to facilitate the market entry of medicinal products, in particular generic, biosimilar, hybrid and bio-hybrid medicinal products ~~that rel~~,on day one a ~~reference medicinal product,~~fter loss of the patent or SPC protection to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The exemption must be confined to conducting studies ~~and~~, trials and other activities needed for the regulatory approval process or administrative purposes, health technology assessment ~~and~~s, obtaining pricing and reimbursement ~~request~~, the public and private procurement of medicinal products to be supplied immediately after expiry of the relevant patents or SPC and complying with other regulatory or administrative requirements, including after a marketing authorisation has been granted, even though this may require substantial amounts of test production to demonstrate reliable manufacturing, both by the applicants and by third party suppliers or service providers. During the term of protection in a MS of the patent or SPC ofor the re~~ference~~levant medicinal product or process, there can be no ~~commercial us~~placing on the market (within the meaning of the Commission Notice – The ‘Blue Guide’ on the implementation of EU product rules 2022 2022/C 247/01) in that Member State of the resulting final medicinal products obtained for the purposes of the regulatory approval process.

Amendment 284 #

Proposal for a directive
Recital 63

(63) ~~It is currently possible for applicants for marketing authorisation of generic, biosimilar, hybrid and bio-hybrid medicinal products to conduct studies, trials and the subsequent practical requireme~~The timely entry of generics and biosimilars onto the Union market is importants, n~~ecessar~~otably to ~~obta~~in cre~~gulatory approvals for those medicinal products during the term of protection of the patent or Supplementary Protection Certifi~~ase competition, to reduce prices and to ensure both the sustainability of national healthcatre ~~(SPC) of the reference medicinal product, without this being considered~~systems and better access to affordable medicines by patient ~~or SPC infringement. The application of this limited exemption is however fragmented across the Union and~~s in the EU. The importance of such timely entry has been underlined by the Council in it is considered necessary, in order to facilitate the market entry of generic, biosimilar, hybrid and bio-hybrid medicinal products that rely on a reference medicinal product, to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The exemption must be confinedclusions of 17 June 2016 on strengthening the balance in the pharmaceutical systems in the Union and its Member States. It is currently possible for applicants for marketing authorisation of medicinal products to conduct studies ~~and~~, trials and othe~~r activities needed for the regulatory approval process, health technology assessment and pricing reimbursement request, even~~ subsequent practical requirements necessary to obtain regulatory approvals and variations thereof, withought this may require substantial amounts of test production to demonstrate reliable manufacturing. During the term of protection of the patent or SPC of the reference medicinal product, there can be no commercial use of the resulting final medicinal products obtained for the purposes of the regulatory approval processbeing considered patent or Supplementary Protection Certificate (SPC) infringement.

Amendment 285 #

Proposal for a directive
Recital 63

(63) It is currently possible for applicants for marketing authorisation of generic, biosimilar, hybrid and bio-hybrid medicinal products to conduct studies, trials and the subsequent practical requirements necessary to obtain and vary regulatory approvals for those medicinal products during the term of protection of the patent or Supplementary Protection Certificate (SPC) of the reference medicinal relevant product, without this being considered patent or SPCupplementary Protection Certificate (SPC) infringement. The application of this limited exemption is however fragmented across the Union and ithe objective of enabling a day-one entry of generic and biosimilar medicinal products has not been fully achieved. The timely entry of generic and biosimilar medicinal products into the Union market is important in order to increase competition, reduce prices, ensure that national healthcare systems are sustainable and improve patients’ access to affordable medicines. It is considered necessary, in order to facilitate the market entry of medicinal products, in particular generic, biosimilar, hybrid and bio-hybrid medicinal products ~~that rel~~, on day one a ~~reference medicinal product~~fter loss of the patent or SPC protection , to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The exemption must be confined to conduct studies and trials and other activities needed for the regulatory approval process, health technology assessment and pricing reimbursement request, even though this may require substantial amounts of test production to demonstrate reliable manufacturing. During the term of protection of the patent or SPC of the reference medicinal product, there can be no commercial use of the resulting final medicinal products obtained for the purposes of the regulatory approval process.

Amendment 286 #

Proposal for a directive
Recital 63

(63) It is currently possible for applicants for marketing authorisation of generic, biosimilar, hybrid and bio-hybrid medicinal products to conduct studies, trials and the subsequent practical requirements necessary to obtain regulatory approvals for those medicinal products during the term of protection of the patent or Supplementary Protection Certificate (SPC) of the reference medicinal product, without this being considered patent or SPC infringement. The application of this limited exemption is however fragmented across the Union and it is considered necessary, in order to facilitate the market entry of generic, biosimilar, hybrid and bio-hybrid medicinal products that rely on a reference medicinal product, on day one after loss of the patent and SPC protection of the said reference medicinal product, to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The timely entry of generic and biosimilar medicinal products into the Union market is important in order to increase competition, reduce prices, ensure that national healthcare systems are sustainable and improve patients’ access to affordable medicines. The exemption must be confined to conduct studies and trials and other activities needed for the regulatory approval process, health technology assessment and for obtaining pricing and reimbursement ~~request~~, even though this may require substantial amounts of test production to demonstrate reliable manufacturing. During the term of protection of the patent or SPC of the reference medicinal product, there can be no ~~commercial use~~placing on the market of the resulting final medicinal products obtained for the purposes of the regulatory approval process.

Amendment 287 #

Proposal for a directive
Recital 63

(63) It is currently possible for applicants for marketing authorisation of generic, biosimilar, hybrid and bio-hybrid medicinal products to conduct studies, trials and the subsequent practical requirements necessary to obtain regulatory approvals for those medicinal products during the term of protection of the patent or Supplementary Protection Certificate (SPC) of the reference medicinal product, without this being considered patent or SPC infringement. The application of this limited exemption is however fragmented across the Union and it is considered necessary, in order to facilitate the market entry ofn day-one of medicinal products, in particular generic, biosimilar, hybrid and bio-hybrid medicinal products that rely on a reference medicinal product, to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The entry of generic, biosimilar, hybrid and bio-hybrid into the Union market on day-one is necessary to increase competition, improve patient's access to affordable medicines and reduce the pressure on national healthcare systems. The exemption must be confined to conduct studies and trials and other activities needed for the regulatory approval process or administrative purposes, health technology assessment and to obtain pricing reimbursement request, even though this may require substantial amounts of test production to demonstrate reliable manufacturing. During the term of protection of the patent or SPC of the reference medicinal product, there can be no commercial use of the resulting final medicinal products obtained for the purposes of the regulatory approval process.

Amendment 288 #

Proposal for a directive
Recital 63

Amendment 289 #

Proposal for a directive
Recital 63 a (new)

(63 a) The application of this limited exemption is however fragmented across the Union and it is considered necessary, in order to facilitate entering the market of any Member State of medicinal products and in particular generic, biosimilar, hybrid and bio-hybrid medicinal products, upon expiry of the corresponding patent or supplementary protection certificate (EU ‘Day-one’ entry) that rely on a reference medicinal product, to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The exemption must be confined to conduct studies, trials and other activities needed for the administrative or regulatory approval process, health technology assessment and and for obtaining pricing and reimbursement, as well as the public and private procurement of medicinal products to be supplied immediately after tbe expiry of the corresponding patent or supplementary protection certificate), even though this may require substantial amounts of test production to demonstrate reliable manufacturing both by the applicant or third party suppliers or service providers. During the term of protection of the patent or SPC of the medicinal product, there can be no placing on the market (within the meaning of the Commission Notice – The ‘Blue Guide’ on the implementation of EU product rules 2022 2022/C 247/01) in that Member State) of the resulting final medicinal products obtained for the purposes of the regulatory approval process.

Amendment 290 #

Proposal for a directive
Recital 64

(64) It will allow all steps required to effectively launch on day-one after patent or SPC protection, inter alia, to conduct ~~stud~~activities to support ~~pricing and reimbursement~~to support regulatory approval, health technology assessments, pricing and reimbursement and other regulatory procedures and requirements in the Union or elsewhere, including after a marketing authorisation has been granted, as well as the manufacture or purchase of ~~patent protected~~ active substances for the ~~purpose of seeking marketing authorisations during that period, contributing to~~aforementioned purposes, contributing to the timely market entry medicinal products, in particular the market entry of generics and biosimilars, on day one ofafter loss of the patent or SPC protection, under fair competitive conditions.

Amendment 291 #

Dolors MONTSERRAT, Massimiliano SALINI, Nathalie COLIN-OESTERLÉ, Stelios KYMPOUROPOULOS

Proposal for a directive
Recital 64

(64) It will allow~~, inter alia, to conduct studies to support pricing and reimbursement~~ all steps required to effectively launch on day-one after patent or SPC protection, inter alia, to conduct studies activities to support regulatory approval, health technology assessments, pricing and reimbursement and other regulatory procedures and requirements in the Union or elsewhere, including after a marketing authorisation has been granted, as well as the manufacture or purchase of patent protected active substances for the aforementioned purposes of seeking marketing authorisations during that period, contributing to the timely market entry of medicinal products, in particular the market entry of generics and biosimilars on day one after of loss of the patent or SPC protection under fair competitive conditions.

Amendment 292 #

Proposal for a directive
Recital 64

(64) It will allow all steps required to effectively launch on day-one after patent or SPC protection, inter alia, to conduct ~~stud~~activities to support ~~pricing and reimbursement as well as the manufacture or purchase of patent protected active substances for the purpose of seeking marketing authorisations during that period, contributing to~~regulatory approval, health technology assessments, pricing and reimbursement and other regulatory procedures and requirements in the Union or elsewhere, including after a marketing authorisation has been granted, as well as the manufacture or purchase of patent protected active substances for the aforementioned purposes, contributing to the timely market entry of medicinal products, in particular the market entry of generics and biosimilars, on day one ofafter loss of the patent or SPC protection, under fair competitive conditions.

Amendment 293 #

Proposal for a directive
Recital 64

(64) It will allow all steps required to effectively launch on day-one after patent or SPC protection, inter alia, to conduct ~~stud~~activities to support ~~pricing and reimbursement~~regulatory approval, health technology assessments, pricing and reimbursement and other regulatory procedures and requirements in the Union or elsewhere, including after a marketing authorisation has been granted, as well as the manufacture or purchase of ~~patent protected~~ active substances for the ~~purpose of seeking marketing authorisations during that period, contributing to~~aforementioned purposes, contributing to the timely market entry of medicinal products, in particular the market entry of generics and biosimilars on day one ofafter loss of the patent or SPC protection, under fair competitive conditions.

Amendment 294 #

Adam JARUBAS, Ewa KOPACZ, Elżbieta Katarzyna ŁUKACIJEWSKA

Proposal for a directive
Recital 64

(64) It will allow all steps required to effectively launch on day-one after patent or SPC protection, inter alia, to conduct ~~stud~~activities to support ~~pricing and reimbursement~~regulatory approval, health technology assessments, pricing and reimbursement and other regulatory procedures and requirements in the Union or elsewhere, including after a marketing authorisation has been granted, as well as the manufacture or purchase of ~~patent protected~~ active substances for the ~~purpose of seeking marketing authorisations during that period, contributing to~~aforementioned purpose, contributing to the timely market entry of medicinal products, in particular the market entry of generics and biosimilars on day one ofafter loss of the patent or SPC protection, under fair competitive conditions.

Amendment 295 #

Proposal for a directive
Recital 64

(64) It will allow all steps required to effectively launch on day-one after patent or SPC protection, inter alia, to conduct ~~stud~~activities to support ~~pricing and reimbursement~~regulatory approval, health technology assessments, pricing and reimbursement and other regulatory procedures and requirements in the Union or elsewhere, including after a marketing authorisation has been granted, as well as the manufacture or purchase of ~~patent protected~~ active substances for the ~~purpose of seeking marketing authorisations during that period, contributing to~~aforementioned purposes contributing to the timely market entry of medicinal products, in particular the market entry of generics and biosimilars on day one ofafter loss of the patent or SPC protection, under fair competitive conditions.

Amendment 296 #

Proposal for a directive
Recital 64

(64) It will allow all steps required to effectively launch on day-one after patent or SPC protection, inter alia, to conduct ~~stud~~activities to support ~~pricing and reimbursement~~regulatory approval, health technology assessments, pricing and reimbursement and other regulatory procedures and requirements in the Union or elsewhere, including after a marketing authorisation has been granted, as well as the manufacture or purchase of ~~patent protected~~ active substances for the ~~purpose of seeking marketing authorisations during that period, contributing to~~aforementioned purposes, contributing to the timely market entry of medicinal products, in particular the market entry of generics and biosimilars, on day one ofafter loss of the patent or SPC protection, under fair competitive conditions.

Amendment 297 #

Proposal for a directive
Recital 64

(64) It will allow all steps required to effectively launch on day-one after patent and SPC protection, inter alia, to conduct ~~stud~~activities to support regulatory approval, health technology assessment, pricing and reimbursement as well as the manufacture or purchase of patent protected active substances for the ~~purpose of seeking marketing authorisations during that period~~aforementioned purposes, contributing to the market entry of generics and biosimilars on day one of loss of the patent or SPC protection.

Amendment 298 #

Proposal for a directive
Recital 64

(64) It will allow all steps required to effectively launch on day-one after patent and SPC protection, inter alia, to conduct ~~stud~~activities to support regulatory approval, health technology assessment, pricing and reimbursement as well as the manufacture or purchase of patent protected active substances for the ~~purpose of seeking marketing authorisations during that period~~aforementioned purpose, contributing to the market entry of generics and biosimilars on day one of loss of the patent or SPC protection.

Amendment 299 #

Proposal for a directive
Recital 65

(65) ~~The competent authorities should refuse the validation for an application for a marketing authorisation referring to data of a reference medicinal product~~Avoiding that circumstances may encourage inappropriate market behaviours hampering the emergence of generic and biosimilar medicinal products, ensuring timely availability of generic and biosimilar medicinal products and ending patent linkage were highlighted as priorities by Council conclusions and a resolution of the European Parliament. The competent authorities should refuse the validation for an application for a marketing authorisation referring to data of a reference medicinal product or for an application for pricing and reimbursement or for the public and private procurement of medicinal products to be supplied immediately after expiry of the relevant patents or SPC only on the basis of the grounds set out in this Directive. The same applies to any decision to grant, vary, suspend, restrict or revoke the marketing authorisation or pricing and reimbursement. The competent authorities cannot base their decision on any other grounds. In particular, those decisions cannot be based on the patent or SPC status of the reference medicinal product and cannot be subject to any requirements that expose an applicant to a risk of infringement of the relevant patent or SPC.

Amendment 300 #

Proposal for a directive
Recital 65

Amendment 301 #

Adam JARUBAS, Ewa KOPACZ, Elżbieta Katarzyna ŁUKACIJEWSKA

Proposal for a directive
Recital 65

(65) ~~The competent authorities should refuse the validation for an application for a marketing authorisation referring to data of a reference medicinal product~~Avoiding that circumstances may encourage inappropriate market behaviours hampering the emergence of generic and biosimilar medicinal products, ensuring timely availability of generic and biosimilar medicinal products and ending patent linkage were highlighted as priorities by Council conclusions and a resolution of the European Parliament. The competent authorities should refuse the validation for an application for a marketing authorisation referring to data of a reference medicinal product or for an application for pricing and reimbursement or for the public and private procurement of medicinal products to be supplied immediately after expiry of the relevant patents or SPC only on the basis of the grounds set out in this Directive. The same applies to any decision to grant, vary, suspend, restrict or revoke the marketing authorisation or pricing and reimbursement. The competent authorities cannot base their decision on any other grounds. In particular, those decisions cannot be based on the patent or SPC status of the reference medicinal product. and cannot be subject to any requirements that expose an applicant to a risk of infringement of the relevant patent or SPC

Amendment 302 #

Proposal for a directive
Recital 65

(65) ~~The competent authorities should refuse the validation for an application for a marketing authorisation referring to data of a reference medicinal product~~Avoiding that circumstances may encourage inappropriate market behaviours hampering the emergence of generic and biosimilar medicinal products, ensuring timely availability of generic and biosimilar medicinal products and ending patent linkage were highlighted as priorities by Council1a and the European Parliament1b. The competent authorities should refuse the validation for an application for a marketing authorisation referring to data of a reference medicinal product or for an application for pricing and reimbursement or for the public and private procurement of medicinal products to be supplied immediately after expiry of the relevant patents or SPC only on the basis of the grounds set out in this Directive. The same applies to any decision to grant, vary, suspend, restrict or revoke the marketing authorisation or pricing and reimbursement. The competent authorities cannot base their decision on any other grounds. In particular, those decisions cannot be based on the patent or SPC status of the reference medicinal product. and cannot be subject to any requirements that expose an applicant to a risk of infringement of the relevant patent or SPC. _________________ 1a Council conclusions on strengthening the balance in the pharmaceutical systems in the EU and its Member States, (OJ C, C/269, 23.07.2016, p. 31) Council Conclusions on Access to medicines and medical devices for a Stronger and Resilient EU, (2021/C 269 I/02) 1b European Parliament resolution of 2 March 2017 on EU options for improving access to medicine (2016/2057(INI))

Amendment 303 #

Dolors MONTSERRAT, Massimiliano SALINI, Nathalie COLIN-OESTERLÉ, Stelios KYMPOUROPOULOS, Tomislav SOKOL

Proposal for a directive
Recital 65

(65) Avoiding that circumstances may encourage inappropriate market behaviours hampering the emergence of generic and biosimilar medicinal products, ensuring timely availability of generic and biosimilar medicinal products and ending patent linkage were highlighted as priorities by Council conclusions1a and a resolution of the European Parliament2a. The competent authorities should refuse the validation for an application for a marketing authorisation referring to data of a reference medicinal product or for an application for pricing and reimbursement only on the basis of the grounds set out in this Directive. The same applies to any decision to grant, vary, suspend, restrict or revoke the marketing authorisation or pricing and reimbursement. The competent authorities cannot base their decision on any other grounds. In particular, those decisions cannot be based on the patent or SPC status of the reference medicinal product. and cannot be subject to any requirements that expose an applicant to a risk of infringement of the relevant patent or SPC. _________________ 1a Council conclusions on strengthening the balance in the pharmaceutical systems in the EU and its Member States. Council Conclusions on Access to medicines and medical devices for a Stronger and Resilient EU 2a European Parliament resolution of 2 March 2017 on EU options for improving access to medicine

Amendment 304 #

Proposal for a directive
Recital 65

(65) The competent authorities should refuse the validation for an application for a marketing authorisation referring to data of a reference medicinal product or for an application for pricing and reimbursement or for the public and private procurement of medicinal products to be supplied immediately after expiry of the relevant patents or SPC only on the basis of the grounds set out in this Directive. The same applies to any decision to grant, vary, suspend, restrict or revoke the marketing authorisation or pricing and reimbursement. The competent authorities cannot base their decision on any other grounds. In particular, those decisions cannot be based on the patent or SPC status of the reference medicinal product and cannot be subject to any requirements that expose an applicant to a risk of infringement of the relevant patent or SPC.

Amendment 305 #

Proposal for a directive
Recital 65 a (new)

(65 a) The One Health Approach is needed in order to address antimicrobial resistance, one of the biggest current health threats as it is estimated that more than 35 000 people in the EU/EEA and more than 1.2 million people globally die each year as a direct consequence of an infection due to bacteria resistant to antibiotics1a. High levels of cooperation are required across sectors and globally; this Directive puts in place coordinated action order to ensure prevention and minimisation of environmental risk assessment throughout the supply chain, use and disposal, awareness raising among patients, consumers and healthcare professionals and prudent and responsible use of antimicrobials; _________________ 1a 4 Murray, C.J.L., Ikuta, K.S., Sharara, F., et al. ‘Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis’, Lancet, Vol. 399, No 10325, pp. 629-655:

Amendment 306 #

Proposal for a directive
Recital 65 a (new)

(65 a) Under EU law, originator reference product patent protection status is not a criterion to be considered by authorities when granting a marketing authorisation, approving pricing or granting reimbursement status or any regulatory approval for a generic medicinal product, due to its anitcompetitive effects. In the context of the goals of the revision of the pharmaceutical framework, it is therefore appropriate to explicitly prohibit patent linkage practices in this context.

Amendment 307 #

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ, Erik POULSEN

Proposal for a directive
Recital 66

(66) In order to address the challenge of antimicrobial resistance, ~~antimicrobials should be packaged in quantities that are appropriate for the therapy cycle relevant for that product and n~~per unit dispensing of antimicrobials has been recognised as a core element in medical guidelines and the marketing authorisation holders should ensure, whenever possible, that antimicrobials may be dispensed in a number corresponding to the quantities prescribed by the treating physician. Dispensing the exact number of units needed would help address antimicrobial resistance as well as environmental impact related to stocking and waste. National rules on antimicrobial subject to prescription ensure that they are dispensed in a way that corresponds to the quantities described by the ptre~~scription~~ating physician based on a personalised approach.

Amendment 308 #

Proposal for a directive
Recital 67

(67) The provision of information to healthcare professionals and to patients on the appropriate use, storage and disposal of antimicrobials is a joint responsibility of marketing authorisation holders and of Member States ~~who~~. Member States should ensure appropriate collection system for all medicinal products.

Amendment 309 #

Proposal for a directive
Recital 67

(67) The provision of information to healthcare professionals and to patients on the appropriate use, storage and disposal of antimicrobials is a joint responsibility of marketing authorisation holders and of Member States who should ensure appropriate collection and disposal system for all medicinal products.

Amendment 310 #

Proposal for a directive
Recital 68

(68) While this Directive restricts the use of antimicrobials by setting ~~certain categories of~~systemic antimicrobials under prescription status, due to the growing antimicrobial resistance in the Union, competent authorities of the Member States should consider further ~~measures for example~~a number of measures, including expanding the prescription status of antimicrobials or the mandatory use of diagnostic tests before prescription. Additionally, the combined use of several antimicrobial active substances may represent a particular risk with respect to the development of antimicrobial resistance. Such combined use should therefore only be prescriped in exceptional cases where the benefit-risk balance of the combination is favourable. Competent authorities of the Member States should consider such further measures according to the level of antimicrobial resistance in their territory and the needs of patients.

Amendment 311 #

Proposal for a directive
Recital 68

(68) While this Directive restricts the use of antimicrobials by setting certain categories of antimicrobials under prescription status, due to the growing antimicrobial resistance in the Union, competent authorities of the Member States should ~~consider~~put in place further measures, where appropriate, for example expanding the prescription status of antimicrobials or the mandatory use of diagnostic tests before prescription. Competent authorities ofshould ensure availability of rapid diagnostic tests in the Member States and should consider such further measures according to the level of antimicrobial resistance in their territory and the needs of patients.

Amendment 312 #

Proposal for a directive
Recital 68 a (new)

(68 a) In line with European Green Deal and the European Union Strategic Approach to Pharmaceuticals in the Environment, this regulatory framework should also contribute to avoiding potential risks to the environment. The evaluation of the framework showed that strengthened measures to reduce the environmental impact of medicinal products in the would be necessary.

Amendment 313 #

Proposal for a directive
Recital 69

(69) The pollution of waters and soils with pharmaceutical residues is an emerging environmental problem, and there is scientific evidence that the presence of those substances in the environment from their manufacturing, use and disposal poses a risk to the environment and public health. The evaluation of the legislation showed that strengthening of existing measures to reduce the impact of medicinal products' lifecycle on the environment and public health is required. Measures under this ~~Regulation~~Directive complement the main environmental legislation, in particular the Water Framework Directive (2000/60/EC50 ), the Environmental Quality Standard Directive (2008/105/EC51 ) the Groundwater Directive (2006/118/EC52 ), the Urban Wastewater Treatment Directive (91/271/EEC53 ), the Drinking Water Directive (2020/218454 ) and the Industrial Emissions Directive (2010/75/EU55 ). _________________ 50 Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1). 51 Directive 2008/105/EC of the European Parliament and of the Council of 16 December 2008 on environmental quality standards in the field of water policy, amending and subsequently repealing Council Directives 82/176/EEC, 83/513/EEC, 84/156/EEC, 84/491/EEC, 86/280/EEC and amending Directive 2000/60/EC of the European Parliament and of the Council (OJ L 348, 24.12.2008, p. 84). 52 Directive 2006/118/EC of the European Parliament and of the Council of 12 December 2006 on the protection of groundwater against pollution and deterioration (OJ L 372, 27.12.2006, p. 19). 53 Council Directive 91/271/EEC of 21 May 1991 concerning urban waste-water treatment (OJ L 135, 30.5.1991, p. 40). 54 Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality of water intended for human consumption (recast) (OJ L 435, 23.12.2020, p. 1). 55 Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control) (recast) (OJ L 334, 17.12.2010, p. 17).

Amendment 314 #

Proposal for a directive
Recital 69

(69) The pollution of waters and soils with pharmaceutical residues is an emerging environmental problem, and there is scientific evidence that the presence of those substances in the environment from their manufacturing, use and disposal poses a risk to the environment and public health. The evaluation of the legislation showed that strengthening of existing measures to reduce the impact of medicinal products' lifecycle on the environment and public health is required. Measures under this Regulation complement the main environmental legislation, in particular the Water Framework Directive (2000/60/EC50[1]), the Environmental Quality Standard Directive (2008/105/EC51[2]) the Groundwater Directive (2006/118/EC52[3]), the Urban Wastewater Treatment Directive (91/271/EEC53[4]), the Drinking Water Directive (2020/2184~~54) and~~[5]), the Industrial Emissions Directive (2010/75/EU~~55). _________________ 50 Directive 2000/60/EC of the European Parliament~~) and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1). 51 Directive 2008/105/EC of the European Parliament and of the Council of 16 December 2008 on environmental quality standards in the field of water policy, amending and subsequently repealing Council Directives 82/176/EEC, 83/513/EEC, 84/156/EEC, 84/491/EEC, 86/280/EEC and amending Directive 2000/60/EC of the European Parliament and of the Council (OJ L 348, 24.12.2008, p. 84). 52 Directive 2006/118/EC of the European Parliament and of the Council of 12 December 2006 on the protection of groundwater against pollution and deterioration (OJ L 372, 27.12.2006, p. 19). 53 Council Directive 91/271/EEC of 21 May 1991 concerning urban waste-water treatment (OJ L 135, 30.5.1991, p. 40). 54 Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality of water intended for human consumption (recast) (OJ L 435, 23.12.2020, p. 1). 55 Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control) (recast) (OJ L 334, 17.12.2010, p. 17Waste Framework Directive (2008/98/EC18a).

Amendment 315 #

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ, Erik POULSEN

Proposal for a directive
Recital 69

(69) The pollution of waters and soils with pharmaceutical residues is an emerging environmental problem, and there is scientific evidence that the ~~presenc~~levels of some of thoese substances inmay pose a risk to the environment from their manufacturing, use and disposal ~~poses a risk to the environment and public health~~. The evaluation of the legislation showed that strengthening of existing measures to reduce the impact of medicinal products' lifecycle on the environment and public health is required. Measures under this Regulation complement the main environmental legislation, in particular the Water Framework Directive (2000/60/EC50 ), the Environmental Quality Standard Directive (2008/105/EC51 ) the Groundwater Directive (2006/118/EC52 ), the Urban Wastewater Treatment Directive (91/271/EEC53 ), the Drinking Water Directive (2020/218454 ) and the Industrial Emissions Directive (2010/75/EU55 ). _________________ 50 Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1). 51 Directive 2008/105/EC of the European Parliament and of the Council of 16 December 2008 on environmental quality standards in the field of water policy, amending and subsequently repealing Council Directives 82/176/EEC, 83/513/EEC, 84/156/EEC, 84/491/EEC, 86/280/EEC and amending Directive 2000/60/EC of the European Parliament and of the Council (OJ L 348, 24.12.2008, p. 84). 52 Directive 2006/118/EC of the European Parliament and of the Council of 12 December 2006 on the protection of groundwater against pollution and deterioration (OJ L 372, 27.12.2006, p. 19). 53 Council Directive 91/271/EEC of 21 May 1991 concerning urban waste-water treatment (OJ L 135, 30.5.1991, p. 40). 54 Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality of water intended for human consumption (recast) (OJ L 435, 23.12.2020, p. 1). 55 Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control) (recast) (OJ L 334, 17.12.2010, p. 17).

Amendment 316 #

Proposal for a directive
Recital 69 a (new)

(69 a) A progressive reform towards unitary packaging of medicines, in particular in hospital pharmacies, could result in a decrease of the materials used for the packaging of medicines, a reduction of the carbon footprint of the transport of medicines, a reduction in medicines waste, a better management of pollution from pharmaceutical waste, a prevention of tension and shortages of medicines, and an innovative tool to fight against antimicrobial resistance. The use of single dose unit containing all usefull information, in hospital environnement, could represent an improvement in favor of minimizing the risk of medication errors and therefore increased patient protection.

Amendment 317 #

Proposal for a directive
Recital 69 a (new)

(69 a) The wide use of pharmaceuticals in human and veterinary medicines, including antimicrobials, and their concentrations in many environmental reservoirs such as soils, sediments and waterbodies has increased in the past 20 years and their environmental concentration and prospected to grow in the coming years due to increased use and aging populations; the occurence of pharmaceutical substances in the environment negatively impact human health as well as wildlife and ecosystems; the chemical and metabolic stability of certain pharmaceuticals means that up to 90 % of their active substances are released into the environment in their original form after use.

Amendment 318 #

Proposal for a directive
Recital 69 a (new)

(69 a) There is strong scientific evidence that the emissions of active substances during manufacturing are a threat to the environment and public health. Therefore, the requirements to protect the environment and public health should be extended in order to cover the entire lifecycle of medicinal products, starting from manufacturing, through use and to disposal.

Amendment 319 #

Proposal for a directive
Recital 69 b (new)

(69 b) There are currently 1,763 centrally authorised substances, yet, only 27 (1.5%) have sufficient empirical data for risk assessment and for 1,201 (68%) there is no monitoring nor ecotoxicological data currently available2b. This Directive should therefore aim to address this lack of monitoring data, lack of data on toxicity to environment, organisms and ecosystems. _________________ 2b Spilsbury (2023) “ Defining the Data Gap: What Do We Know about Environmental Exposure, Hazards and Risks of Pharmaceuticals in the European Aquatic Environment?” bioRxiv, doi: 10.1101/2023.07.10.548305.

Amendment 320 #

Proposal for a directive
Recital 70

(70) Marketing authorisation applications for medicinal products in the Union should include an Environmental Risk Assessment (ERA) and risk mitigation measures. The proven efficacy and safety of a medicinal product for human use should remain a top criteria in terms of marketing authorisation. However, applicants for marketing authorisation should ensure they complete the ERA in parallel with the marketing authorisation application to be able to sufficiently mitigate negative environmental impacts. The ERA should also evaluate the risks to the environment and public health, including antimicrobial resistance that arise in the manufacturing of medicinal products. If the applicant fails to submit a complete or sufficiently substantiated environmental risk assessment or they do not propose risk mitigation measures to sufficiently address the risks identified in the environmental risk assessment, the marketing authorisation should be refused. The ERA should be updated in a timely manner when new data or knowledge about relevant risks become available. and risk mitigation measures should be adapted accordingly. Moreover, to take into account the additional exposure resulting from the use of the medicinal product, the ERA should be updated in any case five years after the initial authorisation.

Amendment 321 #

Proposal for a directive
Recital 70

(70) Marketing authorisation applications for medicinal products in the Union should include an Environmental Risk Assessment (ERA) and risk mitigation measures. If the applicant fails to submit a complete or sufficiently substantiated environmental risk assessment or they do not propose risk mitigation measures to sufficiently address the risks identified in the environmental risk assessment, the marketing authorisation ~~should be refused~~could be refused. Refusal of a marketing authorization should not be considered if the medicinal product can be authorized under the conditional marketing authorization process or the Temporary Emergency Marketing Authorization in order to not prohibit or delay patient access to medicines. The ERA should be updated when new data or knowledge about relevant risks become available.

Amendment 322 #

Proposal for a directive
Recital 70

(70) Marketing authorisation applications for medicinal products in the Union should include an Environmental Risk Assessment (ERA) and risk mitigation measures in instances where the ERA indicates that medicinal products may be hazardous to the environment. If the applicant fails to submit a complete or sufficiently substantiated environmental risk assessment or they do not propose risk mitigation measures to sufficiently address the risks identified in the environmental risk assessment and does not rectify deficiencies highlighted by the Agency or relevant authority, the marketing authorisation holder should be ~~refused~~subject to proportionate measures taken to ensure compliance while not hindering or postponing patient access to medications. The ERA should be updated when new data or knowledge about relevant risks become available.

Amendment 323 #

Catherine AMALRIC, Max ORVILLE, Billy KELLEHER

Proposal for a directive
Recital 70

(70) Marketing authorisation applications for medicinal products in the Union should include an Environmental Risk Assessment (ERA) and risk mitigation measures where medicinal products are demonstrated to pose a risk to the environment according to the ERA. If the applicant fails to submit a complete or sufficiently substantiated environmental risk assessment or they do not propose risk mitigation measures to sufficiently address the risks identified in the environmental risk assessment, ~~the marketing authorisation should be refused. The ERA should be updated when new data or knowledg~~and fails to address short- comings indicated by the Agency or competent authority, the marketing authorisation shall be provisional while not prohibiting or delaying patient access to medicines. The ERA should be updated when new data that changes the ERA conclusions or evidence about relevant risks become available.

Amendment 324 #

Proposal for a directive
Recital 70

(70) Marketing authorisation applications for medicinal products in the Union should include an Environmental Risk Assessment (ERA) and risk mitigation measures. If the applicant fails to submit a complete or sufficiently substantiated environmental risk assessment or they do not propose risk mitigation measures to sufficiently address the risks identified in the environmental risk assessment, the marketing authorisation should be refused. The ERA should be updated when new data or knowledge about relevant risks become available. The Commission may explore creating an ecolabeling of medicinal products which respect the ERA's guidelines during their entire life cycle.

Amendment 325 #

Proposal for a directive
Recital 70

(70) Marketing authorisation applications for medicinal products in the Union should include an Environmental Risk Assessment (ERA) and risk mitigation measures. If the applicant fails to submit a complete or sufficiently substantiated environmental risk assessment or they do not propose risk mitigation measures to sufficiently address the risks identified in the environmental risk assessment, the marketing authorisation should be refused unless health benefits from authorisation of medicine outweight the enviromental risk. The ERA should be updated when new data or knowledge about relevant risks become available.

Amendment 326 #

Proposal for a directive
Recital 70

(70) Marketing authorisation applications for medicinal products in the Union should include an Environmental Risk Assessment (ERA) and risk mitigation measures. If the applicant fails to submit a complete or sufficiently substantiated environmental risk assessment or they do not propose risk mitigation measures to sufficiently address the risks identified in the environmental risk assessment, the marketing authorisation holder should be ~~refused~~subject to proportionate measures to establish compliance. The ERA should be updated when new data or knowledge about relevant risks become available.

Amendment 327 #

Proposal for a directive
Recital 70

(70) Marketing authorisation applications for medicinal products in the Union should include an Environmental Risk Assessment (ERA) and risk mitigation measures. If the applicant fails to submit a complete or sufficiently substantiated environmental risk assessment or, they do not propose risk mitigation measures to sufficiently address the risks identified in the environmental risk assessment or the environmental risk is deemed unacceptable, the marketing authorisation should be refused. The ERA should be updated each time when new data or knowledge about relevant risks become available.

Amendment 328 #

Proposal for a directive
Recital 70

(70) Marketing authorisation applications for medicinal products in the Union should include an Environmental Risk Assessment (ERA) and risk mitigation measures. If the applicant fails to submit a complete or sufficiently substantiated environmental risk assessment or they do not propose risk mitigation measures to sufficiently address the risks identified in the environmental risk assessment, the marketing authorisation holder should be ~~refused~~subject to proportionate measures to establish compliance. The ERA should be updated when new data or knowledge about relevant risks become available.

Amendment 329 #

Proposal for a directive
Recital 70 a (new)

(70 a) In exceptional cases where the ERA is incomplete due to missing data and this can be duly justified and substantiated by the marketing authorisation holder it should still be able to be placed on the market for reasons in the interest of public health, and with certain post authorisation conditions and oblgiations. Where a medicinal product has been authorised and the ERA is imcomplete for the reason above, the marketing authorisation holder should submit the completed ERA in the timeline agreed with the authorities and deliver upon any other post authorisation obligations.

Amendment 330 #

Proposal for a directive
Recital 70 b (new)

(70 b) Detailed requirements for an ERA should be set out in the annexes to this Directive for medicinal products that have been authorised prior to October 2005, i.e. prior to the requirement of submitting an ERA, and specific provisions should be introduced to set up a programme for the environmental risk assessement of those products that are identified as potentially harmful to the environment. Moreover, the establishment of a single Union assessment of the environmental properties of active substances for veterinary use by means of an active substance based review (‘monograph’) system could be potential alternative. Such a system should be set up by the Agency following a positive recommendation of the Commission.

Amendment 331 #

Proposal for a directive
Recital 71

(71) Marketing authorisation applicants should ~~take into account~~consider the relevance of environmental risk assessment ~~procedure~~s of other EU legal frameworks that may apply to chemicals dependent on their use. Further to this Regulation, there are four main other frameworks: (i) Industrial chemicals (REACH, (Regulation (EC) No 1907/2006); (ii) Biocides (Regulation (EC) No 528/2012); (iii) Pesticides (Regulation (EC) No 1107/2009); and (iv) Veterinary medicines (Regulation (EU) 2019/6)). As a part of the Green Deal, the Commission has proposed a ‘one-substance one- assessment’ (OS-OA) approach for chemicals56 , in order to increase the efficiency of the registration system, reduce costs and unnecessary animal testing while not prohibiting or delaying patient access to medicinal products. _________________ 56 Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions, The European Green Deal, Brussels (2019), COM(2019) 640 final.

Amendment 332 #

Proposal for a directive
Recital 72

(72) TLike every industrial sector, the production of medicines has a negative impact on the environment through CO2 emissions emitted by the medicine’s global supply chains and through pharmaceutical effluents from the production, use and disposal. In addition, the emissions and discharges of antimicrobials to the environment from manufacturing sites may lead to antimicrobial resistance (“AMR”), which is a global concern regardless where the emissions and discharges take place. Therefore, ~~the ERA scope should be extended to cover the risk of AMR selection dur~~addressing manufacturing, use and disposal through monitoring, assessing and preventing the enegatirve ~~life cycle of antimicrob~~impact, addressing inefficiencies and developing greener pharmaceuticals is crucials, in~~cluding manufacturing.~~ order to mitigate threats to public health.

Amendment 333 #

Proposal for a directive
Recital 72

(72) The emissions and discharges of antimicrobials to the environment from manufacturing sites may lead to the proliferation of antimicrobial resistance (“AMR”), which is a global concern regardless of where the emissions and discharges take place. Therefore, the ERA scope should be extended to cover the risk of AMR selection during the entire life cycle of antimicrobials, including manufacturing.

Amendment 334 #

Proposal for a directive
Recital 72

(72) The emissions and discharges of anti~~microbial~~biotics to the environmental from manufacturing sites may lead to anti~~microbial~~biotic resistance (~~“AMR”~~‘’ABR’’), which is a global concern regardless of where the emissions and discharges take place. Therefore, the ERA scope should be extended to cover the risk of ~~AMR selection during the entire life cycle of antimicrobials, including manufacturing~~antibiotic resistance selection during manufacturing of the antibiotics.

Amendment 335 #

Proposal for a directive
Recital 72

(72) The emissions and discharges of anti~~microbial~~biotics to the environment from manufacturing sites may lead to anti~~microbial~~biotic resistance (“AMBR”), which is a global concern regardless where the emissions and discharges take place. Therefore, the ERA scope should be extended to cover the risk of ~~AMR selection during the entire life cycle of antimicrobials, including manufacturing~~antibiotic resistance selection during manufacturing of the antibiotics.

Amendment 336 #

Proposal for a directive
Recital 74

(74) For medicinal products authorised prior to October 2005, without any ERA, specific provisions should be introduced to set up a risk based prioritisation programme for the ERA submission or update by the market authorisation holders for those medicinal products that present a serious risk to the environment.

Amendment 337 #

Proposal for a directive
Recital 74

(74) For medicinal products authorised prior to October 2005, without any ERA, specific provisions should be introduced to set up a risk based prioritisation programme for the ERA submission or update by the current market authorisation holders for those medicinal products that present a serious risk to the environment.

Amendment 338 #

Proposal for a directive
Recital 74 a (new)

(74 a) In order to reduce duplication, optimise resources, reduce the use of animals in research, address current lack of understanding and resources on the individual and aggregated impact of pharmaceutical substances in the environment, and in line with the Aarhus Convention, all data related to the environmental risk assessment studies should be made publicly available and easily accessible in a database stablished by the Agency.

Amendment 339 #

Dolors MONTSERRAT, Nathalie COLIN-OESTERLÉ, Tomislav SOKOL

(76) To ensure that all children in the Union have access to the products specifically authorised for paediatric use, when an agreed paediatric investigation plan has led to the authorisation of a paediatric indication for a product already marketed for other therapeutic indications, the marketing authorisation holder should be obliged to ~~plac~~make the ~~produc~~medicinal product available to patients and the prescribing doctors who requested it in the same markets within two years of the date of approval of the indication.

Amendment 340 #

Proposal for a directive
Recital 76

(76) To ensure that all children in the Union have access to the products specifically authorised for paediatric use, when an agreed paediatric investigation plan has led to the authorisation of a paediatric indication for a product already marketed for other therapeutic indications, the marketing authorisation holder should be obliged to ~~plac~~make the product available for ordering for paediatric patients in the same markets within two years of the date of approval of the indication.

Amendment 341 #

Proposal for a directive
Recital 76 a (new)

(76 a) For the purpose of paediatric marketing authorization of medicinal products already approved for use in adults, when the agreed paediatric investigation plan cannot be timely accomplished due to failure to conduct paediatric clinical studies, the competent authorities may consider the evidence obtained from extrapolation of adult data and from the appropriately designed post- marketing long-term studies for monitoring safety and efficacy.

Amendment 342 #

Proposal for a directive
Recital 79

(79) As a general rule, risk management plans for generic and biosimilar medicinal products should not be developed and submitted, considering that the reference medicinal product has such a plan, except in specific cases, where a risk management plan should be provided. Furthermore, as a general rule a marketing authorisation ~~should be granted for an unlimited period; exceptionally, one renewal may be decided only~~for products other than generics should be granted for a period of five years in order to allow for the integration of real world evidence and re-assessment of the risk- benefit balance; once renewed, the marketing authorisation should be valid for an unlimited period unless the competent authority exceptionally decides that an additional five-year renewal or revocation of the marketing authorisation is necessary based on justified grounds related to the safety of the medicinal product.

Amendment 343 #

Proposal for a directive
Recital 90

(90) It is recognised that the development of pharmaceuticals is an area where neither science, nor technology stand still. The last decades have seen new categories of medicinal products emerging from biological medicinal products to biosimilars or advanced therapy medicinal products or in the future phages therapies. Those categories of products may in some instances require adapted rules to fully take account of their specific characteristics. For that reason a forward looking legal framework should include provisions to enable such adapted frameworks subject to strict criteria and under a Commission empowerment guided by the scientific input of the European Medicines Agency, as well as incentives for the industry to develop pharmaceuticals that are less harmful to the environment.

Amendment 344 #

Proposal for a directive
Recital 91

(91) The adaptations may entail adapted, enhanced, waived or deferred requirements compared to standard medicinal products. They could in particular include changes to the dossier requirements for such medicinal products, the way their quality, safety ~~and~~, efficacy and environmental risk is demonstrated by applicants or tailored manufacturing controls and good manufacturing practices requirements, as well as additional control methods prior and during their administration and use. The adaptions should however not go beyond what is necessary for the attainment of the objective of adaptation to the specific characteristics.

Amendment 345 #

Susana SOLÍS PÉREZ, Catherine AMALRIC, Ondřej KNOTEK

Proposal for a directive
Recital 93

(93) To optimise the use of resources for both applicants for marketing authorisation and competent authorities and avoid duplication of assessment of chemical active substances of medicinal products, including radionuclides and their salts for radionuclide radiopharmaceuticals, and cell and gene therapies, marketing authorisation applicants should be able to rely on an active substance master file certificate or a monograph of the European Pharmacopeia, instead of submitting the relevant data as required in accordance with Annex II. An active substance master file certificate may be granted by the Agency when the relevant data on the active substance concerned is not already covered by a monograph of the European Pharmacopeia or by another active substance master file certificate. The Commission should be empowered to establish the procedure for the single assessment of an active substance master file. To further optimise the use of resources, the Commission should be empowered to allow use of a certification scheme also for additional master files, including quality master files, i.e. for active substances other than chemical active substances, or for other substances present or used in the manufacture of a medicinal product, required in accordance with Annex II, e.g. in case of novel excipients, adjuvants, ~~radiopharmaceutical precursor~~chemical precursors for complex radiopharmaceuticals, radionuclides for radiolabelling purposes and active substance intermediates, when the intermediate is a chemical active substance by itself or used in conjugation with a biological substance, as well as for raw materials and starting materials used for manufacturing of cell therapy and gene therapy.

Amendment 346 #

Proposal for a directive
Recital 93

(93) To optimise the use of resources for both applicants for marketing authorisation and competent authorities and avoid duplication of assessment of chemical active substances of medicinal products and cell and gene therapies, marketing authorisation applicants should be able to rely on an active substance master file certificate or a monograph of the European Pharmacopeia, instead of submitting the relevant data as required in accordance with Annex II. An active substance master file certificate may be granted by the Agency when the relevant data on the active substance concerned is not already covered by a monograph of the European Pharmacopeia or by another active substance master file certificate. The Commission should be empowered to establish the procedure for the single assessment of an active substance master file. To further optimise the use of resources, the Commission should be empowered to allow use a certification scheme also for additional quality master files i.e. for active substances other than chemical active substances, or for other substances present or used in the manufacture of a medicinal product, required in accordance with Annex II, e.g. in case of novel excipients, adjuvants, radiopharmaceutical precursors and active substance intermediates, when the intermediate is a chemical active substance by itself or used in conjugation with a biological substance as well as for the raw and initial materials employed in the production of cell and gene therapies, such as cytokines, culture media, reagents, plasmids, and viral vectors.

Amendment 347 #

Proposal for a directive
Recital 93

(93) To optimise the use of resources for both applicants for marketing authorisation and competent authorities and avoid duplication of assessment of chemical active substances of medicinal products, marketing authorisation applicants should be able to rely on an active substance master file certificate or a monograph of the European Pharmacopeia, instead of submitting the relevant data as required in accordance with Annex II. An active substance master file certificate may be granted by the Agency when the relevant data on the active substance concerned is not already covered by a monograph of the European Pharmacopeia or by another active substance master file certificate. The Commission should be empowered to establish the procedure for the single assessment of an active substance master file. To further optimise the use of resources, the Commission should be empowered to allow use a certification scheme also for additional quality master files i.e. for active substances other than chemical active substances, or for other substances present or used in the manufacture of a medicinal product, required in accordance with Annex II, e.g. in case of novel excipients, adjuvants, raw materials, viral vectors and other starting materials, growth media, radiopharmaceutical precursors and active substance intermediates, when the intermediate is a chemical active substance by itself or used in conjugation with a biological substance.

Amendment 348 #

Proposal for a directive
Recital 93

(93) To optimise the use of resources for both applicants for marketing authorisation and competent authorities and avoid duplication of assessment of chemical active substances of medicinal products, marketing authorisation applicants should be able to rely on an active substance master file certificate ~~or a monograph of the European Pharmacopeia~~, instead of submitting the relevant data as required in accordance with Annex II. An active substance master file certificate may be granted by the Agency when the relevant data on the active substance concerned is not already covered by ~~a monograph of the European Pharmacopeia~~ or by another active substance master file certificate. The Commission should be empowered to establish the procedure for the single assessment of an active substance master file. To further optimise the use of resources, the Commission should be empowered to allow use a certification scheme also for additional quality master files i.e. for active substances other than chemical active substances, or for other substances present or used in the manufacture of a medicinal product, required in accordance with Annex II, e.g. in case of novel excipients, adjuvants, radiopharmaceutical precursors and active substance intermediates, when the intermediate is a chemical active substance by itself or used in conjugation with a biological substance.

Amendment 349 #

Proposal for a directive
Recital 100

(100) It is necessary to take account of changes arising as a result of international harmonisation of definitions, terminology and technological developments in the field of pharmacovigilance and digitalisation.

Amendment 350 #

Proposal for a directive
Recital 101

(101) The increasing use of electronic networks for communication of information on adverse reactions to medicinal products marketed in the Union is intended to allow competent authorities to share the information at the same time. In that regard, patients, consumers and healthcare professionals who report adverse reactions should be able to opt in to be notified in case there exists any update on the safety profile of the products.

Amendment 351 #

Proposal for a directive
Recital 104

(104) The use of colours in human and veterinary medicinal products is ~~currently~~ regulated by Directive 2009/35/EC of the European Parliament and of the Council60 , and restricted to those authorised in accordance with Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives61 , for which specifications are laid down in Commission Regulation (EU) No 231/201262 . Uses of excipients other than colours in medicinal products are subject to the Union rules on medicinal products and are evaluated as part of the overall benefit risk profile of a medicinal product. _________________ 60 Directive 2009/35/EC of the European Parliament and of the Council of 23 April 2009 on the colouring matters which may be added to medicinal products (OJ L 109, 30.4.2009, p. 10). 61 Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (OJ L 354, 31.12.2008, p. 16). 62 Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1).

Amendment 352 #

Proposal for a directive
Recital 105

(105) Experience has shown the need to maintain ~~to a certain extent~~ the principle of the use in medicinal products of those colours authorised as food additives. However, it is also appropriate to foresee, in exceptional circumstances, the necessity for a specific assessment for the use of the colour in medicines when a food additive is removed from Union list of food additives. Therefore, in this specific case, EMA should carry out its own assessment for the use of the colour in medicines, taking into account the EFSA opinion and its underlying scientific evidence, as well as any additional scientific evidence and giving particular consideration to the use in medicines. EMA should ~~also be responsible for following any scientific evidence for the colours retained for specific medicine use only. Directive 2009/35/EC should therefore be repealed.~~ establish a list of substances which has been banned in food, but for specific reasons are still authorised in medicines. The authorisation of substances on the list should be limited to maximum additional five years. Within that period, marketing authorisation holders who use the excipients should conduct studies to ensure use of available alternatives complying with the Union list of food additives.

Amendment 353 #

Proposal for a directive
Recital 105

(105) Experience has shown the need to maintain to a certain extent the principle of the use in medicinal products of those colours authorised as food additives. However, it is also appropriate to foresee a specific assessment for the use of the colour in medicines when a food additive is removed from Union list of food additives when it has a functionality beyond colouring. Therefore, in this specific case, EMA should carry out its own assessment for the use of the colour in medicines, taking into account the EFSA opinion and its underlying scientific evidence, as well as any additional scientific evidence and giving particular consideration to the use in medicines. EMA should also be responsible for following any scientific evidence for the colours retained for specific medicine use only. Directive 2009/35/EC should therefore be repealed.

Amendment 354 #

Proposal for a directive
Recital 109

(109) There may be cases where manufacturing or testing steps of medicinal products need to take place in sites close to patients, for example advanced therapy medicinal products with short shelf-life. In such cases, these manufacturing or testing steps may need to be decentralised to multiple sites to reach patients across the Union. When the manufacturing or testing steps are decentralised, they should be carried out under the responsibility of the qualified person of an authorised central site. Additionally, in order to ensure smooth functioning of decentralised sites under this framework with the activities relevant for other Union legal frameworks, competent authorities of Member States supervising the decentralised site should coordinate their acitivities and supervisory tasks with the relevant authorities responsible for the supervision of the manufacturing or testing activities under other Union acts. The decentralised sites should not require a separate manufacturing authorisation from the one granted to the relevant central site but should be registered by the competent authority of the Member State in which the decentralised site is established. In the case of medicinal products containing, consisting or derived from autologous SoHO, the decentralised sites have to be registered as a SoHO entity as defined in and pursuant to [SoHO Regulation] for the activities of donor review and eligibility assessment, donor testing and collection, or just for collection in the case of products manufactured for autologous use.

Amendment 355 #

Proposal for a directive
Recital 111

(111) Verification of compliance with the legal requirements of manufacturing, distribution and use of medicinal products by relevant entities through a system of supervision, is of fundamental importance to ensure that the objectives of this Directive are effectively achieved. Therefore, the competent authorities of the Member States should have the power to perform on site or remote inspections, as part of the system of supervision at all stages of manufacturing, distribution and use of medicinal products or active substances and rely on the outcome of inspections conducted by trusted third countries competent authorities. To preserve the effectiveness of the inspections, the competent authorities should have the possibility to perform joint inspections and ~~also, where necessary,~~ unannounced inspections.

Amendment 356 #

Catherine AMALRIC, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ, Erik POULSEN

Proposal for a directive
Recital 118

(118) It is therefore appropriate to harmonise the basic principles applicable to the prescription status of medicinal products in the Union or in the Member State concerned, while taking as a starting point the principles already established on this subject by the Council of Europe as well as the work of harmonisation completed within the framework of the United Nations, concerning psychotropic or narcotic substances - the United Nations Single Convention of 1961 on narcotic drugs and Convention on Psychotropic Substances of 1971. Therefore, research on interactions between alcohol, painkillers and psychoactive substances, in particular the high- THC concentration cannabis, should be developed.

Amendment 357 #

Proposal for a directive
Recital 123

(123) Certain Member States impose on wholesalers who supply medicinal products to pharmacists and on persons authorised to supply medicinal products to the public certain public service obligations. Those Member States should be able to continue to impose those obligations on wholesalers established within their territory. They should also be able to impose them on wholesalers in other Member States on condition that they do not impose any obligation more stringent than those that they impose on their own wholesalers and provided that such obligations may be regarded as warranted on grounds of public health protection and are proportionate in relation to the objective of such protection. Member States should also impose certain obligations of public services to wholesalers within the limits of their responsibilities to ensure that medicinal products made available on one market are not placed on another market to avoid creating a shortage for patients.

Amendment 358 #

Proposal for a directive
Recital 123

(123) Certain Member States impose on wholesalers who supply medicinal products to pharmacists and on persons authorised to supply medicinal products to the public certain public service obligations. Those Member States should be able to continue to impose those obligations on wholesalers established within their territory. They should also be able to impose them on wholesalers in other Member States on condition that they do not impose any obligation more stringent than those that they impose on their own wholesalers and provided that such obligations may be regarded as warranted on grounds of public health protection and are proportionate in relation to the objective of such protection. Proportionate restrictions should also be placed on wholesalers to ensure that products made available on one market are not placed on another market if it would create or exacerbate a shortage for patients.

Amendment 359 #

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ, Erik POULSEN, Ondřej KNOTEK

Proposal for a directive
Recital 123 a (new)

(123 a)Pharmacists have always had a role in primary care, particularly to compound, dispense and sell medicinal products that patients need, to provide advice on their proper use and possible adverse effects and to support patients suffering of acute and chronic illnesses. As responsible for dispensing the medicinal products, pharmacists also monitor their proper use and compliance by the patient, provide advice in particular to avoid the risks of iatrogenics (all the undesirable effects caused by taking one or more medications) and carry out medication reviews. In an hospital environment, hospital pharmacists are even setting up pharmaceutical consultations and designing personalised pharmaceutical plans, in cooperation with health professionals, patients and carers. Hospital pharmacists and community pharmacists could play a major role in the progressive use of electronic package leaflets.

Amendment 360 #

Proposal for a directive
Recital 125

(125) Sharing accurate information with the general public in order to ensure trust in science and the regulatory system and supporting health literacy of patient and consumers is crucial. Competent authorities should also share up to date information with healthcare professionals, including pharmacists, and the scientific community. The provisions governing the information supplied to users should provide a high degree of consumer protection, in order that medicinal products may be used correctly on the basis of full and comprehensible information.

Amendment 361 #

(127) The use of electronic and technological possibilities other than paper package leaflets, which is complementary to the paper leaflets which are crucial for patients with limited digital health literacy, can facilitate access to medicinal products, medicinal products distribution and should always guarantee equal ~~or better~~ quality of information to all patients compared to the paper form of product information. Ensuring the protection of personal data pursuant to Regulation 2016/679 and prohibition of the identification, profiling or tracking of individuals is necessary in this regard.

Amendment 362 #

Proposal for a directive
Recital 128

(128) Member States have varying levels of digital literacy and internet access. In addition, patient and healthcare professional needs may differ. It is therefore necessary that Member States have a discretion on the adoption of measures enabling the electronic provision of product information while ensuring that no patient is left behind, taking into account the needs of different age categories and the different levels of digital literacy in the population, and making sure that product information is easily accessible to all patients. Member States should progressively allow the possibility for electronic product information, as an addition to the paper leaflet, while ensuring full compliance with the rules on protection of personal data, and adhere to harmonised standards developed at EU level. The information in digital format should be easily accessible to all patients, for instance by including in the outer packaging of the product a digitally readable barcode, which would direct the patient to the electronic version of the package leaflet.

Amendment 363 #

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ, Erik POULSEN, Ondřej KNOTEK

Proposal for a directive
Recital 128

(128) Member States have varying levels of digital literacy and internet access. In addition, patient and healthcare professional needs may differ. It is therefore necessary that Member States have a discretion on the adoption of measures enabling the electronic provision of product information while ensuring that no patient is left behind, taking into account the needs of different age categories and the different levels of digital literacy in the population, and making sure that product information is easily accessible to all patients. Member States should progressively allow the possibility for electronic product information, while ensuring full compliance with the rules on protection of personal data, and adhere to harmonised standards developed at EU level. Based on the findings from hospital pilots, the obligation to provide a paper leaflet should be lifted for medicinal products not intended for self- administration by the patient.

Amendment 364 #

Proposal for a directive
Recital 129

(129) Where Member States decide that the package leaflet should be made available in principle only electronically, they should also ensure that a paper version of the package leaflet is to be made available on demand and without additonal cost to patients. They should also ensure that the information in digital format is easily accessible to all patients, for instance by including in the outer packaging of the product a digitally readable barcode, which would direct the patient to the electronic version of the package leaflet.deleted

Amendment 365 #

Proposal for a directive
Recital 129

(129) ~~Where~~ Member States ~~decide that~~should make the package leaflet ~~should be made available in principle only~~available electronically, and they should also ensure that a paper version of the package leaflet is ~~to be made available on demand and without additonal cost to patients~~provided.. They should also ensure that the information in digital format is easily accessible to all patients, for instance by including in the outer packaging of the product a digitally readable barcode, which would direct the patient to the electronic version of the package leaflet. However, Member States should be able to choose to use only electronic leaflets for a limited range of medicinal products dispensed to in hospital patients where the provision of medical information can be ensured by a health professional. The Commission should be empowered in the future to, by means of delegated acts, transition completely to electronic leaflets.

Amendment 366 #

Proposal for a directive
Recital 129

(129) Where Member States decide that the package leaflet should be made available in principle only electronically, they should also ensure that a paper version of the package leaflet is ~~to be made~~, by default, available on demand and without additonal cost to patients, for example printed by pharmacies. They should also ensure that the information in digital format is easily accessible to all patients, for instance by including in the outer packaging of the product a digitally readable barcode or a QR code, which would direct the patient to the electronic version of the package leaflet.

Amendment 367 #

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ, Erik POULSEN, Ondřej KNOTEK

Proposal for a directive
Recital 130

(130) The use of multi-language packages can be a tool for access to medicinal products, in particular for small markets and in public health emergencies. Where multi-language packages are used, Member States may allow the use on the labelling and package leaflet of an official language of the Union that is commonly understood in the Member States where the multi- language package is marketed. While electronic medicinal product information will facilitate their redistribution between Member States, language requirements on labels will remain a challenge. Removing the obligation for an official language and introducing the obligation to use the international non-proprietary name for medicinal products not intended for self- administration by the patient, in addition to providing electronic product information, could improve the availability of medicinal products and enable easier redistribution between Member States.

Amendment 368 #

Proposal for a directive
Recital 130 a (new)

(130a) Medium-term harmonisation of the provisions on e-leaflets can be a tool to tackle the problem of shortages of medicinal products. The Commission should be empowered to swiftly harmonise requirements concerning paper or electronic formats. If the electronic format were made generally applicable, a single European system would have to ensure that patients had access to e- leaflets for their products.

Amendment 369 #

Proposal for a directive
Recital 131

(131) To ensure a high level of transparency o~~f public support to the~~n research and development costs of medicinal products, the reporting of all public contribution for the development of a particular medicinal product should be a requirement for all medicines. Given however the practical difficulty to identify how indirect public funding instruments, such as tax advantages, have supported a particular product, the reporting obligation should only concern the direct public financial suppos at any stage of the development, including but not limited to contracts, grants, tax breaks, and advance purchase agreements for the development, production and procurement of a particular medicinal product and its underlying technology and intellectual propert,y s~~uch as direct grant~~hould be a requirement for all all market authorizations for ~~contra~~medical products. Therefore, the provisions of this Directive ensure, without prejudice to the rules on the protection of confidential and personal data, transparency regarding any ~~direct~~form of financial support received from any public authority or public body to carry out any activities for the research and development of medicinal products.

Amendment 370 #

Proposal for a directive
Recital 131

(131) To ensure a high level of transparency of public and private support to the research and development of medicinal products, the reporting of public and private contribution for the development of a particular medicinal product should be a requirement for all medicines. Given however the practical difficulty to identify how indirect public funding instruments, such as tax advantages, have supported a particular product, the reporting obligation should only concern the direct public financial support, such as direct grants or contractThis should apply also to any independent legal entity from which it obtained a license in relation to the medicinal product in its previous phases of development. The information should be dissagregated to each stage of drug research and development, basic research, pre-clinical research, phase I, II, III of the clinical investigation of the medicinal product; as well as post-market studies. Therefore, the provisions of this Directive ensure, without prejudice to the rules on the protection of confidential and personal data, transparency regarding any direct and indirect financial support received from any public authority or public body to carry out any activities for the research and development of medicinal products.

Amendment 371 #

Proposal for a directive
Recital 131

(131) To ensure a high level of transparency of public support to the research and development of medicinal products, the reporting of public contribution for the development of a particular medicinal product should be a requirement for all medicines. Given however the practical difficulty to identify how indirect public funding instruments, such as tax advantages, have supported a particular product, the reporting obligation should only concern the direct public financial support, such as direct grants or contracts. Therefore, tThe provisions of this Directive ~~ensure,~~ are without prejudice to the rules on the protection of confidential and personal data, and ensure transparency regarding any direct and indirect financial support received from any public authority or, public body, philanthropic and other non-profit organisation including academia to carry out any activities for the research and development of medicinal products. In addition, when submitting a request for pricing and reimbursement, marketing authorisation holders should disclose, upon request, the company’s expenditure related to the research and development costs of the product.

Amendment 372 #

Proposal for a directive
Recital 131

(131) To ensure a high level of transparency of public support to the research and development of medicinal products, the reporting of public contribution for the development of a particular medicinal product should be a requirement for all medicines. Given however the practical difficulty to identify how indirect public funding instruments, such as tax advantages, have supported a particular product, the reporting obligation should only concern the direct public financial support, such as direct grants or contracts. Therefore, the provisions of this Directive ensure, without prejudice to the rules on the protection of confidential and personal data, transparency regarding any direct financial support received from any EU public authority or EU public body to carry out any activities for the research and development of medicinal products.

Amendment 373 #

Proposal for a directive
Recital 131

(131) To ensure a high level of transparency of public support to the research and development of medicinal products, the reporting of public contribution for the development of a particular medicinal product should be a requirement for all medicines. Given however the practical difficulty to identify how indirect public funding instruments, such as tax advantages, have supported a particular product, the reporting obligation should only concern the direct public financial support, such as direct grants or contracts. Therefore, the provisions of this Directive ensure, without prejudice to the rules on the protection of confidential and personal data, transparency regarding any direct financial support received from any EU public authority or EU public body to carry out any activities for the research and development of medicinal products.

Amendment 374 #

Proposal for a directive
Recital 133

(133) In order to ensure a harmonised and consistent reporting of public and private contribution for the development of a particular medicinal products, the Commission should be able to adopt implementing acts to clarify the principles and format that the marketing authorisation holder should adhere to when reporting this information.

Amendment 375 #

Proposal for a directive
Recital 133 a (new)

(133 a)It is imperative to clarify in the legislative framework that all those products that have not been subject to an authorisation process provided for in this Directive or in [revised Regulation] and cannot be considered as a medicinal product, but rather as non-medicinal products, should not be presented to the public with pharmacological properties or unproven therapeutic benefits. The presentation and promotion of non- medicinal products for unauthorised therapeutic indications poses an obvious risk, which can encourage people to abandon science-based therapeutic treatments and put their health at risk. Products classified as non-medicinal must be explicitly prohibited from using these types of false claims linked to improving health. Likewise, citizens should be given the education and tools to reject and report such unsubstantiated health claims.

Amendment 376 #

Proposal for a directive
Recital 135

(135) Advertising, even of medicinal products not subject to a prescription, could affect public health and distort competition. Therefore, advertising of medicinal products should meet certain criteria. ~~Persons qualified to prescribe, administer or supply medicinal products can properly evaluate the information available in advertising because of their knowledge, training and experience.~~ The advertising of medicinal products to persons who cannot properly assess the risk associated with their use may lead to medicinal product misuse or overconsumption which is liable to harm public health. Therefore advertisement to the general public of medicinal products that are available only on medical prescription should be prohibited. Furthermore, distribution of samples free of charge to the general public for promotional ends is to be prohibited, also teleshopping for medicinal products shall be prohibited pursuant to Directive 2010/13/EU of the European Parliament and of the Council65 . It should be possible within certain restrictive conditions to provide samples of medicinal products free of charge to persons qualified to prescribe or supply them so that they can familiarise themselves with new products and acquire experience in dealing with them. _________________ 65 Directive 2010/13/EU of the European Parliament and of the Council of 10 March 2010 on the coordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the provision of audiovisual media services (Audiovisual Media Services Directive) (OJ L 095 15.4.2010, p. 1).

Amendment 377 #

Proposal for a directive
Recital 135

(135) Advertising, even of medicinal products not subject to a prescription, could affect public health and distort competition. Therefore, advertising of medicinal products should meet certain criteria ensuring high standards of protection. Persons qualified to prescribe, administer or supply medicinal products can properly evaluate the information available in advertising because of their knowledge, training and experience. The advertising of medicinal products to persons who cannot properly assess the risk associated with their use may lead to medicinal product misuse or overconsumption which is liable to harm public health. Therefore advertisement to the general public of medicinal products that are available only on medical prescription should be prohibited. Furthermore, distribution of samples free of charge to the general public for promotional ends is to be prohibited, also teleshopping for medicinal products shall be prohibited pursuant to Directive 2010/13/EU of the European Parliament and of the Council65 [1]. It should be possible within certain restrictive conditions to provide samples of medicinal products free of charge to persons qualified to prescribe or supply them so that they can familiarise themselves with new products and acquire experience in dealing with them. _________________ 65 Directive 2010/13/EU of the European Parliament and of the Council of 10 March 2010 on the coordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the provision of audiovisual media services (Audiovisual Media Services Directive) (OJ L 095 15.4.2010, p. 1).

Amendment 378 #

Proposal for a directive
Recital 136

(136) Advertising of medicinal products should aim at disseminating objective and unbiased information about the medicinal product. For that purpose, it is expressly forbidden highlight negatively another medicinal product or to suggest that advertised medicinal product might be safer or more effective than another medicinal product. ~~Comparison of medicinal products should only be allowed if such information is listed in the summary of product characteristics of the medicinal product being advertised.~~ This prohibition covers any medicinal product, also biosimilars, and therefore it would be misleading to refer in the advertising, that a biosimilar medicinal product would not be interchangeable with the original biological medicinal product or another biosimilar from the same original biological medicinal product. Additional strict rules about negative and comparative advertising of competitor medicinal products will prohibit claims that can mislead persons qualified to prescribe, administer or supply them.

Amendment 379 #

Proposal for a directive
Recital 138 a (new)

(138 a)While it is prohibited for companies to use celebrities for advertising of their medicinal products in the EU, patients and consumers are increasingly exposed to such promotional practices due to the global reach of social media. Online advertising, including on social media, may be initiated by companies in other regions or promoted be celebrities and influencers. Therefore, the Commission should assess the exposure and impact of pharmaceutical advertising and promotions online, and adopt specific rules to regulate such advertising and promotional practices and limit content exposure on consumers and patients which would be otherwise prohibited.

Amendment 380 #

Proposal for a directive
Recital 139 a (new)

(139 a)Evidence gathered by healthcare professional organisations suggests that even minimal inducement may result in bias decisions in regard to prescription behaviour of physicians. In order to avoid conflict of interest and unethical or biased behaviours, full transparency about the relationship between the pharmaceutical industry and healthcare professionals and organisations should be guaranteed. Member States should maintain a transparency register of transfer of value regarding advertising activities, including hospitality at congresses and other events, which target persons qualified to prescribe medicinal products. The Commission should establish a web portal to list all national registers of transfers of value regarding to persons qualified to prescribe medicinal products.

Amendment 381 #

Proposal for a directive
Recital 145

(145) In order to ensure uniform conditions for the implementation of this ~~Regulation~~Directive, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council66 . _________________ 66 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13)[1].

Amendment 382 #

Proposal for a directive
Recital 150

(150) This Directive seeks to enable the right access to preventive healthcare and to benefit from medical treatment under the conditions established by national laws and practices and to ensure a high level of human health protection in the definition and implementation of all the Union’s policies and activities as laid down in Article 35 of the Charter of Fundamental Rights of the European Union. Similarly, this Directive respects the Aarhus Convention which protects every person’s right to live in a healthy environment.

Amendment 383 #

Proposal for a directive
Article premier – paragraph 1

1. This Directive ~~lays down rules for th~~shall apply to medicinal products for human use intended to be plac~~ing~~ed on the market~~, manufacturing, import, export, supply, distribution, pharmacovigilance, control and use of medicinal products for human use~~ in Member States and either prepared industrially or manufactured by a method involving an industrial process.

Amendment 384 #

Proposal for a directive
Article 1 – paragraph 2

2. The provisions of this Directive shall apply to industrially produced medicinal products for human use intended to be placed on the market in Member States.

Amendment 385 #

Proposal for a directive
Article 1 – paragraph 2

2. This Directive shall apply to medicinal products for human use intended to be placed on the market in the Member States and which are either prepared industrially or manufactured by a method involving an industrial process.

Amendment 386 #

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Andreas GLÜCK

2. This Directive shall apply to medicinal products for human use intended to be placed on the market in the Member States and which are industrially prepared or manufactured by a method involving an industrial process.

Amendment 387 #

Proposal for a directive
Article 1 – paragraph 2

2. This Directive shall apply to medicinal products for human use intended to be placed on the market in Member States and either prepared industrially or manufactured by a method involving an industrial process.

Amendment 388 #

Proposal for a directive
Article 1 – paragraph 4

Amendment 389 #

Proposal for a directive
Article 1 – paragraph 4 – subparagraph 1 (new)

Where the Agency and the advisory and regulatory bodies established in other Union legislation cannot reach consensus on the regulatory status or Union law applicable to the product:

Amendment 390 #

Proposal for a directive
Article 1 – paragraph 4 – point a (new)

(a) the Commission shall be empowered to take a decision on the regulatory status or the Union law applicable to the law in question, duly taking into account the relevant opinions and conclusions of the Agency and other advisory bodies and regulatory bodies established under Union law. This decision along with the supporting analysis and conclusion shall be made publicly available;

Amendment 391 #

Proposal for a directive
Article 1 – paragraph 4 – point b (new)

(b) for transparency purposes, the respective opinions and conclusions of the Agency and the relevant advisory and regulatory bodies should be made publicly available.

Amendment 392 #

Proposal for a directive
Article 1 – paragraph 5 – point b

(b) medicinal product prepared in a pharmacy in accordance with a pharmacopoeia and intended to be supplied directly to the patients served by the pharmacy in question or to another pharmacy which intends to supply the medicinal product directly to the patient (‘officinal formula’);

Amendment 393 #

Proposal for a directive
Article premier – paragraph 5 – point c a (new)

(ca) medicinal products prepared in advance, in duly justified cases, by the pharmaceutical department of a hospital (‘hospital preparations’). Hospital preparations shall be dispensed on medical prescription to one or more patients by the pharmacy supplying the hospital.

Amendment 394 #

Proposal for a directive
Article 1 – paragraph 5 – point c a (new)

(c a) medicinal product prepared in advance, in duly justified cases, by the pharmaceutical department of a hospital (‘hospital formula’), supplied on medical prescription to one or several patients by the hospital’s pharmaceutical department.

Amendment 395 #

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Erik POULSEN

Proposal for a directive
Article 1 – paragraph 5 – point c a (new)

(c a) medicinal product prepared in advance, in duly justified cases, by the pharmaceutical department of a hospital (‘hospital formula’). Hospital formulae are supplied on medical prescription to one or several patients by the hospital’s pharmaceutical department.

Amendment 396 #

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Erik POULSEN

Proposal for a directive
Article 1 – paragraph 5 – point c b (new)

(c b) radiopharmaceuticals, prepared in hospitals, health centres or clinics, by pharmacists or other persons legally authorised in the Member State concerned to carry out such process, or in accordance with a pharmacopoeia and if the radiopharmaceutical is intended to be used in-house, for diagnostic as well as therapeutic applications.

Amendment 397 #

Proposal for a directive
Article 1 – paragraph 6

6. Medicinal products referred to in paragraph 5, point (a), may be prepared in duly justified cases in advance by a pharmacy serving a hospital, on the basis of the estimated medical prescriptions within that hospital for the following seven days.deleted

Amendment 398 #

6. Medicinal products referred to in paragraph 5, point (a), may be prepared in ~~duly justified cases in~~ advance by a pharmacy serving a hospital, on the basis of the estimated medical prescriptions within that hospital for ~~the following seven days.~~a given period of time in duly justified cases, including medicine shortages as described in [revised Regulation (EC) No 726/2004] and supply disruptions caused by market withdrawals for commercial reasons. By way of derogation from points (a) and (b) in paragraph 5, pharmacies may prepare medicinal products dispensed outside the hospital pharmacy on a routine basis in the situations described in the first subparagraph

Amendment 399 #

Proposal for a directive
Article 1 – paragraph 6

6. Medicinal products referred to in paragraph 5, point (a), (b), (ca) and (cb), may be prepared in duly justified cases in advance by a pharmacy ~~serving a hospital,~~ on the basis of the estimated medical prescriptions l within ~~that hospital for the following seven days~~a time limit set based on the appropriate stability of the product.

Amendment 400 #

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Erik POULSEN

Amendment 401 #

Proposal for a directive
Article 1 – paragraph 6

Amendment 402 #

Proposal for a directive
Article 1 – paragraph 6

6. Medicinal products referred to in paragraph 5, point (ab), may be prepared in duly justified cases in advance by a pharmacy serving a hospital, on the basis of the estimated medical prescriptions within that hospital for the following seven days.

Amendment 403 #

Proposal for a directive
Article 1 – paragraph 6 a (new)

6 a. The stipulations mentioned in paragraph 5, points (a) and (b), as well as paragraph 6, are contingent upon the provision that all referenced items are formulated to cater to the unique requirements of individual patients. Furthermore, these items must adhere to all protocols set forth by the Convention on the Elaboration of a European Pharmacopoeia. This includes conformity with all relevant general and specific Monographs that have been ratified in accordance with that Convention.

Amendment 404 #

Proposal for a directive
Article 1 – paragraph 7

7. Member States shall take the necessary measures to achieve autonomy of supply of substances of human origin, to develop the production and use of SoHO therapies and medicinal products derived from substances of human origin coming from voluntary unpaid donations, under the provisions on [Regulation (EC) repealing Directives 2002/98/EC and 2004/23/EC].

Amendment 405 #

Proposal for a directive
Article 1 – paragraph 7

7. Member States shall take the necessary measures to develop the production and use of medicinal products derived from substances of human origin coming from voluntary unpaid donations, in accordance with rules established under [SoHO Regulation].

Amendment 406 #

Proposal for a directive
Article 1 – paragraph 10

10. This Directive shall not affect the application of national legislation prohibiting or restricting the following: (a) the sale, supply or use of medicinal products as contraceptives or abortifacients; (b) the use of any specific type of substance of human origin or animal cells, on grounds not dealt with in the aforementioned Union law; (c) the sale, supply or use of medicinal products containing, consisting of or derived from these animal cells or substances of human origin, on grounds not dealt with in Union law.deleted

Amendment 407 #

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER

Proposal for a directive
Article 1 – paragraph 10 – introductory part

10. TIn accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union, and in line with the decisions of the European Court of Justice, this Directive shall not affect the application of national legislation prohibiting or restricting the following:

Amendment 408 #

Proposal for a directive
Article 1 – paragraph 10 – point a

~~(a) the sale, supply or use of medicinal products as contraceptives or abortifacients;~~deleted

Amendment 409 #

Tilly METZ

Proposal for a directive
Article 1 – paragraph 10 – point a

~~(a) the sale, supply or use of medicinal products as contraceptives or abortifacients;~~deleted

Amendment 410 #

Isabella ADINOLFI, Sirpa PIETIKÄINEN

Proposal for a directive
Article 1 – paragraph 10 – point a

~~(a) the sale, supply or use of medicinal products as contraceptives or abortifacients;~~deleted

Amendment 411 #

Malin BJÖRK

Proposal for a directive
Article 1 – paragraph 10 – point a

~~(a) the sale, supply or use of medicinal products as contraceptives or abortifacients;~~deleted

Amendment 412 #

1. By way of derogation from Article 1(1), only this Article shall apply to advanced therapy medicinal products prepared ~~on a non-routine basis~~incidentally and exceptionally on a non-routine basis as defined in this paragraph and in accordance with the requirements set in paragraph 3 and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product for an individual patient (‘advanced therapy medicinal products prepared under hospital exemption’). For the purpose of this Article, 'non-routine basis' refers to the tailored preparation of an advanced therapy medicinal product under a hospital exemption, which occurs sporadically, under extraordinary circumstances, and is not part of a regular process, aimed at addressing the unique health requirements of a specific patient. This is applicable when no medicinal product with central authorization is accessible, nor is there a suitable clinical trial or program for compassionate use active for that particular medical need, for which the patient qualifies within the European Union. Indicators that an activity is conducted routinely include: (a) production of a product through processes that are standardized or repetitive; (b) engagement in planning processes that extend beyond the immediate clinical requirements of individual patients. The Agency is authorized to formulate guidelines for the practical application of what constitutes a 'non-routine basis'. In doing so, it shall engage with national regulatory authorities and key stakeholders, including entities holding hospital exemption approvals, the pharmaceutical industry, and patient groups. Reflecting advancements in science and technology, the Commission has the authority to update the definition of 'non-routine' through implementing acts.

Amendment 413 #

Proposal for a directive
Article 2 – paragraph 1

Amendment 414 #

Proposal for a directive
Article 2 – paragraph 1

1. By way of derogation from Article 1(1), only this Article shall apply to advanced therapy medicinal products prepared on a non-routine basis in accordance with the requirements set in paragraph 3 and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product for an individual patient (‘advanced therapy medicinal products prepared under hospital exemption’). Such use shall not be made in any one of the following situations: (a) there is a similar advanced therapy medicinal product that is covered by a marketing authorisation granted under [revised Regulation (EC) No 726/2004] and the use in the individual patient is not excluded by the terms of the summary of product characteristics of that product or ; (b) the individual patient is eligible for enrolment in an ongoing clinical trial or compassionate use programme for a similar advanced therapy medicinal product.

Amendment 415 #

Proposal for a directive
Article 2 – paragraph 1

1. By way of derogation from Article 1(1), only this Article shall apply to advanced therapy medicinal products prepared on a non-routine basis in accordance with the requirements set in paragraph 3 and used within ~~the same Member State~~ in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product for an individual patient (‘advanced therapy medicinal products prepared under hospital exemption’). A non-routine basis entails a treatment scale that does not exceed the treatment capacity of a hospital. Member States shall ensure that only hospitals are granted hospital exemption approvals. A transition period of 5 years is granted to holders of a hospital exemption (public and private) that exceed preparation on a nonroutine basis to obtain a centralised marketing authorisation. During the transition period, deviations from a non- routine basis guarantee patient access. Member States shall ensure that the scope for use is centred around targeting unmet medical need, in situations when similar treatment is not available and/or affordable.

Amendment 416 #

Proposal for a directive
Article 2 – paragraph 1

1. By way of derogation from Article 1(1), only this Article shall apply to advanced therapy medicinal products exceptionally prepared on a non-routine basis in accordance with the requirements set in paragraph 3 and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a product custom-made ~~product for an individual patient~~to meet the special needs of an individual patient in cases of medical need when there is no suitable advanced therapy medicinal product available in the relevant indication, either as an authorised medicinal product, under a compassionate use programme referred to in Article 26 of [revised Regulation 726/2004] or under a clinical trial for which the patient is eligible [in the Union] (‘advanced therapy medicinal products prepared under hospital exemption’).

Amendment 417 #

Proposal for a directive
Article 2 – paragraph 1

Amendment 418 #

Proposal for a directive
Article 2 – paragraph 1

1. By way of derogation from Article 1(1), only this Article shall apply to advanced therapy medicinal products prepared indicentally and exceptionally on a non-routine basis in accordance with the requirements set in paragraph 3 and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product for an individual patient (‘advanced therapy medicinal products prepared under hospital exemption’).

Amendment 419 #

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Erik POULSEN, Ondřej KNOTEK

Proposal for a directive
Article 2 – paragraph 1

Amendment 420 #

Proposal for a directive
Article 2 – paragraph 1

Amendment 421 #

Proposal for a directive
Article 2 – paragraph 1

1. By way of derogation from Article 1(1), only this Article shall apply to advanced therapy medicinal products prepared ~~on a non-routine basis~~ in accordance with the requirements set in paragraph 3 and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product for an individual patient (‘advanced therapy medicinal products prepared under hospital exemption’).

Amendment 422 #

Proposal for a directive
Article 2 – paragraph 1 a (new)

1 a. For the purpose of this Article, ‘non-routine basis’ means an advanced therapy medicinal product prepared under hospital exemption on an exceptional basis to meet the special needs of an individual patient, where there is neither a centrally authorised medicinal product available, nor an ongoing relevant clinical trial or compassionate use programme for the same indication with an advanced therapy medicinal product for which the patient is eligible. Standardised or repetitive processes, as well as major production planning in advance, which can be considered industrial and beyond what is needed to address the immediate clinical needs of individual patients, will be the indications that an activity occurs on a routine basis. The European Medicines Agency will be the deciding body to establish whether a process is on a routine or non-routine basis, and will do so in close consultation with the competent Member State authority and stakeholders, including representatives of hospital exemption approval holders, industry, and patients.

Amendment 423 #

Proposal for a directive
Article 2 – paragraph 1 a (new)

1 a. Whenever a hospital exemption exceeds preparation on a non-routine basis, holders of this exemption are granted a transition period of 5 years to obtain a centralised marketing authorisation for the advanced therapy medicinal product under the hospital exemption. For the duration of this transition period, the holder may exceed preparation on non-routine basis in order to guarantee patient access. Member States shall ensure that the use remains focused on unmet medical needs in situations when similar treatment is not available and/or affordable.

Amendment 424 #

Proposal for a directive
Article 2 – paragraph 2 – subparagraph 1

The manufacturing of an advanced therapy medicinal product prepared under hospital exemption shall require an approval by the competent authority of the Member State (‘hospital exemption approval’). Member States shall ~~notify~~provide a copy of any such approval, as well as subsequent changes, to the Agency. The application for a hospital exemption approval shall be submitted to the competent authority of the Member State where the hospital is located. An approval shall be subject to re-evaluation every year, taking into account the data submitted in accordance with paragraph 4, the completeness and reliability of these data, and other relevant information. An approval shall not be maintained when the conditions under paragraph 1 are not fulfilled any more.

Amendment 425 #

Proposal for a directive
Article 2 – paragraph 2 – subparagraph 2

The application for a hospital exemption approval shall be submitted to the competent authority of the Member State where the hospital is located. The approval shall be based on a risk- benefit assessment and be compliant with the conditions and definitions under this Article. The approval shall be valid for no longer than one year and may be extended only following an assessment of whether the hospital exemption approval is still required to meet special individual patient needs, including if either no centrally authorised product or no adequate clinical trial option or compassionate use program has been made available in the Union since the grant of the hospital exemption approval, and if the manufacturing of such product does not result in any one of the conditions highlighted in the definition of non- routine basis in paragraph 1, over the course of the year. The Commission, by means of implementing acts, may supplement the details of the application for the approval or renewal of hospital exemption referred to in this Article

Amendment 426 #

Proposal for a directive
Article 2 – paragraph 2 – subparagraph 2

The application for a hospital exemption approval shall be submitted to the competent authority of the Member State where the hospital is located. Approval will be contingent on an evaluation of the risks and benefits, in complicance with the requirements and interpretations provided in this Article.Such approval will not exceed a one-year term and can only be renewed after a thorough review to confirm the ongoing necessity of the hospital exemption for individual patient requirements.This includes verifying the continued absence of any centrally approved product, suitable clinical trial, compassionate use program, or other regulated options within the EU since the original approval was granted, and ensuring that the production of the product remains infrequent as specified in this article. The Commission is empowered to elaborate on the particulars of submitting and updating applications for hospital exemption approval as delineated in this Article, through implementing acts.

Amendment 427 #

Proposal for a directive
Article 2 – paragraph 2 – subparagraph 2

The application for a hospital exemption approval shall be submitted to the competent authority of the Member State where the hospital is located. The approval shall be valid for no longer than one year and may be extended only following an assessment of whether the hospital exemption approval is still required to meet special individual patient needs, including if either no centrally authorised product, compassionate use programme as referred to in referred to in Article 26 of [revised Regulation 726/2004] or no adequate clinical trial option has been made available [in the Union] since the grant of the hospital exemption approval

Amendment 428 #

Proposal for a directive
Article 2 – paragraph 2 a (new)

2 a. Member States may allow for cross-border exchange of advanced therapy medicinal products prepared under hospital exemption in case of unmet medical needs, if preparation on a non-routine basis is maintained. Competent authorities should share with each other information on hospital exemption approvals and the evidence used for such approvals upon request. In case of deviations between national laws, the authorities of the importing country should indicate that these deviations are acceptable. Requirements in Article 2(3-6) should be maintained.

Amendment 429 #

Proposal for a directive
Article 2 – paragraph 2 a (new)

2 a. Without prejudice to the requirements of Articles 2(3), 2(4), 2,(5) and 2(6), Member States may allow for cross-border exchange of advanced therapy medicinal products prepared under hospital exemption in case of unmet needs, under the condition that preparation on a non-routine basis is maintained and following approval of the importing Member States' competent authority. Competent authorities should share information on hospital exemption approvals on their territory and upon request also share the evidence used for such approvals after approval of the exemption holder.

Amendment 430 #

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Erik POULSEN, Andreas GLÜCK, Ondřej KNOTEK

Proposal for a directive
Article 2 – paragraph 2 a (new)

2 a. Member States may authorise the cross-border exchange of advanced therapy medicinal products prepared under hospital exemption in case of shortages of critical medicines or to ensure the treatment of patients affected by rare diseases, in the absence of other solutions.

Amendment 431 #

Proposal for a directive
Article 2 – paragraph 2 c (new)

2 c. By way of derogation from paragraph 1, in case of unmet medical need, Member States may allow for mutual recognition and cross-border exchange of advanced therapy medicinal products prepared under hospital exemption.

Amendment 432 #

Proposal for a directive
Article 2 – paragraph 2 d (new)

2 d. National competent authorities shall provide free of charge scientific advice to the entities developing products under hospital exemption, upon request.

Amendment 433 #

3. Member States shall ensure that advanced therapy medicinal products prepared under hospital exemption comply with the requirements equivalent to the good manufacturing practices and traceability for advanced therapy medicinal products referred to in Articles 5 and 15 of Regulation (EC) No 1394/200769 [1] respectively, and with pharmacovigilance requirements equivalent to those provided for at Union level pursuant to [revised Regulation (EC) No 726/2004]. ~~_________________ 69 Regulation (EC) No 1394/2007 of the European Parliament~~This shall include site inspections and GMP CPF accreditation, as well as traceability and pharmacovigilance plans and of the ~~Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 1)~~evaluation of the preclinical and clinical data generated by the applicant.

Amendment 434 #

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Erik POULSEN, Ondřej KNOTEK

Proposal for a directive
Article 2 – paragraph 3

3. Member States shall ensure that advanced therapy medicinal products prepared under hospital exemption comply with the ~~requirements equivalent to the~~good pharmacy preparation practices that are adapted to hospital proceesses and based on good manufacturing practices and traceability for advanced therapy medicinal products referred to in Articles 5 and 15 of Regulation (EC) No 1394/200769 respectively, and with pharmacovigilance requirements equivalent to those provided for at Union level pursuant to [revised Regulation (EC) No 726/2004]. _________________ 69 Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 1).

Amendment 435 #

Proposal for a directive
Article 2 – paragraph 3

3. Member States shall ensure that advanced therapy medicinal products prepared under hospital exemption comply with the ~~requirements equivalent to the~~good pharmacy preparation practices that are adapted to hospital processes and based on good manufacturing practices and traceability for advanced therapy medicinal products referred to in Articles 5 and 15 of Regulation (EC) No 1394/200769 respectively, and with pharmacovigilance requirements equivalent to those provided for at Union level pursuant to [revised Regulation (EC) No 726/2004]. _________________ 69 Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 1).

Amendment 436 #

Proposal for a directive
Article 2 – paragraph 3

3. Member States shall ensure that advanced therapy medicinal products prepared under hospital exemption comply with the requirements equivalent to the good manufacturing practices, long-term follow up and traceability for advanced therapy medicinal products referred to in Articles 5 and 15 of Regulation (EC) No 1394/200769 respectively, and with pharmacovigilance requirements equivalent to those provided for at Union level pursuant to [revised Regulation (EC) No 726/2004]. _________________ 69 Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 1).

Amendment 437 #

Proposal for a directive
Article 2 – paragraph 4

4. Member States shall ensure that data on the use, safety and the efficacy of advanced therapy medicinal products prepared under hospital exemption is collected and reported by the hospital exemption approval holder to the competent authority of the Member State at least annually. The competent authority of the Member State shall ~~review such data and shall verify the compliance of advanced therapy medicinal products prepared under hospital exemption with the requirements referred to in paragraph 3~~set the requirements for the collection and reporting of such data, in a structured and standarized way that allows obtaining more robust, reliable and comparable results and conclusions. The competent authority of the Member State shall review such data and shall verify the compliance of advanced therapy medicinal products prepared under hospital exemption with the requirements referred to in paragraph 3. Competent authorities shall ensure that sufficient scientific and regulatory advice is provided to non-profit and academic institutions in order to ensure appropriate reporting mechanisms.

Amendment 438 #

Proposal for a directive
Article 2 – paragraph 4

4. Member States shall ensure that data on the use, quality, safety and the efficacy of advanced therapy medicinal products prepared under hospital exemption is collected and reported by the hospital exemption approval holder to the competent authority of the Member State at least annually. The data shall include the results of patient follow-up for a sufficient period of time after the administration of the product. The competent authority of the Member State shall review such data and shall verify the compliance of advanced therapy medicinal products prepared under hospital exemption with the requirements referred to in paragraph 3.

Amendment 439 #

Proposal for a directive
Article 2 – paragraph 4

Amendment 440 #

Proposal for a directive
Article 2 – paragraph 4

4. Member States shall ensure that data on the use, quality, safety and the efficacy of advanced therapy medicinal products prepared under hospital exemption is collected and reported by the hospital exemption approval holder to the competent authority of the Member State at least annually. The collected data must encompass ongoing monitoring results for an adequate duration following the product's use. The competent authority of the Member State shall review such data and shall verify the compliance of advanced therapy medicinal products prepared under hospital exemption with the requirements referred to in paragraph 3.

Amendment 441 #

Proposal for a directive
Article 2 – paragraph 4

4. Member States shall ensure that data on the use, quality, safety and the efficacy of advanced therapy medicinal products prepared under hospital exemption, as well as any relevant data from patient follow-up is collected and reported by the hospital exemption, approval holder to the competent authority of the Member State at least annually. The competent authority of the Member State shall review such data and shall verify the compliance of advanced therapy medicinal products prepared under hospital exemption with the requirements referred to in paragraph 3.

Amendment 442 #

Ondřej KNOTEK, Catherine AMALRIC, Billy KELLEHER, Susana SOLÍS PÉREZ

Proposal for a directive
Article 2 – paragraph 4

4. Member States shall ensure that data on the use, quality, safety and the efficacy of advanced therapy medicinal products prepared under hospital exemption is collected and reported by the hospital exemption approval holder to the competent authority of the Member State at least annually. The competent authority of the Member State shall review such data and shall verify the compliance of advanced therapy medicinal products prepared under hospital exemption with the requirements referred to in paragraph 3.

Amendment 443 #

Proposal for a directive
Article 2 – paragraph 4

4. Member States shall ensure that data on the use, safety, quality and the efficacy of advanced therapy medicinal products prepared under hospital exemption is collected and reported by the hospital exemption approval holder to the competent authority of the Member State at least annually. The competent authority of the Member State shall review such data and shall verify the compliance of advanced therapy medicinal products prepared under hospital exemption with the requirements referred to in paragraph 3.

Amendment 444 #

Proposal for a directive
Article 2 – paragraph 4 a (new)

4 a. Competent authorities shall ensure that sufficient scientific and regulatory advice is provided to non-profit and academic institutions in order to assist them through the requirements of the hospital exemption clause. In cases where a product under hospital exemption becomes a suitable candidate to begin a centralized marketing authorization procedure, competent authorities shall assist non-profit and academic institutions also through this authorization process.

Amendment 445 #

Proposal for a directive
Article 2 – paragraph 5

5. Should the holder of the hospital exemption approval fail to meet the conditions outlined in the preceding paragraphs, the authorization will be withdrawn by the national regulatory authority. If a hospital exemption approval is revoked due to quality, safety or efficacy concerns the competent authority of the Member States that approved the hospital exemption shall inform the Agency and the competent authorities of the other Member States. as well as inform the patient who has received the advanced therapy medicinal product produced under the hospital exemption. Additionally, there should be a notification to the patient who has been administered the advanced therapy medicinal product formulated under the hospital exemption.

Amendment 446 #

Ondřej KNOTEK, Catherine AMALRIC, Billy KELLEHER, Susana SOLÍS PÉREZ

Proposal for a directive
Article 2 – paragraph 5

5. Where the hospital exemption approval holder has not complied with the requirements referred to in paragraphs 1, 2, 3 and 4, the hospital exemption approval shall be revoked by the competent authority of the Member State. If a hospital exemption approval is revoked due to quality, safety or efficacy concerns the competent authority of the Member States that approved the hospital exemption shall inform the Agency and the competent authorities of the other Member States.

Amendment 447 #

Proposal for a directive
Article 2 – paragraph 5

5. If a hospital exemption approval is revoked due to safety, quality, or efficacy concerns the competent authority of the Member States that approved the hospital exemption shall inform the Agency and the competent authorities of the other Member States.

Amendment 448 #

Proposal for a directive
Article 2 – paragraph 5

5. If a hospital exemption approval is revoked due to quality, safety or efficacy concerns the competent authority of the Member States that approved the hospital exemption shall inform the Agency and the competent authorities of the other Member States.

Amendment 449 #

Proposal for a directive
Article 2 – paragraph 5

Amendment 450 #

Proposal for a directive
Article 2 – paragraph 6

6. The competent authority of the Member State shall transmit the data related to the use, quality, safety and efficacy of an advanced therapy medicinal product prepared under the hospital exemption approval to the Agency annually. The Agency shall, in collaboration with the competent authorities of Member States and the Commission, set up and maintain a repository of that data, such an EU-wide registry will be obligatory and open to the public, requiring regular updates to remain current and encompass a catalogue of the advanced therapy medicinal products formulated under hospital exemption currently employed in the Union, also specifying instances where such approval has been suspended or revoked.

Amendment 451 #

Proposal for a directive
Article 2 – paragraph 6

6. The competent authority of the Member State shall transmit the data related to the use, safety and efficacy of an advanced therapy medicinal product prepared under the hospital exemption approval to the Agency annually. The Agency shall, in collaboration with the competent authorities of Member States and the Commission, set up and maintain a repository of that data, as well as of information on the authorisation, suspension or withdrawal of hospital exemption approvals, reimbursement prices, and public and private contributions to the development of the product; which shall be updated regularly.

Amendment 452 #

Proposal for a directive
Article 2 – paragraph 6

Amendment 453 #

Proposal for a directive
Article 2 – paragraph 6

6. The competent authority of the Member State shall transmit the data related to the use, safety and efficacy of an advanced therapy medicinal product prepared under the hospital exemption approval to the Agency annually. The Agency shall, in collaboration with the competent authorities of Member States and the Commission, set up and maintain a publicly accessible repository of that data. , including information on authorisations, suspensions or withdrawals of products under hospital exemption referred to in paragraph 1.

Amendment 454 #

Proposal for a directive
Article 2 – paragraph 6

6. The competent authority of the Member State shall transmit the data related to the use, safety and efficacy of an advanced therapy medicinal product prepared under the hospital exemption approval to the Agency annually. The Agency shall, in collaboration with the competent authorities of Member States and the Commission, set up and maintain a repository of that data. The Agency shall ensure that an overview of approved advanced therapy medicinal products prepared under hospital exemption is made public.

Amendment 455 #

Ondřej KNOTEK, Catherine AMALRIC, Billy KELLEHER, Susana SOLÍS PÉREZ

Proposal for a directive
Article 2 – paragraph 6

6. The competent authority of the Member State shall transmit the data related to the use, safety and efficacy of an advanced therapy medicinal product prepared under the hospital exemption approval to the Agency annually. The Agency shall, in collaboration with the competent authorities of Member States and the Commission, set up and maintain a repository of that data. The Agency shall ensure that an overview of approved advanced therapy medicinal products prepared under hospital exemption is made public.

Amendment 456 #

Proposal for a directive
Article 2 – paragraph 6

6. The competent authority of the Member State shall transmit the data related to the use, safety, quality and efficacy of an advanced therapy medicinal product prepared under the hospital exemption approval to the Agency annually. The Agency shall, in collaboration with the competent authorities of Member States and the Commission, set up and maintain a publicly accessible repository of that data in the form of an EU-wide registry.

Amendment 457 #

Proposal for a directive
Article 2 – paragraph 6

Amendment 458 #

Proposal for a directive
Article 2 – paragraph 7 – subparagraph 1 – introductory part

The Commission shall adopt ~~implementing acts~~delegated acts related to points (a) and (d) and implementing acts in points (b) and (c) to specify the following:

Amendment 459 #

Ondřej KNOTEK, Billy KELLEHER, Susana SOLÍS PÉREZ

Proposal for a directive
Article 2 – paragraph 7 – subparagraph 1 – point a

(a) details of the application for the approval of hospital exemption referred to in paragraph 1, second subparagraph, including the evidence on quality, safety and efficacy of the advance therapy medicinal products prepared under hospital exemption for the approval and the subsequent changes;deleted

Amendment 460 #

Proposal for a directive
Article 2 – paragraph 7 – subparagraph 1 – point a a (new)

(a a) the data to be collected by Member States, including a description of the use of hospital exemption, the number of patients treated, the clinical and quality of life outcomes used to measure efficacy and safety of the advance therapy medicinal products prepared under the hospital exemption;

Amendment 461 #

Susana SOLÍS PÉREZ, Ondřej KNOTEK

Proposal for a directive
Article 2 – paragraph 7 – subparagraph 1 – point a a (new)

(a a) the data collection by Member States should cover the application of the hospital exemption, details of the patient group treated including patient counts, and the outcomes related to clinical efficacy and safety, as well as quality of life assessments.

Amendment 462 #

Proposal for a directive
Article 2 – paragraph 7 – subparagraph 1 – point c

~~(c) the modalities for the exchange of knowledge between hospital exemption approval holders within the same Member State or different Member States;~~deleted

Amendment 463 #

Proposal for a directive
Article 2 – paragraph 7 – subparagraph 1 – point c

(c) the modalities for the exchange of knowledge between hospital exemption approval holders and holders of, or applicants for, marketing authorisations for advanced therapy medicinal products within the same Member State or different Member States;

Amendment 464 #

Susana SOLÍS PÉREZ, Catherine AMALRIC, Ondřej KNOTEK

Proposal for a directive
Article 2 – paragraph 7 – subparagraph 1 – point d

~~(d) the modalities for preparation and use of advanced therapy medicinal products under hospital exemption on a non-routine basis.~~deleted

Amendment 465 #

Proposal for a directive
Article 2 – paragraph 7 – subparagraph 1 – point d

(d) the modalities for harmonised implementation of the preparation and use of advanced therapy medicinal products under hospital exemption on a non-routine basis.

Amendment 466 #

Ondřej KNOTEK, Catherine AMALRIC, Billy KELLEHER, Susana SOLÍS PÉREZ

Proposal for a directive
Article 2 – paragraph 7 – subparagraph 1 – point d

(d) the modalities for harmonised implementation of preparation and use of advanced therapy medicinal products under hospital exemption on a non-routine basis.

Amendment 467 #

Proposal for a directive
Article 2 – paragraph 7 – subparagraph 1 – point d

(d) the modalities for preparation and use of advanced therapy medicinal products under hospital exemption ~~on a non-routine basis.~~;

Amendment 468 #

Proposal for a directive
Article 2 – paragraph 7 – subparagraph 1 – point d a (new)

(d a) the modalities of guidance for academic and other not-for-profit entities through the requirements of the hospital exemption clause and the centralised marketing authorisation procedure.

Amendment 469 #

Proposal for a directive
Article 2 – paragraph 7 – subparagraph 2

Those delegated acts shall be adopted pursuant to Article 215 and implementing acts shall be adopted in accordance with the examination procedure referred to in Article 214(2).

Amendment 470 #

Proposal for a directive
Article 2 – paragraph 8

8. The Agency shall provide to the Commission a report on the experience acquired with the hospital exemption approvals on the basis of contributions from Member States and the data referred to in paragraph 4. The first report shall be provided three years after [OP please insert the date =18 months after the date of entering into force of this Directive] and then every five years thereafter. These reports and the data contained therein shall be made publicly available and shall be considered in any subsequent legislative decision or amendment, following stakeholders' consultation.

Amendment 471 #

Proposal for a directive
Article 2 – paragraph 8

8. The Agency shall provide to the Commission a report on the experience acquired with the hospital exemption approvals on the basis of contributions from Member States and the data referred to in paragraph 4. The first report shall be provided three years after [OP please insert the date =18 months after the date of entering into force of this Directive] and then every five years thereafter. The contents of these reports, which detail the data, will be accessible to the public and will be taken into account during future legislative deliberations or amendments, subsequent to consultations with involved parties.

Amendment 472 #

Proposal for a directive
Article 2 – paragraph 8

8. The Agency shall provide to the Commission a public access report on the experience acquired with the hospital exemption approvals on the basis of contributions from Member States and the data referred to in paragraph 4. The first report shall be provided three years after [OP please insert the date =18 months after the date of entering into force of this Directive] and then every five years thereafter.

Amendment 473 #

Proposal for a directive
Article 2 – paragraph 8 a (new)

8 a. In order to inform patients, healthcare professionals and other stakeholders, the EMA shall make the hospital exemption approvals, the repository mentioned in paragraph 6 and the reports mentioned in paragraph 8 publicly available, after deletion of personal data and commercially confidential information.

Amendment 474 #

Proposal for a directive
Article 2 – paragraph 8 a (new)

8 a. Competent authorities shall guarantee that the authorization of products through the centralized procedure shall not adversely affect the activities and responsibilities of developers functioning under the hospital exemption as outlined in paragraphs 3 and 4.

Amendment 475 #

Proposal for a directive
Article 3 – paragraph 1 – subparagraph 1

A Member State may, in order to fulfil special needs, exclude from the scope of this Directive medicinal products supplied in response to a bona fide unsolicited order, including those prepared in accordance with the specifications of an authorised healthcare professional and for use by an individual patient under their direct personal responsibility or prepared in accordance with the specifications of a competent authority. However, in such case Member States shall encourage healthcare professionals and patients to report data on the safety of the use of such products to the competent authority of the Member State in accordance with Article 97.

Amendment 476 #

Proposal for a directive
Article 3 – paragraph 1 – subparagraph 1

A Member State may, in order to fulfil special needs, exclude from the scope of this Directive medicinal products supplied in response to a bona fide unsolicited order, including those prepared in accordance with the specifications of an authorised healthcare professional and for use by an individual patient under their direct personal responsibility or developed in accordance with the specifications of a competent authority. However, in such case Member States shall encourage healthcare professionals and patients to report data on the safety of the use of such products to the competent authority of the Member State in accordance with Article 97.

Amendment 477 #

Proposal for a directive
Article 3 – paragraph 1 – subparagraph 1

A Member State may, in order to fulfil special needs, exclude from the scope of this Directive medicinal products supplied in response to a bona fide unsolicited order, prepared in accordance with the specifications of an authorised healthcare professional and for use by an individual patient under their direct personal responsibility, or prepared in accordance with the specifications of a competent authority. However, in such case Member States shall encourage healthcare professionals and patients to report data on the safety of the use of such products to the competent authority of the Member State in accordance with Article 97.

Amendment 478 #

Proposal for a directive
Article 3 – paragraph 1 – subparagraph 1

A Member State may, in order to fulfil special needs, exclude from the scope of this Directive medicinal products supplied in response to a bona fide unsolicited order, prepared in accordance with the specifications of an authorised healthcare professional and for use by an individual patient under their direct personal responsibility. However, in such case Member States shall e~~ncourage~~stablish channels for healthcare professionals and patients to report data on the safety of the use of such products to the competent authority of the Member State in accordance with Article 97.

Amendment 479 #

Proposal for a directive
Article 3 – paragraph 1 – subparagraph 2

For allergen medicinal products supplied in accordance with this paragraph, the competent authorities of the Member State may request the submission of relevant information in accordance with Annex II.deleted

Amendment 480 #

Proposal for a directive
Article 3 – paragraph 1 – subparagraph 2

For allergen medicinal products supplied in accordance with this paragraph, the competent authorities of the Member State ~~may~~shall request the submission of relevant information in accordance with Annex II.

Amendment 481 #

Proposal for a directive
Article 3 – paragraph 2

2. Without prejudice to Article 30 of [revised Regulation (EC) No 726/2004], only Member States may temporarily authorise in the case of an official sanitary emergency, if doesn't exist other effective therapeutical alternative, the use and distribution of an unauthorised medicinal product in response to a ~~suspected or~~ confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation any of which could cause harm.

Amendment 482 #

Proposal for a directive
Article 3 – paragraph 3

3. Member States ~~shall ensure that marketing authorisation holders, manufacturers and healthcare professionals are not subject to civil or administrative liability for any consequences~~will be responsible resulting from the use of a medicinal product otherwise than for the authorised therapeutic indications or from the use of an unauthorised medicinal product, where such use is recommended ~~or required~~ by a competent authority in response to the ~~suspected or~~officially confirmed spread, as provided for in Article 3(2), of pathogenic agents, toxins, chemical agents or nuclear radiation any of which could cause harm. Such provisions shall apply whether or not a national or a centralised marketing authorisation has been granted.

Amendment 483 #

Proposal for a directive
Article 4 – paragraph 1 – point 1 – introductory part

(1) ‘medicinal product’ means any known substance or combination of substances that fulfils at least one of the following conditions:

Amendment 484 #

Proposal for a directive
Article 4 – paragraph 1 – point 1 – point a

(a) ~~any substance or combination of substances that is presented as having properties~~presents pharmacological activity that can be used for treating or preventing disease in human beings; or

Amendment 485 #

Proposal for a directive
Article 4 – paragraph 1 – point 1 – point b

(b) ~~any substance or combination of substances that~~ may be used in or administered to human beings with a view to either restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis;.

Amendment 486 #

Proposal for a directive
Article 4 – paragraph 1 – point 4 a (new)

(4 a) ‘plasma for fractionation’ means the liquid part of human blood separated from whole blood or collected by apheresis and intended to be used as the starting material for manufacture of plasma-derived medicinal products;

Amendment 487 #

Proposal for a directive
Article 4 – paragraph 1 – point 10 a (new)

(10 a) 'clock stop’ means a period of time during which the evaluation of a medicine is officially stopped, while the applicant prepares responses to questions from the regulatory authority. The clock resumes when the applicant has sent its responses.

Amendment 488 #

Proposal for a directive
Article 4 – paragraph 1 – point 11

(11) ‘non-clinical’ means a study or a test conducted in vitro, ex vivo, in silico, or in chemico, or a non-human in vivo test related to the investigation of the safety and efficacy of a medicinal product. Such test may include simple and complex human cell-based assays, microphysiological systems including organ-on-chip, computer modelling and simulation, other non-human or human biology-based test methods, aquatic egg models as well as invertebrate species and animal-based tests;

Amendment 489 #

Proposal for a directive
Article 4 – paragraph 1 – point 11

(11) ‘non-clinical’ means a study or a test conducted in vitro, ex vivo, in silico, or in chemico, or a non-human in vivo test related to the investigation of the safety and efficacy of a medicinal product. Such test may include simple and complex human cell-based assays, microphysiological systems including organ-on-chip, computer modelling and other in silico methods, other non-human or human biology-based test methods, and animal-based tests;

Amendment 490 #

Proposal for a directive
Article 4 – paragraph 1 – point 12

(12) ‘reference medicinal product’ means a medicinal product that is or has been authorised in the Union under Article 5, in accordance with Article 6, that can be used for comparative purposes againts another medicinal product of similar characteristics;

Amendment 491 #

Proposal for a directive
Article 4 – paragraph 1 – point 13

(13) ‘generic medicinal product’ means a medicinal product that has the same qualitative and quantitative composition in active substances ~~and~~ ,the same pharmaceutical form and pharmaceutical equivalence as the reference medicinal product;

Amendment 492 #

Proposal for a directive
Article 4 – paragraph 1 – point 15

(15) ‘letter of access’ means an original document, signed by the owner of the data or ~~its~~their representative, that states that the data may be used for the benefit of a third party by a competent authority or the Commission for the purposes of this Directive;

Amendment 493 #

Proposal for a directive
Article 4 – paragraph 1 – point 16

(16) ‘fixed dose combination medicinal product’ means a medicinal product consisting of a combination of active substances, at a fixed dose, intended to be placed on the market as a single pharmaceutical form;

Amendment 494 #

Proposal for a directive
Article 4 – paragraph 1 – point 20

(20) ‘kit for radiopharmaceutical preparations’ means any preparation to be reconstituted or combined with radionuclides in the final radiopharmaceutical, usually prior to its administration;

Amendment 495 #

Proposal for a directive
Article 4 – paragraph 1 – point 22

(22) ‘antimicrobial’ means any medicinal product with a direct action on micro-organisms used for treatment or prevention of infections or infectious diseases, including antibiotics, antivirals, antiparasitics, antiprotozoals and antifungals;

Amendment 496 #

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ, Erik POULSEN

Proposal for a directive
Article 4 – paragraph 1 – point 22

Amendment 497 #

Proposal for a directive
Article 4 – paragraph 1 – point 22

Amendment 498 #

Proposal for a directive
Article 4 – paragraph 1 – point 22

Amendment 499 #

Proposal for a directive
Article 4 – paragraph 1 – point 22

(22) ‘antimicrobial’ means any medicinal product with a direct action on micro-organisms (including viruses) used for treatment or prevention of infections or infectious diseases, including antibiotics, antivirals and antifungals;

Amendment 500 #

Proposal for a directive
Article 4 – paragraph 1 – point 26

(26) ‘combination of a medicinal product with a product other than a medical device’ means a combination of a medicinal product with a product other than a medical device (as defined by Regulation (EU) 2017/745) and Regulation (EU) 2017/746) and where the two are intended for use in the given combination in accordance with the summary of product characteristics;

Amendment 501 #

Proposal for a directive
Article 4 – paragraph 1 – point 28

(28) 'vaccine’ means any medicinal product that is intended to elicit an immune response against an antigen or antigens for prevention, including post exposure prophylaxis, and for treatment of diseases caused by an infectious agent;

Amendment 502 #

Proposal for a directive
Article 4 – paragraph 1 – point 28

(28) 'vaccine’ means any medicinal product that is intended to elicit an immune response for prevention, including post exposure prophylaxis, and ~~for treatment of~~ diseases caused by an infectious agent;

Amendment 503 #

Proposal for a directive
Article 4 – paragraph 1 – point 29 – introductory part

(29) ‘gene therapy medicinal product’ means a biological medicinal product, except vaccines against infectious diseases, that contains or consists of:

Amendment 504 #

Proposal for a directive
Article 4 – paragraph 1 – point 29 – point a

(a) a substance or a combination of substances intended to edit the host genome in a sequence-specific manner or that contains or consists of cells subjected to such genetic modifications; or

Amendment 505 #

Proposal for a directive
Article 4 – paragraph 1 – point 29 – point a

(a) a substance or a combination of substances ~~intended to~~that edit the host genome in a sequence-specific manner or that contain or consists of cells subjected to such modification; or

Amendment 506 #

Proposal for a directive
Article 4 – paragraph 1 – point 29 – point a

(a) a substance or a combination of substances ~~intended to~~ edit the host genome in a sequence-specific manner or that contain or consists of cells subjected to such modification; or

Amendment 507 #

Proposal for a directive
Article 4 – paragraph 1 – point 29 – point b

(b) a recombinant or synthetic nucleic acid used in or administered to human beings with a view to regulating, replacing or adding a genetic sequence that mediates its effect by transcription or translation of the transferred genetic materials or that contain or consists of cells subjected to these modifications;deleted

Amendment 508 #

Proposal for a directive
Article 4 – paragraph 1 – point 29 – point b

Amendment 509 #

Proposal for a directive
Article 4 – paragraph 1 – point 29 – point b

(b) a recombinant ~~or synthetic~~ nucleic acid used in or administered to human beings with a view to regulating, replacing or adding a genetic sequence that mediates its effect by transcription or translation of the transferred genetic materials or that contain or consists of cells subjected to these modifications;

Amendment 510 #

Dolors MONTSERRAT, Tomislav SOKOL

Proposal for a directive
Article 4 – paragraph 1 – point 30 – paragraph 1 – point b

(b) is present~~ed as having~~s properties for, or is used in or administered to human beings with a view to treating, preventing or diagnosing a disease through the pharmacological, immunological or metabolic action of its cells or tissues.

Amendment 511 #

Proposal for a directive
Article 4 – paragraph 1 – point 30 a (new)

(30 a) ‘platform technology’ means a specific technology or a collection of technologies used in the manufacturing process and/or the quality control, the nonclinical or clinical testing of one or more medicinal products and/or components that rely on prior knowledge and are established under the same underlying scientific principles. The Commission should promote the development of Platform Technologies that should be part of an open platform, available for the different developers (academic, small biotech and big pharma) generating knowledge and data that once available can accelerate the process of development and evaluation of new therapies. In this context, the supported Platform Technology will appear in the status of PRE-COMPETITION and if it is having advantage of as an existing patent, it will be available under reasonable fee. These Platform Technologies once open to all the stakeholders can be easily updated while having regulatory support in benefit of EU patients.

Amendment 512 #

Billy KELLEHER, Ondřej KNOTEK, Catherine AMALRIC

Proposal for a directive
Article 4 – paragraph 1 – point 30 a (new)

(30 a) 'platform technology’ means a specific technology or a collection of technologies used in the manufacturing process and/or the quality control, the nonclinical or clinical testing of one or more medicinal products and/or components that rely on prior knowledge and are established under the same underlying scientific principles.

Amendment 513 #

Billy KELLEHER

Proposal for a directive
Article 4 – paragraph 1 – point 30 b (new)

(30 b) 'platform technology’ means a specific technology or a collection of technologies used in the manufacturing process and/or the quality control, the nonclinical or clinical testing of one or more medicinal products and/or components that rely on prior knowledge and are established under the same underlying scientific principles.

Amendment 514 #

Proposal for a directive
Article 4 – paragraph 1 – point 30 a (new)

(30 a) platform technology master file’ means a document that contains a detailed description of a platform technology for which the underlying scientific principles under which the platform technology is established, and which is prepared in a separate document by the owner of the platform technology. This can encompass quality, pre-clinical and/or clinical data in relation to the medicinal products and/or components the platform technology refers to

Amendment 515 #

Dolors MONTSERRAT, Tomislav SOKOL

Proposal for a directive
Article 4 – paragraph 1 – point 30 b (new)

(30 b) ‘platform technology master file’ means a document that contains a detailed description of a platform technology for which the underlying scientific principles under which the platform technology is established. This can encompass quality, pre-clinical and/or clinical data in relation to the medicinal products and/or components the platform technology refers to.

Amendment 516 #

Proposal for a directive
Article 4 – paragraph 1 – point 31 – point a

(a) a method involving an industrial process which includes pooling of donations, for purposes beyond processing of SoHOs for concentrates or pathogen inactivation; or

Amendment 517 #

Proposal for a directive
Article 4 – paragraph 1 – point 31 – point a

(a) a method involving an industrial process which includes pooling of donations with a view to a future fractionation; or

Amendment 518 #

Proposal for a directive
Article 4 – paragraph 1 – point 31 – point a

(a) a method involving an industrial process which includes pooling of donations for subsequent fractionation; or

Amendment 519 #

Proposal for a directive
Article 4 – paragraph 1 – point 31 – point b

(b) a process that extracts an active ingredient from the substance of human origin or transforms the substance of human origin by changing its inherent properties; where a process involves the pooling, concentration, separation or isolation of elements in the preparation of SoHOs, or any other method that increases the microbiological quality, it should not be considered a change in their inherent properties;

Amendment 520 #

Proposal for a directive
Article 4 – paragraph 1 – point 31 – point b

(b) a process that extracts an active ingredient from the substance of human origin or transforms the substance of human origin by changing its inherent properties; when a process concerns pooling, concentrating, separating or isolating elements in the preparation of SoHO, as well as methods that increase micro-biological quality, this should not be considered as changing their inherent properties;

Amendment 521 #

Proposal for a directive
Article 4 – paragraph 1 – point 33

(33) ‘environmental risk assessment’ means the evaluation of the risks and potential risks to the environment, or risks to public health, posed by the release of the medicinal product in the environment from the use, manufacturing and disposal of the medicinal product and the identification of risk prevention, limitation and mitigation measures. For medicinal product with an antimicrobial mode of action, the ERA also encompasses an evaluation of the risk for antimicrobial resistance selection in the environment due to the manufacturing, use and disposal of that medicinal product;

Amendment 522 #

Proposal for a directive
Article 4 – paragraph 1 – point 33

(33) ‘environmental risk assessment’ means the evaluation of the risks to the environment, including global warming, or risks to public health, posed by the ~~release of the medicinal product~~manufacture, use and disposal of the medicine, as well as its release into the environment ~~from the use and disposal of the medicinal product and~~. The assessment includes the ide~~ntific~~termination of ~~risk~~measures to prevent~~ion~~, limit~~ation~~ and mitigat~~ion measure~~e these risks. For medicinal product with an antimicrobial mode of action, the ERA also encompasses an evaluation of the risk for antimicrobial resistance selection in the environment due to the manufacturing, use and disposal of that medicinal product;

Amendment 523 #

Proposal for a directive
Article 4 – paragraph 1 – point 33

(33) ‘environmental risk assessment’ means the evaluation of the potential risks to the environment, ~~or risks to public health,~~ posed by the release of the medicinal product in the environment from the use ~~and disposal~~ of the medicinal product and ~~the identification of risk prevention, limitation and~~ mitigation measures. For medicinal product with an anti~~microbial~~biotic mode of action, the ERA also encompasses an evaluation of the risk for anti~~microbial~~biotic resistance selection in the environment due to the manufacturing, use and disposal of that medicinal product;

Amendment 524 #

Proposal for a directive
Article 4 – paragraph 1 – point 33

(33) ‘environmental risk assessment’ means the evaluation of the potential and actual risks to the environment, or risks to public health, including antimicrobial resistance, posed by the release of the medicinal product in the environment from the manufacturing, use and disposal of the medicinal product and the identification of risk prevention, limitation and mitigation measures. For medicinal product with an antimicrobial mode of action, the ERA also encompasses an evaluation of the risk for antimicrobial resistance selection in the environment due to the manufacturing, use and disposal of that medicinal product;

Amendment 525 #

Proposal for a directive
Article 4 – paragraph 1 – point 33

(33) ‘environmental risk assessment’ means the evaluation of the ~~risks~~potential to the environment, ~~or risks to public health,~~ posed by the release of the medicinal product in the environment from the use ~~and disposal~~ of the medicinal product and ~~the identification of risk prevention, limitation and~~ mitigation measures. For medicinal product with an anti~~microbial~~biotic mode of action, the ERA also encompasses an evaluation of the risk for anti~~microbial~~biotic resistance selection in the environment due to the manufacturing, use and disposal of that medicinal product;

Amendment 526 #

Proposal for a directive
Article 4 – paragraph 1 – point 34

(34) ‘antimicrobial resistance’ means the ability of a micro-organism to survive or to grow in the presence of a concentration of an antimicrobial agent that is usually or was in the past sufficient to inhibit or kill that micro- organism;

Amendment 527 #

Proposal for a directive
Article 4 – paragraph 1 – point 35 – point b

(b) of undesirable effects or risks on the environment posed by the medicinal product;

Amendment 528 #

Proposal for a directive
Article 4 – paragraph 1 – point 35 – point c

(c) of undesirable effects ~~on public health~~ due to the release of the medicinal product in the environment including anti~~- microbial~~biotic resistance;

Amendment 529 #

Proposal for a directive
Article 4 – paragraph 1 – point 36 a (new)

(36 a) 'Quality Master File' means a comprehensive document provided by the manufacturer of an active substance, excluding chemical active substances. This document includes a thorough description of the manufacturing process, quality control procedures throughout production, and the validation process. It is mandated by Annex II and is prepared as a distinct document, encompassing details about the active substance or any other substances utilized in the production of a medicinal product.

Amendment 530 #

Proposal for a directive
Article 4 – paragraph 1 – point 39

(39) ~~‘medicinal~~'Prescription' means a prescription~~’ means any~~ for a medicinal pr~~escription~~oduct issued by a ~~professional person qualified to do so;~~member of a regulated health profession within the meaning of Article 3 (1) (a) of Directive 2005/36/EC who is legally entitled to do so in the Member State in which the prescription is issued

Amendment 531 #

Proposal for a directive
Article 4 – paragraph 1 – point 41

(41) ‘benefit-risk balance’ means an evaluation of the positive therapeutic effects of the medicinal product in relation to the risks referred to in point (35)~~, subpoint (a)~~;

Amendment 532 #

Proposal for a directive
Article 4 – paragraph 1 – point 41

(41) ‘benefit-risk balance’ means an evaluation of the positive therapeutic effects of the medicinal product in relation to the risks referred to in point (35)~~, subpoint (a)~~;

Amendment 533 #

Proposal for a directive
Article 4 – paragraph 1 – point 53 a (new)

(53 a) ‘patients’ organisations’ means not-for-profit organisations which are patient focused, and where patients and/or carers, when patients are unable to represent themselves, represent a majority of members in governing bodies;

Amendment 534 #

Proposal for a directive
Article 4 – paragraph 1 – point 58

(58) ‘risk management system’ means a set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise public health or environment risks relating to a medicinal product, including the assessment of the effectiveness of those activities and interventions;

Amendment 535 #

Proposal for a directive
Article 4 – paragraph 1 – point 59

(59) ‘adverse reaction’ means an effect on a person in response to a received medicinal product that is noxious and unintended;

Amendment 536 #

Proposal for a directive
Article 4 – paragraph 1 – point 60

(60) ‘serious adverse reaction’ means an adverse reaction that results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, produces a notable reduction of patient’s quality of life or is a congenital anomaly or a birth defect;

Amendment 537 #

Proposal for a directive
Article 4 – paragraph 1 – point 61 b (new)

(61 b) 'adverse event' means any health problem that occurs after administration without necessarily being caused by the administration of a medication. Later it will be determined if they are coincident or related.

Amendment 538 #

Proposal for a directive
Article 4 – paragraph 1 – point 62

(62) ‘homeopathic medicinal product’ means a medicinal product prepared from homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias currently used officially in the Member States;deleted

Amendment 539 #

Proposal for a directive
Article 4 – paragraph 1 – point 64

(64) ‘herbal medicinal product’ means any medicinal product, exclusively containing as source of active ingredients one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more herbal preparations;

Amendment 540 #

Proposal for a directive
Article 4 – paragraph 1 – point 70

(70) ‘public service obligation’ means to guarantee permanently an adequate range and the necessary quantity of medicinal products to meet the requirements of a specific geographical area and to deliver the supplies requested within a very short time over the whole of the area in question.

Amendment 541 #

Proposal for a directive
Article 4 – paragraph 1 – point 70

(70) ‘public service obligation’ means to ~~guarante~~ensure permanently an adequate range of medicinal products to meet the requirements of a specific geographical area and to deliver the supplies requested within a very short time over the whole of the area in question.

Amendment 542 #

Proposal for a directive
Article 4 – paragraph 1 – point 70

Amendment 543 #

Proposal for a directive
Article 4 – paragraph 1 – point 70 a (new)

(70 a) ‘decentralised site’ means a site where manufacturing or testing steps of medicinal products take place in compliance with the principles of good manufacturing practice under the responsibility of the qualified person of a central site holding a manufacturing authorisation.”

Amendment 544 #

Proposal for a directive
Article 4 – paragraph 1 – point 70 a (new)

(70 a) "decentralised manufacturing" means a production model where manufacturing of medicinal products needs to take place in local sites close to patients.

Amendment 545 #

Proposal for a directive
Article 4 – paragraph 2

~~2. The Commission is empowered to adopt~~ delegated acts in accordance with Article 215 to amend the definitions in paragraph 1, points (2) to (6), (8), (14), (16) to (31), in the light of technical and scientific progress and taking into account definitions agreed at Union and international level without extending the scope of the definitions.

Amendment 546 #

Proposal for a directive
Article 4 – paragraph 2

Amendment 547 #

Proposal for a directive
Article 4 – paragraph 2

Amendment 548 #

Proposal for a directive
Article 5 – paragraph 2

2. When an initial marketing authorisation has been granted in accordance with paragraph 1, any development concerning the medicinal product covered by the authorisation such as additional therapeutic indication, strengths, pharmaceutical forms, administration routes, presentations, as well as any variations of the marketing authorisation shall also be granted an authorisation in accordance with paragraph 1 or be included in the initial marketing authorisation. All those marketing authorisations as well as those obtained by this marketing authorisation holder according to Articles 9 to 12 shall be considered as belonging to the same global marketing authorisation, in particular for the purpose of the marketing authorisations applications under Articles 9 to 12, including as regards the expiry of the regulatory data protection period for applications using a reference medicinal product.

Amendment 549 #

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER

Proposal for a directive
Article 5 – paragraph 2 a (new)

2 a. Developments lacking therapuetic contributions shall always be granted in accodrance with paragraph 1 and be considered as belonging to the same global marketing authorisation.

Amendment 550 #

Proposal for a directive
Article 6 – paragraph 2 – subparagraph 1 (new)

The marketing authorisation application shall include the results of controlled clinical trials randomised versus an established medicinal product of proven therapeutic value with clinical endpoints or versus placebo in case of lack of established medicinal product of proven therapeutic value. Any other design shall be duly justified and accepted only for exceptional situations.

Amendment 551 #

Billy KELLEHER, Ondřej KNOTEK, Catherine AMALRIC

Proposal for a directive
Article 6 – paragraph 2 a (new)

2 a. The marketing authorisation application shall include the particulars and documentation listed in Annex I, submitted in accordance with Annex II. Where justified for therapeutic purposes, a marketing authorisation may be granted for a medicinal product for which an active substance master file, an additional quality master file and/or a platform technology master file exists and is referred to in the application.

Amendment 552 #

Proposal for a directive
Article 6 – paragraph 3 a (new)

3 a. Applications for market authorisation shall provide evidence from comparative studies with a standard-of- care active comparator, including, but not limited to, randomised controlled trials. In exceptional circumstances, where such studies cannot be provided for scientifically substantiated reasons, the applicant shall submit such duly justified reasoning to the national competent authority as part of the application for marketing authorisation. The Agency shall set the scientific guidelines on criteria for proposing a comparator for a clinical trial, taking into account the results of the consultation of the Commission and the authorities or bodies involved in the mechanism of consultation referred to in Article 162 of [revised Regulation (EC) No 726/2004].

Amendment 553 #

Proposal for a directive
Article 6 – paragraph 3 b (new)

3 b. Applications for marketing authorisation shall include patient experience data (PROMs/PREMs) in the marketing application dossier. Where such data cannot be provided, the applicant should provide a justification to the Agency.

Amendment 554 #

Proposal for a directive
Article 6 – paragraph 4

4. The risk management system referred to in Annex I shall be proportionate to the identified risks and the potential public health or environment risks of the medicinal product, and the need for post-authorisation safety data.

Amendment 555 #

Proposal for a directive
Article 6 – paragraph 5 – subparagraph 1 – point a

(a) the results of all studies performed and details of all information collected in compliance with an agreed paediatric investigation plan;. In the absence of randomised controlled studies involving an active comparator group, scientific substantiation is required as to why the studies referred to could not be carried out.

Amendment 556 #

Proposal for a directive
Article 6 – paragraph 5 – subparagraph 1 – point a a (new)

(a a) when the agreed paediatric investigation plan cannot be timely accomplished due to failure to conduct paediatric clinical studies, the evidence obtained from extrapolation and all information on safety and efficacy collected from the appropriately designed post-marketing long-term studies

Amendment 557 #

Proposal for a directive
Article 6 – paragraph 5 – subparagraph 1 – point a a (new)

(a a) in the absence of comparative studies, a justification to substantiate the reasons why the above mentioned studies could not be conducted;

Amendment 558 #

Proposal for a directive
Article 6 – paragraph 7 – subparagraph 1

The marketing authorisation applicant shall demonstrate that the principle of replacement, reduction and refinement of animal testing for scientific purposes has been applied in compliance with Directive 2010/63/EU with regard to any animal study conducted in support of the application. Where appropriate the marketing authorisation applicant shall not carry out animal testing to meet the requirements of this legislation where non-animal methods that are acceptable to the competent authorities, are available.’

Amendment 559 #

Proposal for a directive
Article 6 – paragraph 7 – subparagraph 2

The marketing authorisation applicant shall not carry out animal testing in case scientifically satisfactory non-animal testing methods are available. The marketing authorisation applicant shall not carry out animal tests in case scientifically satisfactory non-animal testing methods are available. Where scientifically satisfactory non-animal testing methods are not available, applicants that use animal testing shall ensure that the principle of replacement, reduction and refinement of animal testing for scientific purposes has been applied in compliance with Directive 2010/63/EU with regard to any animal study conducted for the purpose of supporting the application.

Amendment 560 #

Proposal for a directive
Article 6 – paragraph 7 – subparagraph 2

The marketing authorisation applicant shall not carry out animal testing in case scientifically satisfactory non-animal testing methods are available, or where the results of animal studies previously carried out by the applicant or others may be used for the medicinal product.

Amendment 561 #

Proposal for a directive
Article 6 – paragraph 7 – subparagraph 2

The marketing authorisation applicant shall not carry out animal testing in case scientifically satisfactory New Approach Methodologies (NAMs), particularly non- animal testing methods are available.

Amendment 562 #

Proposal for a directive
Article 6 – paragraph 7 a (new)

7 a. A marketing authorisation may be granted for a medicinal product on the basis of an active substance master file, an additional quality master file or a platform technology master file.

Amendment 563 #

Proposal for a directive
Article 9 – paragraph 3 – subparagraph 1

Paragraph 1 shall also apply if the reference medicinal product has not been authorised in the Member State in which the application for the generic medicinal product is submitted~~. In this~~, unless the applicant of the generic product is also the marketing authorisation holder or a related company of the reference medicinal product. In the latter case the complete dossier should be submitted. In the former case, the applicant shall indicate in the application the name of the Member State in which the reference medicinal product is or has been authorised. At the request of the competent authority of the Member State in which the application is submitted, the competent authority of the other Member State shall transmit within a period of one month a confirmation that the reference medicinal product is or has been authorised together with the full composition of the reference medicinal product and if necessary, any other relevant documentation.

Amendment 564 #

Proposal for a directive
Article 10 – paragraph 1

In cases where the medicinal product does not fall within the definition of a generic medicinal product or has changes in strength, pharmaceutical form, route of administration or therapeutic indications, compared to the reference medicinal product, the results of the appropriate non- clinical tests or clinical studies shall be provided to the competent authorities to the extent necessary to establish a scientific bridge to the data relied upon in the marketing authorisation for the reference medicinal product, and to demonstrate the safety and efficacy profile of the hybrid medicinal product. The Agency shall adopt guidelines on the appropriate tests and clinical studies for marketing authorisation of hybrid medicinal products.

Amendment 565 #

Proposal for a directive
Article 10 – paragraph 1

In cases where the medicinal product does not fall within the definition of a generic medicinal product or has changes in strength, pharmaceutical form, route of administration or therapeutic indications, compared to the reference medicinal product, the results of the appropriate non- clinical tests orand clinical studies shall be provided to t~~he competent authorities to the extent necessary to establish a scientific bridge to the data relied upon in~~o the extent necessary to demonstrate essential similarity to the marketing authorisation for the reference medicinal product, and to demonstrate the safety and efficacy profile of the hybrid medicinal product in any additional indication.

Amendment 566 #

Proposal for a directive
Article 11 – paragraph 1

For a ~~biological~~ medicinal product that is similar to a reference biological medicinal product (‘biosimilar medicinal product’), the results of appropriate comparability tests and studies shall be provided to the competent authorities. The type and quantity of supplementary data to be provided must comply with the relevant criteria stated in Annex II and the related detailed guidelines. The results of other tests and studies from the reference medicinal product's dossier shall not be provided.

Amendment 567 #

Proposal for a directive
Article 11 – paragraph 1 a (new)

Where a medicinal product is not a biological medicinal product but it is similar to a reference biological medicinal product (‘synthetic follow-on medicinal product’), paragraph 1 shall apply and the synthetic follow-on medicinal product shall be subject to the requirements of this Directive and [revised Regulation 726/2004] applicable to biosimilar medicinal products.

Amendment 568 #

Proposal for a directive
Article 12

In cases where a biosimilar medicinal product has changes in strength, pharmaceutical form, route of administration or therapeutic indications, compared to the reference biological medicinal product (‘bio-hybrid’), the results of the appropriate non-clinical tests or clinical studies shall be provided to the competent authorities to the extent necessary to establish a scientific bridge to the data relied upon in the marketing authorisation for the reference biological medicinal product, and to demonstrate the safety or efficacy profile of the biosimilarArticle 12 deleted Applications concerning bio-hybrid medicinal product.s

Amendment 569 #

Proposal for a directive
Article 12 – paragraph 1

In cases where a biosimilar medicinal product has changes in strength, pharmaceutical form, route of administration or therapeutic indications, compared to the reference biological medicinal product (‘bio-hybrid’), the results of the appropriate non-clinical tests or clinical studies shall be provided to the competent authorities to the extent necessary to establish a scientific bridge to the data relied upon in the marketing authorisation for the reference biological medicinal product, and to demonstrate the safety orand efficacy profile of the biosimilar medicinal product. The Agency shall adopt guidelines on the appropriate tests and clinical studies for marketing authorisation of bio-hybrid medicinal products.

Amendment 570 #

Proposal for a directive
Article 13 – paragraph 1

~~In cases where no reference medicinal product is or has been authorised for the active substance of the medicinal product concerned, t~~The applicant shall, by way of derogation from Article 6(2), not be required to provide the results of non- clinical tests or clinical studies if the applicant can demonstrate that the active substances of the medicinal product have been in well- established medicinal use within the Union for ~~the same therapeutic use and route of administration and for~~ at least ten years, with recognised efficacy and an acceptable level of safety in terms of the conditions set out in Annex II. In that event, the test and trial results shall be replaced by appropriate bibliographic data in the form of scientific literature.

Amendment 571 #

Proposal for a directive
Article 13 – paragraph 1

In cases where no reference medicinal product is or has been authorised for the active substance of the medicinal product concerned, or there was a reference medicinal product but it is not currently available, the applicant shall, by way of derogation from Article 6(2), not be required to provide the results of non- clinical tests or clinical studies if the applicant can demonstrate that the active substances of the medicinal product have been in well-established medicinal use within the Union for the same therapeutic use and route of administration and for at least ten years, with recognised efficacy and an acceptable level of safety in terms of the conditions set out in Annex II. In that event, the test and trial results shall be replaced by appropriate bibliographic data in the form of scientific literature.

Amendment 572 #

Proposal for a directive
Article 13 – paragraph 1

In cases where no reference medicinal product is or has been authorised for the active substance of the medicinal product concerned, the applicant shall, by way of derogation from Article 6(2), not be required to provide the results of non- clinical tests or clinical studies if the applicant can demonstrate that the active substances of the medicinal product have been in well-established medicinal use within the Union for the same therapeutic use and route of administration and for at least ten years, with recognised efficacy and an acceptable level of safety in terms of the conditions set out in Annex II. In that event, the test and trial results shall be replaced by appropriate bibliographic data in the form of scientific literature, including from systematic reviews and reports from unpublished studies and data.

Amendment 573 #

Billy KELLEHER, Ondřej KNOTEK

Proposal for a directive
Article 13 – paragraph 1

In cases where no reference medicinal product is ~~or has been~~ authorised for the active substance of the medicinal product concerned, the applicant shall, by way of derogation from Article 6(2), not be required to provide the results of non- clinical tests or clinical studies if the applicant can demonstrate that the active substances of the medicinal product have been in well-established medicinal use within the Union for the same therapeutic use and route of administration and for at least ten years, with recognised efficacy and an acceptable level of safety in terms of the conditions set out in Annex II. In that event, the test and trial results shall be replaced by appropriate bibliographic data in the form of scientific literature and demonstration that this literature is relevant for the applied product.

Amendment 574 #

Proposal for a directive
Article 15 – paragraph 2 – subparagraph 1

Where justified for therapeutic purposes, a marketing authorisation may~~, in exceptional circumstances,~~ be granted for a medicinal product comprised of a fixed component and a variable component that is pre-defined in order to, where appropriate, target different variants of an infectious agent or, where necessary, to tailor the medicinal product to characteristics of an individual patient or a group of patients ~~(‘platform technology’)~~.

Amendment 575 #

Proposal for a directive
Article 15 – paragraph 3 – subparagraph 1

Where justified for public health reasons and when the active substances cannot be combined within a fixed dose combination medicinal product, a marketing authorisation may, in exceptional circumstances, be granted to a multi- medicinal product p~~ackage~~roduct.

Amendment 576 #

Proposal for a directive
Article 15 – paragraph 3 a (new)

3 a. Where a fixed dose combination medicinal product consists solely of active substances that meet the criteria for well- established medical use as defined in Article 13 [Applications based on bibliographic data], such a medicinal product shall also be considered to meet those criteria. The application for marketing authorisation for a medicinal product as referred to in Article 15 (4) (a) shall fulfil the information requirements set out in Annex II, Part II, Section 1 [Well- established medicinal use]

Amendment 577 #

Proposal for a directive
Article 15 – paragraph 3 a (new)

3 a. The Commission is empowered to adopt delegated acts in accordance with Article 215 to supplement this Directive by amending Annexes IV to VI by specyfying additional requirements for multi- medicinal product package.

Amendment 578 #

Proposal for a directive
Article 16 – paragraph 1

1. A marketing authorisation shall be required for radio~~nuclide~~pharmaceuticals generators, kits, and ~~radionuclide precursors, unless they are used as starting material, active substance or intermediate of radiopharmaceuticals covered by a marketing authorisation under Article 5(1)~~precursors radiopharmaceuticals.

Amendment 579 #

Proposal for a directive
Article 16 – paragraph 1

1. A marketing authorisation shall be required for radionuclide generators, kits for radiopharmaceutical preparations, and radionuclide precursors, unless they are used as starting material, active substance or intermediate of radiopharmaceuticals covered by a marketing authorisation under Article 5(1).

Amendment 580 #

Proposal for a directive
Article 16 – paragraph 2

2. A marketing authorisation shall not be required for radionuclides or radionuclide generators solely used for radiolabelling purposes, or for a radiopharmaceutical prepared at the time of use by an authorised person or ~~by an~~ establishment ~~authorised, according to national legislation, to use such radiopharmaceutical in an approved healthcare establishment exclusively from authorised radionuclide generators, kits~~using an authorised kit for radiopharmaceutical preparation in combination with a radionuclide or radionuclide ~~precurs~~generators in accordance with the ~~manufacturer's instructions~~summary of product characteristics of the kit ('kit-radiolabelling').

Amendment 581 #

Proposal for a directive
Article 16 – paragraph 2

2. A marketing authorisation shall not be required for a radiopharmaceutical prepared at the time of use by a person or by an establishment authorised, according to national legislation, to use such radiopharmaceutical in an approved healthcare establishment exclusively from authorised radionuclide generators, kits for radiopharmaceutical preparations or radionuclide precursors in accordance with the manufacturer's instructions.

Amendment 582 #

Proposal for a directive
Article 17 – paragraph 1 – point a

(a) an antimicrobial stewardship and access plan as referred to in Annex I;

Amendment 583 #

Proposal for a directive
Article 17 – paragraph 1 – point a

(a) an antimicrobial ~~stewardship~~resistance mitigation plan as referred to in Annex I;

Amendment 584 #

Proposal for a directive
Article 17 – paragraph 1 – point b

(b) a description of the special information requirements outlined in Article 69 and listed in Annex I, for prior review and approval by the competent authority.

Amendment 585 #

Proposal for a directive
Article 17 – paragraph 1 – point b

(b) a description of the special information requirements outlined in Article 69 and listed in Annex I, for prior vetting by the competent authority.

Amendment 586 #

Proposal for a directive
Article 17 – paragraph 1 a (new)

1 a. After granting marketing authorisation, the competent authority shall make publicly available the documents referred to in paragraph 1.

Amendment 587 #

Proposal for a directive
Article 17 – paragraph 2

2. The competent authority ~~may~~shall impose obligations on the marketing authorisation holder if it finds the risk mitigation measures contained in the antimicrobial stewardship and access plan unsatisfactory.

Amendment 588 #

Proposal for a directive
Article 17 – paragraph 2

Amendment 589 #

Proposal for a directive
Article 17 – paragraph 2

Amendment 590 #

Proposal for a directive
Article 17 – paragraph 2

Amendment 591 #

Proposal for a directive
Article 17 – paragraph 2

2. The competent authority may impose obligations on the marketing authorisation holder if it finds the risk mitigation measures contained in the antimicrobial ~~stewardship~~resistance mitigation plan unsatisfactory.

Amendment 592 #

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ, Erik POULSEN

Proposal for a directive
Article 17 – paragraph 3

~~3. The marketing authorisation holder shall ensure that the pack size of the antimicrobial corresponds to the usual posology and duration of treatment.~~deleted

Amendment 593 #

Proposal for a directive
Article 17 – paragraph 3

3. The marketing authorisation holder shall ensure, wherever possible, that the antimicrobial may be dispensed per unit in a number corresponding to the quantities corresponding to the duration of treatment. If an antimicrobial can not be dispensed per unit, the marketing authorisation holder shall ensure that the pack size of the antimicrobial corresponds to the usual posology and duration of treatment.

Amendment 594 #

Proposal for a directive
Article 17 – paragraph 3

3. The marketing authorisation holder shall ensure, wherever possible, that the antimicrobial may be dispensed per unit in a number corresponding to the quantities described on the prescription. If an antimicrobial can not be dispensed per unit, the marketing authorization holder shall ensure that the pack size of the antimicrobial corresponds to the usual posology and duration of treatment.

Amendment 595 #

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ, Erik POULSEN

Proposal for a directive
Article 17 – paragraph 3

3. The marketing authorisation holder shall ensure that the ~~pack size of the antimicrobial~~antimicrobial may be dispensed per unit in a number correspondsing to the ~~usual posology and duration of treatment~~quantities prescribed by the treating physician.

Amendment 596 #

Proposal for a directive
Article 17 – paragraph 3 – subparagraph 1 (new)

Pharmacists should play a role in antimicrobial stewardship, including advising on the prudent use of antibiotics and other antimicrobials, as well as their correct disposal.

Amendment 597 #

Proposal for a directive
Article 17 – paragraph 3 a (new)

3 a. By derogation from paragraph 3, in duly justified cases, national authorities may allow for pack sizes of the antimicrobial to correspond with the usual posology and duration of treatment.

Amendment 598 #

Proposal for a directive
Article 18 – paragraph 1 – subparagraph 2

As part of the assessment, in accordance with Article 29, of the integral combination of a medicinal product and a medical device the competent authorities shall assess the benefit-risk balance of the integral combination of a medicinal product and a medical device, taking into account the suitability of the use of the medicinal product together with the medical device, particularly for paediatric patients, encompassing aspects such as storage, assembly, cleanliness, and the technique required for application or intake.

Amendment 599 #

Proposal for a directive
Article 18 – paragraph 1 – subparagraph 2

As part of the assessment, in accordance with Article 29, of the integral combination of a medicinal product and a medical device the competent authorities shall assess the benefit-risk balance of the integral combination of a medicinal product and a medical device, taking into account the suitability of the use of the medicinal product together with the medical device, especially by paediatric patients, including storage, assemblage, hygiene and application/intake technique required.

Amendment 600 #

Proposal for a directive
Article 18 – paragraph 3

3. The application for a marketing authorisation for an integral combination of a medicinal product with a medical device shall include the ~~documentation~~evidence supporting the compliance of the medical device part with the general safety and performance requirements as referred to in paragraph 2 in accordance with Annex II, including, where relevant, the ~~conformity~~ assessment report by a notified body.

Amendment 601 #

Proposal for a directive
Article 18 – paragraph 4

4. In its evaluation of the integral combination of a medicinal product with a medical device concerned, the competent authorities shall recognise the results of the assessment of compliance of the medical device part of that integral combination with the general safety and performance requirements in accordance with Annex I of Regulation (EU) 2017/745 including~~, where relevant,~~ the results of the assessment by a notified body.

Amendment 602 #

Proposal for a directive
Article 19 – paragraph 1 – subparagraph 2

As part of the assessment, in accordance with Article 29, of the medicinal product referred to in the first subparagraph, the competent authorities shall assess the benefit-risk balance of the medicinal product taking into account the use of the medicinal product together with the medical device, especially by paediatric patients, including storage, assemblage, hygiene and application/intake technique required.

Amendment 603 #

Proposal for a directive
Article 19 – paragraph 4

4. In its evaluation of the medicinal product referred to in paragraph 1 the competent authority shall recognise the results of the assessment of compliance of the medical device concerned with the general safety and performance requirements in accordance with Annex I of Regulation (EU) 2017/745 ~~including, where relevant, the results of the assessment by a notified body.~~

Amendment 604 #

Proposal for a directive
Article 20 – title

Combinations of medicinal products with products other than medical devices

Amendment 605 #

Proposal for a directive
Article 20 – paragraph 2 a (new)

2 a. The Commission is empowered to adopt delegated acts in accordance with Article 215 to supplement this Directive by specifying the following: a) specific categories of products other than medical devices that may be used in combination with medicinal products; b) specific requirements of suitability for the abovementioned categories of products other than medical devices; c) amending Annexes IV to VI by specyfying additional requirements for combinations of medicinal products with products other than medical devices.

Amendment 606 #

Proposal for a directive
Article 21 – paragraph 1

The applicant of a marketing authorisation for a medicinal product referred to in Articles 9 and 11 shall not be required to submit a risk management plan and a summary thereof, provided that no additional risk minimisation measures exist for the reference medicinal product and provided that the marketing authorisation for the reference medicinal product has not been withdrawn prior to the submission of the application or in other situations as laid down in Article 91.

Amendment 607 #

Proposal for a directive
Article 22 – paragraph 1

1. When preparing the environmental risk assessment (‘ERA’) to be submitted pursuant to Article 6(2), the applicant shall take into account the scientific guidelines on the environmental risk assessment of medicinal products for human use as referred to in paragraph 6, and guidelines relating to the assessment of the greenhouse gas emissions footprint of a medicine, or provide the reasons for any divergence from the scientific guidelines to the Agency or, as appropriate to the competent authority of the Member State concerned, in a timely manner. Where available, the applicant shall take into account existing ERAs performed under other Union legislation.

Amendment 608 #

Proposal for a directive
Article 22 – paragraph 1

1. When preparing the environmental risk assessment (‘ERA’) to be submitted pursuant to Article 6(2), the applicant shall take into account the scientific guidelines on the environmental risk assessment of medicinal products for human use as referred to in paragraph 6, or provide the duly justified reasons for any divergence from the scientific guidelines to the Agency or, as appropriate to the competent authority of the Member State concerned, in a timely manner. Where available, the applicant shall take into account existing ERAs performed under other Union legislation.

Amendment 609 #

Proposal for a directive
Article 22 – paragraph 1

1. When preparing the environmental risk assessment (‘ERA’) to be submitted pursuant to Article 6(2), the applicant shall take into account the scientific guidelines on the environmental risk assessment of medicinal products for human use as referred to in paragraph 65, or provide the reasons for any divergence from the scientific guidelines to the Agency or, as appropriate to the competent authority of the Member State concerned, in a timely manner. Where available, the applicant shall take into account existing ERAs performed under other Union legislation.

Amendment 610 #

Proposal for a directive
Article 22 – paragraph 1

1. When preparing the environmental risk assessment (‘ERA’) to be submitted pursuant to Article 6(2), the applicant shall take into account the scientific guidelines on the environmental risk assessment of medicinal products for human use as referred to in paragraph 65, or provide the reasons for any divergence from the scientific guidelines to the Agency or, as appropriate to the competent authority of the Member State concerned, in a timely manner. Where available, the applicant shall take into account existing ERAs performed under other Union legislation.

Amendment 611 #

Proposal for a directive
Article 22 – paragraph 1 a (new)

1 a. The ERA shall evaluate possible risks to the environment due to use and disposal of the medicinal product according to the requirements referred to in Annex II. With regard to risks resulting from manufacturing, the ERA shall provide information on discharges and emissions of the active substance and other environmentally relevant substances according to the requirements referred to in Annex II.

Amendment 612 #

Proposal for a directive
Article 22 – paragraph 2 – introductory part

2. The ERA shall evaluate the possible risks to the environment due to the use and disposal of the medicinal product according to the requirements referred to in Annex II . It shall indicate whether the medicinal product or any of its ingredients or other constituents is one of the following substances according to the criteria of Annex I to the Regulation (EC) No 1272/2008:

Amendment 613 #

Proposal for a directive
Article 22 – paragraph 2 – point c

Amendment 614 #

Proposal for a directive
Article 22 – paragraph 2 – point c a (new)

(c a) very persistent and very mobile (vPvM);

Amendment 615 #

Proposal for a directive
Article 22 – paragraph 2 – subparagraph 1

or(d) are endocrine active agents.

Amendment 616 #

Proposal for a directive
Article 22 – paragraph 2 a (new)

2 a. With regards to risks resulting from manufacturing, the ERA shall provide information on discharged and emissions of the active susbtance(s) and other environmentally relevant susbtances according to the requirements referred to in Annex II.

Amendment 617 #

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ, Erik POULSEN

Proposal for a directive
Article 22 – paragraph 3

3. The applicant shall also include in the ERA risk mitigation measures to avoid or where it is not possible, to reduce discharges and emissions of the medicinal product to the environment and information on available techniques that will be used to reduce those discharges and emissions, in particular those occurring in manufacturing effluents before these effluents leave the manufacturing sites and to limit emissions to air, water and soil of pollutants listed in Directive 2000/60/EC, Directive 2006/118/EC, Directive 2008/105/EC and Directive 2010/75/EU. The applicant shall provide detailed explanation that the proposed mitigation measures are appropriate and sufficient to address the identified risks to the environment.

Amendment 618 #

Proposal for a directive
Article 22 – paragraph 3

3. The applicant shall also include in the ERA risk mitigation measures to avoid or where it is not possible, limit emissions to air, water and soil of pollutants listed in Directive 2000/60/EC, Directive 2006/118/EC, Directive 2008/105/EC and Directive 2010/75/EU. The applicant shall provide detailed explanation that the proposed mitigation measures are appropriate and sufficient to address the identified risks to the environment. When necessary, it shall also include information on available techniques and on the techniques that will be used to reduce the discharges and emissions of the medicinal product, in particular those occuring in manufacturing effluents before these effluents leave the manufacturing sites.

Amendment 619 #

Proposal for a directive
Article 22 – paragraph 3

3. The applicant shall also include in the ERA risk minimisation and mitigation measures to avoid or where it is not possible, limit emissions to air, water and soil of pollutants listed in Directive 2000/60/EC, Directive 2006/118/EC, Directive 2008/105/EC and Directive 2010/75/EU. The applicant shall provide detailed explanation that the proposed mitigation measures are appropriate and sufficient to address the identified risks to the environment.:

Amendment 620 #

Proposal for a directive
Article 22 – paragraph 3

3. The applicant shall also include in the ERA risk mitigation measures to avoid or where it is not possible, limit emissions to air, water and soil of pollutants listed in Directive 2000/60/EC, Directive 2006/118/EC, Directive 2008/105/EC and Directive 2010/75/EU or in the cases where risks to the environment are identified in the scientific guidelines drawn up by the Agency on the ERA requirements for medicinal products for human use as referred to in paragraph 5. The applicant shall provide detailed explanation that the proposed mitigation measures are appropriate and sufficient to address the identified risks to the environment.

Amendment 621 #

Proposal for a directive
Article 22 – paragraph 3

3. The applicant shall also include in the ERA risk mitigation measures to avoid or where it is not possible, limit emissions to air, water and soil of pollutants listed in Directive 2000/60/EC, Directive 2006/118/EC, Directive 2008/105/EC and Directive 2010/75/EU. It will also focus on the risks associated with the inappropriate handling of a medicinal product that has become waste and include measures to minimise these risks. The applicant shall provide detailed explanation that the proposed mitigation measures are appropriate and sufficient to address the identified risks to the environment.

Amendment 622 #

Proposal for a directive
Article 22 – paragraph 3

Amendment 623 #

Proposal for a directive
Article 22 – paragraph 3

3. TWhen the ERA indicates a risk to the environment, the applicant shall also include in the ERA risk mitigation measures to avoid or where it is not possible, limit emissions to air, water and soil of pollutants listed in Directive 2000/60/EC, Directive 2006/118/EC, Directive 2008/105/EC and Directive 2010/75/EU. The applicant shall provide detailed explanation that the proposed mitigation measures are appropriate and sufficient to address the identified risks to the environment.

Amendment 624 #

Proposal for a directive
Article 22 – paragraph 3

3. The applicant shall also include in the ERA risk for the environment mitigation measures to avoid or where it is not possible, limit emissions to air, water and soil of pollutants listed in Directive 2000/60/EC, Directive 2006/118/EC, Directive 2008/105/EC and Directive 2010/75/EU. The applicant shall provide detailed explanation that the proposed mitigation measures are appropriate and sufficient to address the identified risks to the environment.

Amendment 625 #

Proposal for a directive
Article 22 – paragraph 3 – point a (new)

(a) emissions to air, water and soil of pollutants listed in Directive 2000/60/EC, Directive 2006/118/EC, Directive 2008/105/EC and Directive 2010/75/EU;

Amendment 626 #

Proposal for a directive
Article 22 – paragraph 3 – point b (new)

(b) energy use, waste generation, non recycling materials;

Amendment 627 #

Proposal for a directive
Article 22 – paragraph 3 – point c (new)

Amendment 628 #

Proposal for a directive
Article 22 – paragraph 3 – point d (new)

(d) any other hazard to the environment, animal and human health.

Amendment 629 #

Proposal for a directive
Article 22 – paragraph 3 – subparagraph 1 (new)

The applicant shall provide detailed explanation that the proposed mitigation measures are appropriate and sufficient to address the identified risks to the environment, as well as any circular economy processes adopted.

Amendment 630 #

Proposal for a directive
Article 22 – paragraph 3 a (new)

3 a. The applicant also includes in the ERA an assessment of the greenhouse gas emissions footprint of the production and use of the medicinal product. It specifies risk mitigation measures aimed at limiting greenhouse gas emissions during the production and use of the medicine. The applicant explains in detail that the proposed mitigation measures are appropriate and sufficient to limit these emissions in line with the European Union's climate objectives of Regulation (EU) 2021/1119 of the European Parliament and of the Council of 30 June 2021 establishing the framework required to achieve climate neutrality.

Amendment 631 #

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ, Erik POULSEN

4. ~~The ERA for antimicrobials~~For antimicrobials and other substances which may cause antimicrobial resistance, including products with an antimicrobial mode of action, the ERA shall include an evaluation of the risk for antimicrobial resistance selection in the environment due to the entire manufacturing supply chain inside and outside the Union, use and disposal, including by healthcare professionals and patients, of the antimicrobial taking into account, where relevant, the existing international standards that have established predicted no effect concentration (PNECs) specific for antibiotics.

Amendment 632 #

Proposal for a directive
Article 22 – paragraph 4

4. The ERA for antimicrobials shall include an evaluation of the risk for antimicrobial resistance selection in the environment due to the entire manufacturing supply chain inside and outside the Union, use and disposal, including also by the healthcare professionnals and patients, of the antimicrobial taking into account, where relevant, the existing international standards that have established predicted no effect concentration (PNECs) specific for antibiotics.

Amendment 633 #

Proposal for a directive
Article 22 – paragraph 4

4. The ERA for antimicrobials shall include an evaluation of the risk for antimicrobial resistance selection in the environment due to the ~~entire~~ manufacturing ~~supply chain inside and outside the Union~~, use and disposal of the anti~~microbial~~biotic taking into account, where relevant, the existing international standards that have established predicted no effect concentration (PNECs) specific for antibiotics.

Amendment 634 #

Proposal for a directive
Article 22 – paragraph 4

4. The ERA for anti~~microbial~~biotics shall include an evaluation of the risk for anti~~microbial~~biotic resistance selection in the environment due to the ~~entire~~ manufacturing ~~supply chain inside and outside the~~of the active substance or medicinal product within the European Union , use and disposal of the anti~~microbial~~biotic taking into account, where relevant, the existing international standards that have established predicted no effect concentration (PNECs) specific for antibiotics.

Amendment 635 #

Proposal for a directive
Article 22 – paragraph 5

5. The Agency shall draw up scientific guidelines in accordance with Article 138 of [revised Regulation No (EC) 726/2004], to specify technical details regarding the ERA requirements for medicinal products for human use including environmental risk mitigation measures thereof. Where appropriate, the Agency shall consult the European Chemical Agency (ECHA), the European Food Safety Authority (EFSA) and the European Environmental Agency (EEA) the European Centre of Disease Control (ECDC) and other relevant stakeholders, including those managing residues from medicinal products and wastewater treatment on the drafting of these scientific guidelines.

Amendment 636 #

Proposal for a directive
Article 22 – paragraph 5

5. The Agency shall draw up scientific 5. guidelines in accordance with Article 138 of [revised Regulation No (EC) 726/2004], to specify technical details regarding the ERA requirements for medicinal products for human use. ~~Where appropriate, t~~The Agency shall consult the European Centre for Disease Prevention and Control (ECDC), the European Chemical Agency (ECHA), the European Food Safety Authority (EFSA) and the European Environmental Agency (EEA) and other stakeholders, including drinking water and wastewater operators, on the drafting of these scientific guidelines.

Amendment 637 #

Proposal for a directive
Article 22 – paragraph 5

5. The Agency shall draw up scientific guidelines in accordance with Article 138 of [revised Regulation No (EC) 726/2004], to specify technical details regarding the ERA requirements for medicinal products for human use. Where appropriate, the Agency shall consult the European Chemical Agency (ECHA), the European Food Safety Authority (EFSA) and the European Environmental Agency (EEA), and relevant stakeholders including drinking water and wastewater operators, on the drafting of these scientific guidelines.

Amendment 638 #

Proposal for a directive
Article 22 – paragraph 6 – subparagraph 1

The marketing authorisation holder shall include analytical techniques and explanations in the methodology on the ERA and update the ERA with new information without undue delay to the relevant competent authorities, in accordance with Article 90(2), if new information pertaining to the assessment criteria referred to in Article 29 becomes available and could lead to a change of the conclusions of the ERA. The update shall include updates on the emissions of the medicinal product in manufacturing effluents and any relevant information from environmental monitoring, including monitoring under Directive 2000/60/EC, from eco-toxicity studies, from new or updated risk assessments under other Union legislation, as referred to in paragraph 1, and environmental exposure data.

Amendment 639 #

Proposal for a directive
Article 22 – paragraph 6 – subparagraph 1

The marketing authorisation holder shall update the ERA with new information without undue delay to the relevant competent authorities, in accordance with Article 90(2), if new information pertaining to the assessment criteria referred to in Article 29 becomes available and could lead to a change of the conclusions of the ERA, including updates on the emissions of the medicinal product in manufacturing effluents. The update shall include any relevant information from environmental monitoring, including monitoring under Directive 2000/60/EC, from eco-toxicity studies, from new or updated risk assessments under other Union legislation, as referred to in paragraph 1, the collation of sales data and environmental exposure data.

Amendment 640 #

Proposal for a directive
Article 22 – paragraph 6 – subparagraph 1

The marketing authorisation holder shall update the ERA with new information without undue delay to the relevant competent authorities, in accordance with Article 90(2), if new information pertaining to the assessment criteria referred to in Article 29 becomes available and ~~could~~ leads to a change of the conclusions of the ERA. The update shall include any relevant information from environmental monitoring, including monitoring under Directive 2000/60/EC, from eco-toxicity studies, from new or updated risk assessments under other Union legislation, as referred to in paragraph 1, and environmental exposure data.

Amendment 641 #

Proposal for a directive
Article 22 – paragraph 6 – subparagraph 2

For an ERA conducted prior to [OP please insert the date = 18 months after the date of entering into force of this Directive], the competent authority shall request the marketing authorisation holder to update the ERA to include risk mitigation measures as referred to in paragraph 3. The competent authority shall also request the marketing authorisation holder to update the ERA if missing information has been identified for medicinal products potentially harmful to the environment.

Amendment 642 #

Proposal for a directive
Article 22 – paragraph 6 – subparagraph 2

For an ERA conducted prior to [OP please insert the date = 18 months after the date of entering into force of this Directive], the competent authority shall request the marketing authorisation holder to update the ERA if missing information has been identified for medicinal products potentially harmful to the environment and to update missing information in relation to risk mitigation measures referred to in paragraph 3.

Amendment 643 #

Proposal for a directive
Article 22 – paragraph 6 – subparagraph 2

For an ERA conducted prior to [OP please insert the date = 18 months after the date of entering into force of this Directive], the competent authority shall request the marketing authorisation holder to update the ERA if missing information has been identified for medicinal products potentially harmful to the environment. The ERA shall be updated when new information becomes available, every 5 years at the latest.

Amendment 644 #

Proposal for a directive
Article 22 – paragraph 7

7. For medicinal products referred to in Articles 9 to 12, the applicant may refer to ERA studies conducted for the reference medicinal product when preparing the ERA and shall provide any other data required in accordance with Annex II and the scientific guidelines referred to in the paragraph 5.

Amendment 645 #

Proposal for a directive
Article 22 – paragraph 7

7. For medicinal products referred to in Articles 9 to 12, the applicant may, where appropriate, refer to ERA studies conducted for the reference medicinal product when preparing the ERA and shall provide any other data required in accordance with Annex II and the scientific guidelines as referred to in the first paragraph.

Amendment 646 #

Proposal for a directive
Article 22 – paragraph 7 a (new)

7 a. The marketing authorisation holder shall ensure that package sizes of the medicinal product correspond to usual dosing and treatment durations and comprehensive shelf-life documentation of the finished, and where applicable, intermediate as well as ready-to-use medicinal product is provided. The Agency may, on its own initiative or upon request of the competent authority of a Member State require the marketing authorisation holder to develop additional package sizes and provide for additional in-use shelf-life data as necessary.

Amendment 647 #

Proposal for a directive
Article 22 – paragraph 7 a (new)

7 a. In line with the Aarhus Convention3a, full environmental assessment studies and summaries with outcomes shall be made publicly available and proactively shared with drinking water and wastewater operators. The competent authorities shall include this information in their repository of medicinal products. _________________ 3a UN Convention on access to information, public participation in decision-making and access to justice in environmental matters, done at Aarhus, Denmark, on 25 June 1998.

Amendment 648 #

Proposal for a directive
Article 22 – paragraph 7 a (new)

7 a. The results of the ERA assessment, including data provided by the marketing authorisation holder, shall be made publicly available by the Agency or, where appropriate, by the competent authority of the Member State after deletion of any information of a commercially confidential nature.

Amendment 649 #

Proposal for a directive
Article 22 – paragraph 7 a (new)

7 a. Priority in market authorisation shall be given to pharmaceuticals that are proven to have less harmful impacts on environment than their equivalents.

Amendment 650 #

Proposal for a directive
Article 22 – paragraph 7 b (new)

7 b. With regard to medicinal products referred to in Articles 9 to 12, the applicant may take into account the ERAs carried out for the reference medicinal product when carrying out the ERA.The Commission is empowered to adopt delegated acts in accordance with Article 215, in order to supplement this Directive by specifying: a) reference methodologies for assessing the greenhouse gas emissions footprint of the production and use of the medicinal product; (b) the minimum data on which to base the assessment of the greenhouse gas emissions footprint of the production and use of the medicinal product; (c) reference methodologies for the assessment of environmental impacts, excluding greenhouse gas emissions, associated with the production, use and dissemination of the medicinal product; d) the minimum data on which to base the assessment of the environmental impacts, excluding greenhouse gas emissions, associated with the production, use and dissemination of the medicinal product.

Amendment 651 #

Proposal for a directive
Article 22 a (new)

Article 22a General requirements for marketing authorisation applications Pursuant to article 6(2), the marketing authorisation applicant shall include patient experience data in the marketing application dossier. Where this is not possible, the marketing authorisation applicant should provide a detailed justification to the Agency. The Agency, in collaboration with patient organisations, competent authorities of the Member States and other relevant parties, shall draw up guidance to design, conduct, analyse, and report relevant studies incorporating robust and meaningful patient experience data for regulatory submission.

Amendment 652 #

Proposal for a directive
Article 22 a (new)

Article 22a In accordance with Article 6(2), applicants for marketing authorization are required to incorporate data on patient experiences within their application dossiers. If inclusion of such data is not feasible, applicants must present a comprehensive explanation to the Agency. The Agency shall cooperate with patient organizations, Member State authorities, and other pertinent entities to develop guidance on the creation, execution, analysis, and reporting of studies that integrate substantial and significant patient experience data for regulatory purposes.

Amendment 653 #

Proposal for a directive
Article 23 – paragraph 1 – subparagraph 1

By [OP please insert the date = 3012 months after the date of the entry into force of this Directive] the Agency shall, after consultation with the competent authorities of the Member States, the European Centre for Disease Prevention and Control (ECDC), the European Chemical Agency (ECHA), the European Food Safety Authority (EFSA) and the European Environmental Agency (EEA), establish a programme for the ERA to be submitted in accordance with Article 22 of the medicinal products authorised before 30 October 2005 that have not been subject to any ERA and that the Agency has identified as potentially harmful to the environment in accordance with paragraph 2.

Amendment 654 #

Proposal for a directive
Article 23 – paragraph 1 – subparagraph 1

By [OP please insert the date = 3012 months after the date of the entry into force of this Directive] the Agency shall, after consultation with the competent authorities of the Member States, the European Chemical Agency (ECHA), the European Food Safety Authority (EFSA) and the European Environmental Agency (EEA), establish a programme for the ERA to be submitted in accordance with Article 22 of the medicinal products authorised before 30 October 2005 that have not been subject to any ERA and that the Agency has identified as potentially harmful to the environment in accordance with paragraph 2.

Amendment 655 #

Proposal for a directive
Article 23 – paragraph 1 – subparagraph 1

By [OP please insert the date = 3024 months after the date of the entry into force of this Directive] the Agency shall, after consultation with the competent authorities of the Member States, the European Chemical Agency (ECHA), the European Food Safety Authority (EFSA) and the European Environmental Agency (EEA), establish a programme for the ERA to be submitted in accordance with Article 22 of the medicinal products authorised before 30 October 2005 that have not been subject to any ERA and that the Agency has identified as potentially harmful to the environment in accordance with paragraph 2.

Amendment 656 #

Proposal for a directive
Article 23 – paragraph 1 – subparagraph 1

By [OP please insert the date = 30 months after the date of the entry into force of this Directive] the Agency shall, after consultation with the competent authorities of the Member States, the European Chemical Agency (ECHA), the European Food Safety Authority (EFSA) and the European Environmental Agency (EEA), establish a programme for the ERA to be submitted in accordance with Article 22 of the medicinal products authorised before 30 October 2005 that have not been subject to any ERA and that the Agency has identified asto potentially ~~harmful~~cause a risk to the environment by risk-based prioritisation in accordance with paragraph 2.

Amendment 657 #

Proposal for a directive
Article 23 – paragraph 1 – subparagraph 2

This programme shall be made publicly available by the Agency and, if necessary, updated.

Amendment 658 #

Proposal for a directive
Article 23 – paragraph 2

2. The Agency shall set the scientific criteria for the identification of the medicinal products as potentially harmful to the environment and for the prioritisation of their ERA, using a risk based approach. For this task, the Agency shall consult relevant stakeholders including drinking water and wastewater operators and may request from marketing authorisation holders the submission of relevant data or information.

Amendment 659 #

Proposal for a directive
Article 23 – paragraph 2

2. The Agency shall set the scientific criteria for the identification of the medicinal products as potentially harmful to the environment and for the prioritisation of their ERA, using a risk based approach. For this task, the Agency ~~may~~shall consult all relevant stakeholders and request from marketing authorisation holders the submission of relevant data or information.

Amendment 660 #

Proposal for a directive
Article 23 – paragraph 2

2. The Agency shall set the scientific criteria for the identification of the medicinal products asthat potentially ~~harmful~~cause a risk to the environment and for the prioritisation of their ERA, using a risk based approach. For this task, the Agency may request from marketing authorisation holders the submission of relevant data or information.

Amendment 661 #

Proposal for a directive
Article 23 – paragraph 2

2. The Agency shall set the scientific criteria for the identification of the medicinal products as potentially ~~harmful~~risk to the environment and for the prioritisation of their ERA, using a risk based approach. For this task, the Agency may request from marketing authorisation holders the submission of relevant data or information.

Amendment 662 #

Proposal for a directive
Article 23 – paragraph 3

3. The marketing authorisation holders for medicinal products identified in the programme referred to in paragraph 1 shall submit the ERA to the Agency. The outcome of the assessment of the ERA including the data submitted by the marketing authorisation holder ~~shall be made publicly available by the Agency~~, including full data sets and summaries of conducted ERA studies, shall be made publicly available by the Agency and shall be proactively shared with drinking water and wastewater operators.

Amendment 663 #

Proposal for a directive
Article 23 – paragraph 3

3. The marketing authorisation holders for medicinal products identified in the programme referred to in paragraph 1 shall submit the ERA to the Agency. The outcome of the assessment of the ERA including ~~the data~~a summary of ERA studies and their results as submitted by the marketing authorisation holder and the assessment of the ERA and scientific guidelines referred to in Article 22(5) shall be made publicly available by the Agency.

Amendment 664 #

Proposal for a directive
Article 23 – paragraph 3

3. The marketing authorisation holders for medicinal products identified in the programme referred to in paragraph 1 shall submit the ERA to the Agency within the time limit set for the medicinal product in the programme. The outcome of the assessment of the ERA including the data submitted by the marketing authorisation holder shall be made publicly available by the Agency.

Amendment 665 #

Proposal for a directive
Article 23 – paragraph 3

3. The current marketing authorisation holders for medicinal products identified in the programme referred to in paragraph 1 shall submit the ERA to the Agency. The outcome of the assessment of the ERA including the data submitted by the marketing authorisation holder shall be made publicly available by the Agency.

Amendment 666 #

Proposal for a directive
Article 23 – paragraph 4

4. Where there are several medicinal products identified in the programme referred to in paragraph 1 that contain the same active substance and that are expected to pose the same risks to the environment, the competent authorities of the Member States or the Agency shall ~~encourage~~inform and recommend the marketing authorisation holders of the possibility to conduct joint studies for the ERA, to minimise unnecessary duplication of data and use of animals. In this regard, to facilitate and foster the increased use of joint studies, the Agency shall oversee these in a cooridnating role, where necessary and appropriate.

Amendment 667 #

Proposal for a directive
Article 23 – paragraph 4

4. Where there are several medicinal products identified in the programme referred to in paragraph 1 that contain the same active substance and that are expected to pose the same risks to the environment, the competent authorities of the Member States or the Agency shall encourage the marketing authorisation holders to conduct joint studies for the ERA, to minimise unnecessary duplication of data and use of animals, specifically to avoid unnecessary testing of vertebrate species and to follow the 3R rule.

Amendment 668 #

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ, Erik POULSEN, Andreas GLÜCK

Proposal for a directive
Article 23 – paragraph 4 a (new)

4 a. The Agency shall ensure that the ERA is followed by clear recommandations to the marketing authorisation holders on how to respect the guidelines and to fulfill the requirements in the future.

Amendment 669 #

Proposal for a directive
Article 24 – paragraph 1

1. The Agency shall, in collaboration with the competent authorities of the Member States, set-up an active, public substance based review system of ERA data (‘ERA monographs’) for authorised medicinal products. An ERA monograph shall include a comprehensive set of physiochemical data, fate data and effect data based on an assessment of a competent authority.

Amendment 670 #

Proposal for a directive
Article 24 – paragraph 2

2. The setting-up of the system of ERA monographs shall be based on a risk- based prioritisation of active substances and relevant data requirements, particularly considering vertebrate studies.

Amendment 671 #

Proposal for a directive
Article 24 – paragraph 3

3. In the preparation of the ERA monograph referred to in paragraph 1, the Agency may request existing information, studies and data from competent authorities of the Member States and from marketing authorisation holders.

Amendment 672 #

Proposal for a directive
Article 24 – paragraph 4

4. The Agency in cooperation with the competent authorities of the Member States shall conduct a proof-of-concept pilot of ERA monographs to be completed within t~~hree~~wo years after entering into force of this Directive.

Amendment 673 #

Proposal for a directive
Article 24 – paragraph 4

4. The Agency in cooperation with the competent authorities of the Member States shall conduct a proof-of-concept pilot of ERA monographs to be completed within three years after entering into force of this Directive taking into consideration outcomes from relevant initiatives.

Amendment 674 #

Proposal for a directive
Article 24 – paragraph 5 – point e a (new)

(e a) risk-based prioritisation of data requirements for active substances to avoid unnecessary testing, particularly in- line with directive 2010/63/EU.

Amendment 675 #

Proposal for a directive
Article 25 – paragraph 6 – subparagraph 2

If the manufacturer of an active substance refuses to undergo such an inspection, the Agency ~~may~~shall suspend or terminate the application for an active substance master file certificate.

Amendment 676 #

Billy KELLEHER, Ondřej KNOTEK

Proposal for a directive
Article 25 – paragraph 7

7. If the active substance master file certificate holder does not fulfil the obligations set out in the paragraphs 5 and 6, the Agency ~~may~~shall suspend or withdraw the certificate and, the competent authorities of the Member States ~~may~~shall suspend or revoke the marketing authorisation of a medicinal product relying on that certificate or take measures to prohibit the supply of the medicinal product relying on that certificate.

Amendment 677 #

Proposal for a directive
Article 26 – paragraph 1 – subparagraph 1 a (new)

Marketing authorisation applicants may, instead of submitting the relevant data on the quality, safety and/or efficacy of a medicinal product required in accordance with Annex II, rely on an additional platform technology master file or a platform technology master file certificate granted by the Agency in accordance with this Article (‘platform technology master file certificate’).

Amendment 678 #

Susana SOLÍS PÉREZ, Catherine AMALRIC, Ondřej KNOTEK

Proposal for a directive
Article 26 – paragraph 3 – point b

(b) additional quality master files for which a certificate may be used in order to provide specific information on the quality of a substance, preparation or other material present or used in the manufacture of a medicinal product including cell and gene therapies;

Amendment 679 #

Proposal for a directive
Article 26 – paragraph 3 – point b

Amendment 680 #

Proposal for a directive
Article 26 – paragraph 4 – subparagraph 2

If the manufacturer of this substance refuses to undergo such an inspection, the Agency ~~may~~shall suspend or terminate the application for the additional quality master file certificate.

Amendment 681 #

2. Colours shall be used in medicinal products only if they are included in ~~one of the following lists:~~the Union list of authorised food additives in Table 1 in Part B of Annex II to Regulation (EC) No 1333/2008 and comply with the purity criteria and specifications laid down in Commission Regulation (EU) No 231/2012.

Amendment 682 #

Proposal for a directive
Article 27 – paragraph 2 – point a

(a) the Union list of authorised food additives in Table 1 in Part B of Annex II to Regulation (EC) No 1333/2008 and comply with the purity criteria and specifications laid down in Commission Regulation (EU) No 231/2012;deleted

Amendment 683 #

Proposal for a directive
Article 27 – paragraph 2 – point b

~~(b) the list established by the Commission pursuant to paragraph 3.~~deleted

Amendment 684 #

Proposal for a directive
Article 27 – paragraph 3 – subparagraph 1

TBy way of derogation from paragraph 2, in duly justified cases, the Commission may establish a list of colours permitted for use in medicinal products other than those included in the Union list of authorised food additives.

Amendment 685 #

Proposal for a directive
Article 27 – paragraph 3 – subparagraph 1 a (new)

Addition of substances on the list referred to in paragraph three shall be limited to maximum five years. Within that period, marketing authorisation holders who use the excipients shall conduct studies to ensure use of available alternatives complying with the conditions set out in paragraph 2.

Amendment 686 #

Proposal for a directive
Article 27 – paragraph 4 – subparagraph 1

If a colour used in medicinal product is removed from the Union list of authorised food additives, on the basis of the scientific opinion of the European Food Safety Authority (‘EFSA’), the Agency shall, on the request of the Commission or on its own initiative, without undue delay issue a scientific opinion as regards the use of the colour concerned in medicinal product, taking into account the opinion of the EFSA ~~if relevant~~. The opinion of the Agency shall be adopted by the Committee for Medicinal Products for Human Use.

Amendment 687 #

Proposal for a directive
Article 27 – paragraph 5

5. If a colour has been removed from the Union list of authorised food additives for reasons that do not require an EFSA opinion, the Commission shall decide on the use of the colour concerned in medicinal products and, where applicable, include it in the list of colours permitted for use in medicinal products referred to in paragraph 3. The Commission ~~may~~shall, in such cases, request the opinion from the Agency.

Amendment 688 #

Proposal for a directive
Article 27 – paragraph 6

6. A colour that has been removed from the Union list of authorised food additives can still be used as a colour in medicinal products for a maximum of two years until the Commission takes the decision on whether to include the colour on the list of colours permitted for use in medicinal products in accordance with paragraph 3.

Amendment 689 #

Proposal for a directive
Article 27 – paragraph 7 a (new)

7 a. The Agency shall draw up an updated list of excipients used in medicines, based on an in-depth evaluation, in particular with regard to their risks in children and pregnant women.

Amendment 690 #

Proposal for a directive
Article 28 – paragraph 1 – point b a (new)

(b a) the creation of the product occurred within a regulatory sandbox as outlined by Article 114 (2) of [revised Regulation (EC) No 726/2004], unless exceptions are warranted by scientific and technical reasoning.

Amendment 691 #

Proposal for a directive
Article 28 – paragraph 6

~~6. When adopting~~ delegated acts referred to in this Article, the Commission shall take into account any available information resulting from a regulatory sandbox established in accordance with Article 115 of the [revised Regulation (EC) No 726/2004].

Amendment 692 #

Proposal for a directive
Article 28 – paragraph 6

Amendment 693 #

Proposal for a directive
Article 28 – paragraph 6 a (new)

6 a. When enacting delegated acts under this Article, the Commission shall engage in dialogue with the Agency, national competent authorities, the Pharmaceutical Committee, and pertinent interested parties.

Amendment 694 #

Proposal for a directive
Article 28 – paragraph 6 b (new)

6 b. The Commission shall submit a report on the acquired experience with adapted frameworks to the European Parliament and the Council of the European Union. The first report is due five years following [insert date = 18 months post-implementation of this Directive] and on a five-year cycle subsequently. Based on the report's findings, the Commission may propose legislative changes to the overarching pharmaceutical laws, reflecting the practical insights gained from employing adapted frameworks. d frameworks.

Amendment 695 #

(a) shall verify within 20 days whether the particulars and documentations submitted in support of the application comply with Articles 6 and 9 to 14 (‘validation’), and examine whether the conditions for issuing a marketing authorisation set out in Articles 43 to 45 are complied with;

Amendment 696 #

Proposal for a directive
Article 29 – paragraph 1 – point a

(a) shall verify whether the particulars and documentations submitted in support of the application comply with Articles 6 and 9 to 14 (‘validation’), and examine whether the conditions for issuing a marketing authorisation set out in Articles 43 toand 454 are complied with;

Amendment 697 #

Proposal for a directive
Article 29 – paragraph 3

3. Where the competent authority of the Member State considers that the marketing authorisation application is incomplete, or contains critical deficiencies that may prevent the evaluation of the medicinal product it shall inform the applicant accordingly and shall set a time limit of minimum 14 days for submitting the missing information and documentation. If the applicant fails to provide the missing information and documentation within the time limit set, the application shall be considered to have been withdrawn by default.

Amendment 698 #

Proposal for a directive
Article 29 – paragraph 4 – subparagraph 2

The competent authority of the Member State shall summarise the deficiencies in writing. On this basis, the competent authority of the Member State shall inform the applicant accordingly and set a time limit of minimum 14 days to address the deficiencies. The application shall be suspended until the applicant addresses the deficiencies. If the applicant fails to address those deficiencies within the time limit set by the competent authority of the Member State, the application shall be considered as withdrawn by default.

Amendment 699 #

Michèle RIVASI

Proposal for a directive
Article 30 – paragraph 1

Member States shall take all appropriate measures to ensure that the procedure for granting a marketing authorisation for medicinal products is completed within a maximum of 2180 days (excluding clock- stops) after the submission of a valid application from the date of validation of a marketing authorisation application.

Amendment 700 #

Proposal for a directive
Article 30 – paragraph 1

Member States shall take all appropriate measures to ensure that the procedure for granting a marketing authorisation for medicinal products is completed within a maximum of 180 days after the submission of a valid application from the date of validation of a marketing authorisation application, according to Council Directive 89/105/EEC.

Amendment 701 #

Proposal for a directive
Article 30 – paragraph 1

Member States shall take all appropriate measures to ensure that the procedure for granting a marketing authorisation for medicinal products is completed within a maximum of 180 days (excluding clock stops) after the submission of a valid application from the date of validation of a marketing authorisation application.

Amendment 702 #

Proposal for a directive
Article 32 – paragraph 2

2. The competent authority in the Member State concerned shall examine the application in accordance with Articles 29 and 30 and grant a marketing authorisation in accordance with Articles 43 to 454 and applicable national provisions.

Amendment 703 #

Dolors MONTSERRAT, Nathalie COLIN-OESTERLÉ, Tomislav SOKOL

Proposal for a directive
Article 33 – paragraph 2

2. The competent authorities in the Member State concerned shall examine the applications in accordance with Articles 29, 30 and 34 and grant a marketing authorisation in accordance with Articles 43 to 454.

Amendment 704 #

Proposal for a directive
Article 34 – paragraph 3

3. ~~The applicant shall inform all the competent authorities of all Member States of its application at the time of submission. T~~Based on information made available by the Coordination group for decentralised and mutual recognition procedures, the competent authority of a Member State may request for justified public health reasons to ~~enter~~recognise the procedure ~~and shall inform~~within 15 days after the procedure has been closed, upon agreement with the applicant and the competent authority of the reference Member State for the decentralised procedure ~~of its request within 30 days from the date of submission of the application~~. The applicant shall provide the competent authorities of those Member States entering the procedure with the application without undue delay.

Amendment 705 #

Dolors MONTSERRAT, Nathalie COLIN-OESTERLÉ, Tomislav SOKOL

Proposal for a directive
Article 34 – paragraph 3

3. The applicant shall inform all the competent authorities of all Member States of its application at the time of submission. The competent authority of a Member State ~~may request for justified public health reasons~~shall have the possibility to to enter the procedure and shall inform the applicant and the competent authority of the reference Member State for the decentralised procedure of its request within 30 days from the date of submission of the application. The applicant shall provide the competent authorities of those Member States entering the procedure with the application without undue delay.

Amendment 706 #

Proposal for a directive
Article 34 – paragraph 4 – subparagraph 2

The competent authority of the reference Member State for the decentralised procedure shall summarise the deficiencies in writing. On this basis, the competent authority of the reference Member State for the decentralised procedure shall inform the applicant and the competent authorities of the Member States concerned accordingly and set a time limit of minimum 14 days to address the deficiencies. The application shall be suspended until the applicant addresses the deficiencies. If the applicant fails to address those deficiencies within the time limit set by the competent authority of the reference Member State for the decentralised procedure, the application shall be considered as ~~withdrawn~~refused.

Amendment 707 #

Proposal for a directive
Article 34 – paragraph 4 – subparagraph 2

Amendment 708 #

Proposal for a directive
Article 34 – paragraph 5

5. Within 1290 days after validation of the application, the competent authority of the reference Member State for the decentralised procedure shall prepare an assessment report, a summary of product characteristics, the labelling and the package leaflet and shall send them to the Member States concerned and to the applicant.

Amendment 709 #

Proposal for a directive
Article 34 – paragraph 5

5. Within 120 days after validation of the application, the competent authority of the reference Member State for the decentralised procedure shall prepare an assessment report, a summary of product characteristics, the labelling and the package leaflet and shall send them to the Member States concerned and to the applicant. During this period, a competent authority of a Member State may request to recognise and enter the procedure after validation and shall inform the applicant and the competent authority of the reference Member State for the decentralised procedure.

Amendment 710 #

Proposal for a directive
Article 34 – paragraph 6

6. Within 690 days of receipt of the assessment report, the competent authorities of the Member States concerned shall approve the assessment report, the summary of product characteristics and the labelling and package leaflet and shall inform the competent authority of the reference Member State for the decentralised procedure accordingly. The competent authority of the reference Member State for the decentralised procedure shall record the agreement of all parties, close the procedure and inform the applicant accordingly.

Amendment 711 #

Proposal for a directive
Article 35 – paragraph 1

An application for marketing authorisation for mutual recognition procedure for national marketing authorisation, granted under Articles 43 to 454 and in accordance with Article 32, shall be submitted to the competent authorities of other Member States in accordance with the procedure laid down in Article 36.

Amendment 712 #

Dolors MONTSERRAT, Nathalie COLIN-OESTERLÉ

Proposal for a directive
Article 36 – paragraph 1

1. An application for mutual recognition of a marketing authorisation, granted under Articles 43 to 454 and in accordance with Article 32, in several Member States in respect of the same medicinal product shall be submitted to the competent authority of the Member State that granted the marketing authorisation (‘reference Member State for the mutual recognition procedure’) and to the competent authorities of the Member States concerned where the applicant seeks to obtain a national marketing authorisation.

Amendment 713 #

Proposal for a directive
Article 36 – paragraph 4

4. ~~The applicant shall inform the competent authorities of all Member States of its application at the time of submission. T~~Based on information made available by the Coordination group for decentralised and mutual recognition procedures, the competent authority of a Member State may request for justified public health reasons to ~~enter~~recognise the procedure ~~and shall inform~~within 15 days after the procedure has been closed, upon agreement with the applicant and the competent authority of the reference Member State for the mutual recognition procedure ~~of its request within 30 days from the date of submission of the application~~. The applicant shall provide the competent authorities of those Member States entering the procedure with the application without undue delay.

Amendment 714 #

Dolors MONTSERRAT, Nathalie COLIN-OESTERLÉ, Tomislav SOKOL

Proposal for a directive
Article 36 – paragraph 4

4. The applicant shall inform the competent authorities of all Member States of its application at the time of submission. The competent authority of a Member State ~~may request for justified public health reasons~~shall have the possibility to enter the procedure and shall inform the applicant and the competent authority of the reference Member State for the mutual recognition procedure of its request within 30 days from the date of submission of the application. The applicant shall provide the competent authorities of those Member States entering the procedure with the application without undue delay.

Amendment 715 #

Proposal for a directive
Article 36 – paragraph 4 a (new)

4 a. In order to examine an application submitted in accordance with Articles 6 and 9 to 14, the competent authorities of the Member States shall verify within 30 days whether the particulars and documentations submitted in support of the application comply with Articles 6 and 9 to 14 (‘validation’), and examine whether the conditions for issuing a marketing authorisation set out in Articles 43 to 45 are complied with;

Amendment 716 #

Proposal for a directive
Article 36 – paragraph 4 a (new)

4 a. In order to examine an application submitted in accordance with Articles 6 and 9 to 14, the competent authorities of the Member States shall verify within 20 days whether the particulars and documentations submitted in support of the application comply with Articles 6 and 9 to 14 (‘validation’), and examine whether the conditions for issuing a marketing authorisation set out in Articles 43 to 45 are complied with;

Amendment 717 #

Proposal for a directive
Article 36 – paragraph 5

5. If the competent authorities of the Member States concerned so require, the marketing authorisation holder shall request the competent authority of the reference Member State for the mutual recognition procedure to perform or update the assessment report drawn on the medicinal concerned by the application. In that case, the reference Member State shall perform or update the assessment report within 90 days after validation of the application. If the competent authorities of the Member States concerned do not require the performance or the update of the assessment report, the reference Member State shall provide the assessment report within 30 days in case medicinal product was previously authorised in European procedure.

Amendment 718 #

Proposal for a directive
Article 36 – paragraph 8

8. Within 30 days after 8. acknowledgement of the agreement, the competent authorities of all Member States concerned in which an application has been submitted in accordance with paragraph 1 shall adopt a decision according to Articles 43 to 454 in conformity with the approved assessment report, the summary of product characteristics, the labelling and package leaflet as approved.

Amendment 719 #

Proposal for a directive
Article 37 – paragraph 2 – subparagraph 1

The coordination group shall be composed of one representative per Member State and one representative from patients’ organisations appointed for a renewable period of three years. Member States and patients may appoint an alternate for a renewable period of three years. Members of the coordination group may arrange to be accompanied by experts.

Amendment 720 #

Proposal for a directive
Article 37 – paragraph 2 – subparagraph 1

The coordination group shall be composed of one representative per Member State and one representative from patients’ organisations appointed for a renewable period of three years. Member States may appoint an alternate for a renewable period of three years. Members of the coordination group may arrange to be accompanied by experts.

Amendment 721 #

Proposal for a directive
Article 42 – paragraph 1 – subparagraph 4

Where, in exceptional circumstances, a draft decision differs from the opinion of the Agency, the Commission shall provide a detailed explanation of the reasons for the differences.

Amendment 722 #

Proposal for a directive
Article 42 – paragraph 1 – subparagraph 5

The Commission shall send the draft decision to the competent authorities of the Member States and the applicant or the marketing authorisation holder and make the decision, including the justification, publicly available.

Amendment 723 #

Proposal for a directive
Article 42 – paragraph 1 – subparagraph 5 a (new)

The Standing Committee on Medicinal Products for Human Use shall give its opinion in writing. Member States shall forward their written observations on the draft decision to the Commission within 10 days.

Amendment 724 #

Proposal for a directive
Article 43 – paragraph 3

3. The competent authorities of the Member States shall, without undue delay, make publicly available the national marketing authorisation together with the summary of product characteristics, the package leaflet, the antimicrobial stewardship plan and special information requirements referred to in Article 17 (1), as well as any conditions established in accordance with Articles 44, 45 and any obligations imposed subsequently in accordance with Article 17 (2) and Article 87, together with any deadlines for the fulfilment of those conditions and obligations for each medicinal product that they have authorised.

Amendment 725 #

Proposal for a directive
Article 43 – paragraph 3

3. The competent authorities of the Member States shall, without undue delay, make publicly available the national marketing authorisation together with the summary of product characteristics, the ~~package leaflet~~labelling, the package leaflet, the information related to antimicrobials referred to in Article 17(1), where applicable, as well as any conditions established in accordance with Articles 44~~, 45~~ and any obligations imposed subsequently in accordance with Article 17(2) and 87, together with any deadlines for the fulfilment of those conditions and obligations for each medicinal product that they have authorised.

Amendment 726 #

Proposal for a directive
Article 43 – paragraph 3

3. The competent authorities of the Member States shall, without undue delay, make publicly available the national marketing authorisation together with the summary of product characteristics, the package leaflet ~~as well as~~, the information referred to in Article 17 (1) for antimicrobials, and any conditions established in accordance with Articles 44, 45 and any obligations imposed subsequently in accordance with Article 17 (2) and Article 87, together with any deadlines for the fulfilment of those conditions and obligations for each medicinal product that they have authorised.

Amendment 727 #

Proposal for a directive
Article 43 – paragraph 4

4. The ~~compete~~relevant authority ofin the Member State ~~may consider and decide upon additional evidence available, independently from the data submitted by~~has the discretion to consider additional high-quality evidence sources, alongside the evidence provided by the marketing authorization holder, for its scientific evaluation. If, after reviewing all evidence, including any supplementary information, the authority deems a modification to the product's summary of characteristics necessary due to its impact on the product's benefit-risk balance within its approved uses, it shall promptly communicate its suggestion to the marketing authoriszation holder. ~~On that basis, the summary of product characteristics shall be updated if the additional evidence has an impact on the benefit-risk balance of a medicinal product.~~ The holder shall receive all extra evidence and related study documents that the proposal is based on. They shall also be asked to present their viewpoint on the provided evidence and, if required, shall have the chance for an oral discussion regarding any proposed updates to the product summary with the authority. The authority shall inform the marketing authorization holder of its decision without unnecessary delay. If the marketing authorization holder disagrees with the authority's decision, they may request a re-evaluation in writing. Upon such a request, the authority shall immediately notify the Agency, providing a detailed account of the unresolved issues and reasons for disagreement, with a copy sent to the holder. Once the holder is informed that the Agency is involved, they shall promptly submit their detailed reasons for the request to the Agency. Within 30 days of receiving these grounds, the Agency shall review the authority's decision and issue a conclusive opinion, including the rationale for its conclusion. If the Agency's final opinion necessitates a change in the product's summary of characteristics, this summary shall be accordingly updated.

Amendment 728 #

Proposal for a directive
Article 43 – paragraph 5

5. The competent authorities of the Member States shall draw up an assessment report and make comments on the file as regards the results of the pharmaceutical and non-clinical tests, the clinical studies, the risk management system, the environmental risk assessment and the pharmacovigilance system of the medicinal product concerned. For expedited review processes, competent authorities shall agree binding timelines with the applicants to provide a full ERA after receiving the marketing authorisation.

Amendment 729 #

Proposal for a directive
Article 43 – paragraph 5

Amendment 730 #

Proposal for a directive
Article 43 – paragraph 5

Amendment 731 #

Proposal for a directive
Article 43 – paragraph 6

6. The competent authorities of the Member States shall make the assessment report publicly available without undue delay, together with the reasons for their opinion, ~~after deletion of any~~including information of a commercially confidential nature if their disclosure is in the public interest or relevant for public health reasons. The justification shall be provided separately for each therapeutic indication applied for.

Amendment 732 #

Proposal for a directive
Article 43 – paragraph 6

6. The competent authorities of the Member States shall make the assessment report publicly available without undue delay, together with the reasons for their opinion, after deletion of any information of a commercially confidential nature unless there is an overriding public interest in disclosure. The justification shall be provided separately for each therapeutic indication applied for.

Amendment 733 #

Proposal for a directive
Article 43 – paragraph 6

6. The competent authorities of the Member States shall make the assessment report publicly available without undue delay, together with the reasons for their opinion, after deletion of any information of a commercially confidential nature, unless there is an overriding public interest in disclosure. The justification shall be provided separately for each therapeutic indication applied for.

Amendment 734 #

Proposal for a directive
Article 43 – paragraph 6

6. The competent authorities of the Member States shall make the environmental risk assessment and its the assessment report publicly available without undue delay, together with the reasons for their opinion, after deletion of any information of a commercially confidential nature. The justification shall be provided separately for each therapeutic indication applied for.

Amendment 735 #

Proposal for a directive
Article 44 – paragraph 1 – subparagraph 1 – point e a (new)

(e a) justification in case marketing authorisation was granted where no comparative data with a standard-of-care active comparator were submitted;

Amendment 736 #

Proposal for a directive
Article 44 – paragraph 1 – subparagraph 1 – point f

(f) to conduct post-authorisation efficacy studies where concerns relating to some aspects of the efficacy of the medicinal product are identified and can be resolved only after the medicinal product has been marketed, timeframes and penalties for non-compliance shall be defined;

Amendment 737 #

Proposal for a directive
Article 44 – paragraph 1 – subparagraph 1 – point g

(g) in case of medicinal products for which there is substantial uncertainty as to the surrogate endpoint relation to the expected health outcome, where appropriate and relevant for the benefit- risk balance, a post-authorisation obligation to substantiate the clinical benefit;deleted

Amendment 738 #

Proposal for a directive
Article 44 – paragraph 1 – subparagraph 1 – point g

(g) in case of medicinal products for which, on duly justified grounds described in the assessment report, there is substantial uncertainty as to the surrogate endpoint relation to the expected health outcome, where appropriate and relevant for the benefit-risk balance, with particular attention to new active substances and therapeutic indications, a post- authorisation obligation to substantiate the clinical benefit;

Amendment 739 #

Proposal for a directive
Article 44 – paragraph 1 – subparagraph 1 – point g

(g) in case of medicinal products for which ~~there is substantial~~, on duly justified grounds described in the assessment report, there is uncertainty as to the surrogate endpoint relation to the expected health outcome, where appropriate and relevant for the benefit-risk balance, with particular attention to new active substances and therapeutic indications, a post- authorisation obligation to substantiate the clinical benefit;

Amendment 740 #

Proposal for a directive
Article 44 – paragraph 1 – subparagraph 1 – point g

(g) in case of medicinal products for which ~~there is substantial~~, on duly justified grounds submitted to the national competent authority, there is uncertainty as to the surrogate endpoint relation to the expected health outcome, where appropriate and relevant for the benefit-risk balance, a post- authorisation obligation to substantiate the clinical benefit;

Amendment 741 #

Proposal for a directive
Article 44 – paragraph 1 – subparagraph 1 – point g

(g) in case of medicinal products for which there is substantial uncertainty as to the surrogate endpoint relation to the expected health outcome, ~~where appropriate and relevant for the benefit- risk balance,~~ a post- authorisation obligation to substantiate the clinical benefit;

Amendment 742 #

Proposal for a directive
Article 44 – paragraph 1 – subparagraph 1 – point h

(h) to conduct post-authorisation environmental risk assessment studies, collection of monitoring data or information on use, where identified or potential concerns about risks to the environment ~~or public health~~, including antimicrobial resistance need to be further investigated after the medicinal product has been marketed;

Amendment 743 #

Proposal for a directive
Article 44 – paragraph 1 – subparagraph 1 – point h

Amendment 744 #

Proposal for a directive
Article 44 – paragraph 2

2. The marketing authorisation shall lay down deadlines for the fulfilment of the conditions referred to in paragraph 1, first subparagraph~~, where necessary~~.

Amendment 745 #

Proposal for a directive
Article 44 – paragraph 2

2. The marketing authorisation shall lay down deadlines for the fulfilment of the conditions referred to in paragraph 1, first subparagraph~~, where necessary~~.

Amendment 746 #

Proposal for a directive
Article 45

National marketing authorisation under 1. In exceptional circumstances where, in an application under Article 6 for a marketing authorisation of a medical product, or in an application under Article 92 for a new therapeutic indication of an existing marketing authorisation, an applicant is unable to provide comprehensive data on the efficacy and safety of the medicinal product under normal conditions of use, the competent authority of the Member State may, by derogation to Article 6, grant an authorisation under Article 43, subject to specific conditions, where the following requirements are met: (a) the applicant has demonstrated, in the application file, that there are objective and verifiable reasons not to be able to submit comprehensive data on the efficacy and safety of the medicinal product under normal conditions of use based on one of the grounds set out in Annex II; (b) except for the data referred to in point (a), the application file is complete and satisfies all the requirements of this Directive; (c) specific conditions are included in the decision of the competent authorities of the Member States, in particular to ensure the safety of the medicinal product as well to ensure that the marketing authorisation holder notifies to the competent authorities of the Member States any incident relating to its use and takes appropriate action where necessary. 2. The maintenance of the authorised new therapeutic indication and the validity of the national marketing authorisation shall be linked to the reassessment of the conditions set out in paragraph 1 after two years from the date when the new therapeutic indication was authorised or the marketing authorisation was granted, and thereafter at a risk-based frequency to be determined by the competent authorities of the Member State and specified in the marketing authorisation. This reassessment shall be conducted on the basis of an application by the marketing authorisation holder to maintain the authorised new therapeutic indication or renew the marketing authorisation underArticle 45 deleted exceptional circumstances.

Amendment 747 #

Proposal for a directive
Article 46 – paragraph 1 – subparagraph 1

~~Without prejudice to paragraph 4, a~~A marketing authorisation for a medicinal product shall be valid for ~~an unlimited period~~five years and might be renewed on the basis of a re- evaluation of the risk-benefit balance by the competent authority of the authorising Member State.

Amendment 748 #

Proposal for a directive
Article 46 – paragraph 1 – subparagraph 1

Without prejudice to paragraph 4 and 4a, a marketing authorisation for a medicinal product shall be valid for ~~an unlimited period~~5 years.

Amendment 749 #

Michèle RIVASI

Proposal for a directive
Article 46 – paragraph 1 – subparagraph 1

Without prejudice to paragraph 4, a marketing authorisation for a medicinal product shall be valid for ~~an unlimited period~~5 years.

Amendment 750 #

Michèle RIVASI

Proposal for a directive
Article 46 – paragraph 1 – subparagraph 2

~~By way of derogation from the first subparagraph, a national marketing authorisation granted in accordance with Article 45(1)~~The national marketing authorisation shall be valid for five years and be subject to renewal in accordance with paragraph 2.

Amendment 751 #

Proposal for a directive
Article 46 – paragraph 1 – subparagraph 2

By way of derogation from the first subparagraph, ~~a national~~ marketing authorisation ~~granted in accordance with~~for products referred to in Article ~~45(1)~~9 shall be valid for ~~five years and be subject to renewal in accordance with paragraph 2~~an unlimited period.

Amendment 752 #

Proposal for a directive
Article 46 – paragraph 1 – subparagraph 3

By way of derogation from the first subparagraph, a competent authority of the Member State may decide at the time of granting the national marketing authorisation, on objectively and duly justified grounds relating to safety of the medicinal product, to limit the validity of the national marketing authorisation to five years.deleted

Amendment 753 #

Proposal for a directive
Article 46 – paragraph 2

2. T~~he marketing authorisation holder may submit an application for a~~o renew~~al of~~ a national marketing authorisation ~~granted under paragraph 1, second or third subparagraph. Such application shall be submitted~~, the marketing authorisation holder shall submit an application at least nine months before the national marketing authorisation ceases to be valid.

Amendment 754 #

Proposal for a directive
Article 46 – paragraph 2

2. The marketing authorisation holder ~~may~~shall submit an application for a renewal of a national marketing authorisation granted under paragraph 1~~, second or third subparagraph. Such application shall be submitted~~ at least nine months before the national marketing authorisation ceases to be valid.

Amendment 755 #

Proposal for a directive
Article 46 – paragraph 4

4. The competent authority of the Member State may renew the national marketing authorisation on the basis of a re-evaluation of the benefit-risk balance. Once renewed, the marketing authorisation shall be valid for an unlimited period, unless the national competent authority decides, on justified grounds, to proceed with one additional five-year renewal.

Amendment 756 #

Proposal for a directive
Article 46 – paragraph 4 a (new)

4 a. When an authorised product previously placed on the market in the authorising Member State is no longer actually present on the market for a period of three consecutive years, the authorisation for that product shall cease to be valid.

Amendment 757 #

Proposal for a directive
Article 46 – paragraph 4 b (new)

4 b. By way of derogation from paragraph 1 and 3, marketing authorisation for a medicinal product shall be withdrawn if the review of the post-authorisation studies referred to in Article 44 paragraph 1 result in a negative risk-benefit assessment.

Amendment 758 #

Annalisa TARDINO

Proposal for a directive
Article 47 – paragraph 1 – point d

Amendment 759 #

Proposal for a directive
Article 47 – paragraph 1 – point d

Amendment 760 #

Proposal for a directive
Article 47 – paragraph 1 – point d

(d) tThe ~~envir~~conmtent~~al risk assessment is incomplete or insufficiently substantiated by the applicant or if the risks identified in the environmental risk assessment have not been sufficiently addressed by the applicant;~~ or timelines of post- authorisation studies to further clarify environmental risk assessment, as required under Article 44, paragraph 1, point (h), cannot be agreed.

Amendment 761 #

Proposal for a directive
Article 47 – paragraph 1 – point d

(d) tThe ~~envir~~conmtental risk assessment is incomplete or insufficiently substantiated by the applicant or if the risks identified in the environmental risk assessment have not been sufficiently addressed by the applicant; or timelines of post- authorisation studies to further clarify environmental risk assessment, as required under Article 44, paragraph 1, point (h), cannot be agreed.

Amendment 762 #

Proposal for a directive
Article 47 – paragraph 1 – point d

(d) the environmental risk assessment is incomplete or insufficiently substantiated or the reason for the imcomplete nature of the ERA are not duly justified or subtantiated by the applicant or if the risks identified in the environmental risk assessment have not been sufficiently addressed by the applicant or by the risk mitigation measures by the applicant, in accordance Article 22 (3) this Directive;

Amendment 763 #

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Susana SOLÍS PÉREZ, Erik POULSEN, Andreas GLÜCK, Ondřej KNOTEK

Proposal for a directive
Article 47 – paragraph 1 – point d

(d) the environmental risk assessment is incomplete or insufficiently substantiated by the applicant or if the risks identified in the environmental risk assessment have not been sufficiently addressed by the applicant, with the exception of medicinal products authorised before 30 October 2005 to avoid restricting patients' access to existing treatments;

Amendment 764 #

Proposal for a directive
Article 47 – paragraph 1 – point d

(d) the environmental risk assessment is incomplete or insufficiently substantiated by the applicant or if the risks identified in the environmental risk assessment have not been sufficiently addressed by the applicant in cases where the medicinal product does not qualify for conditional marketing authorization or the Temporary Emergency Marketing Authorization;

Amendment 765 #

Proposal for a directive
Article 47 – paragraph 1 – point d

(d) the environmental risk assessment is incomplete or insufficiently substantiated by the applicant or if the risks identified in the environmental risk assessment have not been sufficiently addressed by the applicant, however with clear prioritization of human health benefits over risk to environment;

Amendment 766 #

Proposal for a directive
Article 47 – paragraph 1 – point e a (new)

(e a) there is an equivalent alternative product on the market with scientifically proven less negative environmental impacts.

Amendment 767 #

Proposal for a directive
Article 49 – paragraph 1 – point a

(a) the results of all clinical studies, conducted in compliance with an agreed paediatric investigation plan as referred to in Article 6(5), point (a), and (aa) shall be included in the summary of product characteristics and, if appropriate, in the package leaflet, or

Amendment 768 #

Proposal for a directive
Article 49 – paragraph 2

2. If the application complies with all the measures contained in the agreed completed paediatric investigation plan and if the summary of product characteristics reflects the results of studies conducted in compliance with that agreed paediatric investigation plan, the competent authority of the Member State shall include within the marketing authorisation a statement indicating compliance of the application with the agreed completed paediatric investigation plan. The competent authority shall make the assessment report regarding compliance with paediatric investigation plan publicly available.

Amendment 769 #

Proposal for a directive
Article 51 – paragraph 1 – point e

(e) is an anti~~microbial~~biotic with an identified antimicrobial resistance risk; or

Amendment 770 #

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER

Proposal for a directive
Article 51 – paragraph 1 – point e

(e) is an anti~~microbial; or~~biotic or systemic antiviral or systemic antifungal;

Amendment 771 #

Proposal for a directive
Article 51 – paragraph 1 – point e

(e) is an antimicrobial of systemic administration; or

Amendment 772 #

Proposal for a directive
Article 51 – paragraph 1 – point e

(e) is an antimicrobial; orf systemic administration;

Amendment 773 #

Proposal for a directive
Article 51 – paragraph 1 – point e

(e) is an antimicrobial for systemic use; or

Amendment 774 #

Proposal for a directive
Article 51 – paragraph 1 – point e

(e) is an antimicrobial for systemic use; or

Amendment 775 #

Proposal for a directive
Article 51 – paragraph 1 – point e

(e) is an antimicrobial for systemic use; or

Amendment 776 #

Proposal for a directive
Article 51 – paragraph 1 – point e

(e) is an anti~~microbial~~biotic ; or

Amendment 777 #

Proposal for a directive
Article 51 – paragraph 1 – point e a (new)

(e a) is an antiparasitic; or

Amendment 778 #

Proposal for a directive
Article 51 – paragraph 1 – point e a (new)

(e a) is an antiparasitic; or

Amendment 779 #

Proposal for a directive
Article 51 – paragraph 1 – point e a (new)

(e a) is an antibiotic; or

Amendment 780 #

Proposal for a directive
Article 51 – paragraph 1 – point f

(f) contains an active substance ~~which are persistent, bioaccumulative and toxic, or very persistent and very bioaccumulative, or persistent, mobile and toxic, or very persistent and very mobile~~ for which medical prescription is required as an agreed risk minimisation measure with regard to the environment, unless the use of the medicinal product and the patient safety require otherwise.

Amendment 781 #

Proposal for a directive
Article 51 – paragraph 1 – point f

(f) contains an active substance, adjuvants or any other ingredient or constituent which are persistent, bioaccumulative and toxic, or very persistent and very bioaccumulative, or persistent, mobile and toxic, or very persistent and very mobile, substances listed in Annex X of the Directive 2000/60/EC or individual priority substances in Annex I of the Directive 2008/105/EC for which medical prescription is required as risk minimisation measure with regard to the environment~~, unless the use of the medicinal product and the patient safety require otherwise~~.

Amendment 782 #

Proposal for a directive
Article 51 – paragraph 1 – point f

(f) contains an active substance ~~which~~or any of its ingredients or constituent parts are persistent, bioaccumulative and toxic, or very persistent and very bioaccumulative, or persistent, mobile and toxic, or very persistent and very mobile or listed in Annex X of Directive 2000/60/EC or Annex I of Directive 2006/118/EC for which medical prescription is required as risk minimisation measure with regard to the environment, unless the use of the medicinal product and the patient safety require otherwise.

Amendment 783 #

Proposal for a directive
Article 51 – paragraph 1 – point f

(f) contains an active substance listed in Article 22, paragraph 2 of this Directive or listed as an individual priority substance in Annex I to Directive 2008/105/EC [Environmental Quality Standards Directive] and which are persistent, bioaccumulative and toxic, or very persistent and very bioaccumulative, or persistent, mobile and toxic, or very persistent and very mobile for which medical prescription is required as risk minimisation measure with regard to the environment, unless the use of the medicinal product and the patient safety require otherwise. Emergency contraception shall be exempted from this requirement.

Amendment 784 #

Proposal for a directive
Article 51 – paragraph 1 – point f

(f) contains an active substance in a concentration which are is persistent, bioaccumulative and toxic, or very persistent and very bioaccumulative, or persistent, mobile and toxic, or very persistent and very mobile for which medical prescription is required as risk minimisation measure with regard to the environment, unless the use of the medicinal product and the patient safety require otherwise.

Amendment 785 #

Proposal for a directive
Article 51 – paragraph 2

2. Member States may set additional conditions on the prescription of antimicrobials, restrict the validity of medical prescription ~~and limit the quantities prescribed to the amount required for the treatment or therapy concerned~~ or submit~~ting~~ certain antimicrobial medicinal products to special medical prescription or restricted prescription.

Amendment 786 #

Proposal for a directive
Article 51 – paragraph 2

2. Member States may set additional conditions on the prescription of antimicrobials, restrict the validity of medical prescription and ~~limit the quantities prescribed to the amount required for the treatment or therapy concerned or~~ submit~~ting~~ certain antimicrobial medicinal products to special medical prescription or restricted prescription.

Amendment 787 #

Proposal for a directive
Article 51 – paragraph 2

2. Member States may set additional conditions on the prescription of antimicrobials, restrict the validity of medical prescription and limit the quantities prescribed to the amount required for the treatment or therapy concerned or submitting certain antimicrobial medicinal products to special medical prescription or restricted prescription. Member States shall ensure that the necessary capacities for appropriate testing and antigen rapid tests are available before the administration of an antibiotic substance, and shall finance such testing through their healthcare systems. A prescription for antibiotic products shall be subject to the following conditions, which shall become effective two years after the entry into force of this Directive: (a) be limited to the amount required for the treatment or therapy concerned; (b) only be prescribed for a limited duration to cover the period of risk when used as prophylaxis; (c) require a justification through diagnostic testing in accordance with Article 51 (2c), point i; (d) not be influenced by any form of economic incentive provided directly or indirectly to persons who prescribe medicinal products, given the risks associated with antimicrobial resistance.

Amendment 788 #

Catherine AMALRIC, Frédérique RIES, Max ORVILLE, Billy KELLEHER, Andreas GLÜCK

Proposal for a directive
Article 51 – paragraph 2

2. Member States shall ensure that prescriptions and dispensation is aligned with the number of units required for the treatment concerned and may set additional conditions on the prescription of antimicrobials, restrict the validity of medical prescription and limit the quantities prescribed to the amount required for the treatment or therapy concerned, restrict the use of certain antimicrobials to the use in hospitals, or submitting certain antimicrobial medicinal products to special medical prescription or restricted prescription, including the requirement that second-line treatments cannot be given before a first-line treatment. Additional measures may include mandatory training of healthcare professionals on the environmental impact of medicines use and disposal and stewardship regarding the use of antimicrobials.

Amendment 789 #

Proposal for a directive
Article 51 – paragraph 2

2. Member States may ~~set~~decide to make an antimicrobial other than those referred to in paragraph 1 point (e) subject to prescription, and additional conditions on the prescription of antimicrobials, restrict the validity of medical prescription and limit the quantities prescribed to the amount required for the treatment or therapy concerned by authorising the use of pre-cut blister units or submitting certain antimicrobial medicinal products to special medical prescription or restricted prescription.

Amendment 790 #

Proposal for a directive
Article 51 – paragraph 2 – subparagraph 1 (new)

Prior to the prescription of an antibiotic product, execpt in cases of emergency, the person qualified to prescribe is required to examine the sensitivity of the bacterial pathogens causing the illness (antibiogram).The antibiogram shall be conducted: (a) in the case of treatments with antibiotics;or (b) when changing the antibiotic product during a course of treatment;or (c) in the case of combined adminstration of antibiotics for one indication, except for authorised ready-made products containing a combination of antibiotic active substances;

Amendment 791 #

Proposal for a directive
Article 51 – paragraph 2 – subparagraph 1 (new)

By derogation from paragraph 2, subparagraph 1a of this article, an antibiogram is not required if: (a) The collection of samples would involve a risk of additional impairment to the health status of the patient to be treated;or (b) There is no suitable method available for the determination of the sensitivity of the pathogen; If, due to an emergency or the derogations outlined above an antibiogram cannot be performed, an appropriate rapid test must be conducted whenever possible.

Amendment 792 #

Proposal for a directive
Article 51 – paragraph 2 a (new)

2 a. Wherever possible, Member States shall provide that prescriptions and dispensation shall be aligned with the number of units required for the treatment or therapy concerned.

Amendment 793 #

Proposal for a directive
Article 51 – paragraph 2 a (new)

2 a. Member States shall, wherever possible, provide for per unit prescription and dispensing for the treatment or therapy concerned.

Amendment 794 #

Proposal for a directive
Article 51 – paragraph 5 – point b

~~(b) other circumstances of use that it has specifi~~deleted.

Amendment 795 #

Proposal for a directive
Article 55

Data protection of evidence for the change of prescription status Where a change of prescription status of a medicinal product has been authorised on the basis of significant non-clinical tests or clinical studies, the competent authority shall not refer to the results of those tests or studies when examining an application by another applicant for or marketing authorisation holder for a change of prescription status of the same substance for one year after the initial change was authorisArticle 55 deleted.

Amendment 796 #

Dolors MONTSERRAT, Nathalie COLIN-OESTERLÉ, Tomislav SOKOL

Proposal for a directive
Article 56 – paragraph 1 a (new)

1 a. The marketing authorisation holder shall, in good faith, file for pricing and reimbursement in the Member States in which the marketing authorisation is valid within 4 months after the marketing authorisation was granted.The marketing authorisation holder shall be exempt from this obligation provided the competent authority of the Member State grants a product specific waiver. The obligation referred to in the first subparagraph shall exclude medicinal products defined in Article 4.1 (13), Article 10, Article 11, Article 12. Member States representatives may request the Commission to discuss issues related to this obligation in the Committee established by Council Decision 75/320/EEC (“Pharmaceutical Committee"). The Commission might invite bodies responsible for health technology assessment as referred to in Regulation (EU) 2021/2282 or national bodies responsible for pricing and reimbursement, as required, to participate in the deliberations of the Pharmaceutical Committee.

Amendment 797 #

Proposal for a directive
Article 56 – paragraph 3 – subparagraph 1

The marketing authorisation holder of a medicinal product placed on the market in a Member State shall, within the limits of its contractual responsibility, ensure appropriate and continued supplies of that medicinal product to wholesale distributors, pharmacies or persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered. Member States shall rely on the information contained in the repositories system referred to in Article 67, paragraph 2, second sub-paragraph, point (e) to ensure Marketing authorisation holders comply with their supply obligations.

Amendment 798 #

Proposal for a directive
Article 56 – paragraph 3 – subparagraph 1

The marketing authorisation holder of a medicinal product placed on the market in a Member State shall, within the limits of its responsibility, ensure appropriate and continued supplies of that medicinal product to wholesale distributors in accordance with Article 166 and 167, pharmacies orand persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered.

Amendment 799 #

Proposal for a directive
Article 56 – paragraph 3 – subparagraph 1

The marketing authorisation holder of a medicinal product placed on the market in a Member State shall~~, within the limits of its responsibility,~~ ensure appropriate and continued supplies of that medicinal product to wholesale distributors, pharmacies or persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered.

Amendment 800 #

Proposal for a directive
Article 56 – paragraph 3 – subparagraph 1

Amendment 801 #

Proposal for a directive
Article 56 – paragraph 3 – subparagraph 1

The marketing authorisation holder of a medicinal product placed on the market in a Member State shall, within the limits of its responsibility, ensure appropriate and continued supplies of that medicinal product to wholesale distributors, pharmacies orand persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered.

Amendment 802 #

Proposal for a directive
Article 56 – paragraph 3 – subparagraph 1

The marketing authorisation holder of a medicinal product placed on the market in a Member State shall, within the limits of its responsibility, ensure appropriate and continued supplies of that medicinal product to wholesale distributors, pharmacies orand persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered.

Amendment 803 #

Proposal for a directive
Article 56 – paragraph 3 – subparagraph 1

Amendment 804 #

Proposal for a directive
Article 56 – paragraph 3 – subparagraph 2

The arrangements for implementing the first subparagraph should~~, moreover, be justified on grounds of public health protection and be proportionate in relation to the objective of suc~~ be based on the high level of human health protection, in compliance with the Treaty rules~~, particularly those concerning the free movement of goods and competition~~.

Amendment 805 #

Proposal for a directive
Article 56 – paragraph 3 a (new)

3 a. For SoHO-derived medicinal products, which are obtained from altruistic and unpaid donations, Member States shall ensure, through public service obligations, that manufacturers, within the limits of their responsibilities, provide an appropriate and continuous supply to patients in each Member State.Member States shall negociate fair and transparent prices for SoHO-derived medicinal products and ensure that low-profit products are also available to patients and that there is a continuous investment on research and innovation for those products. When medicinal products are derived from donated SoHOs, manufacturers must, as for public service obligation in the Member States, report annually to the authorities the amount of processed locally-collected SoHOs and medicinal products prepared from them.

Amendment 806 #

Proposal for a directive
Article 56 – paragraph 4

4. The marketing authorisation holder shall, at all stages of manufacturing and distribution, within the limits of its responsability, ensure that the starting materials and ingredients of the medicinal products and the medicinal products themselves comply with the requirements of this Directive and, where relevant, the [revised Regulation (EC) No 726/2004] and other Union law and shall verify that such requirements are met.

Amendment 807 #

Joanna KOPCIŃSKA, Margarita DE LA PISA CARRIÓN, Andrey SLABAKOV

Proposal for a directive
Article 56 – paragraph 7

7. Where the marketing authorisation holder considers or has reason to believe that the medicinal product it has made available on the market is not in conformity with the marketing authorisation or this Directive and the [revised Regulation (EC) No 726/2004] it shall immediately take the necessary corrective actions to bring that medicinal product into conformity, to withdraw it or recall it, as appropriate, in consultation with the competent authorities. The marketing authorisation holder shall immediately inform the competent authorities and the distributors concerned to that effect.

Amendment 808 #

Proposal for a directive
Article 56 – paragraph 9

9. Upon request the marketing authorisation holder shall provide the competent authority with all data relating to the volume of sales of the medicinal product in the Union or Member State, and any data in its possession relating to the volume of prescriptions in the Union or Member State. The marketing Authorisation Holder could rely on the information contained in the repositories system referred to in Article 67, paragraph 2, second sub-paragraph, point (e) for the provision of data relating to the volume of sales of the medicinal product.

Amendment 809 #

Dolors MONTSERRAT, Nathalie COLIN-OESTERLÉ, Tomislav SOKOL

Proposal for a directive
Article 56 – paragraph 9

Amendment 810 #

Proposal for a directive
Article 56 – paragraph 9

9. Upon request the marketing authorisation holder shall provide the competent authority with all data relating to the volume of sales of the medicinal product, in the Union or Member State. The Marketing Authorisation Holder could rely on the information contained in the repositories system referred to in Article 67, paragraph 2, second sub- paragraph, point (e) for the provision of data relating to the volume of sales of the medicinal product and any data in its possession relating to the volume of prescriptions.

Amendment 811 #

Proposal for a directive
Article 56 – paragraph 9 a (new)

9 a. The marketing authorisation holder shall also be responsible for making the medicinal product available in therapy-appropriate package sizes and provide for comprehensive shelf-life documentation. Requests by the Agency pursuant to Article 22 paragraph 8 shall be complied with by the marketing authorisation holder without delay.

Amendment 812 #

Proposal for a directive
Article 57 – title

Responsibility to report on public financial support and cost data for all applicable research and development activities of medicinal products

source: 756.261

2023/12/01 ITRE 745 amendments...

Amendment 100 #

Proposal for a directive
Recital 59 a (new)

(59 a) If negotiations between Member States and developers are conducted sincerely but fail to result in an agreement on the distribution and ongoing supply of a therapy, the introduction of a mediation process is warranted. This mechanism, overseen by the Commission, should safeguard developers from unfairly missing out on incentives due to factors beyond their influence.

Amendment 101 #

Proposal for a directive
Recital 61

Amendment 102 #

Proposal for a directive
Recital 61

(61) When a compulsory licence has been granted by a relevant authority in the Union to tackle a public health emergency, regulatory data protection may, if still in force, prevent the effective use of the compulsory licence as they impede the authorisation of generic medicinal products, and thus access to the medicinal products needed to address the crisis. For this reason, data and market protection should be suspended for the indication that is relevant to the public health emergency when a compulsory licence has been issued to tackle a public health emergency. Such a suspension of the regulatory data protection should be allowed only in relation to the compulsory licence granted and its beneficiary. The suspension shall comply with the objective, the territorial scope, the duration and the subject matter of the granted compulsory licence.

Amendment 103 #

Proposal for a directive
Recital 61

(61) When a compulsory licence has been granted by a relevant authority in the Union to ~~tackle a~~safeguard public health ~~emergency~~, regulatory data protection may, if still in force, prevent the effective use of the compulsory licence as they impede the authorisation of generic medicinal products, and thus access to the medicinal products needed to address ~~the~~a crisis or safeguard public health interests as determined on a Member State level. For this reason, data and market protection should be suspended when a compulsory licence has been issued to ~~tackle a~~safeguard public health ~~emergency~~.. Such a suspension of the regulatory data protection should be allowed only in relation to the compulsory licence granted and its beneficiary. The suspension shall comply with the objective, the territorial scope, the duration and the subject matter of the granted compulsory licence.

Amendment 104 #

Proposal for a directive
Recital 61 a (new)

Amendment 105 #

Proposal for a directive
Recital 62

Amendment 106 #

Proposal for a directive
Recital 62

(62) The suspension of the regulatory data protection should be granted only for the duration of the compulsory licence and only in the relevant Member States. A ‘suspension‘ of data and market protection in cases of public health emergency shall mean that data and market protection shall produce no effect in relation to the particular licensee of the compulsory licence while that compulsory licence is in effect. When the compulsory licence ends, the data and market protection shall resume their effect. The suspension should not result in an extension of the original duration.

Amendment 107 #

Proposal for a directive
Recital 62

(62) The suspension of the regulatory data protection should be granted only for the duration of the compulsory licence. A ‘suspension‘ of data and market protection ~~in cases of~~to safeguard public health ~~emergency~~ shall mean that data and market protection shall produce no effect in relation to the particular licensee of the compulsory licence while that compulsory licence is in effect. When the compulsory licence ends, the data and market protection shall resume their effect. The suspension should not result in an extension of the original duration.

Amendment 108 #

Proposal for a directive
Recital 63

Amendment 109 #

Proposal for a directive
Recital 63

(63) It is currently possible for applicants for marketing authorisation of ~~generic, biosimilar, hybrid and bio-hybrid~~ medicinal products to conduct studies, trials and the subsequent practical requirements necessary to obtain and vary regulatory approvals for those medicinal products during the term of protection of the patent or Supplementary Protection Certificate (SPC) of the reference medicinal product, without this being considered patent or SPC infringement. The application of th, without this being considered patent or SPC infringement. The application of this limited exemption is however fragmented across the Union and the objective of enabling a day-one entry of generic and biosimilar medicinal products has not been fully achieved. The timely entry of generic and biosimilar medicinal products into the Union market is lim~~ited exemption is however fragmented across the Union and i~~portant in order to increase competition, reduce prices, ensure that national healthcare systems are sustainable and improve patients’ access to affordable medicines. It is considered necessary, in order to facilitate the market entry of medicinal products, in particular generic, biosimilar, hybrid and bio-hybrid medicinal products ~~that rel~~, on day one a ~~reference medicinal product,~~fter loss of the patent or SPC protection to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The exemption must be confined to conducting studies ~~and~~, trials and other activities needed for the regulatory approval process, health technology assessment ~~and~~s, obtaining pricing and reimbursement request, the public and private procurement of medicinal products to be supplied immediately after expiry of the relevant patents or SPC and complying with other regulatory or administrative requirements, including after a marketing authorisation has been granted, even though this may require substantial amounts of test production to demonstrate reliable manufacturing both by the applicants and by third party suppliers or service providers. During the term of protection in a MS of the patent or SPC ofor the re~~ference~~levant medicinal product or process, there can be no ~~commercial us~~placing on the market (within the meaning of the Commission Notice – The ‘Blue Guide’ on the implementation of EU product rules 2022 2022/C 247/01) in that Member State of the resulting final medicinal products obtained for the purposes of the regulatory approval process.

Amendment 110 #

Proposal for a directive
Recital 63

(63) ~~It is currently possible for applicants for marketing authorisation of generic, biosimilar, hybrid and bio-hybrid medicinal products to conduct studies, trials and the subsequent practical requireme~~The timely entry of generics and biosimilars onto the Union market is importants, n~~ecessar~~otably to ~~obta~~in cregulatory approvals for those medicinal products during the term of protection of the patent or Supplementary Protection Certificate (SPC) of the reference medicinal product, without this being consideredase competition, to reduce prices and to ensure both the sustainability of national healthcare systems and better access to affordable medicines by patient ~~or SPC infringement. The application of this limited exemption is however fragmented across the Union and~~s in the EU. The importance of such timely entry has been underlined by the Council in it is considered necessary, in order to facilitate the market entry of generic, biosimilar, hybrid and bio-hybrid medicinal products that rely on a reference medicinal product, to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The exemption must be confinedclusions of 17 June 2016 on strengthening the balance in the pharmaceutical systems in the Union and its Member States. It is currently possible for applicants for marketing authorisation of medicinal products to conduct studies ~~and~~, trials and othe~~r activities needed for the regulatory approval process, health technology assessment and pricing reimbursement request, even~~ subsequent practical requirements necessary to obtain regulatory approvals and variations thereof, withought this may require substantial amounts of test production to demonstrate reliable manufacturing. During the term of protection of the patent or SPC of the reference medicinal product, there can be no commercial use of the resulting final medicinal products obtained for the purposes of the regulatory approval processbeing considered patent or Supplementary Protection Certificate (SPC) infringement.

Amendment 111 #

Proposal for a directive
Recital 63

(63) ~~It is currently possible for applicants for marketing authorisation of generic, biosimilar, hybrid and bio-hybrid medicinal products to conduct studies, trials and the subsequent practical requireme~~The timely entry of generics and biosimilars onto the Union market is importants, n~~ecessar~~otably to ~~obta~~in cregulatory approvals for those medicinal products during the term of protection of the patent or Supplementary Protection Certificate (SPC) of the reference medicinal product, without this being consideredase competition, to reduce prices and to ensure both the sustainability of national healthcare systems and better access to affordable medicines by patient ~~or SPC infringement. The application of this limited exemption is however fragmented across the Union and~~s in the EU. The importance of such timely entry has been underlined by the Council in it is considered necessary, in order to facilitate the market entry of generic, biosimilar, hybrid and bio-hybrid medicinal products that rely on a reference medicinal product, to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The exemption must be confinedclusions of 17 June 2016 on strengthening the balance in the pharmaceutical systems in the Union and its Member States. It is currently possible for applicants for marketing authorisation of medicinal products to conduct studies ~~and~~, trials and othe~~r activities needed for the regulatory approval process, health technology assessment and pricing reimbursement request, even~~ subsequent practical requirements necessary to obtain regulatory approvals and variations thereof, withought this may require substantial amounts of test production to demonstrate reliable manufacturing. During the term of protection of the patent or SPC of the reference medicinal product, there can be no commercial use of the resulting final medicinal products obtained for the purposes of the regulatory approval processbeing considered patent or Supplementary Protection Certificate (SPC) infringement.

Amendment 112 #

Proposal for a directive
Recital 63

Amendment 113 #

Proposal for a directive
Recital 63

(63) It is currently possible for applicants for marketing authorisation of generic, biosimilar, hybrid and bio-hybrid medicinal products to conduct studies, trials and the subsequent practical requirements necessary to obtain regulatory approvals for those medicinal products during the term of protection of the patent or Supplementary Protection Certificate (SPC) of the reference medicinal product, without this being considered patent or SPC infringement. The application of this limited exemption is however fragmented across the Union and it is considered necessary, ~~in order to facilitate the market entry of generic, biosimilar, hybrid and bio-hybrid medicinal products that rely on a reference medicinal product,~~ to clarify its scope and limitations in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The exemption must be confined to conduct studies and trials and other activities needed for the regulatory approval process~~, health technology assessment and pricing reimbursement request, even though this may require substantial amounts of test production to demonstrate reliable manufacturing~~. During the term of protection of the patent or SPC of the reference medicinal product, there can be no commercial use of the resulting final medicinal products obtained for the purposes of the regulatory approval process. Any (excess) patented products that were manufactured for the purpose of Art 85 (a) or (b) shall not be commercially exploited, including after the approval of said marketing authorization application. These should be dealt with in accordance with TRIPS Article 46.

Amendment 114 #

Proposal for a directive
Recital 63 a (new)

Amendment 115 #

Proposal for a directive
Recital 63 a (new)

Amendment 116 #

Proposal for a directive
Recital 64

(64) It will allow all steps required to effectively launch on day-one after patent or SPC protection, inter alia, to conduct ~~stud~~activities to support ~~pricing and reimbursement as well as the manufacture or purchase of patent protected active substances for the purpose of seeking marketing authorisations during that period, contributing to~~regulatory approval, health technology assessments, pricing and reimbursement and other regulatory procedures and requirements in the Union or elsewhere, including after a marketing authorisation has been granted, as well as the manufacture or purchase of patent protected active substances for the aforementioned purposes, contributing to the timely market entry of medicinal products, in particular the market entry of generics and biosimilars, on day one ofafter loss of the patent or SPC protection, under fair competitive conditions.

Amendment 117 #

Proposal for a directive
Recital 64

(64) It will allow all steps required to effectively launch on day-one after patent or SPC protection, inter alia, to conduct ~~stud~~activities to support ~~pricing and reimbursement~~regulatory approval, health technology assessments, pricing and reimbursement and other regulatory procedures and requirements in the Union or elsewhere, including after a marketing authorisation has been granted, as well as the manufacture or purchase of ~~patent protected~~ active substances for the ~~purpose of seeking marketing authorisations during that period, contributing to~~aforementioned purposes, contributing to the timely market entry of medicinal products, in particular the market entry of generics and biosimilars, on day one ofafter loss of the patent or SPC protection, under fair competitive conditions.

Amendment 118 #

Proposal for a directive
Recital 64

Amendment 119 #

Proposal for a directive
Recital 64

Amendment 120 #

Proposal for a directive
Recital 64

(64) It will allow, inter alia, ~~to conduct studies to support pricing and reimbursement as well as~~ the manufacture or purchase of patent protected active substances for the purpose of seeking marketing authorisations during that period, contributing to the market entry of generics and biosimilars on day one of loss of the patent or SPC protection.

Amendment 121 #

Proposal for a directive
Recital 64

Amendment 122 #

Proposal for a directive
Recital 65

Amendment 123 #

Proposal for a directive
Recital 65

(65) Avoiding that circumstances may encourage inappropriate market behaviours hampering the emergence of generic and biosimilar medicinal products, ensuring timely availability of generic and biosimilar medicinal products and ending patent linkage were highlighted as priorities by Council conclusions1a and a resolution of the European Parliament2a. The competent authorities should refuse the validation for an application for a marketing authorisation referring to data of a reference medicinal product or for an application for pricing and reimbursement only on the basis of the grounds set out in this Directive. The same applies to any decision to grant, vary, suspend, restrict or revoke the marketing authorisation or pricing and reimbursement. The competent authorities cannot base their decision on any other grounds. In particular, those decisions cannot be based on the patent or SPC status of the reference medicinal product. and cannot be subject to any requirements that expose an applicant to a risk of infringement of the relevant patent or SPC. _________________ 1a Council conclusions on strengthening the balance in the pharmaceutical systems in the EU and its Member States and Council Conclusions on Access to medicines and medical devices for a Stronger and Resilient EU 2a European Parliament resolution of 2 March 2017 on EU options for improving access to medicine

Amendment 124 #

Proposal for a directive
Recital 65 a (new)

Amendment 125 #

Proposal for a directive
Recital 65 a (new)

(65 a) Under EU law, originator reference product patent protection status is not a criterion to be considered by authorities when granting a marketing authorisation, approving pricing or granting reimbursement status or any regulatory approval for a generic medicinal product, due to its anticompetitive effects. In the context of the goals of the revision of the pharmaceutical framework, it is therefore appropriate to explicitly prohibit patent linkage practices in this context.

Amendment 126 #

Proposal for a directive
Recital 67

Amendment 127 #

Proposal for a directive
Recital 68 a (new)

Amendment 128 #

Proposal for a directive
Recital 69

Amendment 129 #

Proposal for a directive
Recital 69 a (new)

(69 a) A progressive reform towards unitary packaging of medicines, in particular in hospital pharmacies, could result in a decrease of the materials used for the packaging of medicines, a reduction of the carbon footprint of the transport of medicines, a reduction in medicines waste, a better management of pollution from pharmaceutical waste, a prevention of tension and shortages of medicines, and an innovative tool to fight against antimicrobial resistance. The use of single dose unit, in hospital environnement, could represent an improvement in favor of minimizing the risk of medication errors and therefore increased patient protection.

Amendment 130 #

Proposal for a directive
Recital 69 a (new)

Amendment 131 #

Proposal for a directive
Recital 70

(70) Marketing authorisation applications for medicinal products in the Union should include an Environmental Risk Assessment (ERA) and risk mitigation measures. The proven efficacy and safety of a medicinal product for human use should remain a top criteria in terms of marketing authorisation, however applicants for marketing authorisation should ensure they complete the ERA in parallel with the marketing authorisation application to be able sufficiently mitigate negative environmental impacts. The ERA should also evaluate the risks to the environment and public health, including antimicrobial resistance that arise in the manufacturing of medicinal products.If the applicant fails to submit a complete or sufficiently substantiated environmental risk assessment or they do not propose risk mitigation measures to sufficiently address the risks identified in the environmental risk assessment, the marketing authorisation should be refused. The ERA should be updated in a timely manner when new data or knowledge about relevant risks become available and risk mitigation measures should be adapted accordingly. Moreover, to take into account the additional exposure resulting from the use of the medicinal product, the ERA should be updated in any case five years after the initial authorisation.

Amendment 132 #

Proposal for a directive
Recital 70

Amendment 133 #

Proposal for a directive
Recital 70

Amendment 134 #

Proposal for a directive
Recital 70

(70) Marketing authorisation applications for medicinal products in the Union should include an Environmental Risk Assessment (ERA) and risk mitigation measures. If the applicant fails to submit a complete or sufficiently substantiated environmental risk assessment or, they do not propose risk mitigation measures to sufficiently address the risks identified or the environmental risk is deemed unacceptable in the environmental risk assessment, the marketing authorisation should be refused. The ERA should be updated ~~when~~each time new data or knowledge about relevant risks become available.

Amendment 135 #

Proposal for a directive
Recital 70

Amendment 136 #

Proposal for a directive
Recital 70 a (new)

(70 a) In exceptional cases where the ERA is incomplete due to missing data and this can be duly justified and substantiated by the marketing authorisation holder it may still be placed on the market for reasons in the interest of public health, and with certain post authorisation conditions and oblgiations. Where a medicinal product has been authorised and the ERA is imcomplete for the reason above, the marketing authorisation holder should submit the completed ERA in the timeline agreed with the authorities and deliver upon any other post authorisation obligations.

Amendment 137 #

Proposal for a directive
Recital 70 b (new)

(70 b) Detailed requirements for an ERA should be set out in the annexes to this Directive for medicinal products that have been authorised prior to October 2005, i.e. prior to the requirement of submitting an ERA, specific provisions should be introduced to set up a programme for the environmental risk assessement of those products that are identified as potentially harmful to the environment. Moreover, the establishment of a single Union assessment of the environmental properties of active substances for veterinary use by means of an active substance based review (‘monograph’) system could be potential alternative. Such a system should be set up by the Agency following a positive recommendation of the Commission.

Amendment 138 #

Proposal for a directive
Recital 71

(71) Marketing authorisation applicants should ~~take into account~~consider the relevance of environmental risk assessment ~~procedure~~s of other EU legal frameworks that may apply to chemicals dependent on their use. Further to this Regulation, there are four main other frameworks: (i) Industrial chemicals (REACH, (Regulation (EC) No 1907/2006); (ii) Biocides (Regulation (EC) No 528/2012); (iii) Pesticides (Regulation (EC) No 1107/2009); and (iv) Veterinary medicines (Regulation (EU) 2019/6)). As a part of the Green Deal, the Commission has proposed a ‘one-substance one- assessment’ (OS-OA) approach for chemicals56 , in order to increase the efficiency of the registration system, reduce costs and unnecessary animal testing. while not prohibiting or delaying patient access to medicinal products. _________________ 56 Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions, The European Green Deal, Brussels (2019), COM(2019) 640 final.

Amendment 139 #

Proposal for a directive
Recital 72

(72) The emissions and discharges of antimicrobials to the environment from manufacturing sites may lead to antimicrobial resistance (“AMR”), which is a global concern regardless where the emissions and discharges take place. Therefore, the ERA scope should be extended to cover the risk of AMR selection during the entire life cycle of antimicrobials, including manufacturing. At the date of adoption of this Directive, there is not a scientifically agreed method to set regulatory values for the contribution of manufacturing to antimicrobial resistance other than for antibiotic resistance. The Commission should therefore issue guidelines on how to conduct ERAs for AMR selection for microbials other than bacteria after consulting the EMA, the European Centre for Disease Prevention and Control (ECDC) and the European Environment Agency.

Amendment 140 #

Proposal for a directive
Recital 72

(72) TLike every industrial sector, the production of medicines has a negative impact on the environment through CO2 emissions deriving from the medicines' global supply chains and through pharmaceutical effluents from the production, use and disposal. In addition, the emissions and discharges of antimicrobials to the environment from manufacturing sites may lead to antimicrobial resistance (“AMR”), which is a global concern regardless where the emissions and discharges take place. Therefore, ~~the ERA scope should be extended to cover the risk of AMR selection during the entire life cycle of antimicrobi~~addressing manufacturing, use and disposal through monitoring, assessing and preventing the negative impact, addressing inefficiencies and developing greener pharmaceuticals, i~~ncluding manufacturing~~s crucial to mitigate threats to public health.

Amendment 141 #

Proposal for a directive
Recital 72

Amendment 142 #

Proposal for a directive
Recital 72

Amendment 143 #

Proposal for a directive
Recital 74

(74) For medicinal products authorised prior to October 2005, without any ERA, specific provisions should be introduced to set up a risk based prioritisation programme for the ERA submission or update by the current market authorisation holders for those medicinal products that present a serious risk to the environment.

Amendment 144 #

Proposal for a directive
Recital 74

(74) For medicinal products that present a significant risk to the environment, and authorised prior to October 2005, without any ERA, specific provisions should be introduced to set up a risk based prioritisation programme for the ERA submission or update by the market authorisation holders.

Amendment 145 #

Proposal for a directive
Recital 74 a (new)

Amendment 146 #

Proposal for a directive
Recital 76

(76) To ensure that all children in the Union have access to the products specifically authorised for paediatric use, when an agreed paediatric investigation plan has led to the authorisation of a paediatric indication for a product already marketed for other therapeutic indications, the marketing authorisation holder should be obliged to ~~plac~~make the product available for ordering for paediatric patients in the same markets within two years of the date of approval of the indication.

Amendment 147 #

Proposal for a directive
Recital 79

(79) As a general rule, risk management plans for generic and biosimilar medicinal products should not be developed and submitted, considering that the reference medicinal product has such a plan, except in specific cases, where a risk management plan should be provided. Furthermore, given that the marketing authorisation holder has to forthwith submit any new data that might impact the benefit-risk balance of its products and given that national competent authorities have several tools available to continuously monitor the benefits and risks of authorised medicines, such as assessment of PSURs, signal detection and referrals, regulatory action will be taken as needed throughout the lifecycle of the product. Therefore, as a general rule a marketing authorisation should be granted for an unlimited period; exceptionally, one renewal may be decided only on justified grounds related to the safety of the medicinal product.

Amendment 148 #

Proposal for a directive
Recital 93

(93) To optimise the use of resources for both applicants for marketing authorisation and competent authorities and avoid duplication of assessment of chemical active substances of medicinal products and cell and gene therapies, marketing authorisation applicants should be able to rely on an active substance master file certificate or a monograph of the European Pharmacopeia, instead of submitting the relevant data as required in accordance with Annex II. An active substance master file certificate may be granted by the Agency when the relevant data on the active substance concerned is not already covered by a monograph of the European Pharmacopeia or by another active substance master file certificate. The Commission should be empowered to establish the procedure for the single assessment of an active substance master file. To further optimise the use of resources, the Commission should be empowered to allow use a certification scheme also for additional quality master files i.e. for active substances other than chemical active substances, or for other substances present or used in the manufacture of a medicinal product, required in accordance with Annex II, e.g. in case of novel excipients, adjuvants, radiopharmaceutical precursors and active substance intermediates, when the intermediate is a chemical active substance by itself or used in conjugation with a biological substance as well as for the raw and initial materials employed in the production of cell and gene therapies, such as cytokines, culture media, reagents, plasmids, and viral vectors.

Amendment 149 #

Proposal for a directive
Recital 93

(93) To optimise the use of resources for both applicants for marketing authorisation and competent authorities and avoid duplication of assessment of chemical active substances of medicinal products and cell and gene therapies, marketing authorisation applicants should be able to rely on an active substance master file certificate or a monograph of the European Pharmacopeia, instead of submitting the relevant data as required in accordance with Annex II. An active substance master file certificate may be granted by the Agency when the relevant data on the active substance concerned is not already covered by a monograph of the European Pharmacopeia or by another active substance master file certificate. The Commission should be empowered to establish the procedure for the single assessment of an active substance master file. To further optimise the use of resources, the Commission should be empowered to allow use of a certification scheme also for additional master files, including quality master files, i.e. for active substances other than chemical active substances, or for other substances present or used in the manufacture of a medicinal product, required in accordance with Annex II, e.g. in case of novel excipients, adjuvants, radiopharmaceutical precursors and active substance intermediates, when the intermediate is a chemical active substance by itself or used in conjugation with a biological substance, as well as for raw materials and starting materials used for manufacturing of cell therapy and gene therapy.

Amendment 150 #

Proposal for a directive
Recital 93

(93) To optimise the use of resources for both applicants for marketing authorisation and competent authorities and avoid duplication of assessment of chemical active substances of medicinal products, marketing authorisation applicants should be able to rely on an active substance master file certificate ~~or a monograph of the European Pharmacopeia~~, instead of submitting the relevant data as required in accordance with Annex II. An active substance master file certificate may be granted by the Agency when the relevant data on the active substance concerned is not already covered by ~~a monograph of the European Pharmacopeia~~ or by another active substance master file certificate. The Commission should be empowered to establish the procedure for the single assessment of an active substance master file. To further optimise the use of resources, the Commission should be empowered to allow use a certification scheme also for additional quality master files i.e. for active substances other than chemical active substances, or for other substances present or used in the manufacture of a medicinal product, required in accordance with Annex II, e.g. in case of novel excipients, adjuvants, radiopharmaceutical precursors and active substance intermediates, when the intermediate is a chemical active substance by itself or used in conjugation with a biological substance.

Amendment 151 #

Proposal for a directive
Recital 96

(96) Scientific and technological progresses in data analytics and data infrastructure provide valuable support to the development, authorisation and supervision of medicinal products. The digital transformation has affected regulatory decision-making, making it more data-driven and multiplying the possibilities for regulatory authorities to access evidence, across the lifecycle of a medicinal product. This Directive recognises the competent authorities of the Member States’ capacity to access and analyse data submitted independently from the marketing authorisation applicant or marketing authorisation holder. On thise basis~~, competent authorities of the Member States should take initiative to~~ of the totality of evidence made available to the Agency, the Agency should be able to propose updates to the summary of product characteristics in case new e~~fficacy or safety data~~vidence has an impacts on the benefit- risk balance of a medicinal product. In such case, the Agency and the marketing authorisation holder should collaborate to determine the particulars of any such update.

Amendment 152 #

Proposal for a directive
Recital 100

Amendment 153 #

Proposal for a directive
Recital 105

Amendment 154 #

Proposal for a directive
Recital 109

(109) There may be cases where manufacturing or testing steps of medicinal products need to take place in sites close to patients, for example advanced therapy medicinal products with short shelf-life. In such cases, these manufacturing or testing steps may need to be decentralised to multiple sites to reach patients across the Union. When the manufacturing or testing steps are decentralised, they should be carried out under the responsibility of the qualified person of an authorised central site. Additionally, in order to ensure smooth functioning of decentralised sites under this framework with the activities relevant for other Union legal frameworks competent authorities of Member States supervising the decentralised site should coordinate their acitivities and supervisory tasks with the relevant authorities responsible for the supervision of the manufacturing or testing activities under other Union acts. The decentralised sites should not require a separate manufacturing authorisation from the one granted to the relevant central site but should be registered by the competent authority of the Member State in which the decentralised site is established. In the case of medicinal products containing, consisting or derived from autologous SoHO, the decentralised sites have to be registered as a SoHO entity as defined in and pursuant to [SoHO Regulation] for the activities of donor review and eligibility assessment, donor testing and collection, or just for collection in the case of products manufactured for autologous use.

Amendment 155 #

Proposal for a directive
Recital 110

(110) The quality of medicinal products manufactured or available in the Union should be guaranteed by requiring that the active substances used in their composition comply with the principles of good manufacturing practice in relation to those medicinal products and that manufacturing is carried out in compliance with local environmental and occupational health and labour rights standards. It has proved necessary to reinforce the Union provisions on inspections and to compile a Union database of the results of those inspections.

Amendment 156 #

Proposal for a directive
Recital 123

Amendment 157 #

Proposal for a directive
Recital 123 a (new)

(123 a)Pharmacists have always had a role in primary care, particularly to compound, dispense and sell medicinal products that patients need, to provide advice on their proper use and possible adverse effects and to support patients suffering of acute and chronic illnesses. As responsible for dispensing the medicinal products, pharmacists also monitor its proper use and compliance by the patient, provide advice in particular to avoid the risks of iatrogenics (all the undesirable effects caused by taking one or more medications) and carry out medication reviews. In an hospital environment, hospital pharmacists are even setting up pharmaceutical consultations and designing personalised pharmaceutical plans, in cooperation with health professionals, patients and carers. Hospital pharmacists and community pharmacists could play a major role in the progressive digitalisation of package leaflets.

Amendment 158 #

Proposal for a directive
Recital 124

(124) Rules should be laid down as to how the labelling and package leaflets are to be presented. The package leaflet should be easily legible, clearly comprehensible and indelible by users, including especially the target patient groups. Patient leaflets are in the category of consultative reading which means that relevant information should be found without reading the whole leaflet. For readability and legibility, the package leaflet can benefit from a typographic hierarchy and a legible typeface. Design choices should serve function and readability, rather than aesthetics, and secondarily consider the environmental sustainability of the leaflet.

Amendment 159 #

Proposal for a directive
Recital 127

(127) The use of electronic and technological possibilities other than paper package leaflets, which are complementary to the paper leaflet that is crucial for patients with limited digital health literacy can facilitate access to medicinal products, medicinal products distribution and should always guarantee equal ~~or better~~ quality of information to all patients compared to the paper form of product information. Ensuring the protection of personal data pursuant to Regulation 2016/679 and prohibition of the identification, profiling or tracking of individuals is necessary in this regard.

Amendment 160 #

Proposal for a directive
Recital 128

Amendment 161 #

Proposal for a directive
Recital 128

(128) Member States have varying levels of digital literacy and internet access. In addition, patient and healthcare professional needs may differ. It is therefore necessary that Member States have a discretion on the adoption of measures enabling the electronic provision of product information while ensuring that no patient is left behind, taking into account the needs of different age categories and the different levels of digital literacy in the population, and making sure that product information is easily accessible to all patients. Member States should progressively allow the possibility for electronic product information, while ensuring full compliance with the rules on protection of personal data, and adhere to harmonised standards developed at EU level. Based on the findings from hospital pilots, the obligation to provide a paper leaflet should be lifted for medicinal products not intended for self administration by the patient

Amendment 162 #

Proposal for a directive
Recital 129

Amendment 163 #

Proposal for a directive
Recital 129

(129) ~~Where~~ Member States ~~decide that~~should make the package leaflet ~~should be made available in principle only~~available electronically, and they should also ensure that a paper version of the package leaflet is ~~to be made available on demand and without additonal cost to patients~~provided.. They should also ensure that the information in digital format is easily accessible to all patients, for instance by including in the outer packaging of the product a digitally readable barcode, which would direct the patient to the electronic version of the package leaflet. However, Member States may choose to use only electronic leaflets for a limited range of medicinal products dispensed to in hospital patients where the provision of medical information can be ensured by health professional. The Commission should be empowered in the future to, by means of delegated acts, transition completely to electronic leaflets.

Amendment 164 #

Proposal for a directive
Recital 130

(130) The use of multi-language packages can be a tool for access to medicinal products, in particular for small markets and in public health emergencies. Where multi-language packages are used, Member States may allow the use on the labelling and package leaflet of an official language of the Union that is commonly understood in the Member States where the multi- language package is marketed. While electronic medicinal product information will facilitate their redistribution between Member States, language requirements on labels will remain a challenge. Removing the obligation for an official language and the obligation to use the international non-proprietary name for medicinal products not intended for self administration by the patient, in addition to providing electronic product information, could improve the availability of medicinal products and enable easier redistribution between Member States.

Amendment 165 #

Proposal for a directive
Recital 131

(131) To ensure a high level of transparency of public and private support to the research and development of medicinal products, the reporting of public and private contribution for the development of a particular medicinal product should be a requirement for all medicines. Given however the practical difficulty to identify how indirect public funding instruments, such as tax advantages, have supported a particular product, the reporting obligation should only concern the direct public finanThis should apply also to any independent legal entity from which it obtained a license in relation to the medicinal product in its previous phases of development. The information should be dissagregated to each stage of drug research and development, basic research, pre-clinical research, phase I, II, III of the clinical investigation of the medicinal ~~support, such as direct grants or contract~~product; as well as post-market studies. Therefore, the provisions of this Directive ensure, without prejudice to the rules on the protection of confidential and personal data, transparency regarding any direct and indirect financial support received from any public authority or public body to carry out any activities for the research and development of medicinal products.

Amendment 166 #

Proposal for a directive
Recital 131

(131) To ensure a high level of transparency of public support to the research and development of medicinal products, the reporting of public contribution for the development of a particular medicinal product should be a requirement for all medicines. Given however the practical difficulty to identify how indirect public funding instruments, such as tax advantages, have supported a particular product, the reporting obligation should only concern the direct public financial support, such as direct grants or contracts. Therefore, tThe provisions of this Directive ~~ensu~~are, without prejudice to the rules on the protection of confidential and personal data, and ensure transparency regarding any direct and indirect financial support received from any public authority or, public body, philantropic and other not-profit organisation including academia to carry out any activities for the research and development of medicinal products. In addition, when submitting a request for pricing and reimbursement, marketing authorisation holders should disclose, upon request, the company’s expenditure related to the research and development costs of the product.

Amendment 167 #

Proposal for a directive
Recital 131

(131) To ensure a high level of transparency of public support to the research and development of medicinal products, the reporting of public contribution for the development of a particular medicinal product should be a requirement for all medicines. Given however the practical difficulty to identify how indirect public funding instruments, such as tax advantages, have supported a particular product, the reporting obligation should only concern the direct public financial support, such as direct grants or contracts. Therefore, the provisions of this Directive ensure, without prejudice to the rules on the protection of confidential and personal data, transparency regarding any direct financial support received from any public authority or public body of the Union to carry out any activities for the research and development of medicinal products.

Amendment 168 #

Proposal for a directive
Recital 131

(131) To ensure a high level of transparency of public support to the research and development of medicinal products, the reporting of public contribution for the development of a particular medicinal product should be a requirement for all medicines. Given however the practical difficulty to identify how indirect public funding instruments, such as tax advantages, have supported a particular product, the reporting obligation should only concern the direct public financial support, such as direct grants or contracts. Therefore, the provisions of this Directive ensure, without prejudice to the rules on the protection of confidential and personal data, transparency regarding any direct financial support received from any EU public authority or EU public body to carry out any activities for the research and development of medicinal products.

Amendment 169 #

Proposal for a directive
Recital 133

Amendment 170 #

Proposal for a directive
Recital 135

(135) Advertising, even of medicinal products not subject to a prescription, could affect public health and distort competition. Therefore, advertising of medicinal products should meet certain criteria ensuring high standards of protection. Persons qualified to prescribe, administer or supply medicinal products can properly evaluate the information available in advertising because of their knowledge, training and experience. The advertising of medicinal products to persons who cannot properly assess the risk associated with their use may lead to medicinal product misuse or overconsumption which is liable to harm public health. Therefore advertisement to the general public of medicinal products that are available only on medical prescription should be prohibited. Furthermore, distribution of samples free of charge to the general public for promotional ends is to be prohibited, also teleshopping for medicinal products shall be prohibited pursuant to Directive 2010/13/EU of the European Parliament and of the Council[65 ]. It should be possible within certain restrictive conditions to provide samples of medicinal products free of charge to persons qualified to prescribe or supply them so that they can familiarise themselves with new products and acquire experience in dealing with them. _________________ 65 Directive 2010/13/EU of the European Parliament and of the Council of 10 March 2010 on the coordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the provision of audiovisual media services (Audiovisual Media Services Directive) (OJ L 095 15.4.2010, p. 1).

Amendment 171 #

Proposal for a directive
Recital 149

(149) In order to supplement or amend certain non-essential elements of this Directive, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of specifying the procedure for examination of application of active substance master file certificate, the publication of such certificates, the procedure for changes to the active substance master file and its certificate, access to the active substance master file and its assessment report; specifying additional ~~quality~~ master files to provide information on a constituent of a medicinal product, the procedure for examination of application of a quality master file certificate or a platform technology master file certificate, the publication of such certificates, the procedure for changes to the ~~quality~~ master file and its certificate, and access to the ~~quality~~ master file and its assessment report; determining the situations in which post-authorisation efficacy studies may be required; specifying the categories of medicinal products to which a marketing authorisation subject to specific obligations could be granted and specifying the procedures and requirements for granting such a marketing authorisation and for its renewal; specifying exemptions to variation and the categories in which variations should be classified and establishing procedures for the examination of applications for variations to the terms of marketing authorisations as well as specifying conditions and procedures for cooperation with third countries and international organisations for examination of applications for such variations. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making67 . In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. _________________ 67 OJ L 123, 12.5.2016, p. 1.

Amendment 172 #

Proposal for a directive
Article 1 – paragraph 2

Amendment 173 #

Proposal for a directive
Article 1 – paragraph 4

4. In cases where, taking into account all its characteristics, questions arise as to the regulatory status of product or a product falls within the definition of a ‘medicinal product’ and within the definition of a product covered by other Union law and there is a conflict between this Directive and other Union l~~aw, the provisions of this Directive shall prevail~~egislation, the Agency and the advisory and regulatory bodies established in other Union legislation shall consult as relevant, in order to find consensus on the regulatory status of the product or the application of Union law to the product. Where the Agency and the advisory and regulatory bodies established in other Union legislation cannot reach consensus on the regulatory status or Union law applicable to the product: (a) The Commission shall be empowered to take a decision on the regulatory status or the Union law applicable to the law in question, duly taking into account the relevant opinions and conclusions of the Agency and other advisory bodies and regulatory bodies established under Union law. This decision along with the supporting analysis and conclusion shall be made publicly available. (b) For transparency purposes, the respective opinions and conclusions of the Agency and the relevant advisory and regulatory bodies should be made publicly available.

Amendment 174 #

Proposal for a directive
Article 1 – paragraph 6

Amendment 175 #

Proposal for a directive
Article 1 – paragraph 6

Amendment 176 #

Proposal for a directive
Article 1 – paragraph 6 a (new)

6 a. The stipulations mentioned in paragraph 5, sections (a) and (b), as well as paragraph 6, are contingent upon the provision that all referenced items are formulated to cater to the unique requirements of individual patients. Furthermore, these items must adhere to all protocols set forth by the Convention on the Elaboration of a European Pharmacopoeia. This includes conformity with all relevant general and specific Monographs that have been ratified in accordance with that Convention.

Amendment 177 #

Proposal for a directive
Article 1 – paragraph 10

Amendment 178 #

Proposal for a directive
Article 2 – paragraph 1

1. By way of derogation from Article 1(1), only this Article shall apply to advanced therapy medicinal products prepared ~~on a non-routine basis~~incidentally and exceptionally on a non-routine basis as defined in this paragraph and in accordance with the requirements set in paragraph 3 and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product for an individual patient (‘advanced therapy medicinal products prepared under hospital exemption’). Within the context of this Article, 'non- routine basis' refers to the tailored preparation of an advanced therapy medicinal product under a hospital exemption, which occurs sporadically, under extraordinary circumstances, and is not part of a regular process, aimed at addressing the unique health requirements of a specific patient. This is applicable when no medicinal product with central authorization is accessible, nor is there a suitable clinical trial or program for compassionate use active for that particular medical need, for which the patient qualifies within the European Union. Indicators that an activity is conducted routinely include: (a) production of a product through processes that are standardized or repetitive; (b) engagement in planning processes that extend beyond the immediate clinical requirements of individual patients. The Agency is authorized to formulate guidelines for the practical application of what constitutes a 'non-routine basis'. In doing so, it must engage with national regulatory authorities and key stakeholders, including entities holding hospital exemption approvals, the pharmaceutical industry, and patient groups. Reflecting advancements in science and technology, the Commission has the authority to update the definition of 'non- routine' through implementing acts.

Amendment 179 #

Proposal for a directive
Article 2 – paragraph 1

Amendment 180 #

Proposal for a directive
Article 2 – paragraph 1 a (new)

1 a. 1a. For the purpose of this Article, ‘non-routine basis’ means an advanced therapy medicinal product prepared under hospital exemption on an incidental and exceptional basis to meet the special needs of an individual patient, where there is neither a centrally authorised medicinal product available,nor an ongoing relevant clinical trial or compassionate use programme for the same indication with an advanced therapy medicinal product for which the patient is eligible in the Union. The following measures shall be an indication that an activity occurs on a routine basis: (a) the manufacturing of a product using standardised or repetitive processes; or (b) the use of processes that involve planning in advance, beyond what is needed to address the immediate clinical needs of individual patients.

Amendment 181 #

Proposal for a directive
Article 2 – paragraph 2 – subparagraph 1

Amendment 182 #

Proposal for a directive
Article 2 – paragraph 2 – subparagraph 2

The application for a hospital exemption approval shall be submitted to the competent authority of the Member State where the hospital is located. Approval will be contingent on an evaluation of the risks and benefits, adhering to the stipulations and interpretations provided in this Article. Such approval will not exceed a one-year term and can only be renewed after a thorough review to confirm the ongoing necessity of the hospital exemption for individual patient requirements. This includes verifying the continued absence of any centrally approved product, suitable clinical trial, compassionate use program, or other regulated options within the EU since the original approval was granted, and ensuring that the production of the product remains infrequent as specified in this article. The Commission is empowered to elaborate on the particulars of submitting and updating applications for hospital exemption approval as delineated in this Article, through implementing acts.

Amendment 183 #

Proposal for a directive
Article 2 – paragraph 2 – subparagraph 2

The application for a hospital exemption approval shall be submitted to the competent authority of the Member State where the hospital is located. The application shall include evidence on quality, safety and efficacy of the advanced therapy medicinal products prepared under hospital exemption. Before a hospital exemption approval is granted, the competent authority of the Member State shall confirm that no advanced therapy medicinal product is authorised within the Union for the same therapeutic indication, and that the manufacturing of such medicinal product complies with the requirements for preparation on a non-routine basis as set out in paragraph 1.

Amendment 184 #

Proposal for a directive
Article 2 – paragraph 3

3. Member States shall ensure that advanced therapy medicinal products prepared under hospital exemption comply with the requirements equivalent to the good manufacturing practices and traceability for advanced therapy medicinal products referred to in Articles 5 and 15 of Regulation (EC) No 1394/2007 [69] respectively, and with pharmacovigilance requirements equivalent to those provided for at Union level pursuant to [revised Regulation (EC) No 726/2004]. ~~_________________ 69 Regulation (EC) No 1394/2007 of the European Parliament~~This shall include site inspections and GMP CPF accreditation, as well as traceability and pharmacovigilance plans and of the ~~Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 1)~~evaluation of the preclinical and clinical data generated by the applicant.

Amendment 185 #

Proposal for a directive
Article 2 – paragraph 4

Amendment 186 #

Proposal for a directive
Article 2 – paragraph 4

4. Member States shall ensure that data on the use, quality, safety and the efficacy of advanced therapy medicinal products prepared under hospital exemption is collected and reported by the hospital exemption approval holder to the competent authority of the Member State at least annually. The collected data must encompass ongoing monitoring results for an adequate duration following the product's use. The competent authority of the Member State shall review such data and shall verify the compliance of advanced therapy medicinal products prepared under hospital exemption with the requirements referred to in paragraph 3.

Amendment 187 #

Proposal for a directive
Article 2 – paragraph 4

4. Member States shall ensure that data on the use, quality, safety and the efficacy of advanced therapy medicinal products prepared under hospital exemption, as well as any relevant data from patient follow-up, is collected and reported by the hospital exemption approval holder to the competent authority of the Member State at least annually. The competent authority of the Member State shall review such data and shall verify the compliance of advanced therapy medicinal products prepared under hospital exemption with the requirements referred to in paragraph 3.

Amendment 188 #

Proposal for a directive
Article 2 – paragraph 4

Amendment 189 #

Proposal for a directive
Article 2 – paragraph 4 a (new)

Amendment 190 #

Proposal for a directive
Article 2 – paragraph 5

5. Should the holder of the hospital exemption approval fail to meet the conditions outlined in the preceding paragraphs, the authorization will be withdrawn by the national regulatory authority. If a hospital exemption approval is revoked due to quality, safety or efficacy concerns the competent authority of the Member States that approved the hospital exemption shall inform the Agency and the competent authorities of the other Member States as well as inform the patient who has received the advanced therapy medicinal product produced under the hospital exemption. Additionally, there should be a notification to the patient who has been administered the advanced therapy medicinal product formulated under the hospital exemption.

Amendment 191 #

Proposal for a directive
Article 2 – paragraph 5

Amendment 192 #

Proposal for a directive
Article 2 – paragraph 5

Amendment 193 #

Proposal for a directive
Article 2 – paragraph 6

6. The competent authority of the Member State shall transmit the data related to the use, quality, safety and efficacy of an advanced therapy medicinal product prepared under the hospital exemption approval to the Agency annually. The Agency shall, in collaboration with the competent authorities of Member States and the Commission, set up and maintain a repository of that data , such an EU-wide registry will be obligatory and open to the public, requiring regular updates to remain current and encompass a catalogue of the advanced therapy medicinal products formulated under hospital exemption currently employed in the Union, also specifying instances where such approval has been suspended or revoked.

Amendment 194 #

Proposal for a directive
Article 2 – paragraph 6

Amendment 195 #

Proposal for a directive
Article 2 – paragraph 6

6. The competent authority of the Member State shall transmit the data related to the use, quality, safety and efficacy of an advanced therapy medicinal product prepared under the hospital exemption approval to the Agency annually. The Agency shall, in collaboration with the competent authorities of Member States and the Commission, set up and maintain a publicly accessible repository of that data, as well as of information on the authorisation, suspension or withdrawal of hospital exemption approvals, which shall be updated regularly.

Amendment 196 #

Proposal for a directive
Article 2 – paragraph 6

Amendment 197 #

Proposal for a directive
Article 2 – paragraph 7 – subparagraph 1 – point b

(b) the format for collection and reporting of data referred to in paragraph 3 and 4;

Amendment 198 #

Proposal for a directive
Article 2 – paragraph 7 – subparagraph 1 – point d

~~(d) the modalities for preparation and use of advanced therapy medicinal products under hospital exemption on a non-routine basis.~~deleted

Amendment 199 #

Proposal for a directive
Article 2 – paragraph 7 – subparagraph 1 – point d

(d) the modalities for harmonised implementation of the preparation and use of advanced therapy medicinal products under hospital exemption on a non-routine basis.

Amendment 200 #

Proposal for a directive
Article 2 – paragraph 7 – subparagraph 1 – point d

(d) the modalities for preparation and use of advanced therapy medicinal products under hospital exemption ~~on a non-routine basis.~~;

Amendment 201 #

Proposal for a directive
Article 2 – paragraph 7 – subparagraph 1 – point d a (new)

(d a) the modalities of guidance for academic and other not-for-profit entities through the requirements of the hospital exemption clause and the centralised marketing authorisation procedure.

Amendment 202 #

Proposal for a directive
Article 2 – paragraph 7 – subparagraph 1 a (new)

the data collection by Member States should cover the application of the hospital exemption, details of the patient group treated including patient counts, and the outcomes related to clinical efficacy and safety, as well as quality of life assessments.

Amendment 203 #

Proposal for a directive
Article 2 – paragraph 8

8. The Agency shall provide to the Commission a report on the experience acquired with the hospital exemption approvals on the basis of contributions from Member States and the data referred to in paragraph 4. The first report shall be provided three years after [OP please insert the date =18 months after the date of entering into force of this Directive] and then every five years thereafter. The contents of these reports, which detail the data, will be accessible to the public and will be taken into account during future legislative deliberations or amendments, subsequent to consultations with involved parties.

Amendment 204 #

Proposal for a directive
Article 2 – paragraph 8

8. The Agency shall provide to the Commission a report on the experience acquired with the hospital exemption approvals on the basis of contributions from Member States and the data referred to in paragraph 4. The report shall be made publicly available. The first report shall be provided three years after [OP please insert the date =18 months after the date of entering into force of this Directive] and then every five years thereafter.

Amendment 205 #

Proposal for a directive
Article 2 – paragraph 8

Amendment 206 #

Proposal for a directive
Article 2 – paragraph 8 a (new)

Amendment 207 #

Proposal for a directive
Article 3 – paragraph 1 – subparagraph 1

Amendment 208 #

Proposal for a directive
Article 3 – paragraph 1 – subparagraph 2

Amendment 209 #

Proposal for a directive
Article 3 – paragraph 2

Amendment 21 #

Proposal for a directive
Recital 3

(3) This revision is part of the implementation of the Pharmaceutical strategy for Europe and aims to ~~promote innovation, in particular for unmet medical needs, while reducing regulatory burden and the environmental impact of medicines; ensure access to innovative and est~~, ensure access to innovative and established medicines for patients and improve affordabili~~shed medicines for patient~~ty of these medicines, with special attention to enhancing security of supply and addressing risks of shortages, taking into account the challenges of the smaller markets of the Union; promote innovation, in particular for unmet medical needs, while reducing regulatory burden and the environmental impact of medicines; and create a balanced and competitive system that keeps medicines affordable for health systems ~~while~~and patients while particularly rewarding targeted innovation that improves access to medicinal products in all Member States, where they address unmet medical needs and where preclincial studies and development has taken place in the Union, reinforcing our industrial ecosystems.

Amendment 210 #

Proposal for a directive
Article 3 – paragraph 3

3. Member States ~~shall ensure that marketing authorisation holders, manufacturers and healthcare professionals are not subject to civil or administrative liability for any consequences~~will be responsable resulting from the use of a medicinal product otherwise than for the authorised therapeutic indications or from the use of an unauthorised medicinal product, where such use is recommended ~~or required~~ by a competent authority in response to the ~~suspected or~~officiatly confirmed spread (indicated in the article 3.2) of pathogenic agents, toxins, chemical agents or nuclear radiation any of which could cause harm. Such provisions shall apply whether or not a national or a centralised marketing authorisation has been granted.

Amendment 211 #

Proposal for a directive
Article 4 – paragraph 1 – point 2 – point d

(d) chemical, e.g. elements, including radioactive isotopes thereof (radionuclides), naturally occurring chemical materials and chemical products obtained by chemical change or synthesis;

Amendment 212 #

Proposal for a directive
Article 4 – paragraph 1 – point 4

(4) ‘starting material’ means any material, including radioactive materials, from which an active substance is manufactured or extracted;

Amendment 213 #

Proposal for a directive
Article 4 – paragraph 1 – point 4 a (new)

Amendment 214 #

Proposal for a directive
Article 4 – paragraph 1 – point 10 a (new)

Amendment 215 #

Proposal for a directive
Article 4 – paragraph 1 – point 18

(18) ‘radiopharmaceutical’ means any medicinal product that, when ready for use, contains ~~one or more~~a radioactive component and that is intended to treat or diagnose a disease, including radionuclide~~s (~~ radio~~active isotopes) included for a medicinal purpose~~pharmaceuticals and complex radiopharmaceuticals, not including radionuclides used only for radiolabelling purposes, medical devices and in-vitro diagnostic devices;

Amendment 216 #

Proposal for a directive
Article 4 – paragraph 1 – point 18 a (new)

(18 a) 'radionuclide radiopharmaceuticals' means a radiopharmaceutical where the radionuclide or its salt is the active substance;

Amendment 217 #

Proposal for a directive
Article 4 – paragraph 1 – point 18 b (new)

(18 b) 'complex radiopharmaceutical' means a radiopharmaceutical where the radionuclide is bound to or within a carrier molecule to achieve the targeted accumulation, including ready-to-use dosage forms and kits for radiopharmaceutical preparation;

Amendment 218 #

Proposal for a directive
Article 4 – paragraph 1 – point 19

(19) ‘radionuclide generator’ means any system incorporating a fixed parent radionuclide from which ~~is produced a daughter radionuclide which is to be obtained by elution or by any other method and used in a radiopharmaceutical~~a daughter radionuclide is produced, where the daughter radionuclide is used either as a medicinal product or as a radionuclide for radiolabelling purposes;

Amendment 219 #

Proposal for a directive
Article 4 – paragraph 1 – point 20

(20) ‘kit~~’ means any preparation to be reconstituted or combined with radionuclides in the final radiopharmaceutical, usually prior to its administration~~ for radiopharmaceutical preparation’ means a pre-formulated medicinal product containing all ingredients required to directly prepare a radiopharmaceutical, with the exception of the radionuclide;

Amendment 22 #

Proposal for a directive
Recital 3

(3) This revision is part of the implementation of the Pharmaceutical strategy for Europe and aims to promote innovation, in particular for unmet medical needs, and, foster an appealing environment for the research, development, and manufacturing of pharmaceuticals within the Union while reducing regulatory and administrative burdesn ands well as the environmental impact of medicines; ensure access to innovative and established medicines for patients, with special attention to enhancing security of supply and addressing risks of shortages, taking into account the challenges of the smaller markets of the Union; and create a balanced and competitive system that keeps medicines affordable for health systems while rewarding innovation.

Amendment 220 #

Proposal for a directive
Article 4 – paragraph 1 – point 21

~~(21) ‘radionuclide precursor’ means any other radionuclide produced for the radio-labelling of another substance prior to administration;~~deleted

Amendment 221 #

Proposal for a directive
Article 4 – paragraph 1 – point 22

Amendment 222 #

Proposal for a directive
Article 4 – paragraph 1 – point 26

(26) ‘combination of a medicinal product with a product other than a medical device’ means a combination of a medicinal product with a product other than a medical device (as defined by Regulations (EU) 2017/745 and (EU) 2017/746) and where the two are intended for use in the given combination in accordance with the summary of product characteristics;

Amendment 223 #

Proposal for a directive
Article 4 – paragraph 1 – point 28

(28) '‘vaccine’ means any medicinal product ~~that is intended to elicit an immune response~~containing antigen(s) or genetic information for antigen(s) that elicit an immune response and therefore are intended for prevention, ~~including~~ post -exposure prophylaxis, and f/or treatment of diseases caused by an infectious agents;

Amendment 224 #

Proposal for a directive
Article 4 – paragraph 1 – point 28

(28) 'vaccine’ means any medicinal product that is intended to elicit an immune response for prevention, including post exposure prophylaxis, ~~and for treatment~~ of diseases caused by an infectious agent;

Amendment 225 #

Proposal for a directive
Article 4 – paragraph 1 – point 30 a (new)

Amendment 226 #

Proposal for a directive
Article 4 – paragraph 1 – point 30 a (new)

(30 a) ‘platform technology’ means a technology or collection of technologies used in the manufacturing process, quality control, or testing of medicinal products or their components that rely on prior knowledge and are established under the same underlying scientific principles;

Amendment 227 #

Proposal for a directive
Article 4 – paragraph 1 – point 30 b (new)

(30 b) ‘platform technology master file’ means a document, prepared by the owner of the platform technology, that contains data of a platform technology for which the underlying scientific principles, under which the platform technology is established, will apply regardless of components added to the platform as part of the manufacturing process for a medicinal product;

Amendment 228 #

Proposal for a directive
Article 4 – paragraph 1 – point 33

(33) ‘environmental risk assessment’ means the evaluation of the potential risks to the environment, orincluding risks to public health arising from risks to the environment, posed by the release of the medicinal product in the environment from the use and disposal of the medicinal product and the identification of risk prevention, limitation and mitigation measures. For medicinal product with an antimicrobial mode of action, the ERA also encompasses an evaluation of the risk for antimicrobial resistance selection in the environment due to the manufacturing, use and disposal of that medicinal product;

Amendment 229 #

Proposal for a directive
Article 4 – paragraph 1 – point 33

Amendment 23 #

Proposal for a directive
Recital 3

Amendment 230 #

Proposal for a directive
Article 4 – paragraph 1 – point 36 a (new)

(36 a) ‘Quality master file’ means a document that contains a detailed description of the manufacturing process, quality control during manufacture and process validation of an active substance other than a chemical active substance, or of any other substances present or used in the manufacture of a medicinal product, required in accordance with Annex II, prepared in a separate document by the manufacturer of the substance or component.

Amendment 231 #

Proposal for a directive
Article 4 – paragraph 1 – point 36 a (new)

(36 a) ‘platform technology master file’ means a document that contains a detailed description of a platform technology for which the underlying scientific principles under which the platform technology is established. This can encompass quality, pre-clinical and/or clinical data in relation to the medicinal products and/or components the platform technology refers to.

Amendment 232 #

Proposal for a directive
Article 4 – paragraph 1 – point 36 b (new)

(36 b) Platform technology’ means a collection of technologies used in the manufacturing process and/or the quality control of one or more medicinal products or their components that rely on shared prior knowledge and are established under the same underlying scientific principles. Platform technologies can encompass a variety of activities, including without being limited to similar formulations, manufacturing steps and analytical testing.

Amendment 233 #

Proposal for a directive
Article 4 – paragraph 1 – point 36 c (new)

(36 c) ‘Platform technology master file’ means a document that contains all data relative to a platform technology for which there is reasonable certainty that the underlying scientific principles under which the platform technology is established will apply regardless of the active substance or other component of interest added to the platform as part of the manufacturing process of a medicinal product. The nature of the data to be included in the platform technology master file will be defined by the applicant depending on the type of platform technology. The platform technology master file needs to be supplied in a separate document by the platform technology owner.

Amendment 234 #

Proposal for a directive
Article 4 – paragraph 1 – point 38 a (new)

(38 a) ‘medicinal product authorised for a paediatric indication’ means a medicinal product which is authorised for use in part or all of the paediatric population and in respect of which the details of the authorised indication are specified in the summary of the product characteristics

Amendment 235 #

Proposal for a directive
Article 4 – paragraph 1 – point 39

Amendment 236 #

Proposal for a directive
Article 4 – paragraph 1 – point 48

(48) ‘common name’ means the international non-proprietary name recommended by the World Health Organization for an active substance, or, if one does not exist, the usual common name;

Amendment 237 #

Proposal for a directive
Article 4 – paragraph 1 – point 53

(53) ‘micro, small and medium-sized enterprises’ means micro, small and medium-sized enterprises as defined in Article 2 of Commission Recommendation 2003/361/EC72 ; and, from ... [18 months after the date of entry into force of this Directive], it means micro, small and medium-sized enterprises as defined in the delegated act referred to in Article 58a(1); _________________ 72 Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36).

Amendment 238 #

Proposal for a directive
Article 4 – paragraph 1 – point 61 a (new)

(61 a) 'adverse event' any health problem that occurs after administration without having to be caused by the administration of a medication. Afterwards, it will be determined if they are coincident or related.

Amendment 239 #

Proposal for a directive
Article 4 – paragraph 1 – point 70

(70) ‘public service obligation’ means to guarantee permanently an adequate range of medicinal products to meet the requirements of a specific geographical area and to deliver the supplies requested within a ~~very short~~reasonable time over the whole of the area in question.

Amendment 24 #

Proposal for a directive
Recital 3

(3) This revision is part of the implementation of the Pharmaceutical strategy for Europe and aims to promote innovation, in particular for unmet medical needs, and create an attractive environment for research, development and production of medicines in the Union while reducing regulatory burden and the environmental impact of medicines; ensure access to innovative and established medicines for patients, with special attention to enhancing security of supply and addressing risks of shortages, taking into account the challenges of the smaller markets of the Union; and create a balanced and competitive system that keeps medicines affordable for health systems while rewarding innovation.

Amendment 240 #

Proposal for a directive
Article 4 – paragraph 1 – point 70 a (new)

(70 a) Decentralised manufacturing means a production model where manufacturing of medicinal products needs to take place in local sites close to patients.

Amendment 241 #

Proposal for a directive
Article 5 – paragraph 2

2. When an initial marketing authorisation has been granted in accordance with paragraph 1, any development concerning the medicinal product covered by the authorisation such as additional therapeutic indication, strengths, pharmaceutical forms, administration routes, presentations, as well as any variations of the marketing authorisation shall also be granted an authorisation in accordance with paragraph 1 or be included in the initial marketing authorisation. All those marketing authorisations as well as those obtained by this marketing authorisation holder according to article 9 to 12 shall be considered as belonging to the same global marketing authorisation, in particular for the purpose of the marketing authorisations applications under Articles 9 to 12, including as regards the expiry of the regulatory data protection period for applications using a reference medicinal product.

Amendment 242 #

Proposal for a directive
Article 6 – paragraph 2 a (new)

2 a. A marketing authorisation may be granted for a medicinal product on the basis of an active substance master file, an additional quality master file or a platform technology master file.

Amendment 243 #

Proposal for a directive
Article 6 – paragraph 5 – subparagraph 1 – point a a (new)

(a a) in the absence of comparative studies, a justification to substantiate the reasons why the above mentioned studies could not be conducted;

Amendment 244 #

Proposal for a directive
Article 6 – paragraph 6 a (new)

6 a. A marketing authorisation may be granted for a medicinal product on the basis of an active substance master file, an additional quality master file or a platform technology master file.

Amendment 245 #

Proposal for a directive
Article 6 – paragraph 7 – subparagraph 2

Amendment 246 #

Proposal for a directive
Article 9 – paragraph 3 – subparagraph 1

Paragraph 1 shall also apply if the reference medicinal product has not been authorised in the Member State in which the application for the generic medicinal product is submitted~~. In this~~, unless the applicant of the generic product is also the MAH or a related company of the reference medicinal product. In the latter case the complete dossier should be submitted. In the former case,, the applicant shall indicate in the application the name of the Member State in which the reference medicinal product is or has been authorised. At the request of the competent authority of the Member State in which the application is submitted, the competent authority of the other Member State shall transmit within a period of one month a confirmation that the reference medicinal product is or has been authorised together with the full composition of the reference medicinal product and if necessary, any other relevant documentation.

Amendment 247 #

Proposal for a directive
Article 10 – paragraph 1

In cases where the medicinal product does not fall within the definition of a generic medicinal product or has changes in strength, pharmaceutical form, route of administration or therapeutic indications, compared to the reference medicinal product, the results of the appropriate non- clinical tests orand clinical studies shall be provided to t~~he competent authorities to the extent necessary to establish a scientific bridge to the data relied upon in~~o the extent necessary to demonstrate (essential) similarity to the marketing authorisation for the reference medicinal product, and to demonstrate the safety and efficacy profile of the hybrid medicinal product in any additional indication.

Amendment 248 #

Proposal for a directive
Article 11 – paragraph 1

Amendment 249 #

Proposal for a directive
Article 11 – paragraph 1 a (new)

Amendment 25 #

Proposal for a directive
Recital 3 a (new)

(3 a) In parallel of this revision, the Union should build a new European pharmaceutical ecosystem to accelerate research and development of a new medicinal product and support innovation through the establishment of public private partnerships, the multiplication of University Hospital Institutes, centres of excellence and bioclusters.

Amendment 250 #

Proposal for a directive
Article 12

Article 12 Applications concerning bio-hybrid medicinal products In cases where a biosimilar medicinal product has changes in strength, pharmaceutical form, route of administration or therapeutic indications, compared to the reference biological medicinal product (‘bio-hybrid’), the results of the appropriate non-clinical tests or clinical studies shall be provided to the competent authorities to the extent necessary to establish a scientific bridge to the data relied upon in the marketing authorisation for the reference biological medicinal product, and to demonstrate the safety or efficacy profile of the biosimilar medicinal product.deleted

Amendment 251 #

Proposal for a directive
Article 13 – paragraph 1

Amendment 252 #

Proposal for a directive
Article 15 – title

Fixed dose combination medicinal product~~, platform technologies~~ and multi-medicinal product packages

Amendment 253 #

Proposal for a directive
Article 15 – paragraph 1

1. Where justified for preventative or therapeutic purposes, a marketing authorisation may be granted for a fixed dose combination medicinal product.

Amendment 254 #

Proposal for a directive
Article 15 – paragraph 1

1. Where justified for preventive or therapeutic purposes, a marketing authorisation may be granted for a fixed dose combination medicinal product.

Amendment 255 #

Proposal for a directive
Article 15 – paragraph 2 – subparagraph 1

Where justified for preventative or therapeutic purposes, a marketing authorisation may, in exceptional circumstances, be granted for a medicinal product comprised of a fixed component and a variable component that is pre- defined in order to, where appropriate, target different variants of an infectious agent or, where necessary, to tailor the medicinal product to characteristics of an individual patient or a group of patients ~~(‘platform technology’)~~.

Amendment 256 #

Proposal for a directive
Article 15 – paragraph 2 – subparagraph 1

Where justified for preventive or therapeutic purposes, a marketing authorisation may, in exceptional circumstances, be granted for a medicinal product comprised of a fixed component and a variable component that is pre- defined in order to, where appropriate, target different variants of an infectious agent or, where necessary, to tailor the medicinal product to characteristics of an individual patient or a group of patients ~~(‘platform technology’)~~.

Amendment 257 #

Proposal for a directive
Article 15 – paragraph 2 – subparagraph 2

An applicant that intends to submit an application for a marketing authorisation for such a medicinal product shall seek, in advance, the agreement concerning the submission of such application by the competent authority concerndeleted.

Amendment 258 #

Proposal for a directive
Article 15 – paragraph 3 – subparagraph 1

Where justified for public health reasons and ~~when the active substances cannot be combined within a fixed dose combination medicinal product~~for a preventive or therapeutic purposes, a marketing authorisation may, in exceptional circumstances, be granted to a multi- medicinal product package.

Amendment 259 #

Proposal for a directive
Article 15 – paragraph 3 – subparagraph 2

An applicant that intends to submit a an application for a marketing authorisation for such a medicinal product shall seek, in advance, the agreement concerning the submission of such application by the competent authority concerndeleted.

Amendment 26 #

Proposal for a directive
Recital 4 a (new)

Amendment 260 #

Proposal for a directive
Article 16 – paragraph 1

1. A marketing authorisation shall be required for radionuclide generators, kits, and radionuclide precursors, unless they are used as starting material, active substance or intermediate of radiopharmaceuticals covered by a marketing authorisation under Article 5(1)pharmaceuticals.

Amendment 261 #

Proposal for a directive
Article 16 – paragraph 1

Amendment 262 #

Proposal for a directive
Article 16 – paragraph 2

Amendment 263 #

Proposal for a directive
Article 16 – paragraph 2

Amendment 264 #

Proposal for a directive
Article 17 – paragraph 1 – point b

(b) a description of the special information requirements outlined in Article 69 and listed in Annex I, for prior review and approval by the competent authority.

Amendment 265 #

Proposal for a directive
Article 17 – paragraph 2

Amendment 266 #

Proposal for a directive
Article 17 – paragraph 3

3. The marketing authorisation holder shall ensure that the pack size of the antimicrobial corresponds to the usual posology and duration of treatment. The marketing authorisation holder shall ensure, wherever possible, that the antimicrobial may be dispensed per unit in a number corresponding to the quantities described on the prescription. If an antimicrobial can not be dispensed per unit, the marketing authorisation holder shall ensure that the pack size of the antimicrobial corresponds to the usual posology and duration of treatment.

Amendment 267 #

Proposal for a directive
Article 17 – paragraph 3 a (new)

3 a. Pharmacists should play a role in antimicrobial stewardship, including advising on the prudent use of antibiotics and other antimicrobials, as well as their correct disposal.

Amendment 268 #

Proposal for a directive
Article 18 – paragraph 1 – subparagraph 1

For integral combinations of a medicinal product and a medical device the marketing authorisation applicant shall submit data establishing the safe and effective use of the integral combination of the medicinal product and the medical device, particularly for pediatric patients, encompassing aspects such as storage, assembly, cleanliness, and the technique required for application or intake .

Amendment 269 #

Proposal for a directive
Article 18 – paragraph 1 – subparagraph 2

As part of the assessment, in accordance with Article 29, of the integral combination of a medicinal product and a medical device the competent authorities shall assess the benefit-risk balance of the integral combination of a medicinal product and a medical device, taking into account the suitability of the use of the medicinal product together with the medical device. In case of combined products intended for paediatric use, a risk/benefit analysis should be taken into account following the opinion of the Paediatric Working Party of the Agency, established in accordance with Article 142 of the Regulation

Amendment 27 #

Proposal for a directive
Recital 4 a (new)

(4 a) The pharmaceutical framework should be consistent with overarching EU industrial policy, including the Council Conclusions from 23 March 2023 which stressed the importance of strengthening incentives for investment in innovation and the 2016 Council Conclusions which stress any revision, including to the incentive framework, should not discourage the development of medicinal products needed for the treatment of rare diseases; increased innovation will further support patient outcomes and public health.

Amendment 270 #

Proposal for a directive
Article 18 – paragraph 3

Amendment 271 #

Proposal for a directive
Article 18 – paragraph 4

4. In its evaluation of the ~~integral combination of a medicinal product with a medical device concerned,~~medicinal product referred to in paragraph 1 the competent authorit~~ies~~y shall recognise the results of the assessment of compliance of the medical device ~~part of that integral combination~~concerned with the general safety and performance requirements in accordance with Annex I of Regulation (EU) 2017/745 ~~including, where relevant, the results of the assessment by a notified body.~~

Amendment 272 #

Proposal for a directive
Article 19 – paragraph 4

Amendment 273 #

Proposal for a directive
Article 22 – paragraph 1

1. When preparing the environmental risk assessment (‘ERA’) to be submitted pursuant to Article 6(2), the applicant shall take into account the scientific guidelines on the environmental risk assessment of medicinal products for human use as referred to in paragraph 6, or provide the duly justified reasons for any divergence from the scientific guidelines to the Agency or, as appropriate to the competent authority of the Member State concerned, in a timely manner. Where available, the applicant shall take into account existing ERAs performed under other Union legislation.

Amendment 274 #

Proposal for a directive
Article 22 – paragraph 1

1. When preparing the environmental risk assessment (‘ERA’) to be submitted pursuant to Article 6(2), the applicant shall take into account the scientific guidelines on the environmental risk assessment of medicinal products for human use as referred to in paragraph 65, or provide the reasons for any divergence from the scientific guidelines to the Agency or, as appropriate to the competent authority of the Member State concerned, in a timely manner. Where available, the applicant shall take into account existing ERAs performed under other Union legislation.

Amendment 275 #

Proposal for a directive
Article 22 – paragraph 1

1. When preparing the environmental risk assessment (‘ERA’) to be submitted pursuant to Article 6(2), the applicant shall take into account the scientific guidelines on the environmental risk assessment of medicinal products for human use as referred to in paragraph 65, or provide the reasons for any divergence from the scientific guidelines to the Agency or, as appropriate to the competent authority of the Member State concerned, in a timely manner. Where available, the applicant shall take into account existing ERAs performed under other Union legislation.

Amendment 276 #

Proposal for a directive
Article 22 – paragraph 1

1. When preparing the environmental risk assessment (‘ERA’) to be submitted pursuant to Article 6(2), the applicant shall take into account the scientific guidelines on the environmental risk assessment of medicinal products for human use as referred to in paragraph 65, or provide the reasons for any divergence from the scientific guidelines to the Agency or, as appropriate to the competent authority of the Member State concerned, in a timely manner. Where available, the applicant shall take into account existing ERAs performed under other Union legislation.

Amendment 277 #

Proposal for a directive
Article 22 – paragraph 1 a (new)

Amendment 278 #

Proposal for a directive
Article 22 – paragraph 2 – introductory part

Amendment 279 #

Proposal for a directive
Article 22 – paragraph 2 – introductory part

2. The ERA shall indicate whether the medicinal product or any of its ingredients or other constituents is classified according to one of the following substances according to the criteria of Annex I to the Regulation (EC) No 1272/2008:

Amendment 28 #

Proposal for a directive
Recital 4 b (new)

(4 b) This Directive acknowledges that fostering a competitive pharmaceutical industry within the EU, bolstering EU- based clinical trials, and localizing the manufacture of active pharmaceutical ingredients are complementary objectives that enhance the Union's strategic health autonomy while increasing the affordability, accessibility, and availability of medicinal products, thereby supporting a more resilient and sustainable European health ecosystem.

Amendment 280 #

Proposal for a directive
Article 22 – paragraph 2 – point c

Amendment 281 #

Proposal for a directive
Article 22 – paragraph 2 – point c a (new)

(c a) very persistent and very mobile (vPvM);

Amendment 282 #

Proposal for a directive
Article 22 – paragraph 2 – point c a (new)

(c a) very persistent and very mobile (vPvM);

Amendment 283 #

Proposal for a directive
Article 22 – paragraph 2 – subparagraph 1

or d) are endocrine active agents.

Amendment 284 #

Proposal for a directive
Article 22 – paragraph 2 – subparagraph 1

~~or are~~(d) endocrine ~~active agent~~disruptors.

Amendment 285 #

Proposal for a directive
Article 22 – paragraph 2 a (new)

2 a. With regards to risks resulting from manufacturing the ERA shall provide information on discharged and emissions of the active susbtance(s) and other environmentally relevant susbtances according to the requirements referred to in Annex II.

Amendment 286 #

Proposal for a directive
Article 22 – paragraph 3

Amendment 287 #

Proposal for a directive
Article 22 – paragraph 3

Amendment 288 #

Proposal for a directive
Article 22 – paragraph 3

3. The applicant shall also include in the ERA risk mitigation measures to avoid or where it is not possible, limit emissions to air, water and soil of pollutants listed in Directive 2000/60/EC, Directive 2006/118/EC, Directive 2008/105/EC and Directive 2010/75/EU or in the cases where risks to the environment are identified in the scientific guidelines drawn up by the Agency on the ERA requirements for medicinal products for human use as referred to in paragraph 5. The applicant shall provide detailed explanation that the proposed mitigation measures are appropriate and sufficient to address the identified risks to the environment.

Amendment 289 #

Proposal for a directive
Article 22 – paragraph 3

3. TWhere the ERA identifies a risk to the environment, the applicant shall also include in the ERA risk mitigation measures to avoid or where it is not possible, limit emissions to air, water and soil of pollutants listed in Directive 2000/60/EC, Directive 2006/118/EC, Directive 2008/105/EC and Directive 2010/75/EU. The applicant shall provide detailed explanation that the proposed mitigation measures are appropriate and sufficient to address the identified risks to the environment.

Amendment 29 #

Proposal for a directive
Recital 6

Amendment 290 #

Proposal for a directive
Article 22 – paragraph 3

3. TWhen the ERA indicate a risk to the environment, the applicant shall also include in the ERA risk mitigation measures to avoid or where it is not possible, limit emissions to ~~air,~~ water and soil of pollutants listed in Directive 2000/60/EC, Directive 2006/118/EC, Directive 2008/105/EC and Directive 2010/75/EU. The applicant shall provide detailed explanation that the proposed mitigation measures are appropriate and sufficient to address the identified risks to the environment.

Amendment 291 #

Proposal for a directive
Article 22 – paragraph 3

3. The applicant shall also include in the ERA risk of environmental mitigation measures to avoid or where it is not possible, limit emissions to air, water and soil of pollutants listed in Directive 2000/60/EC, Directive 2006/118/EC, Directive 2008/105/EC and Directive 2010/75/EU. The applicant shall provide detailed explanation that the proposed mitigation measures are appropriate and sufficient to address the identified risks to the environment.

Amendment 292 #

Proposal for a directive
Article 22 – paragraph 4

Amendment 293 #

Proposal for a directive
Article 22 – paragraph 4

Amendment 294 #

Proposal for a directive
Article 22 – paragraph 4

4. The ERA for anti~~microbial~~biotics shall include an evaluation of the risk for anti~~microbial~~biotic resistance selection in the environment due to the ~~entire~~ manufacturing ~~supply chain inside and outside the~~of the active substance or medicinal product within the European Union, use and disposal of the antimicrobial antibiotic taking into account, where relevant, the existing international standards that have established predicted no effect concentration (PNECs) specific for antibiotics.

Amendment 295 #

Proposal for a directive
Article 22 – paragraph 4

Amendment 296 #

Proposal for a directive
Article 22 – paragraph 4 – subparagraph 1 (new)

By way of derogation from the first subparagraph, the obligation to conduct a risk assessment for antimicrobial resistance shall only cover the risk for antibiotic resistance. That derogation shall cease to apply by ... [3 years after the date of entry into force of this Directive].

Amendment 297 #

Proposal for a directive
Article 22 – paragraph 4 a (new)

4 a. By ... [18 months after the date of entry into force of this Directive], the Commission shall, after having consulted the Agency, the European Environmental Agency (EEA), and the ECDC, issue guidelines on how to conduct the ERA for antimicrobials other than antibiotics.

Amendment 298 #

Proposal for a directive
Article 22 – paragraph 5

5. The Agency shall draw up scientific guidelines in accordance with Article 138 of [revised Regulation No (EC) 726/2004], to specify technical details regarding the ERA requirements for medicinal products for human use including environmental risk mitigation measures thereof. Where appropriate, the Agency shall consult the European Chemical Agency (ECHA), the European Food Safety Authority (EFSA) and the European Environmental Agency (EEA) on, the European Centre of Disease Control (ECDC) and other relevant stakeholders, including those managing residues from medicinal products and wastewater treatment the drafting of these scientific guidelines.

Amendment 299 #

Proposal for a directive
Article 22 – paragraph 5

5. The Agency shall draw up scientific guidelines in accordance with Article 138 of [revised Regulation No (EC) 726/2004], to specify technical details regarding the ERA requirements for medicinal products for human use. Where appropriate, the Agency shall consult the European Chemical Agency (ECHA), the European Food Safety Authority (EFSA) ~~and~~, the European Environmental Agency (EEA), the ECDC and other relevant stakeholders, including those managing residues from medicinal products and their production in the environment, on the drafting of these scientific guidelines.

Amendment 30 #

Proposal for a directive
Recital 8

(8) This revision should maintains the level of harmonisation that has been achieved. Where necessary and appropriate, it further reduces the remaining disparities, by laying down rules on the supervision and control of medicinal products and the rights and duties incumbent upon the competent authorities of the Member States with a view to ensuring compliance with legal requirements. In the light of experience gained on the application of the Union pharmaceutical legislation and the evaluation of its functioning, the regulatory framework need to be adapted to scientific and technological progress, the current market conditions and economic reality within the Union. Scientific and technological developments induce innovation and development of medicinal products, including for children and patients affected by rare diseases in all therapeutic areas where there is still unmet medical need. To harness these developments, the Union pharmaceutical framework should be adapted to meet scientific developments such as genomics, accommodate cutting edge medicinal products, e.g. personalised medicinal products and technological transformation such as data analytics, digital tools and the use of artificial intelligence. These adaptations also contribute to competitiveness of the Union pharmaceutical industry.

Amendment 300 #

Proposal for a directive
Article 22 – paragraph 5

5. The Agency shall draw up scientific guidelines in accordance with Article 138 of [revised Regulation No (EC) 726/2004], to specify technical details regarding the ERA requirements for medicinal products for human use. ~~Where appropriate, t~~The Agency shall consult the European Centre for Disease Prevention and Control (ECDC), the European Chemical Agency (ECHA), the European Food Safety Authority (EFSA) and the European Environmental Agency (EEA) and other stakeholders, including drinking water and wastewater operators, on the drafting of these scientific guidelines.

Amendment 301 #

Proposal for a directive
Article 22 – paragraph 6 – subparagraph 1

Amendment 302 #

Proposal for a directive
Article 22 – paragraph 6 – subparagraph 1

Amendment 303 #

Proposal for a directive
Article 22 – paragraph 6 – subparagraph 1

The marketing authorisation holder shall update the ERA with new information without undue delay to the relevant competent authorities, in accordance with Article 90(2), if new information pertaining to the assessment criteria referred to in Article 29 becomes available and ~~could~~ leads to a change of the conclusions of the ERA. The update shall include any relevant information from environmental monitoring, including monitoring under Directive 2000/60/EC, from eco-toxicity studies, from new or updated risk assessments under other Union legislation, as referred to in paragraph 1, and environmental exposure data.

Amendment 304 #

Proposal for a directive
Article 22 – paragraph 6 – subparagraph 1

The marketing authorisation holder shall update the ERA with new information without undue delay to the relevant competent authorities, in accordance with Article 90(2), if new information pertaining to the assessment criteria referred to in Article 29 becomes available and ~~could~~ leads to a change of the conclusions of the ERA. The update shall include any relevant information from environmental monitoring, including monitoring under Directive 2000/60/EC, from eco-toxicity studies, from new or updated risk assessments under other Union legislation, as referred to in paragraph 1, and environmental exposure data.

Amendment 305 #

Proposal for a directive
Article 22 – paragraph 6 – subparagraph 2

For an ERA conducted prior to [OP please insert the date = 18 months after the date of entering into force of this Directive], the competent authority shall request the marketing authorisation holder to update the ERA if missing information has been identified for medicinal products potentially harmful to the environment. The competent authority may also request the marketing authorisation holder to include in the ERA risk mitigation measures provided for in paragraph 3.

Amendment 306 #

Proposal for a directive
Article 22 – paragraph 6 – subparagraph 2

For an ERA conducted prior to [OP please insert the date = 18 months after the date of entering into force of this Directive], the competent authority shall request the marketing authorisation holder to update the ERA if missing information has been identified for medicinal products potentially harmful to the environment and to update missing information in relation to risk mitigation measures referred to in paragraph 3.

Amendment 307 #

Proposal for a directive
Article 22 – paragraph 6 – subparagraph 2

For an ERA conducted prior to [OP please insert the date = 18 months after the date of entering into force of this Directive], the competent authority shall request the marketing authorisation holder to update the ERA if missing information has been identified for medicinal products potentially harmful to the environment. The ERA shall be updated when new information becomes available, every 5 years at the latest.

Amendment 308 #

Proposal for a directive
Article 22 – paragraph 7

Amendment 309 #

Proposal for a directive
Article 22 – paragraph 7

7. For medicinal products referred to in Articles 9 to 12, the applicant may refer to ERA studies conducted for the reference medicinal product when preparing the ERAand shall provide any other data required in accordance with Annex II and the scientific guidelines referred to in the paragraph 5.

Amendment 31 #

Proposal for a directive
Recital 11

(11) The Directive should work in synergy with the Regulation to enable innovation and promote competitiveness of the ~~Union~~EU's pharmaceutical industry, in particular of SMEs. Furthermore, it aims to prioritize the expansion of EU-based clinical trials and the local production of active pharmaceutical ingredients, thereby reinforcing the strategic autonomy of the European health ecosystem. In this respect a balanced system of incentives is proposed that rewards innovation especially in areas of unmet medical need, EU-based innovation and innovation that reaches patients and improves access across the Union. To make the regulatory system more efficient and innovation- friendly the Directive also aims at reducing administrative burden and simplifying procedures for undertakings.

Amendment 310 #

Proposal for a directive
Article 22 – paragraph 7 a (new)

7 a. In line with the Aarhus Convention1a, full environmental assessment studies and summaries with outcomes shall be made publicly available and proactively shared with drinking water and wastewater operators. The competent authorities shall include this information in their repository of medicinal products. _________________ 1a UN Convention on access to information, public participation in decision-making and access to justice in environmental matters, done at Aarhus, Denmark, on 25 June 1998.

Amendment 311 #

Proposal for a directive
Article 22 – paragraph 7 a (new)

7 a. The outcome of the assessment of the ERA, including the data submitted by the marketing authorisation holder, shall be made publicly available by the Agency or, as appropriate, by the competent authority of the Member State after deletion of any information of a commercially confidential nature.

Amendment 312 #

Proposal for a directive
Article 22 a (new)

Article22a In accordance with Article 6(2), applicants for marketing authorization are required to incorporate data on patient experiences within their application dossiers. If inclusion of such data is not feasible, applicants must present a comprehensive explanation to the Agency. The Agency shall cooperate with patient organizations, Member State authorities, and other pertinent entities to develop guidance on the creation, execution, analysis, and reporting of studies that integrate substantial and significant patient experience data for regulatory purposes.

Amendment 313 #

Proposal for a directive
Article 23 – paragraph 1 – subparagraph 1

Amendment 314 #

Proposal for a directive
Article 23 – paragraph 1 – subparagraph 1

Amendment 315 #

Proposal for a directive
Article 23 – paragraph 1 – subparagraph 1

By [OP please insert the date = 30 months after the date of the entry into force of this Directive] the Agency shall, after consultation with the competent authorities of the Member States, the European Chemical Agency (ECHA), the European Food Safety Authority (EFSA) and the European Environmental Agency (EEA), establish a programme for the ERA to be submitted in accordance with Article 22 of the medicinal products authorised before 30 October 2005 that have not been subject to any ERA and that the Agency has identified as potentially ~~harmful~~posing an unacceptable risk to the environment in accordance with paragraph 2.

Amendment 316 #

Proposal for a directive
Article 23 – paragraph 1 – subparagraph 1

By [OP please insert the date = 3012 months after the date of the entry into force of this Directive] the Agency shall, after consultation with the competent authorities of the Member States, the European Chemical Agency (ECHA), the European Food Safety Authority (EFSA) and the European Environmental Agency (EEA), establish a programme for the ERA to be submitted in accordance with Article 22 of the medicinal products authorised before 30 October 2005 that have not been subject to any ERA and that the Agency has identified as potentially harmful to the environment in accordance with paragraph 2.

Amendment 317 #

Proposal for a directive
Article 23 – paragraph 1 – subparagraph 2

This programme shall not exceed 10 years and shall be made publicly available by the Agency.

Amendment 318 #

Proposal for a directive
Article 23 – paragraph 2

2. The Agency shall set the scientific criteria for the identification of the medicinal products as potentially ~~harmful~~posing an unacceptable risk to the environment and for the prioritisation of their ERA, using a risk based approach. For this task, the Agency may request from marketing authorisation holders the submission of relevant data or information, and may consult with relevant stakeholders including actors managing residues from medicinal products and their production in the environment, in particular water.

Amendment 319 #

Proposal for a directive
Article 23 – paragraph 2

2. The Agency shall set the scientific criteria for the identification of the medicinal products as potentially harmful to the environment and for the prioritisation of their ERA, using a risk based approach. For this task, the Agency ~~may~~shall consult all relevant stakeholders and request from marketing authorisation holders the submission of relevant data or information.

Amendment 32 #

Proposal for a directive
Recital 11

Amendment 320 #

Proposal for a directive
Article 23 – paragraph 2

Amendment 321 #

Proposal for a directive
Article 23 – paragraph 2

2. The Agency shall set the scientific criteria for the identification of the medicinal products ~~as potentially harmful~~that pose a potential risk to the environment and for the prioritisation of their ERA, using a risk based approach. For this task, the Agency may request from marketing authorisation holders the submission of relevant data or information.

Amendment 322 #

Proposal for a directive
Article 23 – paragraph 3

3. The marketing authorisation holders for medicinal products identified in the programme referred to in paragraph 1 shall submit the ERA to the Agency. The outcome of the assessment of the ERA including ~~the data~~a summary of ERA studies and their results as submitted by the marketing authorisation holder and the assessment of the ERA and scientific guidelines referred to in Article 22(5) shall be made publicly available by the Agency.

Amendment 323 #

Proposal for a directive
Article 23 – paragraph 3

3. The marketing authorisation holders for medicinal products identified in the programme referred to in paragraph 1 shall submit the ERA to the Agency. The outcome of the assessment of the ERA, including ~~the data~~full data sets and summaries of conducted ERA studies submitted by the marketing authorisation holder, shall be made publicly available by the Agency and shall be proactively shared with drinking and wastewater operators.

Amendment 324 #

Proposal for a directive
Article 23 – paragraph 3

Amendment 325 #

Proposal for a directive
Article 23 – paragraph 4

Amendment 326 #

Proposal for a directive
Article 23 – paragraph 4

4. Where there are several medicinal products identified in the programme referred to in paragraph 1 that contain the same active substance and that are expected to pose the same risks to the environment, the competent authorities of the Member States or the Agency shall encourage the marketing authorisation holders to conduct joint studies for the ERA, to minimise unnecessary duplication of data and use of animals, specifically to avoid unnecessary testing of vertebrate species and to follow the 3R rule.

Amendment 327 #

Proposal for a directive
Article 23 – paragraph 4 a (new)

4 a. The Agency shall ensure that the ERA is followed by clear recommandations to the marketing authorisation holders on how to respect the guidelines and to fulfill the requirements in the future.

Amendment 328 #

Proposal for a directive
Article 24 – paragraph 2

2. The setting-up of the system of ERA monographs shall be based on a risk- based prioritisation of active substances and relevant data requirements, particularly considering vertebrate studies.

Amendment 329 #

Proposal for a directive
Article 24 – paragraph 2

2. The setting-up of the system of ERA monographs shall be based on a risk- based prioritisation of active substances and data requested.

Amendment 33 #

Proposal for a directive
Recital 11

(11) The Directive should work in synergy with the Regulation to enable innovation and promote competitiveness of the Union pharmaceutical industry, in particular SMEs. In this respect a balanced system of incentives is proposed that rewards innovation especially infor paediatric and orphan medicinal products and in other areas of unmet medical need and innovation that reaches patients and improves access across the Union. To make the regulatory system more efficient and innovation- friendly the Directive also aims at reducing administrative burden and simplifying procedures for undertakings.

Amendment 330 #

Proposal for a directive
Article 24 – paragraph 4

4. The Agency in cooperation with the competent authorities of the Member States shall conduct a proof-of-concept pilot of ERA monographs to be completed within three years after entering into force of this Directive, while taking into account outcomes from relevant Union initiatives, such as with regard to animal testing.

Amendment 331 #

Proposal for a directive
Article 24 – paragraph 4

Amendment 332 #

Proposal for a directive
Article 24 – paragraph 5 – point e a (new)

(e a) the risk-based prioritisation of data requirements for active substances, including to avoid unnecessary animal testing.

Amendment 333 #

Proposal for a directive
Article 25 – paragraph 2 – subparagraph 3

The Agency shall establish a repository of active substance master files, their assessments reports and their certificates and ensure that personal data and commercially sensitive information is protected. The Agency shall ensure that the competent authorities of the Member State have access to this repository.

Amendment 334 #

Proposal for a directive
Article 26 – paragraph 1 – subparagraph 1

Marketing authorisation applicants may, instead of submitting the relevant data on an active substance other than a chemical active substance, or on other substances present or used in the manufacture of a medicinal product, including raw materials and starting materials used for the manufacturing of cell therapies and gene therapies, required in accordance with Annex II, rely on an additional quality master file, an additional quality master file certificate granted by the Agency in accordance with this Article (‘additional quality master file certificate’), or a certificate confirming that the quality of that substance is suitably controlled by the relevant monograph of the European Pharmacopeia.

Amendment 335 #

Proposal for a directive
Article 26 – paragraph 1 – subparagraph 2

Marketing authorisation applicants may only rely on an additional ~~quality~~ master file ~~certificate~~ if no certificate exists on the same additional ~~quality~~ master file.

Amendment 336 #

Proposal for a directive
Article 26 – paragraph 1 – subparagraph 2 a (new)

Marketing authorisation applicants may also, instead of submitting the relevant data on a platform technology used in the context of the manufacturing process of a medicinal product, rely on a platform technology master file, or a platform technology master file certificate granted by the Agency in accordance with this Article. Marketing authorisation applicants may only rely on an additional platform technology master file if no certificate exists on the same additional platform technology master file.

Amendment 337 #

Proposal for a directive
Article 26 – paragraph 2

2. Article 25, paragraphs 1 to 5, 7 and 8 shall also apply mutadis mutandis to additional ~~quality~~ master file certification.

Amendment 338 #

Proposal for a directive
Article 26 – paragraph 3 – point b

Amendment 339 #

Proposal for a directive
Article 26 – paragraph 3 – point b

(b) additional quality master files for which a certificate may be used in order to provide specific information on the quality of a substance present or used in the manufacture of a medicinal product, including cell therapies and gene therapies;

Amendment 34 #

Proposal for a directive
Recital 11 a (new)

(11 a) This Directive should be consistent with the Union’s objectives with regard to promotion of research, innovation and industrial competitiveness, including with regard to a globally competitive system of intellectual property (IP) incentives. The provisions of this Directive should be coordinated with the Union’s industrial and digital strategies as well as its trade policy to ensure that the Union is capable of competing with challenger regions, as highlighted by the resolution of the European Parliament of 24 November 2021 on a pharmaceutical strategy for Europe1a. Likewise, the conclusions of the Council of 23 March 2023 on competitiveness, single market and the economy have stressed the importance of strengthening incentives for investments in innovation. In that regard, it should be considered how the European life science sector, including the pharmaceutical industry, contributes as a whole to meeting those objectives and thus how this Directive should work to support it. _________________ 1a OJ C 224, 8.6.2022, p. 47.

Amendment 340 #

Proposal for a directive
Article 26 – paragraph 3 – point b

(b) additional ~~quality~~ master files for which a certificate may be used in order to provide specific information ~~on the quality of a substance present or used in the manufacture of a medicinal product~~referred to in paragraphs 1 and 1a of this Article;

Amendment 341 #

Proposal for a directive
Article 26 – paragraph 3 – point b a (new)

(b a) the rules governing the content and format of the application for an additional master file certificate;

Amendment 342 #

Proposal for a directive
Article 26 – paragraph 3 – point c

(c) the rules for the examination of an applications for ~~making publicly available of additional quality master fil~~an additional master file certificate and for the granting of the certificates;

Amendment 343 #

Proposal for a directive
Article 26 – paragraph 3 – point d

(d) the rules for introducing changes to the additional ~~quality~~ master file and the certificate;

Amendment 344 #

Proposal for a directive
Article 26 – paragraph 3 – point e

(e) the rules on access for competent authorities of the Member State to the ~~additional~~ quality master file and its assessment report;

Amendment 345 #

Proposal for a directive
Article 26 – paragraph 3 – point f

(f) the rules on access for marketing authorisation applicants and marketing authorisation holders relying on an additional ~~quality~~ master file certificate to the additional ~~quality~~ master file and to the assessment report.

Amendment 346 #

Proposal for a directive
Article 26 a (new)

Article 26a Additional platform technology master files 1. Marketing authorisation applicants may, instead of submitting the relevant data on the quality, safety and efficacy of a medicinal product, required in accordance with Annex II, rely on an additional platform technology master file or an additional platform technology master file certificate granted by the Agency in accordance with this Article (‘additional platform technology master file certificate’). 2. Article 25(1) to (5), (7) and (8) shall also apply mutatis mutandis to additional platform technology master file certification. 3. The description of the platform technology master file shall represent the applicant's basis for relevant data on quality, safety and efficacy of the medicinal product as required in Annex II. To adequately describe the platform technology master file, appropriate information as laid down in scientific guidelines published by the Agency shall be provided. 4. The Commission is empowered to adopt delegated acts in accordance with Article 215 to supplement this Directive by specifying: (a) the rules governing the content and format of the application for an additional platform technology master file certificate; (b) additional platform technology master files for which a certificate may be used in order to provide specific information on the platform technology on the basis of which a substance present or used in the manufacture of a medicinal product is manufactured; (c) the rules for the examination of applications for making publicly available of additional platform technology master file certificates; (d) the rules for introducing changes to the additional platform technology master file and the certificate; (e) the rules on access for competent authorities of the Member State to the additional platform technology master file and its assessment report; (f) the rules on access for marketing authorisation applicants and marketing authorisation holders relying on a additional platform technology master file certificate to the additional platform technology master file and to the assessment report. 5. The Agency shall develop and publish scientific guidelines on the requirements for an additional platform technology master file. 6. If requested by the Agency, the manufacturer of a substance present or used in the manufacturing of a medicinal product for which an application for an additional platform technology master file certificate has been submitted or the additional platform technology master file certificate holder shall undergo an inspection to verify the information contained in the application or the master file. If the holder of the additional platform technology master file refuses to undergo such an inspection, the Agency may suspend or terminate the application for the additional platform technology master file certificate.

Amendment 347 #

Proposal for a directive
Article 28 – paragraph 1 – point b a (new)

Amendment 348 #

Proposal for a directive
Article 28 – paragraph 6 a (new)

Amendment 349 #

Proposal for a directive
Article 28 – paragraph 6 b (new)

6 b. The Commission shall submit a report on the acquired experience with adapted frameworks to the European Parliament and the Council of the European Union. The inaugural report is due five years following [insert date = 18 months post-implementation of this Directive] and on a five-year cycle subsequently. Depending on the report's findings, the Commission may propose legislative changes to the overarching pharmaceutical laws, reflecting the practical insights gained from employing adapted frameworks.

Amendment 35 #

Proposal for a directive
Recital 11 a (new)

(11 a) It is however, difficult to establish a direct link between incentives offered nowadays at Union level and Union competitiveness in the pharmaceutical sphere vis a vis third country based companies. While incentives can make the EU a more attractive market for industry, they remain agnostic to medicines´ geographical origin. Medicines originating from third country based companies are eligible to all EU incentives. Equally, EU based innovative companies can benefit from incentives elsewhere if they sell their products in these markets. Therefore a reduction in the regulatory data protection period does not harm EU companies vis a vis non EU companies coming to the EU market in terms of competitiveness.

Amendment 350 #

Proposal for a directive
Article 29 – paragraph 1 – point a

Amendment 351 #

Proposal for a directive
Article 29 – paragraph 3

Amendment 352 #

Proposal for a directive
Article 29 – paragraph 4 – subparagraph 2

Amendment 353 #

Proposal for a directive
Article 30 – paragraph 1

Member States shall take all appropriate measures to ensure that the procedure for granting a marketing authorisation for medicinal products is completed within a maximum of 180 days (excluding clock stops) after the submission of a valid application from the date of validation of a marketing authorisation application.

Amendment 354 #

Proposal for a directive
Article 30 – paragraph 1

Member States shall take all appropriate measures to ensure that the procedure for granting a marketing authorisation for medicinal products is completed within a maximum of 1820 days after the submission of a valid application from the date of validation of a marketing authorisation application.

Amendment 355 #

Proposal for a directive
Article 30 – paragraph 1 a (new)

Without prejudice to national provisions regarding the setting of prices for medicinal products or their inclusion in the scope of national health insurance schemes, where a marketing authorisation has been granted in accordance with [revised Regulation (EC) No 726/2004], Member States shall ensure that the medicinal product is made available on the market within 90 days from the date of the issuing of the marketing authorisation as referred to in Article 16 of the [revised Regulation (EC) No 726/2004]

Amendment 356 #

Proposal for a directive
Article 34 – paragraph 3

Amendment 357 #

Proposal for a directive
Article 34 – paragraph 3

Amendment 358 #

Proposal for a directive
Article 34 – paragraph 4 – subparagraph 2

Amendment 359 #

Proposal for a directive
Article 34 – paragraph 4 – subparagraph 2

Amendment 36 #

Proposal for a directive
Recital 11 a (new)

Amendment 360 #

Proposal for a directive
Article 34 – paragraph 5

Amendment 361 #

Proposal for a directive
Article 36 – paragraph 4

Amendment 362 #

Proposal for a directive
Article 36 – paragraph 4

Amendment 363 #

Proposal for a directive
Article 36 – paragraph 4 a (new)

Amendment 364 #

Proposal for a directive
Article 36 – paragraph 4 a (new)

Amendment 365 #

Proposal for a directive
Article 37 – paragraph 2 – subparagraph 1

The coordination group shall be composed of one representative per Member State and one representative from patients’ organisations appointed for a renewable period of three years. Member States may appoint an alternate for a renewable period of three years. Members of the coordination group may arrange to be accompanied by experts.

Amendment 366 #

Proposal for a directive
Article 38 – paragraph 3

3. Within the coordination group, all disagreeing Member States concerned shall use their best endeavours to reach agreement on the action to be taken. They shall allow the applicant the opportunity to make its point of view known orally or in writing. If, within 630 days of the communication of the points of disagreement, the Member States reach an agreement by consensus, the reference Member State shall record the agreement, close the procedure and inform the applicant accordingly. The procedure laid down in Articles 34(7) or 36(8) shall apply.

Amendment 367 #

Proposal for a directive
Article 38 – paragraph 4

4. If within the 630-day period laid down in paragraph 3, an agreement by consensus cannot be reached, the position of the majority of the Member States represented within the coordination group shall be forwarded to the Commission, which shall apply the procedure laid down in Articles 41 and 42.

Amendment 368 #

Proposal for a directive
Article 40 – paragraph 2

2. The coordination group shall lay down a list of medicinal products for which a harmonised summary of product characteristics is to be drawn up, including the harmonisation of the approved paediatric indications, dosages and ages for which the product is recommended, taking into account the proposals from the competent authorities of all Member States, and shall forward that list to the Commission.

Amendment 369 #

Proposal for a directive
Article 41 – paragraph 1 – subparagraph 1

When reference is made to the procedure laid down in this Article, the Committee for Medicinal Products for Human Use referred to in Article 148 of [revised Regulation (EC) No 726/2004] shall consider the matter concerned and shall issue a reasoned opinion within 630 days from the date when the matter was referred to it.

Amendment 37 #

Proposal for a directive
Recital 11 b (new)

Amendment 370 #

Proposal for a directive
Article 42 – paragraph 5 a (new)

5 a. The Standing Committee on Medicinal Products for Human Use shall give its opinion in writing. Member States shall forward their written observations on the draft decision to the Commission within 10 days.

Amendment 371 #

Proposal for a directive
Article 43 – paragraph 3

Amendment 372 #

Proposal for a directive
Article 43 – paragraph 4

4. The ~~compete~~relevant authority ofin the Member State ~~may consider and decide upon additional evidence available, independently from the data submitted by~~has the discretion to consider additional high-quality evidence sources, alongside the evidence provided by the marketing authorization holder, for its scientific evaluation. If, after reviewing all evidence, including any supplementary information, the authority deems a modification to the product's summary of characteristics necessary due to its impact on the product's benefit-risk balance within its approved uses, it will promptly communicate its suggestion to the marketing authoriszation holder. ~~On that basis, the summary of product characteristics shall be updated if the additional evidence has an impact on the benefit-risk balance of a medicinal product~~The holder will receive all extra evidence and related study documents that the proposal is based on. They will also be asked to present their viewpoint on the provided evidence and, if required, will have the chance for an oral discussion regarding any proposed updates to the product summary with the authority. The authority will inform the marketing authorization holder of its decision without unnecessary delay. Should the marketing authorization holder disagree with the authority's decision, they can request a re-evaluation in writing. Upon such a request, the authority must immediately notify the Agency, providing a detailed account of the unresolved issues and reasons for disagreement, with a copy sent to the holder. Once the holder is informed that the Agency is involved, they must promptly submit their detailed reasons for the request to the Agency. Within 30 days of receiving these grounds, the Agency will review the authority's decision and issue a conclusive opinion, including the rationale for its conclusion. If the Agency's final opinion necessitates a change in the product's summary of characteristics, this summary will be accordingly updated.

Amendment 373 #

Proposal for a directive
Article 43 – paragraph 5

Amendment 374 #

Proposal for a directive
Article 43 – paragraph 6

6. The competent authorities of the Member States shall make the assessment report publicly available without undue delay, together with the reasons for their opinion, after deletion of any information of a commercially confidential nature, unless there is an overriding public interest in disclosure. The justification shall be provided separately for each therapeutic indication applied for.

Amendment 375 #

Proposal for a directive
Article 44 – paragraph 1 – subparagraph 1 – point g

Amendment 376 #

Proposal for a directive
Article 44 – paragraph 1 – subparagraph 1 – point h

(h) to conduct post-authorisation environmental risk assessment studies, collection of monitoring data or information on use, where identified or potential concerns about risks to the environment or, including public health, ~~including~~and in particular antimicrobial resistance need to be further investigated after the medicinal product has been marketed;

Amendment 377 #

Proposal for a directive
Article 47 – paragraph 1 – point d

Amendment 378 #

Proposal for a directive
Article 47 – paragraph 1 – point d

Amendment 379 #

Proposal for a directive
Article 47 – paragraph 1 – point d

Amendment 38 #

Proposal for a directive
Recital 11 b (new)

(11 b) This Directive recognizes that there is no trade-off between maintaining a competitive pharmaceutical industry in the EU and ensuring the affordability, accessibility, and availability of medicinal products in the EU.

Amendment 380 #

Proposal for a directive
Article 47 – paragraph 1 – point d

(d) the environmental risk assessment is incomplete or insufficiently substantiated by the applicant or if the risks identified in the environmental risk assessment have not been sufficiently addressed by the applicant, with the exception of medicinal products authorised before 30 october 2005 to avoid restricting patients' access to existing treatments;

Amendment 381 #

Proposal for a directive
Article 47 – paragraph 1 a (new)

1 a. The national marketing authorisation may furthermore be refused if, after verification of the particulars and documentations referred to in Article 6 and subject to the specific requirements laid down in Articles 9 to 14, the view is taken that the environmental risk assessment is incomplete or insufficiently substantiated by the applicant or if the risks identified in the environmental risk assessment have not been sufficiently addressed by the applicant and the competent authority deems that post- authorisation environmental risk assessment studies in accordance with Article 44(1), point (h), would be an insufficient measure to ensure environmental protection.

Amendment 382 #

Proposal for a directive
Article 51 – paragraph 1 – point e

(e) is an anti~~microbial~~biotic with an identified antimicrobial resistance risk; or

Amendment 383 #

Proposal for a directive
Article 51 – paragraph 1 – point e

(e) is an antimicrobial; orf systemic administration;

Amendment 384 #

Proposal for a directive
Article 51 – paragraph 1 – point e

(e) is an antimicrobial for systemic use; or

Amendment 385 #

Proposal for a directive
Article 51 – paragraph 1 – point e a (new)

(e a) is an antibiotic; or

Amendment 386 #

Proposal for a directive
Article 51 – paragraph 1 – point f

Amendment 387 #

Proposal for a directive
Article 51 – paragraph 2

Amendment 388 #

Proposal for a directive
Article 51 – paragraph 2 a (new)

2 a. Member States shall, wherever possible, provide for per unit prescription and dispensing for the treatment or therapy concerned.

Amendment 389 #

Proposal for a directive
Article 56 – paragraph 3 – subparagraph 1

Amendment 39 #

Proposal for a directive
Recital 12

Amendment 390 #

Proposal for a directive
Article 56 – paragraph 3 – subparagraph 1

The marketing authorisation holder of a medicinal product placed on the market in a Member State or a wholesale distributor who is designated by the marketing authorisation holder shall, within the limits of its responsibility, ensure appropriate and continued supplies of that medicinal product to wholesale distributors, in accordance with Articles 166 and 167, pharmacies or and persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered.

Amendment 391 #

Proposal for a directive
Article 56 – paragraph 3 – subparagraph 1

The marketing authorisation holder of a medicinal product placed on the market in a Member State shall, within the limits of its responsibility, ensure appropriate and continued supplies of that medicinal product to wholesale distributors in accordance with Articles 166 and 167, pharmacies or persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered.

Amendment 392 #

Proposal for a directive
Article 56 – paragraph 3 – subparagraph 1

The marketing authorisation holder of a medicinal product placed on the market in a Member State shall, within the limits of its responsibility, ensure appropriate and continued supplies of that medicinal product to wholesale distributors, pharmacies orand persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered.

Amendment 393 #

Proposal for a directive
Article 56 – paragraph 3 – subparagraph 1 a (new)

For SoHO-derived medicinal products, which are obtained from altruistic and unpaid donations, Member States shall ensure, through public service obligations, that manufacturers, within the limits of their responsibilities, provide an appropriate and continuous supply to patients in each Member State. Member States shall negociate fair and transparent prices for SoHO-derived medicinal products and ensure that low-profit products are also available to patients and that there is a continuous investment on research and innovation for those products. When medicinal products are derived from donated SoHOs, manufacturers must, as for public service obligation in the Member States, report annually to the authorities the amount of processed locally-collected SoHOs and medicinal products prepared from them.

Amendment 394 #

Proposal for a directive
Article 56 – paragraph 4

Amendment 395 #

Proposal for a directive
Article 56 – paragraph 7

Amendment 396 #

Proposal for a directive
Article 56 – paragraph 9

9. Upon request the marketing authorisation holder shall provide the competent authority with all data relating to the volume of sales of the medicinal product in the EU or Member State. The Marketing Authorisation Holder could rely on the information contained in the repositories system referred to in Article 67, paragraph 2, second sub-paragraph, point (e) for the provision of data relating to the volume of sales of the medicinal product , and any data in its possession relating to the volume of prescriptions.

Amendment 397 #

Proposal for a directive
Article 56 – paragraph 9

9. Upon request the marketing authorisation holder shall provide the competent authority with all data relating to the volume of sales of the medicinal product in the EU or Member State, and any data in its possession relating to the volume of prescriptions in the EU or Member State. The marketing Authorisation Holder could rely on the information contained in the repositories system referred to in Article 67, paragraph 2, second sub-paragraph, point (e) for the provision of data relating to the volume of sales of the medicinal product.

Amendment 398 #

Proposal for a directive
Article 57 – title

Responsibility to report on public financial support and cost data for all applicable research and development activities of medicinal products

Amendment 399 #

Proposal for a directive
Article 57 – paragraph 1

1. The marketing authorisation holder shall declare to the public any direct and indirect financial support received from any ~~public authority or publicly funded body~~foreign or european private entity, including philantropic entities, public authority or publicly funded body, including tax advantages and subsidies, in relation to any activities for the research and development of the medicinal product covered by a national or a centralised marketing authorisation, irrespective of the legal entity that received that support.

Amendment 40 #

Proposal for a directive
Recital 12

Amendment 400 #

Proposal for a directive
Article 57 – paragraph 1

1. The marketing authorisation holder shall declare to the public any direct and indirect financial support received from any public authority or publicly funded body, philantropic or non-for profit organisation or fund in relation to any activities for the research and development of the medicinal product covered by a national or a centralised marketing authorisation, irrespective of the legal entity that received that support.

Amendment 401 #

Proposal for a directive
Article 57 – paragraph 1

1. The marketing authorisation holder shall declare to the public any direct financial support received from any public authority or publicly funded body based in the European Union, in relation to any activities for the research and development of the medicinal product covered by a national or a centralised marketing authorisation, irrespective of the legal entity based in the European Union that received that support.

Amendment 402 #

Proposal for a directive
Article 57 – paragraph 1

1. The marketing authorisation holder shall declare to the public any direct financial support received from any public authority or publicly funded body of the European Union, in relation to any activities for the research and development of the medicinal product covered by a national or a centralised marketing authorisation, irrespective of the legal entity that received that support.

Amendment 403 #

Proposal for a directive
Article 57 – paragraph 1

1. The marketing authorisation holder shall declare to the public any direct financial support received from any public authority or publicly funded body of the Union, in relation to any activities for the research and development of the medicinal product covered by a national or a centralised marketing authorisation, irrespective of the legal entity that received that support.

Amendment 404 #

Proposal for a directive
Article 57 – paragraph 1 a (new)

1 a. The marketing authorisation holder shall declare all cases where the product was acquired at any stage of development from an entity not engaged in an economic activity (‘not-for-profit entity’) or a public-private research consortium.

Amendment 405 #

Proposal for a directive
Article 57 – paragraph 1 a (new)

1 a. The marketing authorisation holder shall also report an estimate of the costs incurred for the research and development of the medicinal product covered by a national or a centralised marketing authorization.

Amendment 406 #

Proposal for a directive
Article 57 – paragraph 2 – point a – point ii

(ii) the public authority or, publicly funded body, philantropic or non-for profit organisation or fund that provided the financial support referred to in point (i);

Amendment 407 #

Proposal for a directive
Article 57 – paragraph 2 – point a – point ii

(ii) the public authority or publicly funded body based in the European Union that provided the financial support referred to in point (i);

Amendment 408 #

Proposal for a directive
Article 57 – paragraph 2 – point a – point ii

(ii) the public authority or publicly funded body of the Union that provided the financial support referred to in point (i);

Amendment 409 #

Proposal for a directive
Article 57 – paragraph 2 – point a – point ii

(ii) the ~~public authority or publicly funded bod~~entity that provided the financial support referred to in point (i);

Amendment 41 #

Proposal for a directive
Recital 15

Amendment 410 #

Proposal for a directive
Article 57 – paragraph 2 – point a – point iii

(iii) the legal entity based in the European Union that received the support referred to in point (i).

Amendment 411 #

Proposal for a directive
Article 57 – paragraph 2 – point a – point iii a (new)

(iii a) any independent legal entity from which it obtained a license in relation to, or acquired, the medicinal product in its previous phases of development, and at which stage of the research and development process. The marketing authorisation holder shall, as much as possible, include in the report information on any public or private funding received by the independent entity for its research activities in relation to the medicinal product.

Amendment 412 #

Proposal for a directive
Article 57 – paragraph 2 – point a – point iii a (new)

(iii a) the percentage of total research and development costs covered by the financial support referred to in paragraph 1;

Amendment 413 #

Proposal for a directive
Article 57 – paragraph 2 – point a – point iii b (new)

(iii b) an estimate of the total costs incurred for the research and development of the medicinal product, which shall be disaggregated to each stage of drug research and development, including basic research, pre-clinical research, phase I, II, III of the clinical investigation of the medicinal product; as well as post-market studies.

Amendment 414 #

Proposal for a directive
Article 57 – paragraph 2 – point a – point iii b (new)

(iii b) where applicable, information related to acquiring of product license from a not-for-profit-entity or a public- private consortium, including the amount of public funding invested prior to acquisition of the product, stage of development and name of the entity.

Amendment 415 #

Proposal for a directive
Article 57 – paragraph 6 a (new)

6 a. The Agency shall provide a publicly accessible website to facilitate access to the electronic links communicated to the Agency in accordance with paragraphs 2 and 3, sorted, where relevant, by medicine and by Member State.

Amendment 416 #

Proposal for a directive
Article 57 a (new)

Article57a Responsibility to report on research and development costs In addition to the information listed in Article 57, the marketing authorisation holder shall, when submitting an application for reimbursement in a Member State for a nationally or centrally authorised product, declare upon request from the national competent authority responsible for pricing and reimbursement a detailed externally- audited reporting on the company’s expenditure related to the research and development cost of the medicinal product.

Amendment 417 #

Proposal for a directive
Article 58 – title

Traceability of substances used in the manufacture of medicinal products and manufacturing in the environmental impact assessment

Amendment 418 #

Proposal for a directive
Article 58 – paragraph 1

1. The marketing authorisation holder shall, when necessary, ensure the traceability of an active substance, starting material, excipient or any other substance intended or expected to be present in a medicinal product at all stages of manufacturing and distribution as laid down in the batch record and related systems.

Amendment 419 #

Proposal for a directive
Article 58 – paragraph 1

1. The marketing authorisation holder shall~~, when necessary,~~ ensure the traceability of an active substance, starting material, excipient or any other substance intended or expected to be present in a medicinal product at all stages of manufacturing and distribution.

Amendment 42 #

Proposal for a directive
Recital 17 a (new)

(17 a) For SoHO derived medicinal products each Member State shoud ensure through public service obligations that those manufacturers provide an appropriate and continuous supply of SoHO derived medicinal products to patients in their territory. Member States should negotiate fair and transparent prices for SoHO derived medicinal products that are derived from altruistic and unpaid donations. Member States should also ensure that affordable SoHO derived medicinal products are available to patients in their territory. In this regard, manufactureres of these products should report annually to authorities on the quantities prepared and the amount supplied for public use.

Amendment 420 #

Proposal for a directive
Article 58 – paragraph 1 a (new)

1 a. The marketing authorisation holder shall include the manufacturing process of the substances referred to in paragraph 1 as an integral part of the environmental impact assessment referred to in Article 22 and in line with requirements set in Annex II.

Amendment 421 #

Proposal for a directive
Article 58 – paragraph 4

4. The marketing authorisation holder ~~and it~~´s suppliers shall have in place systems and procedures to identify the other natural or legal persons to whom products referred to in paragraph 2 have been supplied. This information shall, upon request, be made available to the competent authorities.

Amendment 422 #

Proposal for a directive
Article 58 a (new)

Article58a Obligation to submit an application for pricing and reimbursement in all Member States 1. The marketing authorisation holder shall, upon request by a Member State in which the marketing authorisation is valid, submit in good faith and within the limits of its responsibilities an application for pricing and reimbursement for the medicinal product no later than two years from the date when the Member State made its request, or within four years from that date for any of the following entities: (i) SMEs; (ii) entities not engaged in an economic activity (‘not-for-profit entity’); and (iii) undertakings that, by the time of granting the marketing authorisation, have received not more than seven centralised marketing authorisations for the undertaking concerned or, in the case of an undertaking belonging to a group, for the group of which it is part, since the establishment of the undertaking or the group, whichever is earliest. For the purposes of this Directive and [revised Regulation (EC) No 726/2004], the Commission shall by ... [18 months after the date of entry into force of this Directive] adopt delegated acts in accordance with Article 215 to supplement this Directive by laying down the criteria to qualify as a micro, small and medium-sized enterprise, taking into account the specificities of enterprises of this sector within the Union. The marketing authorisation holder shall notify that it fulfilled the obligations set out in the first subparagraph through the EU Access to Medicines Notification System provided for in Article 58b. 2. For the purposes of paragraph 1 of this Article, Member States shall make their request within two years of the granting of a marketing authorisation and notify this in the EU Access to Medicines Notification System provided for in Article 58b. Following the filing for pricing and reimbursement by the marketing authorisation holder, Directive 89/105/EEC shall apply. Where a Member State has not complied with the time limits laid down in Directive 89/105/EEC, the obligation on the marketing authorisation holder set out in this Article shall be considered to be fulfilled in that Member State. Without prejudice to the deadline and procedure set out in paragraph 1, Member States shall in the case of vaccines have included this product in their national immunisation programme, or shall have initiated the process for this, before making their request. 3. By way of derogation from paragraph 1, the marketing authorisation holder for a designated orphan medicinal product or for an advanced therapy medicinal product may choose instead: (a) to make a medicinal product available to patients and the prescribing doctors who requested it; or (b) to submit an application for pricing and reimbursement in good faith and within the limits of its responsibility only in the Member States where the relevant patient population has been identified. 4. Following agreement between a Member State and a marketing authorisation holder, timelines that are different from those set out in paragraphs 1 and 2 may apply. A Member State may choose, after making a request in accordance with paragraph 1, to issue a product-specific waiver after which the obligation to submit an application shall be considered to be fulfilled in that Member State. 5. The Commission shall, after consultation with the Agency, adopt by means of implementing acts a list of products to be exempted from the obligations set out in this Article. The inclusion of a medicinal product in that list shall where relevant take into account circumstances related to regulatory and reimbursement procedures pertaining to particular products, or to the administration of a medicinal product in most Member States being impracticable. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 214(2). 6. Where a marketing authorisation is transferred to a different legal entity before the end of the period referred to in paragraph 1, the obligations shall be transferred to the new marketing authorisation holder. 7. The Commission shall by means of implementing acts establish a conciliation mechanism to facilitate discussions between applicants and Member States to resolve potential disputes related to the process for submission of applications for pricing and reimbursement and with respect to the timelines set out in Directive 89/105/EEC. In respect of national competences with regard to assessments on the added value of a medicinal product or subsequent decisions on pricing and reimbursement as well as on budgetary decisions and the allocation of financial resources in the area of protection and improvement of human health, the conciliation mechanism shall exclude opinions on these issues. In the event of continued disagreement between an applicant and a Member State regarding the fulfilment of the obligations set out in this Article, the Commission shall be empowered to issue a legally binding Commission decision following an opinion of the Agency. 8. The provisions of this Article shall not prevent a marketing authorisation holder from submitting an application for pricing and reimbursement and placing a medicinal product on the market of a Member State without a Member State having made a request in accordance with paragraph 1. 9. The Commission shall assess barriers to timely access to medicinal products in each Member State as well as on an aggregated Union level and publish a report with the results of its assessment. The report shall be drawn up for the first time by [OP: Please insert date of the end of the second year after the date of entry into force of this Directive] and every four years thereafter.

Amendment 423 #

Proposal for a directive
Article 58 a (new)

Article58a Obligation to submit an application for pricing and reimbursement in all Member States 1. The marketing authorisation holder shall, upon request by a Member State in which the marketing authorisation is valid, submit in good faith and within the limits of its responsibility an application for pricing and reimbursement for the medicinal product no later than two years from the date when the Member State made its request, or within four years from that date for any of the following entities: (i) SMEs; (ii) entities not engaged in an economic activity (‘not-for-profit entity’); and (iii) undertakings that, by the time of granting the marketing authorisation, have received not more than seven centralised marketing authorisations for the undertaking concerned or, in the case of an undertaking belonging to a group, for the group of which it is part, since the establishment of the undertaking or the group, whichever is earliest. For the purposes of this Directive and [revised Regulation (EC) No 726/2004], the Commission shall by ... [18 months after the date of entry into force of this Directive] adopt delegated acts in accordance with Article 215 to supplement this Directive by laying down the criteria to qualify as a micro, small and medium-sized enterprise, taking into account the specificities of enterprises of this sector within the Union. The marketing authorisation holder shall notify that it fulfilled the obligations set out in the first subparagraph through the EU Access to Medicines Notification System provided for in Article 58b. 2. For the purposes of paragraph 1of this Article, Member States shall make their request within two years of the granting of a marketing authorisation. Following the filing for pricing and reimbursement by the marketing authorisation holder, Directive89/105/EEC shall apply. Where a Member State has not complied with the timelines laid down in Directive 89/105/EEC, the obligation on the marketing authorisation holder set out in this Article shall be considered to be fulfilled in that Member State. 3. By way of derogation from paragraph 1, the marketing authorisation holder for a designated orphan medicinal product or for an advanced therapy medicinal product may choose instead: (a) to make a medicinal product directly available to patients and the prescribing doctors who requested it; or (b) to submit an application for pricing and reimbursement within the limits of its responsibility only in the Member States where the relevant patient population has been identified and/ or where there is appropriate infrastructure to diagnose and administer the medicinal product. 4. Following agreement between a Member State and a marketing authorisation holder, timelines that are different from those set out in paragraphs 1 and 2 may apply. Following consultation with the Marketing Authorisation Holder a Member State may choose, after making a request in accordance with paragraph 1, to issue a product-specific waiver after which the obligation to submit an application shall cease. 5. The Commission shall, after consultation of the Agency and other relevant stakeholders, adopt by means of implementing acts a list of products to be exempted from the obligations set out in this Article. Inclusion of a medicinal product in that list may be based on criteria such as the administration of a medicinal product in most Member States being impracticable. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 214(2). 6. Where a marketing authorization is transferred to a different legal entity before the end of the period referred to in paragraph 1, the obligations shall be transferred to the new marketing authorisation holder. 7. The Commission shall by means of implementing acts establish a conciliation mechanism to facilitate discussions between applicants and Member States to resolve potential process-related disputes with regards to the submitted applications for pricing and reimbursement and with respect to the timelines set out in Directive 89/105/EEC. The conciliation mechanism expressively excludes any other matters such as relating to the value assessment of medicinal products and the allocation of resources assigned to medical care or price levels. In the event of continued disagreement between an applicant and a Member State regarding the fulfilment of the obligations set out in this Article, the Commission shall be empowered to issue a legally binding Commission decision following an opinion of the Agency. 8. Member States and the Marketing Authorization Holders may request the Commission to discuss issues related to the practical implementation of this Article and to align with any other relevant stakeholders on any further guidance required to ensure the appropriate implementation thereof based on clear and predictable criteria. These guidelines shall be reviewed and updated regularly in consultation with all relevant parties to account for new technologies and any relevant changes in the access ecosystem.

Amendment 424 #

Proposal for a directive
Article 58 a (new)

Article 58a Obligation to launch products in Member States 1. The marketing authorisation holder shall, upon request by a Member State in which the marketing authorisation is valid, release and continuously supply into the supply chain the requested product in a sufficient quantity and in the presentations necessary to cover the needs of the patients in the Member State no later than nine months from the date when the Member State made its request, or within 18 months from that date for any of the following entities: (i) SMEs; (ii) entities not engaged in an economic activity (‘not-for-profit entity’); or (iii) undertakings that, by the time of granting the marketing authorisation, have received not more than seven centralised marketing authorisations for the undertaking concerned or, in the case of an undertaking belonging to a group, for the group of which it is part, since the establishment of the undertaking or the group, whichever is earliest. 2. The obligation laid down in paragraph 1 shall not prevent the marketing authorisation holder from submitting a pricing and reimbursement application in a Member State before receiving the request. 3. Following agreement between a Member State and a marketing authorisation holder, timelines other than those set out in paragraph 1 may apply. 4. For products authorised under [revised Regulation 726/2004], the marketing authorisation holder shall notify the Agency about the result of placing on the market of the products, in order to fulfil obligations set out in Article 138(2) of [revised Regulation 726/2004]. 5. Following the filing for pricing and reimbursement by the marketing authorisation holder, Directive 89/105/EEC shall apply. 6. Where a marketing authorisation is transferred to a different legal entity before the end of the period referred to in paragraph 1, the obligations shall be transferred to the new marketing authorisation holder.

Amendment 425 #

Proposal for a directive
Article 58 b (new)

Article 58b EU Access to Medicines Notification System 1. The Commission shall, in collaboration with the Member States, set up and maintain an electronic notification system (the “EU Access to Medicines Notification System”) as a single-entry point for the notification of compliance with the obligations set out in Article 58a. The EU Access to Medicines Notification System shall be interoperable with the other Union-wide data repositories for medicinal products. 2. The marketing authorisation holder shall use the EU Access to Medicines Notification System to notify their compliance with the obligations set out in Article 58a. In the Member States where the marketing authorisation is valid, the national competent authority shall use the EU Access to Medicines Notification System to indicate that the marketing authorisation holder has fulfilled its obligations set out in Article 58a. 3. By ... [3 years following the date of entry into force of this Directive], the Commission shall adopt implementing acts to establish technical and organisational requirements, including on security aspects and data governance, which are necessary for the practical implementation of the EU Access to Medicines Notification System. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 214(2). 4. By ... [5 years after the date of entry into force of this Directive] and every 3 years thereafter, the Commission shall present a report to the European Parliament and the Council on the use and functioning of the EU Access to Medicines Notification System. 5. By ... [5 years after the date of entry into force of this Directive], the Commission shall assess the feasibility of extending the EU Access to Medicines Notification System to other areas of the process for pricing of medicinal products as set out in Directive 89/105/EEC and, if appropriate, adopt implementing acts to establish this extended system. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 214(2).

Amendment 426 #

Proposal for a directive
Article 59 – paragraph 1

Where medicinal products are authorised for a paediatric indication following completion of an agreed paediatric investigation plan and those medicinal products have already been marketed with other therapeutic indications, the marketing authorisation holder shall, within two years of the date on which the paediatric indication is authorised, place the medicinal product on the Union market taking into account the paediatric indication, and make the medicinal product available to patients and the prescribing doctors who requested it in all Member States where the medicinal product is already placed on the market.

Amendment 427 #

Proposal for a directive
Article 63 – paragraph 3

3. Member States may decide that the package leaflet shall be made available in paper format or electronically, or both. In the absence of such specific rules in a Member State, a package leaflet in paper format shall be included in the packaging of a medicinal productAfter carefully considering all relevant factors, including but not limited to the level of digitalisation of the country and the status of digital literacy of its citizens, Member States may decide that the package leaflet shall be made available in paper format or electronically, or both. The electronic format should allow the reactive integration of new data on the drug including pharmacovigilance data. In the absence of such specific rules in a Member State, a package leaflet in paper format shall be included in the packaging of a medicinal product. If a Member State decides that the package leaflet shall be made available electronically, a paper package leaflet in addition to the electronic format may always be made available on a voluntary basis. If the package leaflet is only made available electronically, the patient’s right to a printed copy of the package leaflet should be guaranteed upon request and free of charge and it should be ensured that the information in digital format is easily accessible to all patients.

Amendment 428 #

Proposal for a directive
Article 63 – paragraph 3

3. Member States ~~may decid~~shall ensure that the p~~ackage leaflet shall be made~~rospectus is available in paper ~~format or~~and electronic~~ally, or both. In the absence of such specific rules in a Member State,~~ form. The marketing authorisation holder shall ensure that a package leaflet in paper form~~at shall be~~ is included ion the packaging of a medicinal product. If the package leaflet is only made available electronically, the patient’s right to a printed copy of the package leaflet should be guaranteed upon request and free of charge and it should be ensured that the information in digital format is easily accessible to all patients.

Amendment 429 #

Proposal for a directive
Article 63 – paragraph 3

Amendment 43 #

Proposal for a directive
Recital 17 a (new)

Amendment 430 #

Proposal for a directive
Article 63 – paragraph 3

3. ~~Member States may decide that t~~The package leaflet shall be made available in paper format or electronically, or both. In the absence of such specific rules in a Member State, a package leaflet in paper format shall be included in the packaging of a medicinal product. If the package leaflet is only made available electronically, the patient’s right to a printed copy of the package leaflet should be guaranteed upon request and free of charge and it shouldboth electronic and paper format. The printed copy of the package leaflet shall be included in the product's packaging. It shall be ensured that the information in digital format is easily accessible to all patients.

Amendment 431 #

Proposal for a directive
Article 63 – paragraph 3

Amendment 432 #

Proposal for a directive
Article 63 – paragraph 3

Amendment 433 #

Proposal for a directive
Article 63 – paragraph 3

3. Member States ~~may decid~~shall ensure that the package leaflet is~~hall be made~~ available in paper format orand electronically~~, or both. In the absence of such specific rules in a Member State, a package leaflet in paper format shall be included in the packagi~~. Member States may choose to use only electronic leaflets for a limited range of a medicin~~al product. If the package leaflet is only made available electronically, the~~es dispensed to in-hospital patient’s ~~right to a printed copy of the package leaflet should be guaranteed upon request and free of charge and it should be ensured that the information in digital format is easily accessible to all patient~~where the provision of medical information will be ensured by health professionals.

Amendment 434 #

Proposal for a directive
Article 63 – paragraph 3

Amendment 435 #

Proposal for a directive
Article 63 – paragraph 3

3. Member States may decide that the package leaflet shall be made available electronically, or both in paper format orand electronically~~, or both~~. In the absence of such specific rules in a Member State, a package leaflet ~~in paper format shall be included~~shall be made available electronically and be included in paper format in the packaging of a medicinal product. If the package leaflet is only made available electronically, the patient’s right to a printed copy of the package leaflet should be guaranteed upon request and free of charge and it should be ensured that the information in digital format is easily accessible to all patients as well as written and designed in a clear and understandable way.

Amendment 436 #

Proposal for a directive
Article 63 – paragraph 3

3. Member States may decide that the package leaflet shall be made available ~~in paper format~~electronically, or electronically~~, or both~~ and in paper format. In the absence of such specific rules in a Member State, a package leaflet in paper format shall be included in the packaging of a medicinal product. If the package leaflet is only made available electronically, the patient’s right to a printed copy of the package leaflet should be guaranteed upon request and free of charge ~~and i~~. It should be ensured that the information in digital format is easily accessible to all patients.

Amendment 437 #

Proposal for a directive
Article 63 – paragraph 3 – subparagraph 1 (new)

By derogation from paragraph 3, when the medicinal products is not delivered directly to the patients, such as in hospital environment, the package leaflet may be available only in electronic format.

Amendment 438 #

Proposal for a directive
Article 63 – paragraph 3 a (new)

3 a. If a Member State has decided that the package leaflet is only to be made available electronically, patients shall be made aware of their right to a printed copy of the package leaflet. If the package leaflet is only to be made available electronically, a package leaflet in paper format may still be provided on a voluntary basis by the marketing authorisation holder in addition to the electronic package leaflet.

Amendment 439 #

Proposal for a directive
Article 63 – paragraph 3 a (new)

3 a. By derogation from paragraph 3, where the medicinal product is not intended to be delivered directly to the patient, the package leaflet may be made available electronically only.

Amendment 44 #

Proposal for a directive
Recital 18

(18) Advanced therapy medicinal products that are prepared incidentally and exceptionally on a non-routine basis according to specific quality standards, and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product for an individual patient, should be excluded from the scope of this Directive whilst at the same time ensuring that relevant Union rules related to quality and safety are not undermined (‘hospital exemption’ ). Hospital exemptions are granted strictly when there is no certified medicinal alternative available, nor an appropriate clinical trial or compassionate use program that aligns with the therapeutic needs for an ATMP for which the patient is qualified within the European jurisdiction, provided that the production of such therapy is a singular event and not part of a standard manufacturing cycle. The system for granting marketing authorizations is underpinned by the evidence from clinical trials, which is essential for confirming product safety and effectiveness. Therefore, it's crucial to ensure that the hospital exemption does not deplete the pool of clinical trial participants or jeopardize the reliability of the marketing authorization process for Advanced Therapy Medicinal Products (ATMPs). Experience has shown that there are great differences in the application of hospital exemption among Member States. To improve the application of hospital exemption this Directive introduces measures for collection, reporting of data as well as review of these data yearly by the competent authorities and their publication by the Agency in a repository. Furthermore, the Agency should provide a report on the implementation of hospital exemption on the basis of contributions from Member States in order to ~~examine whether an adapted framework should be established for certain less complex ATMPs that have been developed and used under the hospital exemption~~assist in the overall surveillance of the products’ quality, safety, and effectiveness.. When an authorisation for the manufacturing and use of an ATMP under hospital exemption is revoked because of safety concerns, the relevant competent authorities shall inform the competent authorities of other Member States.

Amendment 440 #

Proposal for a directive
Article 63 – paragraph 3 a (new)

3 a. By derogation from paragraph 3, where the medicinal product is not intended to be delivered directly to the patient, the package leaflet may be made available electronically only.

Amendment 441 #

Proposal for a directive
Article 63 – paragraph 3 a (new)

3 a. By derogation from paragraph 3, where the medicinal product is not intended to be delivered directly to the patient, the package leaflet may be made available electronically only.

Amendment 442 #

Proposal for a directive
Article 63 – paragraph 3 a (new)

3 a. By derogation from paragraph 3, if the medicinal product is not meant to be directly administered to the patient, the package leaflet can be provided electronically exclusively.

Amendment 443 #

Proposal for a directive
Article 63 – paragraph 4 – subparagraph 1 (new)

A package leaflet shall include key information summarising benefit and harma data for each authorised indication.

Amendment 444 #

Proposal for a directive
Article 63 – paragraph 4 a (new)

4 a. Where the medicinal product is not intended to be delivered directly to and administered by the patient, the Commission is empowered to adopt delegated acts in accordance with Article 215 to amend paragraph 3 of this Article by making only the electronic version of the package leaflet mandatory in this specific context. In such a case, a package leaflet in paper format may still be provided on a voluntary basis by the marketing authorisation holder in addition to the electronic package leaflet.

Amendment 445 #

Proposal for a directive
Article 63 – paragraph 5

~~5. The Commission is empowered to adopt~~ delegated acts in accordance with Article 215 to amend paragraph 3 by making mandatory the electronic version of the package leaflet. That delegated act shall also establish the patient’s right to a printed copy of the package leaflet upon request and free of charge. The delegation of powers shall apply as of [OP please insert the date = five years following 18 months after the date of entering into force of this Directive].

Amendment 446 #

Proposal for a directive
Article 63 – paragraph 5

Amendment 447 #

Proposal for a directive
Article 63 – paragraph 5

Amendment 448 #

Proposal for a directive
Article 63 – paragraph 5

5. The Commission is empowered to adopt delegated acts in accordance with Article 215 to amend paragraph 3 by making mandatory the electronic version of the package leaflet and removing the obligation to include a package leaflet in paper format in the package. That delegated act shall also establish the patient’s right to a printed copy of the package leaflet upon request and free of charge. The delegation of powers shall apply as of [OP please insert the date = ~~fiv~~one years following 18 months after the date of entering into force of this Directive].

Amendment 449 #

Proposal for a directive
Article 63 – paragraph 5

Amendment 45 #

Proposal for a directive
Recital 18

Amendment 450 #

Proposal for a directive
Article 63 – paragraph 5

Amendment 451 #

Proposal for a directive
Article 63 – paragraph 5

5. The Commission is empowered to adopt delegated acts in accordance with Article 215 to amend paragraph 3 by making mandatory the electronic version of the package leaflet and eliminating the requirement to include a printed package leaflet within the packaging. That delegated act shall also establish the patient’s right to a printed copy of the package leaflet upon request and free of charge. The delegation of powers shall apply as of [OP please insert the date = ~~fiv~~one years following 18 months after the date of entering into force of this Directive].

Amendment 452 #

Proposal for a directive
Article 63 – paragraph 5

5. The Commission is empowered to adopt delegated acts in accordance with Article 215 to amend paragraph 3 ~~by making mandatory the electronic version of the packag~~in order to progressively reduce the use of the paper format of the leaflet. That delegated act shall also establish the patient’s right to a printed copy of the package leaflet upon request and free of charge. The delegation of powers shall apply as of [OP please insert the date = five years following 18 months after the date of entering into force of this Directive].

Amendment 453 #

Proposal for a directive
Article 63 – paragraph 6

6. The Commission shall adopt implementing acts in accordance with the examination procedure referred to in Article 214(2) to establish common standards for the electronic version of the package leaflet, the summary of product characteristics and the labelling, taking into account available technologies. Member States shall implement this article after the publication of the Commissions implementing acts on the common standards for electronic versions of the package leaflet.

Amendment 454 #

Proposal for a directive
Article 63 – paragraph 6

6. The Commission shall adopt implementing acts in accordance with the examination procedure referred to in Article 214(2) to establish common standards for the electronic version of the package leaflet, the summary of product characteristics and the labelling, taking into account available technologies. The Commission shall consult the European Data Protection Supervisor and the Agency in this process.

Amendment 455 #

Proposal for a directive
Article 63 – paragraph 6

6. TBy ... [12 months after the date of entry into force of this Directive], the Commission shall adopt implementing acts in accordance with the examination procedure referred to in Article 214(2) to establish common standards for the electronic version of the package leaflet, the summary of product characteristics and the labelling, taking into account available technologies.

Amendment 456 #

Proposal for a directive
Article 63 – paragraph 6

6. The Commission shall adopt implementing acts in accordance with the examination procedure referred to in Article 214(2) to establish common standards for the electronic version of the package leaflet, the summary of product characteristics and the labelling, taking into account available technologies at the latest by [1 year after publication of the text].

Amendment 457 #

Proposal for a directive
Article 63 – paragraph 6

6. The Commission shall adopt implementing acts in accordance with the examination procedure referred to in Article 214(2) to establish common standards for the electronic version of the package leaflet, the summary of product characteristics and the labelling, taking into account available technologies at the latest by [1 year after publication of the text].

Amendment 458 #

Proposal for a directive
Article 63 – paragraph 6

6. The Commission shall adopt implementing acts in accordance with the examination procedure referred to in Article 214(2) to establish common standards for the electronic version of the package leaflet, the summary of product characteristics and the labelling, taking into account available technologies at the latest by [1 year after publication of the text].

Amendment 459 #

Proposal for a directive
Article 63 – paragraph 6

6. The Commission shall adopt implementing acts in accordance with the examination procedure referred to in Article 214(2) to establish common standards for the electronic version of the package leaflet, the summary of product characteristics and the labelling, taking into account available technologies at the latest by [1 year after publication of the text].

Amendment 46 #

Proposal for a directive
Recital 18

Amendment 460 #

Proposal for a directive
Article 63 – paragraph 6 a (new)

6 a. After consultation with Member States and relevant stakeholders, the Agency shall implement a system providing public access to the electronic version of the package leaflet, the summary of product characteristics and the labelling on the database provided in Article 138 of [revised Regulation (EC) No 726/2004] The system shall be implemented by the Agency and used by all Member States at the latest by [30 months after publication].

Amendment 461 #

Proposal for a directive
Article 63 – paragraph 6 a (new)

6 a. Following consultation with Member States and pertinent stakeholders, the Agency will make a system available to accommodate the electronic product information in the database specified in Article 138(1)(n) and 138(2) of the Revised Regulation. By [30 months after publication], at the latest, the Agency will have the system operational and all Member States will be using it.

Amendment 462 #

Proposal for a directive
Article 63 – paragraph 6 a (new)

6 a. The Agency shall make available a system to accommodate the electronic product information in the database provided in Article 138(1)(n) and 138(2) of the Revised Regulation … after consultation with Member States and the relevant stakeholders. The system shall be implemented by the Agency and used by all Member States at the latest by [30 months after publication].

Amendment 463 #

Proposal for a directive
Article 63 – paragraph 6 a (new)

Amendment 464 #

Proposal for a directive
Article 63 – paragraph 7

7. Wheren the p~~ackage leaflet is made~~rospectus is available electronically, the individual International Directorate’s right to privacy shall be ~~ensur~~guaranteed. Any technology ~~giv~~providing access to ~~the~~ information shall ensure the protection of personal data in accordance with Regulation (EU) 2016/679 and Directive 2002/58/EC and shall not allow the identification or ~~tracking of individual~~monitoring of persons, nor shall it be used for commercial purposes., including advertising and marketing activities

Amendment 465 #

Proposal for a directive
Article 63 – paragraph 7

7. Where the package leaflet is made available electronically, the individual right to privacy shall be ensured. Any technology giving access to the information shall ensure the protection of personal data in line with Regulation (EU) 2016/679 and Directive 2002/58/EC and not allow the identification, profiling or tracking of individuals, nor shall it be used for commercial purposes, including advertising and marketing activities.

Amendment 466 #

Proposal for a directive
Article 63 – paragraph 7

7. Wheren accessing the package leaflet ~~is made available~~ electronically, the individual right to privacy shall be ensured. Any technology giving access to the information shall ensure the protection of personal data according to relevant Union legislation, and shall not allow the identification, profiling or tracking of individuals, nor shall it be used for commercial purposes including advertising and marketing activities.

Amendment 467 #

Proposal for a directive
Article 63 – paragraph 7

7. Where the package leaflet is made available electronically, the individual right to privacy shall be ensured. Any technology giving access to the information shall ensure the protection of personal data pursuant to Regulation 2016/679 and not allow the identification, profiling or tracking of individuals, nor shall it be used for commercial purposes.

Amendment 468 #

Proposal for a directive
Article 63 – paragraph 7 – subparagraph 1 (new)

The progressive transition to the electronic version of the package leaflet shall be supported by pharmacists in their duties to compound, dispense and sell medicinal products that patients need, to provide advice on their proper use and possible adverse effects and, if needed, to design a personalised pharmaceutical plans, as prescription assistance software and dispensing assistance software evolve.

Amendment 469 #

Proposal for a directive
Article 63 – paragraph 7 a (new)

7 a. The competent authority of the Member State or, where appropriate, the Agency, shall supervise the technology providing access to the electronic version of the package leaflet, ensuring compliance with paragraph 7. The competent authority of the Member State shall decide on the means of storage and access to the electronic version of the prospectus which shall be available through the national web portals and the web portal of the European Agency for Medicinal product within the meaning of Article 102(1). In addition to the measures specified in paragraph 2, for medicinal products included in the list referred to in Article 112 a of [revised Regulation (EC) No 726/2004], the following additional declaration shall be included: "This drug is subject to additional monitoring". This reference shall be preceded by the symbol referred to in Article 112 bis and followed by a standard explanatory phrase.

Amendment 47 #

Proposal for a directive
Recital 18 a (new)

(18 a) Hospital exemption pathway is a crucial way of providing patients with access to innovative and affordable treatments that may not be available through other channels. Any limitations to this pathway should avoided, but only based on efficacy, quality and safety criteria, without time restrictions or restrictions on quantities. Competent authorities must guarantee that the authorisation of other products through the centralized procedure does not adversely affect the activities and responsibilities of developers functioning under the hospital exemption. The Agency, as well as competent authorities at the national level, should support academic institutions and other non-profit entities through the requirements of the hospital exemption clause and, when adequate, should provide guidance through centralised marketing authorisation procedure.

Amendment 470 #

Proposal for a directive
Article 63 – paragraph 7 a (new)

7 a. The Agency shall develop a system providing public access to the electronic version of package leaflets. By ... [12 months after the date of entry into force of this Directive], the system shall be accessible in all Member States.

Amendment 471 #

Proposal for a directive
Article 64 – paragraph 2 – subparagraph 1 (new)

In addition to the measures specified in paragraph 2, for medicinal products included in the list referred to in Article 112a of the [revised Regulation (EC) No 726/2004], the following additional statement shall be included ‘This medicinal product is subject to additional monitoring’. This statement shall be preceded by the symbol referred to in Article 112a and followed by a standardised explanatory sentence.

Amendment 472 #

Proposal for a directive
Article 64 – paragraph 3

3. ~~The package leaflet shall reflect~~In addition to the measures specified in paragraph 2, for medicinal products included in the list referred to in Article 112a of the [re~~sults of consultations with target patient groups to ensure that it is legible, clear and easy to use~~vised Regulation (EC) No 726/2004], the following additional statement shall be included ‘This medicinal product is subject to additional monitoring’. This statement shall be preceded by the symbol referred to in the aforementioned Article and followed by a standardised explanatory sentence that is appropriate, clearly legible, and easy to understand by users.

Amendment 473 #

Proposal for a directive
Article 64 – paragraph 3

3. ~~The package leaflet shall reflect the results of~~Following a consultations with target patient groups ~~to ensure that it is legible, clear and easy to use~~and other relevant stakeholders, the Commission shall adopt guidelines to ensure that the package leaflet is legible, clear and easy to use as well as on the need for and modalities of further user testing.

Amendment 474 #

Proposal for a directive
Article 66 – paragraph 2 – point a a (new)

(a a) the strength of the medicinal product;

Amendment 475 #

Proposal for a directive
Article 66 – paragraph 3 – point a

(a) the name of the medicinal product and~~, if necessary, the route of administr~~ the international non-proprietary name (INN) either in the local language or in Lation;

Amendment 476 #

Proposal for a directive
Article 66 – paragraph 3 – point a a (new)

(a a) Pharmaceutical form

Amendment 477 #

Proposal for a directive
Article 66 – paragraph 3 – point b

(b) the ~~method~~route of administration;

Amendment 478 #

Proposal for a directive
Article 66 a (new)

Article66a Labelling of blister packs in case of unit dose dispensing Wherever a Member State imposes dispensing of medicinal products by pharmacists, to fight against antibioresistance, or for any other reason, it ensures that the doses are packaged and labelled on unit dose pre-cut blisters. Each per-cut blister shall include the following labelling particulars : (a) the name of the medicinal product; (b) the strength of the medicinal product; (c) a data matrix barcode in which the following information is encoded: (i) the Global Trading Index Number (GTIN); (ii) the expiry date; (iii) the batch number. Member States shall promote the use of unit dose pre-cut blisters in hospital environment and, progressively, in dispensing pharmacies, when necessary.

Amendment 479 #

Proposal for a directive
Article 67 – paragraph 1 – subparagraph 2

Medicinal products not subject to prescription shall not bear the safety features referred to in Annex IV, unless, by way of exception, they have been listed in accordance with the procedure referred to in paragraph 2, second subparagraph, point (b), or where the marketing authorisation holder chooses to do so voluntarily.

Amendment 48 #

Proposal for a directive
Recital 18 a (new)

(18 a) The Agency should establish a programme with the objective to guide academic and other not-for-profit entities through the centralised marketing authorisation procedure. That programme should be able to draw on results of the European Medicines Agency (EMA) pilot programme for enhanced support to academic and non-profit developers of advanced therapy medicinal products, started in September 2022.

Amendment 480 #

Proposal for a directive
Article 67 – paragraph 6

6. Member States may, for the purposes of reimbursement, pharmacovigilance, pharmacoepidemiology, shortage monitoring or prevention, for implementation of Article 56(3), for compliance with enforcement of distributor public service obligations, making product information available electronically, or for data protection prolongation for market launch use the information contained in the repositories system referred to paragraph 2, second subparagraph, point (e).

Amendment 481 #

Proposal for a directive
Article 67 – paragraph 6

6. Member States may, for the purposes of reimbursement, pharmacovigilance, and pharmaco- epidemiology ~~or for data protection prolongation for market launch~~, use the information contained in the repositor~~ies~~y system referred to ~~paragraph 2, second subparagraph, point (~~in the second subparagraph of paragraph 2, letter e).

Amendment 482 #

Proposal for a directive
Article 67 – paragraph 6

6. Member States may, for the purposes of reimbursement, pharmacovigilance, pharmacoepidemiology or ~~for data protection prolongation for market launch~~monitoring of medicine shortages use the information contained in the repositories system referred to paragraph 2, second subparagraph, point (e).

Amendment 483 #

Proposal for a directive
Article 67 – paragraph 7 a (new)

7 a. For the purpose of patient safety, Member States may decide that medicinal products imported or distributed in parallel shall be repackaged in new outer packaging

Amendment 484 #

Proposal for a directive
Article 67 – paragraph 7 a (new)

7 a. For the purpose of patient safety, Member States may decide that medicinal products imported or distributed in parallel shall be repackaged in new outer packaging.

Amendment 485 #

Proposal for a directive
Article 69 – paragraph 1

1. The marketing authorisation holder shall ensure availability of educational material to healthcare professionals, ~~including through medical sales representatives as referred to in Article 175(1), point (c)~~, regarding the appropriate use of diagnostic tools, testing or other diagnostic approaches related to antimicrobial- resistant pathogens, that may inform on the use of the antimicrobial. As referred to in paragraph 1 (b) of Article 17, the competent authority responsible for approving the antimicrobial shall review the content of the educational material and validate the final version.

Amendment 486 #

Proposal for a directive
Article 69 – paragraph 2 – subparagraph 2

Member States ~~may decid~~shall ensure that the awareness card is~~hall be~~ made available in paper format or both in paper format and electronically~~, or both~~. In the absence of such specific rules in a Member State, an awareness card in paper format shall be included in the packaging of an antimicrobial.

Amendment 487 #

Proposal for a directive
Article 69 – paragraph 2 – subparagraph 2

Member States ~~may decid~~shall ensure that the awareness card is~~hall be~~ made available in both in paper format orand electronically~~, or both~~. In the absence of such specific rules in a Member State, an awareness card in paper format shall be included in the packaging of an antimicrobial.

Amendment 488 #

Proposal for a directive
Article 69 – paragraph 3

3. The text of the awareness card shall be standarded by the Agency and shall be aligned with Annex VI.

Amendment 489 #

Proposal for a directive
Article 69 – paragraph 3 – subparagraph 1 (new)

Members States shall introduce appropriate disposal systems for antimicrobials in the community setting, and inform the general public on the correct disposal methods for antimicrobial.

Amendment 49 #

Proposal for a directive
Recital 18 a (new)

Amendment 490 #

Proposal for a directive
Article 69 a (new)

Article69a The marketing authorization holder may add to the fixed-dose combination medicinal product's packaging an "awareness card" in digital or paper form. This card shall inform patients about the importance therapeutic adherence and available support for adherence in their Member State. The content of the awareness card should comply with Annex VI.

Amendment 491 #

Proposal for a directive
Article 74 – paragraph 4

4. TBased on any of the grounds listed in Article 75, the competent authorities of the Member State may also grant a full or partial exemption to the obligation that the labelling and the package leaflet must be in an official language or official languages of the Member State where ~~the~~a medicinal product is placed on the market, as specified, for the purposes of this Directive, by that Member State. For the purpose of multi-language packages, Member States may allow the use on the labelling and package leaflet of an official language of the Union that is commonly understood in the Member States where the multi-language package is marketedWhen a competent authority grants an exemption to the language requirements that apply to the paper package leaflet, the patients’ right to a printed copy of the document in the official language or official languages of the Member State should be guaranteed upon request and free of charge.

Amendment 492 #

Proposal for a directive
Article 74 – paragraph 4 – subparagraph 1 (new)

The offical language obligation as mentioned in paragraph 1 shall not apply when the medicinal product is not intended to be delivered to the patient for slef-administration.In this case a single appropriate language could be used.

Amendment 493 #

Proposal for a directive
Article 74 – paragraph 4 a (new)

4 a. Where a competent authority grants a full or partial exemption to the language requirements in accordance with paragraph 4, patients' right to a copy of the document in the official language of the Member State shall be guaranteed upon request and free of charge.

Amendment 494 #

Proposal for a directive
Article 74 – paragraph 4 a (new)

4 a. By derogation, when dully justified (eg. health emergencies), the official language obligation as mentioned in Article 74.1 shall not apply when the product is not intended to be delivered to the patient for self-administration.

Amendment 495 #

Proposal for a directive
Article 74 – paragraph 4 a (new)

4 a. The official language obligation as mentioned in Article 74.1 shall not apply when the product is not intended to be delivered to the patient for self- administration. In this case a single appropriate language can be used.

Amendment 496 #

Proposal for a directive
Article 80 – title

Regulatory data ~~and~~, market protection and market exclusivity

Amendment 497 #

Proposal for a directive
Article 80 – paragraph 2 a (new)

2 a. The period referred to in parragraph 2 shall be extended by an addittional period of one year, where the marketing authorization holder obtains, during the data protection period referred to in Article 81, an authorisation for an additional therapeutic indication for which the marketing authorisation holder has demonstrated, with supporting data, a significant clinical benefit in comparison with existing therapies. This extension may only be granted once.

Amendment 498 #

Proposal for a directive
Article 80 – paragraph 4

4. By way of derogation from the paragraphs 1 and 2, when a compulsory licence has been granted by a relevant authority in the Union to a party to ~~address a~~safeguard public health ~~emergency~~, the data and market protection as well as the market exclusivity referred to in Article 71 of [revised Regulation (EC) No 726/2004], shall be suspended with regard to that party insofar as the compulsory licence requires, and during the duration period of the compulsory licence. Relevant authorities in the Union shall also be able to reduce the duration of data protection, market protection, or market exclusivity for medicinal products that are not protected by a patent or a supplementary protection certificate, where necessary to safeguard public health.

Amendment 499 #

Proposal for a directive
Article 80 – paragraph 4

4. By way of derogation from the paragraphs 1 and 2, when a compulsory licence has been granted by the final decision of a relevant authority in the Union to a party to address a public health emergency, the data and market protection shall be suspended with regard to that party insofar as the compulsory licencse requires, ~~and during the duration period of the compulsory licence~~for the indication relevant to the public health emergency, only for the duration period of the compulsory licence and, where relevant, only in the Member State(s) where the compulsory license is granted. The marketing authorization holder of the medicinal product for which the data and market protection are suspended shall be notified by the relevant competent authority on or before the date such suspension takes effect.

Amendment 50 #

Proposal for a directive
Recital 18 a (new)

(18 a) The Agency ought to create a program aimed at assisting academic institutions and non-profit organizations in navigating the centralized marketing authorization process. This initiative should be informed by insights from the EMA's pilot program that began in September 2022, which provided specialized support to academic and non- profit developers of advanced therapy medicinal products.

Amendment 500 #

Proposal for a directive
Article 80 – paragraph 4

4. By way of derogation from the paragraphs 1 and 2, when a compulsory licence has been granted by ~~a relevant authority in the Union~~the final decision of National Parliaments to a party to address a public health emergency, the data and market protection shall be suspended with regard to that party insofar as the compulsory licencse requires, ~~and during the duration period of the compulsory licence~~for the indication relevant to the public health emergency, only for the duration period of the compulsory licence and, where relevant, only in the Member State(s) where the compulsory license is granted. The marketing authorization holder of the medicinal product for which the data and market protection are suspended shall be notified by the relevant competent authority before the date such suspension takes effect.

Amendment 501 #

Proposal for a directive
Article 80 – paragraph 4

4. By way of derogation from the paragraphs 1 and 2, when a compulsory licence has been granted by the ultimate decision of a relevant authority in the Union to a party to address a public health emergency, the data and market protection shall be suspended with regard to that party insofar as the compulsory licencse requires, ~~and during the duration period of the compulsory licence~~for the indication pertaining to the public health emergency, solely during the compulsory license's period, and, if applicable, exclusively within the Member State where the compulsory license is authorized. The competent authority relevant to the suspension of data and market protection shall notify the marketing authorization holder of the medicinal product prior to the effective date of such suspension.

Amendment 502 #

Nicola DANTI

Proposal for a directive
Article 80 – paragraph 4

4. By way of derogation from the paragraphs 1 and 2, when a compulsory licence has been granted by a relevant authority in the Union to a party to address a public health emergency, the data and market protection shall be suspended with regard to that party insofar as the compulsory licence requires, and ~~during~~exclusively for the duration period of the compulsory licence and, where applicable, only in the Member States where the compulsory licence is granted.

Amendment 503 #

Proposal for a directive
Article 80 – paragraph 4

4. By way of derogation from the paragraphs 1 and 2, when a compulsory licence has been granted by a relevant authority in the Union to a party to address a public health emergency, the data and market protection shall be suspended for the indication that is relevant to the public health emergency with regard to that party insofar as the compulsory licence requires, in the relevant Member States and during the duration period of the compulsory licence.

Amendment 504 #

Proposal for a directive
Article 80 – paragraph 4 a (new)

4 a. The marketing authorisation holder for the medicinal product for which a compulsory licence has been granted shall be informed of the decision without delay.

Amendment 505 #

Proposal for a directive
Article 81 – paragraph 1

1. The regulatory data protection period shall be ~~six~~nine years from the date when the marketing authorisation for that medicinal product was granted in accordance with Article 6(2). For marketing authorisations that belong to the same global marketing authorisation the period of data protection shall start from the date when the initial marketing authorisation was granted in the Union.

Amendment 506 #

Proposal for a directive
Article 81 – paragraph 1

Amendment 507 #

Proposal for a directive
Article 81 – paragraph 1

1. The regulatory data protection period shall be ~~six~~four years from the date when the marketing authorisation for that medicinal product was granted in accordance with Article 6(2). For marketing authorisations that belong to the same global marketing authorisation the period of data protection shall start from the date when the initial marketing authorisation was granted in the Union.

Amendment 508 #

Proposal for a directive
Article 81 – paragraph 1

Amendment 509 #

Proposal for a directive
Article 81 – paragraph 1

Amendment 51 #

Proposal for a directive
Recital 19

(19) This Directive should be without prejudice to the provisions of Council Directive 2013/59/Euratom41 , including with respect to justification and optimisation of protection of patients and other individuals subject to medical exposure to ionising radiation. In the case of radiopharmaceuticals used for therapy, marketing authorisations, posology and administration rules have to notably respect that Directive’s requirements that exposures of target volumes are to be individually planned, and their delivery appropriately verified taking into account that doses to non-target volumes and tissues are to be as low as reasonably achievable and consistent with the intended therapeutic purpose of the exposure.. _________________ 41 Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and 2003/122/Euratom (OJ L 13, 17.1.2014, p. 1).

Amendment 510 #

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – introductory part

Subject to a scientific evaluation by the relevant competent authority, the data protection period referred to in paragraph 1 shall be prolonged by: 24 months where

Amendment 511 #

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point a

(a) 24 months, where the marketing authorisation holder demonstrates that the conditions referred to in Article 82(1) are fulfilled within two years, from the date when the marketing authorisation was granted or, within three years from that date for any of the following entities: (i) SMEs within the meaning of Commission Recommendation 2003/361/EC; (ii) entities not engaged in an economic activity (‘not-for-profit entity’); and (iii) undertakings that, by the time of granting of a marketing authorisation, have received not more than five centralised marketing authorisations for the undertaking concerned or, in the case of an undertaking belonging to a group, for the group of which it is part, since the establishment of the undertaking or the group, whichever is earliest.deleted

Amendment 512 #

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point a

Amendment 513 #

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point a

Amendment 514 #

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point a

Amendment 515 #

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point a – introductory part

(a) ~~24 months, where~~ the marketing authorisation ~~holder demonst~~is grantes that the conditions referred to in Article 82(1) are fulfilled within two years, from the date when the marketing authorisation was granted or, within three years from that date for any of the following entities:d in relation to a disease in respect of which there is no medicinal product authorised in the Union, or

Amendment 516 #

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point a – introductory part

(a) 2436 months, where the marketing authorisation holder demonstrates that the conditions referred to in Article 82(1) are fulfilled within two years, from the date when the marketing authorisation was granted or, within ~~three~~four years from that date for any of the following entities:

Amendment 517 #

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point a – point i

~~(i) SMEs within the meaning of Commission Recommendation 2003/361/EC;~~deleted

Amendment 518 #

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point a – point ii

~~(ii) entities not engaged in an economic activity (‘not-for-profit entity’); an~~deleted

Amendment 519 #

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point a – point iii

(iii) undertakings that, by the time of granting of a marketing authorisation, have received not more than five centralised marketing authorisations for the undertaking concerned or, in the case of an undertaking belonging to a group, for the group of which it is part, since the establishment of the undertaking or the group, whichever is earliest.deleted

Amendment 52 #

Proposal for a directive
Recital 26

(26) In order to reward the compliance with all the measures included in the agreed paediatric investigation plan, for products covered by a supplementary protection certificate, if relevant information on the results of the studies conducted is included in the product information, a reward should be granted in the form of a ~~six month~~n extension of the supplementary protection certificate created by [Regulation (EC) No 469/2009 of the European Parliament and of the Council42 - OP please replace reference by new instrument when adopted]. _________________ 42 Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (OJ L 152, 16.6.2009, p. 10).

Amendment 520 #

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point a a (new)

(a a) in case of the marketing authorisation is granted in relation to a disease in respect of which there has already been a medicinal product authorised in the Union, the initial marketing authorisation application use a relevant and evidence-based comparator in accordance with scientific advice provided by the Agency

Amendment 521 #

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point a a (new)

(a a) 12 months, where the marketing authorisation holder demonstrates that the preclinical development of the medicinal product has been done within the Union as referred to in Article 82a;

Amendment 522 #

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point b

(b) six months, where the marketing authorisation applicant demonstrates at the time of the initial marketing authorisation application that the medicinal product addresses an unmet medical need as referred to in Article 83;deleted

Amendment 523 #

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point b

(b) ~~six~~eighteen months, where the marketing authorisation applicant demonstrates at the time of the initial marketing authorisation application that the medicinal product addresses an unmet medical need as referred to in Article 83;

Amendment 524 #

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point b

(b) ~~six~~12 months, where the marketing authorisation applicant demonstrates at the time of the initial marketing authorisation application that the medicinal product addresses an unmet medical need as referred to in Article 83;

Amendment 525 #

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point b

Amendment 526 #

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point c

(c) six months, for medicinal products containing a new active substance, where the clinical trials supporting the initial marketing authorisation application use a relevant and evidence-based comparator in accordance with scientific advice provided by the Agency;deleted

Amendment 527 #

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point c

Amendment 528 #

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point c

(c) ~~six~~12 months, for medicinal products containing a new active substance, where the clinical trials supporting the initial marketing authorisation application use a relevant and evidence-based comparator in accordance with scientific advice provided by the Agency in consultation with health technology assessment authorities, set out in a delegated act in accord with article 215;

Amendment 529 #

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point c

(c) ~~six months, for medicinal products containing a new active substance, where the clinical trials supporting the initial~~A period of twelve months, during which the applicant for marketing authorization shows, either at the point of the first application for marketing authoriszation ~~application use a relevant and evidence-based comparator in accordance with scientific advice provided by the Agency;~~or upon modification, that the pharmaceutical product fulfills a previously unaddressed healthcare necessity in at least one of its uses, as mentioned in Article 83.

Amendment 53 #

Proposal for a directive
Recital 27

Amendment 530 #

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point c

(c) six months, for medicinal products ~~containing a new active substance,~~ where the clinical trials supporting the ~~initial~~ marketing authorisation application use a relevant and evidence-based comparator in accordance with scientific advice provided by the Agency;

Amendment 531 #

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point d

(d) 12 months, where the marketing authorisation holder obtains, during the data protection period, an authorisation for an additional therapeutic indication for which the marketing authorisation holder has demonstrated, with supporting data, a significant clinical benefit in comparison with existing therapies.deleted

Amendment 532 #

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point d

(d) 12six months, where the marketing authorisation holder obtains, during the data protection period, an authorisation for an additional therapeutic indication for which the marketing authorisation holder has demonstrated, with supporting data, a significant clinical benefit in comparison with existing therapies.

Amendment 533 #

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point d a (new)

(d a) 12 months, where the applicant for marketing authorisation undertakes to facilitate the formation of public-private partnerships, centers of excellence, and bioclusters, thereby expediting the research and development of a new medicinal product.

Amendment 534 #

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point d a (new)

(d a) 12 months, where the marketing authorisation applicant has submitted a clinical trial application for a new medicinal product within the territory of the EU.

Amendment 535 #

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point d b (new)

(d b) 12 months, for new medicinal products developed, produced, used and diposed in full respect of the scientific guidelines of the environmental risk assessment of medicinal products for human use.

Amendment 536 #

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point d b (new)

(d b) 12 months, for medicinal products containing critical active pharmaceutical ingredients produced in the Union or the EEA.

Amendment 537 #

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point d c (new)

(d c) 12 months, where the marketing authorisation applicant has committed to support the establishment of public- private partnerships, University Hospital Institutes, centres of excellence and bioclusters to accelerate research and development of a new medicinal product.

Amendment 538 #

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point d d (new)

(d d) 12 months, for medicinal products containing critical active pharmaceutical ingredients produced within the EU.

Amendment 539 #

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 2

In the case of a conditional marketing authorisation granted in accordance with Article 19 of [revised Regulation (EC) No 726/2004] the prolongation referred to in the first subparagraph, point (b), shall only apply if, within ~~four~~three years of the granting of the conditional marketing authorisation, the medicinal product has been granted a marketing authorisation in accordance with Article 19(7) of [revised Regulation (EC) No 726/2004.

Amendment 54 #

Proposal for a directive
Recital 31

(31) Directive 2010/63/EU of the European Parliament and of the Council43[1] lays down provisions on the protection of animals used for scientific purposes based on the principles of replacement, reduction and refinement. Any study involving the use of animals, which provides essential information on the quality, safety and efficacy of a medicinal product, should take into account those principles of replacement, reduction and refinement, where they concern the care and use of live animals for scientific purposes, and should be undertaken as a last resort and be optimised in order to provide the most satisfactory results whilst using the minimum number of animals. The marketing authorisation applicant should not carry out animal tests in case scientifically satisfactory non-animal testing methods are available. Where scientifically satisfactory non-animal testing methods are not available, applicants that use animal testing should ensure that the principle of replacement, reduction and refinement of animal testing for scientific purposes has been with regard to any animal study conducted for the purpose of supporting the application. The procedures of such testing should be designed to avoid causing pain, suffering, distress or lasting harm to animals and should follow the available EMA and ICH guidelines. In particular, the marketing authorisation applicant and the marketing authorisation holder should take into account the principles laid down in Directive 2010/63/EU, including, where possible, use new approach methodologies in place of animal testing. These can include but are not limited to: in vitro models, such as microphysiological systems including organ-on-chips, (2D and 3D-) cell culture models, organoids and human stem cells-based models; in silico tools or read-across models. ~~_________________ 43 Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).~~

Amendment 540 #

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 2

In the case of a conditional marketing authorisation granted in accordance with Article 19 of [revised Regulation (EC) No 726/2004] the prolongation referred to in the first subparagraph, point (b), shall only apply if, ~~within four years of the granting of the conditional marketing authorisa~~throughout the period of regulatory data protection, the medicinal product has been granted a marketing authorisation in accordance with Article 19(7) of [revised Regulation (EC) No 726/2004.

Amendment 541 #

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 3

~~The prolongation referred to in the first subparagraph, point (d), may only be granted once.~~deleted

Amendment 542 #

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 3

The prolongation referred to in the first subparagraph, point (d), may only be granted ontwice.

Amendment 543 #

Proposal for a directive
Article 81 – paragraph 3

3. The Agency shall set the scientific guidelines referred to in paragraph 2, point (c), on criteria for proposing a comparator for a clinical trial, taking into account the results of the consultation of the Commission and the authorities or bodies involved in the mechanism of consultation referred to in Article 162 of [revised Regulation (EC) No 726/2004].deleted

Amendment 544 #

Proposal for a directive
Article 81 – paragraph 3 a (new)

3 a. All product-specific regulatory protection periods shall be made publicly available in the medicine repository on the website of the national competent authority and the Agency.

Amendment 545 #

Proposal for a directive
Article 82

~~[...]~~deleted

Amendment 546 #

Proposal for a directive
Article 82

~~[...]~~deleted

Amendment 547 #

Proposal for a directive
Article 82

~~[...]~~deleted

Amendment 548 #

Proposal for a directive
Article 82

~~[...]~~deleted

Amendment 549 #

Proposal for a directive
Article 82 – paragraph 1 – subparagraph 1

The prolongation of the data protection period referred to in Article 81(2), first subparagraph, point (a), shall only be granted to medicinal products if they are released and continuously supplied into the supply chain in a sufficient quantity and in the presentations necessary to cover the needs of the patients in the Member States in which the marketing authorisation is valid.deleted

Amendment 55 #

Proposal for a directive
Recital 39

Amendment 550 #

Proposal for a directive
Article 82 – paragraph 1 – subparagraph 1

The prolongation of the data protection period referred to in Article 81(2), first subparagraph, point (a), shall only be granted to medicinal products if they are ~~released and continuously supplied into the supply chain in a sufficient quantity and in the presentations necessary to cover the needs of the patients~~made available to patients or prescribing doctors who requested the medicinal product, in the Member States in which the marketing authorisation is valid.

Amendment 551 #

Proposal for a directive
Article 82 – paragraph 1 – subparagraph 2

Amendment 552 #

Proposal for a directive
Article 82 – paragraph 1 – subparagraph 2

The prolongation referred to in the first subparagraph shall apply to medicinal products that have been granted a centralised marketing authorisation, as referred to in Article 5 or that have been granted a national marketing authorisation through the decentralised procedure, ~~as referred to in Chapter III, Section 3~~covering all the Member States entered into the decentralised procedure, as referred to in Chapter III, Section 3. The prolongation of the data protection period in regards medicinal products which obtained marketing authorisation in accordance with Articles 5 and 6 of [revised Regulation (EC) No 726/2004] as referred to in Article 81(2), first subparagraph, point (a), shall apply to medicinal products if they are released and continuously supplied into the supply chain in a sufficient quantity and in the presentations necessary to cover the needs of the patients in the Member States concerned in which the marketing authorisation is valid.

Amendment 553 #

Proposal for a directive
Article 82 – paragraph 2

2. To receive a prolongation referred to in Article 81(2), first subparagraph, point (a), the marketing authorisation holder shall apply for a variation of the relevant marketing authorisation. The application for a variation shall be submitted between 34 and 36 months after the date when the initial marketing authorisation was granted, or for entities referred to in Article 81(2), first subparagraph, point (a), between 46 and 48 months, after that date. The application for a variation shall contain documentation from the Member States in which the marketing authorisation is valid. Such documentation shall: (a) confirm that the conditions set out in paragraph 1 have been satisfied in their territory; or (b) waive the conditions set out in paragraph 1 in their territory for the purpose of the prolongation. Positive decisions adopted in accordance with Articles 2 and 6 of Council Directive 89/105/EEC74 shall be considered equivalent to a confirmation referred to in the third subparagraph, point (a). _________________ 74 Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems (OJ L 40, 11.2.1989, p. 8).deleted

Amendment 554 #

Proposal for a directive
Article 82 – paragraph 2 – subparagraph 3 – introductory part

The application for a variation shall contain documentation from the Member States competent authority in which the marketing authorisation is valid. Such documentation shall:

Amendment 555 #

Proposal for a directive
Article 82 – paragraph 2 – subparagraph 3 a (new)

Where the conditions set out in paragraph 1 have not been fully satisified due to duly justified circumstances out of the control of the marketing authoristisation holder the Member State shall confirm the conditions in paragraph 1 have been satisified in their territory, subject to guarantee that these conditions will be fulfilled in an acceptable period of time agreed between the marketing authorisation holder and the Member State.

Amendment 556 #

Proposal for a directive
Article 82 – paragraph 2 – subparagraph 4

Positive decisions adopted in accordance with Articles 2 and 6 of Council Directive 89/105/EEC74[1] shall be considered equivalent to a confirmation referred to in the third subparagraph, point (a)~~. _________________ 74 Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusi~~, as long as the medicinal product is effectively con tin ~~the scope of national health insurance systems (OJ L 40, 11.2.1989, p. 8)~~uously supplied on the market.

Amendment 557 #

Proposal for a directive
Article 82 – paragraph 3

3. To receive the documentation referred to in paragraph 2, third subparagraph, the marketing authorisation holder shall make a request to the relevant Member State. Within 60 days from the request of the marketing authorisation holder, the Member State shall issue a confirmation of compliance or, a reasoned statement of non- compliance or alternatively provide a statement of non-objection to prolong the period of regulatory data protection pursuant to this Article.deleted

Amendment 558 #

Proposal for a directive
Article 82 – paragraph 3

3. To receive the documentation referred to in paragraph 2, third subparagraph, the marketing authorisation holder shall make a request to the relevant Member State competent authority. Within 60 days from the request of the marketing authorisation holder, the ~~Member State~~competent authority shall issue a confirmation of compliance or, a reasoned statement of non-compliance based on objective and veriafable criteria, or alternatively provide a statement of non- objection to prolong the period of regulatory data protection pursuant to this Article. When a competent authority issues a justified statement of non-fulfilment, it must detail the requisite actions that would allow the conditions to be met and enable the resubmission of a request for confirmation of fulfilment within a reasonable e time frame. The authority shall subsequently provide a confirmation of fulfilment or a reasoned statement of non-fulfilment within two months from the date of the resubmission request.

Amendment 559 #

Proposal for a directive
Article 82 – paragraph 3 a (new)

3 a. The Commission is tasked with creating a mediation mechanism via implementing acts. This mechanism will support dialogue between developers and Member States to address disputes arising from a declaration of non-compliance by a Member State after earnest negotiations, or due to negotiation delays. Within this framework, there will be an option for a Commission decision that can supersede the documents referred to in paragraph 2.

Amendment 56 #

Proposal for a directive
Recital 41

Amendment 560 #

Proposal for a directive
Article 82 – paragraph 4

4. In cases where a Member State has not replied to the application of the marketing authorisation holder within the deadline referred to in paragraph 3, it shall be considered that a statement of non-objection has been provided. For medicinal products granted a centralised marketing authorisation the Commission shall vary the marketing authorisation pursuant to Article 47 of [revised Regulation (EC) No 726/2004] to prolong the data protection period. For medicinal products granted a marketing authorisation in accordance with the decentralised procedure, the competent authorities of the Member States shall vary the marketing authorisation pursuant to Article 92 to prolong the data protection period.deleted

Amendment 561 #

Proposal for a directive
Article 82 – paragraph 4 – subparagraph 1

In cases where a Member State has not replied to the application of the marketing authorisation holder within the deadline referred to in paragraph 3, it shall be considered that a statement of non- objection has been provided. Should a Member State fail to adhere to the deadlines specified in Articles 2 and 6 of Directive 89/105/EEC, the conditions outlined in paragraph 1 will cease to be applicable within that Member State's jurisdiction with regard to the extension period.

Amendment 562 #

Proposal for a directive
Article 82 – paragraph 5

5. Member States representatives may request the Commission to discuss issues related to the practical application of this Article in the Committee established by Council Decision 75/320/EEC75 (‘Pharmaceutical Committee’). The Commission may invite bodies responsible for health technology assessment as referred to in Regulation (EU) 2021/2282 or national bodies responsible for pricing and reimbursement, as required, to participate in the deliberations of the Pharmaceutical Committee. _________________ 75 Council Decision of 20 May 1975 setting up a pharmaceutical committee (OJ L 147, 9.6.1975, p. 23).deleted

Amendment 563 #

Proposal for a directive
Article 82 – paragraph 5

5. The Commission shall check the application referred to in paragraph 2, subparagraph 2, and grant approval or rejection to the prolongation referred to in Article 81(2). In those cases in which one or more Member States have issued a reasoned statement for refusal of the prolongation, the Commission shall ensure that the reasons described are justified and substantiated. The Commission shall ensure that Marketing Authorisation Holders are not unduly prevented from receiving the incentives for actions beyond their control. Member States representatives may request the Commission to discuss issues related to the practical application of this Article in the Committee established by Council Decision 75/320/EEC75 (‘Pharmaceutical Committee’). The Commission may invite bodies responsible for health technology assessment as referred to in Regulation (EU) 2021/2282 or national bodies responsible for pricing and reimbursement, as required, to participate in the deliberations of the Pharmaceutical Committee. ~~_________________ 75 Council Decision of 20 May 1975 setting up a pharmaceutical committee (OJ L 147, 9.6.1975, p. 23).~~

Amendment 564 #

Proposal for a directive
Article 82 – paragraph 5 a (new)

5 a. The Commission shall make publicly available any information related to the decision taken on the grant or refusal of the prolongation of the data exclusivity period

Amendment 565 #

Proposal for a directive
Article 82 – paragraph 5 b (new)

5 b. Following the extension of the regulatory data protection as referred to in Article 81(2), the medicinal products should be released and continuously supplied into the supply chain in a sufficient quantity and in the presentations necessary to cover the needs of the patients in the Member States in which the marketing authorisation is valid, for the entire duration of the protection time. Where the marketing authorisation holder fails to comply with this obligation, penalties should be established including the revocation of the extended regulatory protection period.

Amendment 566 #

Proposal for a directive
Article 82 – paragraph 6

6. The Commission, based on the experience of Member States and relevant stakeholders, may adopt implementing measures relating to the procedural aspects outlined in this Article and regarding the conditions mentioned in paragraph 1. Those implementing acts shall be adopted in accordance with the procedure referred to in Article 214(2).deleted

Amendment 567 #

Proposal for a directive
Article 82 – paragraph 6

6. The Commission, based on the experience of Member States and relevant stakeholders, may adopt implementing measures relating to the procedural aspects outlined in this Article and regarding the conditions mentioned in paragraph 1. ~~Those implementing acts shall be adopted in accordance with the procedure referred to in Article 214(2).~~

Amendment 568 #

Proposal for a directive
Article 82 – paragraph 6

6. The Commission, based on the experience of Member States and relevant stakeholders, may adopt ~~implementing~~delegated measures relating to the procedural aspects outlined in this Article and regarding the conditions mentioned in paragraph 1. Those ~~implementing~~delegated acts shall be adopted in accordance with the procedure referred to in Article 21~~4(2)~~5.

Amendment 569 #

Proposal for a directive
Article 82 – paragraph 6 a (new)

6 a. The Commission, via implementing acts, shall compile a list of products that, either due to their nature or other duly justified and accredited limiting factors or technical specificites, shall be exempt from the stipulations outlined in Article 81(2), point (a), and within this same Article 81, paragraphs 1 to 7. These specified products will be granted an automatic extension of the data protection period for 12 months, as detailed in Article 81(2), point (a). The adoption of these implementing acts shall proceed in line with the examination procedure described in Article 214(2) and (3).

Amendment 57 #

Proposal for a directive
Recital 44

(44) As regards access to medicinal products, previous amendments to the Union pharmaceutical legislation have addressed this issue by providing for accelerated assessment of marketing authorisation applications or by allowing conditional marketing authorisation for medicinal products for unmet medical need. While these measures accelerated the authorisation of innovative and promising therapies, these medicinal products do not always reach the patient and patients in the Union still have different levels of access to medicinal products. Patient access to medicinal products depends on many factors. Marketing authorisation holders are not obliged to market a medicinal product in all Member States; they may decide not to market their medicinal products in, or withdraw them from, one or more Member States, often due to profitability considerations. National pricing and reimbursement policies, the size of the population, the organisation of health systems, and national administrative procedures are other factors influencing market launch and patient access.

Amendment 570 #

Proposal for a directive
Article 82 a (new)

Article82a Pricing and refund request 1. Within an agreed period following the granting of a marketing authorization, a Member State in which such authorization is valid may request the marketing authorization holder to submit an application for pricing and reimbursement. 2. Within that period following receipt of an application in accordance with paragraph 1, the marketing authorization holder shall submit an application for pricing and reimbursement in that Member State. By way of derogation from paragraph 2, the following entities may submit an application for pricing and reimbursement within an extended period of time from the date of receipt of the application from the Member State: (i) SMEs; (ii) entities not engaged in an economic activity ("non-profit entity"); and (iii) companies which, at the time the marketing authorization is granted, have not received more than seven centralized marketing authorizations for the company concerned or, in the case of a company belonging to a group, for the group of which it is a member, since the creation of the company or the group, whichever condition is met first. 3. The Commission shall, after consulting the Agency and relevant stakeholders, as patient’s representatives or MHAs, establish a list of products exempted from the conditions. Products shall be included in the list on the basis of relevant criteria, including cases where the administration of a medicinal product in the majority of Member States is impracticable, where the regulatory processes related to the application for pricing and reimbursement of a product are considered to be beyond the control of the marketing authorisation holder, or where for an orphan medicinal product or an advanced therapy medicinal product the product can be made available to patients without an application for pricing and reimbursement. 4. Time limits other than those set out in paragraphs 1 to 3 may apply if a Member State and a marketing authorization holder reach an agreement to that effect.

Amendment 571 #

Proposal for a directive
Article 82 a (new)

Article82a Prolongation of the data protection period for medicinal products developed within the Union 1. A regulatory data protection period of one year shall be granted for a medicinal product if the marketing authorisation holder can demonstrate that its preclinical development was perfomed in the Union, even if another independent legal entity performed those studies, in initial stages of development, before the marketing authorisation holder acquired it. 2. One year after the date of entering into force of this Directive [OP please insert the date =12 months after the date of entering into force of this Directive], the Commission shall publish a study on the most adecuate indicators to evaluate that the provision in paragraph 1 is met. When performing the study, the Commission shall prioritize those indicators that could bring better outcomes for the promotion of research and development within the Union, specially that performed in SMEs. 3. The Commission shall adopt delegated measures relating to the procedural aspects outlined in this Article and regarding the conditions mentioned in paragraph 1. Those delegated acts shall be adopted in accordance with the procedure referred to in Article 215. When setting up the conditions mentioned in paragraph 1, the Commission shall take into account the conclusions drawn from the study mentioned in paragraph 2.

Amendment 572 #

Proposal for a directive
Article 82 b (new)

Article82b Medication Access Notification System 1.The Commission, in collaboration with the Member States shall establish the electronic notification system electronic notification system ("Access to Medicinal Products to Medicinal Products") The Access to Medicinal Products Notification System shall be interoperable with other other Union data registers on medicinal products. medicinal products. 2. The marketing authorisation holder marketing authorisation holder shall use the notification system EU Access to Medicinal Products Notification System to report its compliance with the its compliance with the commitment set out in in Article 82a. 3. The Commission and Members States Medicament Agencies shall submit an evaluation report to the European European Parliament and the Council on the use use and functioning of the Notification System Medicinal Products within the EU.

Amendment 573 #

Proposal for a directive
Article 83 – paragraph 1 – introductory part

1. A medicinal product shall be considered as addressing an unmet medical need if at least one of its therapeutic indications relates to a progressive, life threatening or severely debilitating or chronic disease and the following conditions are met:

Amendment 574 #

Proposal for a directive
Article 83 – paragraph 1 – introductory part

1. A medicinal product shall be considered as addressing an unmet medical need if at least one of its therapeutic indications relates to a progressive, life threatening or, severely debilitating or chronic disease and the following conditions are met:

Amendment 575 #

Proposal for a directive
Article 83 – paragraph 1 – introductory part

Amendment 576 #

Proposal for a directive
Article 83 – paragraph 1 – introductory part

Amendment 577 #

Proposal for a directive
Article 83 – paragraph 1 – introductory part

1. A medicinal product shall be considered as addressing an unmet medical need if at least one of its therapeutic indications relates to a life threatening, chronic, or severely debilitating disease and the following conditions are met:

Amendment 578 #

Proposal for a directive
Article 83 – paragraph 1 – point a

(a) there is no medicinal product authorised in the Union for such disease, or, where despite medicinal products being authorised for such disease in the Union, the disease is associated with a remaining high morbidity or mortality; the product lessens the complexity or frequency of treatment or administration, or the profile of adverse reactions; the product enhances patients' quality of life;

Amendment 579 #

Proposal for a directive
Article 83 – paragraph 1 – point a

(a) there is no medicinal product ~~authorised in the Union~~, medical service or SoHO preparation authorised in the Member State or the Union or other therapeutic option available for such disease, or, where despite medicinal products being authorised or therapeutic options available for such disease in the Union, the disease is associated with a remaining high morbidity or mortality; and

Amendment 58 #

Proposal for a directive
Recital 45

(45) Addressing unequal patient access and affordability of medicinal products has become a key priority of the Pharmaceutical Strategy for Europe, as also highlighted by Council conclusions 45 and a resolution of the European Parliament 46 . Member States called for revised mechanisms and incentives for development of medicinal products tailored to the level of unmet medical need, while ensuring health system sustainability, patient access and availability of affordable medicinal products in all Member States. _________________ 45 Council conclusions on strengthening the balance in the pharmaceutical systems in the EU and its Member States, (OJ C, C/269, 23.07.2016, p. 31). Council Conclusions on Access to medicines and medical devices for a Stronger and Resilient EU, (2021/C 269 I/02). 46 European Parliament resolution of 2 March 2017 on EU options for improving access to medicine (2016/2057(INI)) Shortages of medicines, 2020/2071(INI)Puting in place tolls to evaluate access to medicines at a Union level is key to follow-up on the results achieved through incentives.

Amendment 580 #

Proposal for a directive
Article 83 – paragraph 1 – point a

(a) there is no medicinal product authorised in the Union for such disease, or, where despite medicinal products being authorised for such disease in the Union, a new form of administration leads to treatment of patients who previously had no access to the product or the disease is associated with a remaining high morbidity or mortality;

Amendment 581 #

Proposal for a directive
Article 83 – paragraph 1 – point a

(a) there is no medicinal product authorised in the Union for such disease, or, where despite medicinal products being authorised for such disease in the Union, the disease is associated with a remaining high morbidity ~~or mortality~~, high mortality or significant negative impact on quality of life;

Amendment 582 #

Proposal for a directive
Article 83 – paragraph 1 – point a

(a) there is no medicinal product authorised in the Union for such disease, or, where despite medicinal products being authorised for such disease in the Union, the disease is associated with a remaining ~~high~~ morbidity ~~or mortality~~, mortality or adversely impacts the quality of life;

Amendment 583 #

Proposal for a directive
Article 83 – paragraph 1 – point a

(a) there is no medicinal product authorised in the Union for such disease, or, where despite medicinal products being authorised for such disease in the Union, the disease is associated with a remaining ~~high~~, morbidity ~~or mortality~~, mortality or impacting the quality of life;

Amendment 584 #

Proposal for a directive
Article 83 – paragraph 1 – point a

Amendment 585 #

Proposal for a directive
Article 83 – paragraph 1 – point b

(b) the use of the medicinal product results in: (i) a meaningful reduction in disease morbidity or, mortality ~~for the relevant patient population~~, severity or long term side effects for the relevant patient population; or (ii) a meaningful positive impact on quality of life; or (iii) a meaningful delay of the onset of the disease or its complications.

Amendment 586 #

Proposal for a directive
Article 83 – paragraph 1 – point b

(b) the use of the medicinal product results in: (i) a meaningful reduction in disease morbidity or, mortality, severity or side effects for the relevant patient population; or (ii) a meaningful positive impact on quality of life; or (iii) a meaningful prevention, delay of the onset, or delay of progression of the disease or its complications.

Amendment 587 #

Proposal for a directive
Article 83 – paragraph 1 – point b

(b) the use of the medicinal product results in ~~a meaningful reduction in disease morbidity or mortality for the relevant patient population.~~:

Amendment 588 #

Proposal for a directive
Article 83 – paragraph 1 – point b

(b) the use of the medicinal product results in a meaningful reduction in disease morbidity or mortality for the relevant patient population or specific subpopulation.

Amendment 589 #

Proposal for a directive
Article 83 – paragraph 1 – point b

(b) the use of the medicinal product results in a meaningful reduction in disease morbidity or, mortality ~~for the relevant patient population.~~, severity or side effects

Amendment 59 #

Proposal for a directive
Recital 46 a (new)

(46 a) Member States apply diverse procedures and measures in the pricing and reimbursement of medicinal products. Those procedures and measures significantly affect access to medicinal products, especially with regard to the speed at which access is achieved. Likewise, Member States apply specific procedures and measures pertaining to the promotion of competition from generic and biosimilar medicinal products. Having regard to the competence of the Member States, and recognising the disparities which can be observed in access to medicines across the Union, the exchange of best practice among national competent authorities in that area should be given greater priority. In that regard, the Commission should play a distinct role in facilitating the exchange of best practices.

Amendment 590 #

Proposal for a directive
Article 83 – paragraph 1 – point b – point i (new)

i) a meaningful reduction in disease morbidity, mortality, severity or side effects for the relevant patient population; or

Amendment 591 #

Proposal for a directive
Article 83 – paragraph 1 – point b – point ii (new)

ii) a meaningful positive impact on quality of life; or

Amendment 592 #

Proposal for a directive
Article 83 – paragraph 1 – point b – point iii (new)

iii) a meaningful prevention, delay of the onset, or delay of progression of the disease or its complications.

Amendment 593 #

Proposal for a directive
Article 83 – paragraph 1 – point b a (new)

(b a) the use of the medical product significantly improves the quality of life;

Amendment 594 #

Proposal for a directive
Article 83 – paragraph 1 – point b b (new)

(b b) the use of the medical product contributes to meaningful prevention, delays the onset, or slows the progression of the disease and its complications

Amendment 595 #

Proposal for a directive
Article 83 – paragraph 1 – point b c (new)

(b c) the use of a medical product leads to improvements in dosing and facilitates the administration of the medication, which includes enhancing treatment compliance;

Amendment 596 #

Proposal for a directive
Article 83 – paragraph 2

~~2. Designated orphan medicinal products referred to in Article 67 of [revised Regulation (EC) No 726/2004] shall be considered as addressing an unmet medical need.~~deleted

Amendment 597 #

Proposal for a directive
Article 83 – paragraph 3

3. ~~Where~~In close cooperation with HTA bodies, the Agency adopts scientific guidelines for the application of this Article it shall take into account the effect of the condition on life expectancy with the provision of standard care; the influence of the condition on patient experience, encompassing quality of life, after administering the current standard of care; and the suitability of the present standard of care for the patient. In formulating these guidelines, the Agency shall include members from patient organizations related to the pertinent disease areas, and consult the Commission and the authorities or bodies referred to in Article 162 of [revised Regulation (EC) No 726/2004].

Amendment 598 #

Proposal for a directive
Article 83 – paragraph 3

3. Where the Agency adopts scientific guidelines for the application of this Article it shall consult the Commission and the authorities or bodies referred to in Article 162 of [revised Regulation (EC) No 726/2004], representatives from patient organisations in the relevant disease areas, healthcare professionals, representatives of the pharmaceutical industry, and other relevant stakeholders.

Amendment 599 #

Proposal for a directive
Article 83 – paragraph 3

3. Where the Agency adopts scientific guidelines for the application of this Article it shall consult the Commission and the authorities or bodies referred to in Article 162 of [revised Regulation (EC) No 726/2004], representatives of patients’ organisations in the relevant disease areas, healthcare professionals, representatives of pharmaceutical industry and other relevant stakeholders.

Amendment 60 #

Proposal for a directive
Recital 47

Amendment 600 #

Proposal for a directive
Article 83 – paragraph 3

3. Where the Agency adopts scientific guidelines for the application of this Article it shall consult the Commission and the authorities or bodies referred to in Article 162 of [revised Regulation (EC) No 726/2004], representatives of patients’ organisations in the relevant disease areas, healthcare professionals, representatives of pharmaceutical industry and other relevant stakeholders.

Amendment 601 #

Proposal for a directive
Article 83 – paragraph 3

3. Where the Agency adopts scientific guidelines for the application of this Article it shall consult the Commission and the authorities or bodies referred to in Article 162 of [revised Regulation (EC) No 726/2004] representatives of patients’ organisations in the relevant disease areas, healthcare professionals, representatives of pharmaceutical industry and other relevant stakeholders.

Amendment 602 #

Proposal for a directive
Article 83 – paragraph 3

3. Where the Agency adopts scientific guidelines for the application of this Article it shall consult the Commission and the authorities or bodies referred to in Article 162 of [revised Regulation (EC) No 726/2004], and where relevant, representatives of patients’ organisations in the relevant disease areas, healthcare professionals, academics and experts.

Amendment 603 #

Proposal for a directive
Article 84 – paragraph 1 – introductory part

1. A non-cumulative period of regulatory data protection period of four years shall be granted for a medicinal product with respect to a new therapeutic ~~indication~~option, including a new indication, posology, pharmaceutical form, method or route of administration or any other way in which the medicinal product may be used, not previously authorised in the Union, provided that:

Amendment 604 #

Proposal for a directive
Article 84 – paragraph 1 – introductory part

Amendment 605 #

Proposal for a directive
Article 84 – paragraph 1 – introductory part

Amendment 606 #

Proposal for a directive
Article 84 – paragraph 1 – introductory part

Amendment 607 #

Proposal for a directive
Article 84 – paragraph 1 – introductory part

Amendment 608 #

Proposal for a directive
Article 84 – paragraph 1 – point a

(a) adequate non-clinical or clinical studies were carried out in relation to the therapeutic indication demonstrating that it is of significant clinical benefit, including studies covering the paediatric population conducted according to a PIP and

Amendment 609 #

Proposal for a directive
Article 84 – paragraph 1 – point a

Amendment 61 #

Proposal for a directive
Recital 48

Amendment 610 #

Proposal for a directive
Article 84 – paragraph 1 – point a

Amendment 611 #

Proposal for a directive
Article 84 – paragraph 1 – point a

Amendment 612 #

Proposal for a directive
Article 84 – paragraph 1 – point a

Amendment 613 #

Proposal for a directive
Article 84 – paragraph 1 – point a

Amendment 614 #

Proposal for a directive
Article 84 – paragraph 1 – point b

(b) the medicinal product is authorised in accordance with Articles 9 to 12 and does not fall in the same global marketing authorization as a medicinal product that has has not previously benefitted from data protection or market exclusitvity, or 25 years have passed since the granting of the initial marketing authorisation of the medicinal product concerned.

Amendment 615 #

Proposal for a directive
Article 84 – paragraph 1 – point b

Amendment 616 #

Proposal for a directive
Article 84 – paragraph 1 – point b

Amendment 617 #

Proposal for a directive
Article 84 – paragraph 3

Amendment 618 #

Proposal for a directive
Article 84 – paragraph 3

Amendment 619 #

Proposal for a directive
Article 84 – paragraph 3

3. During the data protection period referred to in paragraph 1, the m~~arketing authorisation shall indicate that the medicinal product is an existing medicinal product authorised in the Union that has been authorised with an additional therapeutic indication~~edicinal product should be designated as a value added medicinal product.

Amendment 62 #

Proposal for a directive
Recital 48

(48) ~~While pricing and reimbursement decisions are a Member State competence~~Member State create shortages in other Member States. For this reason, the Pharmaceutical Strategy for Europe announced actions to support cooperation of Member States to improve affordability. While the price paid within a given Member State reflects the preference of a national health system, more coordination on pricing and procurement could contribute to more equal and timely access to medicines, including for Member States with lower purchasing power. The Commission may support joint price negotiation with pharmaceutical companies, as per the Beneluxa Initiative on Pharmaceutical Policy and the Valletta Declaration. The Commission has transformed the group of National Competent Authorities on Pricing and Reimbursement and public healthcare payers (NCAPR) from an ad- hoc forum to a continuous voluntary cooperation with the aim to exchange information and best practices on pricing, payment and procurement policies to improve the affordability and cost- effectiveness of medicines and health system’s sustainability. The Commission is committed to stepping up this cooperation and further supporting information exchange among national authorities, including on national pricing, reimbursment and public procurement of medicines, while fully respecting the competences of Member States in this area. The Commission may also invite NCAPR members to participate in deliberations of the Pharmaceutical Committee on topics that may have an impact on pricing or reimbursement policies, such as the market launch incentive.

Amendment 620 #

Proposal for a directive
Article 84 a (new)

Article84a Reporting of research and development costs from the marketing authorisation holder 1.Where the marketing authorisation holder benefits from data and market protection granted under this Directive it shall: (a) Upon request, submit to the Commission and/or the competent authorities of the Member States responsible for pricing and reimbursement an electronic report with detailed information on their expenditure in research and development activities related to the medicinal product. (b) make the report available within 30 days from the receipt of the request; (c) publish a summary of the report on the same webpage where the information described in Article 57 will be published. The link should be communicated to the competent authority of the Member State granting the marketing authorisation or, where appropriate, to the Agency. (d) ensure that the electronic report and lay summary are accurate and have been audited by an independent external auditor. 2. The Commission shall promote transparency and data sharing mechanisms regarding reimbursement prices of medicinal products by the Member States. 3. The Commission shall adopt delegated acts to lay down the methodology and format in which the information should be reported and published pursuant to paragraph 1.

Amendment 621 #

Proposal for a directive
Article 85 – paragraph 1 – introductory part

Amendment 622 #

Proposal for a directive
Article 85 – paragraph 1 – introductory part

Amendment 623 #

Proposal for a directive
Article 85 – paragraph 1 – introductory part

Amendment 624 #

Proposal for a directive
Article 85 – paragraph 1 – introductory part

Patent rights, or supplementary protection certificates under the [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted] shall not be regarded as infringed when ~~a reference medicinal product is us~~studies, trials and other activities are conducted for the purposes of:

Amendment 625 #

Proposal for a directive
Article 85 – paragraph 1 – point a – introductory part

Amendment 626 #

Proposal for a directive
Article 85 – paragraph 1 – point a – introductory part

(a) ~~studies, trials and other activities conducted to generate data for an application, for:~~deletion

Amendment 627 #

Proposal for a directive
Article 85 – paragraph 1 – point a – introductory part

(a) studies, trials and other necessary activities conducted to generate data for an application, for:

Amendment 628 #

Proposal for a directive
Article 85 – paragraph 1 – point a – introductory part

(a) studies, trials and other activities are conducted ~~to generate data for an application, for~~for the purpose of:

Amendment 629 #

Proposal for a directive
Article 85 – paragraph 1 – point a – introductory part

(a) studies, trials and other activities are conducted ~~to generate data for an application, for~~for the purpose of:

Amendment 63 #

Proposal for a directive
Recital 49

(49) ~~Joint procurement, whether within a country or across countries, can improve access, affordability, and security of supply of medicines, in particular for smaller countries.~~ Member States interested in joint procurement of medicines can make use of Directive 2014/24/EU47 , which sets out purchasing procedures for public buyers, the Joint Procurement Agreement48 and the proposed revised Financial Regulation49 . Upon request from the Member States the Commission may support interested Member States by facilitating coordination to enable access to medicines for patients in the Union as well as information exchange, in particular for medicines for rare and chronic diseases.In the event of joint procurement of medicinal products as a medical countermeasure in cases of serious cross- border threats to health, the provisions of Regulation (EU) 2022/2371 of the European Parliament and of the Council49a apply. _________________ 47 Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65). 48 Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU. 49 COM/2022/223 final.

Amendment 630 #

Proposal for a directive
Article 85 – paragraph 1 – point a – introductory part

(a) studies~~, trials and other activitie~~ and trials conducted to generate data for an application, for:

Amendment 631 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point i

(i) a marketing authorisation ~~of generic, biosimilar, hybrid or bio-hybrid medicinal products and for subsequent variations~~;

Amendment 632 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point i

(i) a marketing authorisation ~~of generic, biosimilar, hybrid or bio-hybrid medi~~for commercinal ~~products and for subsequent variations~~use;

Amendment 633 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point i

(i) obtaining a marketing authorisation of generic, biosimilar, innovative, hybrid or bio-hybrid medicinal products and for subsequent variations;

Amendment 634 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point i

(i) obtaining a marketing authorisation ~~of generic, biosimilar, hybrid or bio-hybrid medicinal products and for~~and subsequent variations;

Amendment 635 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point i

(i) obtaining a marketing authorisation ~~of generic, biosimilar, hybrid or bio-hybrid medicinal~~for products and ~~for~~ subsequent variations;

Amendment 636 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point i

(i) obtaining a marketing authorisation ~~of generic, biosimilar, hybrid or bio-hybrid medicinal~~for products and ~~for~~ subsequent variations;

Amendment 637 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point ii

(ii) conducting a health technology assessment as defined in Regulation (EU) 2021/2282;

Amendment 638 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point ii

(ii) conducting a health technology assessment as defined in Regulation (EU) 2021/2282;

Amendment 639 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point ii

(ii) conducting health technology assessment as defined in Regulation (EU) 2021/2282;

Amendment 64 #

Proposal for a directive
Recital 49

(49) Joint procurement, whether within a country or across countries, can improve access, affordability, and security of supply of medicines, in particular for smaller countries. Member States interested in joint procurement of medicines can make use of Directive 2014/24/EU47 , which sets out purchasing procedures for public buyers, the Joint Procurement Agreement48 and the proposed revised Financial Regulation49 . Upon request from the Member States the Commission may support interested Member States by facilitating coordination to enable access to medicines for patients in the Union as well as information exchange, in particular for medicines for rare and chronic diseases. Joint procurement should not have an adverse impact on access to medicines for countries not taking part in the procurement. _________________ 47 Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65). 48 Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU. 49 COM/2022/223 final.

Amendment 640 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point ii

(ii) conducting a health technology assessment as defined in Regulation (EU) 2021/2282;

Amendment 641 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point iii

~~(iii) pricing and reimbursement.~~deleted

Amendment 642 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point iii

~~(iii) pricing and reimbursement.~~deleted

Amendment 643 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point iii

~~(iii) pricing and reimbursement.~~deleted

Amendment 644 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point iii

(iii) obtaining pricing and reimbursement approval.

Amendment 645 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point iii

(iii) obtaining pricing and reimbursement. approval;

Amendment 646 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point iii

(iii) obtaining pricing and reimbursement. approval

Amendment 647 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point iii

(iii) obtaining pricing and reimbursement. approval;

Amendment 648 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point iii a (new)

Amendment 649 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point iii a (new)

Amendment 65 #

Proposal for a directive
Recital 49

(49) Joint procurement, whether within a country or across countries, can improve access, affordability, and security of supply of medicines, in particular for smaller countries. Member States interested in joint procurement of medicines can make use of Directive 2014/24/EU47 , which sets out purchasing procedures for public buyers, the Joint Procurement Agreement48 and the proposed revised Financial Regulation49 . Upon request from the Member States the Commission may support interested Member States by facilitating coordination to enable access to medicines for patients in the Union as well as information exchange, in particular for medicines for rare and chronic diseases. _________________ 47 Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65). 48 Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross- border threats to health and repealing Decision No 1082/2013/EU. 49 COM/2022/223 final, antibiotics and generic and biosimilar medicinal products.

Amendment 650 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point iii a (new)

(iii a) enabling public and private procurement of medicinal products after expiry of the relevant patents or supplementary protection certificate

Amendment 651 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point iii a (new)

(iii a) enabling public and private procurement of medicinal products after expiry of the relevant patents or supplementary protection certificate;

Amendment 652 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point iii b (new)

Amendment 653 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point iii b (new)

Amendment 654 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point iii b (new)

(iii b) complying with any other regulatory or administrative requirement in the Union or elsewhere;

Amendment 655 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point iii b (new)

(iii b) complying with any other regulatory or administrative requirement in the Union or elsewhere;

Amendment 656 #

Proposal for a directive
Article 85 – paragraph 1 – point a – point iii c (new)

(iii c) ensuring the subsequent practical requirements associated with the abovementioned activities

Amendment 657 #

Proposal for a directive
Article 85 – paragraph 1 – point b

Amendment 658 #

Proposal for a directive
Article 85 – paragraph 1 – point b

Amendment 659 #

Proposal for a directive
Article 85 – paragraph 1 – point b

Amendment 66 #

Proposal for a directive
Recital 49

(49) Joint procurement, whether within a country or across countries, can improve access, affordability, and security of supply of medicines, in particular for smaller countries. Member States interested in joint procurement of medicines can make use of Directive 2014/24/EU47 , which sets out purchasing procedures for public buyers, the Joint Procurement Agreement48 and the proposed revised Financial Regulation49 . Upon request from the Member States the Commission may support interested Member States by facilitating coordination to enable access to medicines for patients in the Union as well as information exchange, in particular for medicines for ~~rare and~~paediatric, rare as well as chronic diseases. _________________ 47 Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65). 48 Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU. 49 COM/2022/223 final.

Amendment 660 #

Proposal for a directive
Article 85 – paragraph 1 – point b

Amendment 661 #

Proposal for a directive
Article 85 – paragraph 1 – point b

Amendment 662 #

Proposal for a directive
Article 85 – paragraph 1 – point b

(b) the activities conducted exclusively for the purposes set out in point (a), may cover the ~~submission of the application for a marketing authorisation and the offer,~~ manufacture, sale, supply, storage, import, use and purchase of patented medicinal products or processes, including by third party suppliers and service providers.

Amendment 663 #

Proposal for a directive
Article 85 – paragraph 1 – point b

(b) the activities conducted exclusively for the purposes set out in point (a), ~~may~~shall cover the ~~submission of the application for a marketing authorisation and the~~ offering, manufacture, sale, supply, storage, import, export, use and purchase of patented medicinal products or processes, including by third party suppliers and service providers.

Amendment 664 #

Proposal for a directive
Article 85 – paragraph 1 a (new)

The activities falling within the first paragraph include the offering, manufacture, sale, supply, storage, import, export, use and purchase of products or processes, including by third party suppliers and service providers.

Amendment 665 #

Proposal for a directive
Article 85 – paragraph 1 a (new)

Amendment 666 #

Proposal for a directive
Article 85 – paragraph 2

This exception shall not cover the placing on the market ~~of the medicinal products resulting from such activities.~~in a Member State, while relevant patent rights or supplementary protection certificates are in force in that Member State, of the medicinal products manifactured for the purposes set out in point a

Amendment 667 #

Proposal for a directive
Article 85 – paragraph 2

Amendment 668 #

Proposal for a directive
Article 85 – paragraph 2

This exception shall not cover the placing on the market of the medicinal products resulting from such activities before expiry of relevant patent or supplementary protection certificates.

Amendment 669 #

Proposal for a directive
Article 85 – paragraph 2

This exception shall not cover the placing on the market of the medicinal products resulting from such activities before expiry of relevant patent or supplementary protection certificates.

Amendment 67 #

Proposal for a directive
Recital 49 a (new)

Amendment 670 #

Proposal for a directive
Article 85 a (new)

Article 85a Applications, decision-making procedures and decisions to regulate marketing authorizations or the prices of generics, biosimilars, hibryds and biohibrids or to determine their inclusion within the scope of public health insurance system of medicinal products shall be considered by Member States as regulatory or administrative procedures which, as such, are independent from the enforcement of intellectual property rights. The protection of intellectual property rights shall not be a valid ground to refuse, suspend, delay, withdraw or revoke decisions relating to marketing authorisations, the price of generics, biosimilars, hibryds and biohibrids or its inclusion within the public health insurance system. The applications, decision-making procedures and decisions referred to in paragraph 1 shall not be subject to conditions which expose applicants to a risk of infringement of the intellectual property rights. Paragraphs 1, 2 and 3 shall apply without prejudice to the Union and national legislation relating to the protection of intellectual property.

Amendment 671 #

Proposal for a directive
Article 85 a (new)

Article 85a Prohibition on patent linkage 1. Member States shall not, when conducting regulatory or administrative procedures in regards to activities carried out in accordance with Article 85, enforce intellectual property rights as a valid ground for refusal, suspension, delay, withdrawal or revocation of marketing authorisation, pricing and reimbursement decisions or tender bids in regards to public and private procurement of medicinal products. 2. If the market authorization holder ceases to commercialise a medicinal product in the Union, the Commission shall have a public purchase option for all related intellectual property rights.

Amendment 672 #

Proposal for a directive
Article 85 a (new)

Amendment 673 #

Proposal for a directive
Article 86 – paragraph 1 – subparagraph 1

Amendment 674 #

Proposal for a directive
Article 86 – paragraph 1 – subparagraph 1 a (new)

Where the agreed paediatric investigation plan is conducted in relation to a disease that is different from the one for which the medicinal product is intended in the adult population, the holder of the patent or supplementary protection certificate shall be entitled to a 12-month extension of referred to in Article 13, paragraphs 1 and 2 of [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted].

Amendment 675 #

Proposal for a directive
Article 86 – paragraph 1 – subparagraph 2

Th~~e first sub~~is paragraph shall also apply where completion of the agreed paediatric investigation plan fails to lead to the authorisation of a paediatric indication, but the results of the studies conducted are reflected in the summary of product characteristics and, if appropriate, in the package leaflet of the medicinal product concerned.

Amendment 676 #

Proposal for a directive
Article 86 – paragraph 1 – subparagraph 2 a (new)

The periods of extension referred to in this paragraph shall not apply to orphan medicinal products which have elected for and benefited from the extension of market exclusivity provided in Article 72(3) of [revised Regulation 726/2004].

Amendment 677 #

Proposal for a directive
Article 86 a (new)

Amendment 678 #

Proposal for a directive
Article 87 – paragraph 1 – subparagraph 1 – point c – paragraph 1

Amendment 679 #

Proposal for a directive
Article 89 – paragraph 1

1. The marketing authorisation holder shall incorporate any safety or efficacy conditions referred to in Articles 44, 45 and 87 (1a and b), in the risk management system.

Amendment 68 #

Proposal for a directive
Recital 50

(50) The establishment of a criteria- based definition of ‘unmet medical need’ is required to incentivise the development of medicinal products in therapeutic areas that lack effective treatments or where only less-than-ideal therapies exist, with the aim of spurring pharmaceutical research and development that genuinely meets patient requirements.that are currently underserved. To ensure that the concept of unmet medical need reflects scientific and technological developments and current knowledge in underserved diseases, the Commission should specify and update using implementing acts, the criteria of satisfactory method of diagnosis, prevention or treatment, ‘remaining ~~high~~ morbidity or mortality’, ‘relevant patient population~~’ following scientific assessment by the Agency. The Agency~~ ’, ‘quality of life’, ‘burden of administration’, ‘appropriate standard of care’, ‘significant added therapeutic value’, ‘patient experience data’ following scientific assessment by the Agency. The Agency shall include patient representatives in its decision-making processes, will seek input from a broad range of authorities or bodies active along the lifecycle of medicinal products in the framework of the consultation process established under the [revised Regulation (EC) No 726/2004] and also take into account scientific initiatives at EU level or between Member States related to analysing unmet medical needs, burden of disease and priority setting for research and development. ~~The criteria for ‘unmet medical need’ can be subsequently used by Member States to identify specific therapeutic areas of interest~~Given that chronic diseases account for 86% of all deaths in the EU, the assessment of disease burden should not be limited to mortality and morbidity metrics alone but ought to incorporate relevant data on patient experiences, including aspects related to quality of life. The inclusion of new therapeutic indications to an authorised medicinal products contributes to the access of patients to additional therapies and therefore should be incentivised.

Amendment 680 #

Proposal for a directive
Article 92 – paragraph 3

Amendment 681 #

Proposal for a directive
Article 94 – paragraph 1

1. On the basis of relevant paediatric clinical studies received in accordance with Article 45(1) of Regulation (EC) No 1901/2006 of the European Parliament and of the Council76 , the competent authorities of the Member States may, following a consultation of the marketing authorisation holder, vary the marketing authorisation of the medicinal product concerned accordingly and update the summary of product characteristics and package leaflet of the medicinal product concerned. The competent authorities shall exchange information regarding the studies submitted and, as appropriate, their implications for any marketing authorisations concerned. _________________ 76 Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 378, 27.12.2006, p. 1).

Amendment 682 #

Proposal for a directive
Article 97 – paragraph 1 – point e a (new)

Amendment 683 #

Proposal for a directive
Article 101 – paragraph 1

1. The management of funds intended for activities connected with pharmacovigilance, the operation of communication networks and market surveillance shall be under the permanent control of the competent authorities of the Member States in order to guarantee their independence in the performance of those pharmacovigilance activities. The competent authorities should guarantee that not less than 10% of these activities and funds are focused on paediatric populations

Amendment 684 #

Proposal for a directive
Article 104 – paragraph 2

2. The marketing authorisation holder shall ensure that information to the public is presented objectively and is not misleading, and it is presented in a clear and adjusted language.

Amendment 685 #

Proposal for a directive
Article 105 – paragraph 2

Amendment 686 #

Proposal for a directive
Article 105 – paragraph 2

Amendment 687 #

Proposal for a directive
Article 105 – paragraph 2

Amendment 688 #

Proposal for a directive
Article 106 – paragraph 1 – subparagraph 1

Each Member State shall record all suspected adverse reactions that occur in its territory and that are brought to its attention from healthcare professionals and patients. This shall include all authorised medicinal products and medicinal products used in accordance with Article 3, paragraphs 1 or 2. Member States shall involve patients and healthcare professionals, as appropriate, in the follow- up of any reports they receive in order to comply with Article 97(1), points (c) and (e), and shall seek to inform directly those stakeholders that reported a suspected adverse drug reaction on decisions taken in relation to the safety of the medicinal product.

Amendment 689 #

Proposal for a directive
Article 112 a (new)

Article112a Medicines under additional monitoring 1.The Agency shall, in collaboration with the Member States, set up, maintain and make public a list of medicinal products that are subject to additional monitoring. That list shall include the international non-proprietary names and active substances of: (a) medicinal products authorised in the Union that contain a new active substance which was not contained in any medicinal product authorised in the Union; (b) any biological medicinal product not covered by point (a) that was authorised after [date of implementation]; (c) medicinal products that are authorised pursuant to this Regulation, subject to the conditions referred to in point (f) of Article 12(4), point (a) of Article 20(1) or Articles 18, 19, 30 or 113; (d) medicinal products that are authorised pursuant to [revised Directive 2001/83/EC], subject to the conditions referred to in points (b) and (c) of the first paragraph of Article 44, Article 45, or point (a) of the first subparagraph of Article 87(1) thereof. At the request of the Commission, following consultation with the Pharmacovigilance Risk Assessment Committee, medicinal products that are authorised pursuant to this Regulation subject to the conditions referred to in points (d), (e) or (g) of Article 12(4), point (b) of Article 20 (1) or Article 46(2), may also be included in the list referred to in paragraph 1 of this Article. At the request of a national competent authority, following consultation with the Pharmacovigilance Risk Assessment Committee, medicinal products that are authorised pursuant to [revised Directive 2001/83/EC] subject to the conditions referred to in points (a), (d) or (f) of the first paragraph of Article 44, point (b) of the first subparagraph of Article 87 or Article 100(2) thereof, may also be included in the list referred to in paragraph 1 of this Article. 2. The list referred to in paragraph 1 shall include an electronic link to the product information and to the summary of the risk management plan. 3. In the cases referred to in points (a) and (b) of paragraph 1 of this Article, the Agency shall remove a medicinal product from the list five years after the Union reference date referred to in Article 108(5) of [revised Directive 2001/83/EC]. In the cases referred to in points (c) and (d) of paragraph 1 of this Article, the Agency shall remove a medicinal product from the list once the conditions have been fulfilled. 4. For medicinal products included in the list referred to in paragraph 1, the summary of product characteristics and the package leaflet shall include the statement ‘This medicinal product is subject to additional monitoring’. The statement shall be preceded by an inverted black triangle, and shall be followed by a standardised explanatory sentence. 5. The Agency shall, in cooperation with the competent authorities, develop and conduct awareness campaigns on the promotion of information about medicines under additional monitoring. Those campaigns shall be intended to raise awareness amongst healthcare professionals, patients, consumers and the general public of the pharmacovigilance system and the additional monitoring of medicines.

Amendment 69 #

Proposal for a directive
Recital 50

Amendment 690 #

Proposal for a directive
Article 123 – paragraph 1 – point b

(b) scientific guidance on post- authorisation efficacy studies, following the consultation process established under Article 162 of the [revised Regulation (EU) 726/2004].

Amendment 691 #

Proposal for a directive
Article 143 – paragraph 1 – subparagraph 2 – point a a (new)

(a a) environmental impact assessment of the product’s manufacturing process;

Amendment 692 #

Proposal for a directive
Article 143 – paragraph 1 – subparagraph 2 – point b a (new)

(b a) proof that the product’s supply chain is diversified, identifying alternatives for each component;

Amendment 693 #

Proposal for a directive
Article 147 – paragraph 1 – subparagraph 1 – point a a (new)

(a a) maintain the market adequately supplied with the registered products, in an adequate and continuous maner, so that the needs of patients are covered;

Amendment 694 #

Proposal for a directive
Article 147 – paragraph 1 – subparagraph 1 – point g

(g) use only active substances that have been manufactured in accordance with good manufacturing practice for active substances and distributed in accordance with good distribution practices for active substances, which include reliable, constant and timely delivery of the active substances to the manufacturing authorization holders;

Amendment 695 #

Proposal for a directive
Article 147 – paragraph 1 – subparagraph 1 – point j a (new)

Amendment 696 #

Proposal for a directive
Article 147 – paragraph 1 – subparagraph 1 – point j a (new)

(j a) use an appropriate wastewater treatment system.

Amendment 697 #

Proposal for a directive
Article 147 – paragraph 1 – subparagraph 3

For the purposes of points (f) and (g), manufacturing authorisation holders shall verify compliance, respectively, by the manufacturer or distributors of active substances with good manufacturing practice and good distribution practices by conducting audits at the manufacturing and distribution sites of the manufacturer and distributors of active substances. Manufacturing authorisation holders shall verify such compliance either by themselves or through an entity acting on their behalf under a contract. Manufacturing authorisation holders may diversify their contracts with manufacturer or distributors of active substances if needed to ensure an adequate, constant and timely provision to comply with their public service obligations for supply.

Amendment 698 #

Proposal for a directive
Article 148 – paragraph 8 – introductory part

Amendment 699 #

Proposal for a directive
Article 148 – paragraph 8 a (new)

8 a. The competent authorities referred to paragraph 8 shall guarantee that the modalitities of coordination shall not adversely affect the preparation of SoHO therapies on a Member State level.

Amendment 70 #

Proposal for a directive
Recital 50

(50) T~~he establishment of~~o incentivize the development of medicinal products in therapeutic areas that are currently underserved, it's essential to establish a criteria- based definition of ‘'unmet medical need~~’ is required to incentivise the development of medicinal products in therapeutic areas that are currently underserv~~.' This concept should reflect scientific and technological advancements as well as current knowledge in underserved diseases. Since chronic diseases account for 86% of all deaths in the EU, the assessment of the disease burden should extend beyond mortality and morbidity measurements. It is of vital importance to incorporate relevant patient experience data, including aspects related to quality of life, to gain a comprehensive understanding of unmet medical needs. To ensure that the concept of unmet medical need reflects scientific and technological developments and current knowledge in underserved diseases, the Commission should specify and update using implementing acts, the criteria of satisfactory method of diagnosis, prevention or treatment, ‘remaining high morbidity or mortality’, ‘relevant patient population’ and 'negative impact on quality of life' following scientific assessment by the Agency. The Agency will seek input from a broad range of authorities or bodies active along the lifecycle of medicinal products, including patients organisations and respresentatives from the industry in the framework of the consultation process established under the [revised Regulation (EC) No 726/2004] and also take into account scientific initiatives at EU level or between Member States related to analysing unmet medical needs, burden of disease and priority setting for research and development. The criteria for ‘unmet medical need’ can be subsequently used by Member States to identify specific therapeutic areas of interest.

Amendment 700 #

Proposal for a directive
Article 148 – paragraph 9

Amendment 701 #

Proposal for a directive
Article 159 – paragraph 1 – subparagraph 1

At the request of a third country, the Commission shall assess whether that country’s regulatory framework applicable to active substances exported to the Union and the respective control and enforcement activities ensure a level of protection of public ~~health~~and worker's health and environment equivalent to that of the Union.

Amendment 702 #

Proposal for a directive
Article 159 – paragraph 2 – subparagraph 2 – point a

(a) the country’s rules for good manufacturing practice; including local environmental manufacturing standards, occupational health and labour rights standards;

Amendment 703 #

Proposal for a directive
Article 160 – paragraph 1 – introductory part

The Commission ~~may~~shall adopt implementing acts in accordance with Article 214(2) to supplement this Directive by specifying:

Amendment 704 #

Proposal for a directive
Article 160 – paragraph 1 – point b a (new)

(b a) the principles and measures on reducing the environmental impact of medicinal products and active substances in manufacturing and distribution

Amendment 705 #

Proposal for a directive
Article 160 – paragraph 2

Where relevant, these principles shall be ~~specified in coherence~~aligned with with any principles of good practices established under any other Union legal framework.

Amendment 706 #

Proposal for a directive
Article 163 – paragraph 1

1. The competent authority of the Member State concerned shall take all appropriate measures to ensure that the wholesale distribution of medicinal products is subject to an authorisation to engage in activity as a wholesaler in medicinal products (“wholesale distribution authorisation”). The wholesale distribution authorisation shall indicate the premises, the categories of medicinal products and the wholesale distribution operations for which it is valid.

Amendment 707 #

Proposal for a directive
Article 166 – paragraph 1 – point c

(c) obtain, including by financial transactions, ~~their supplies of medi~~(except in the case of financinal ~~products only from persons who are themselves in possession of a wholesale distribution authorisation in the Union or a manufacturing authorisation referred to in Article 163(3);~~transactions for equivalent activities. Member States shall rely on the information contained in the repositories system to ensure wholesale distributors comply with their supply obligations.

Amendment 708 #

Proposal for a directive
Article 166 – paragraph 1 – point d

Amendment 709 #

Proposal for a directive
Article 166 – paragraph 1 – point g – point v

(v) the batch number and serial number of the medicinal products, at least for medicinal products bearing the safety features referred to in Article 67;

Amendment 71 #

Proposal for a directive
Recital 50

Amendment 710 #

Proposal for a directive
Article 166 – paragraph 1 – point l

(l) continuously guarantee the appropriate and continued supply of an adequate range of medicinal products to meet the requirements of a specific geographical area, and deliver the supplies requested over the whole of the area in question, within a reasonable timeframe, which shall be defined in the national legislation;deleted

Amendment 711 #

Proposal for a directive
Article 166 – paragraph 1 – point m

(m) cooperate with all relevant stakeholders, including marketing authorisation holders and competent authorities of the Member States on the security of supply.

Amendment 712 #

Proposal for a directive
Article 166 – paragraph 1 a (new)

1 a. Member States shall designate wholesale distribution authorisation holders who shall continuously guarantee the appropriate and continued supply of an adequate range of medicinal products to meet the requirements of a specific geographical area, and deliver the supplies requested over the whole of the area in question, within a reasonable timeframe, which shall be defined in national legislation.

Amendment 713 #

Proposal for a directive
Article 167 – paragraph 1

Amendment 714 #

Proposal for a directive
Article 167 – paragraph 2

Amendment 715 #

Proposal for a directive
Article 167 – paragraph 2

2. The wholesale distributors of a medicinal product placed on the market in a Member State shall, within the limits of their responsibilities, ensure appropriate and continued supplies of that medicinal product, in a sufficient quantity and a timely manner, to pharmacies and persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered.

Amendment 716 #

Proposal for a directive
Article 167 – paragraph 2

2. The wholesale distributors of a medicinal product placed on the market in a Member State shall, within the limits of their responsibilities, ensure ~~appropriate~~that medicinal products are released and continuedously supplie~~s of that medicinal product~~d to pharmacies and persons authorised to supply medicinal products in a sufficient quantity so that the needs of patients in the Member State in question are covered.

Amendment 717 #

Proposal for a directive
Article 167 – paragraph 3 a (new)

Amendment 718 #

Proposal for a directive
Article 172 – paragraph 1 – point a

Amendment 719 #

Proposal for a directive
Chapter XII a (new)

XII a Chapter XII(a) Public procurement of medicinal products Article 174a Procurement of medicinal products 1. Member States may consider strategic approaches when engaging in procurement procedures, including criteria beyond price, in line with Directive 2014/24/EU on public procurement. When doing so they may put in place practices supporting security of supply and availability of medicines including: a) preliminary market consultation; b) awarding multiple contracts to reduce the risk of supply disruptions and mantain a competitive environment; c) increased use of “most economically advantageous tender” (MEAT) award criteria in public tenders, using qualitative criteira such as security of supply and production in the EU/EEA or in countries with which the EU has concluded an agreement on government procurement; (d) ensuring that the duration of contracts is tailored to favour predictability of demand and long-term availability. Article 174b Joint procurement of medicinal products 1. The Commission and any of the Member States may engage, as contracting parties, in a joint procurement procedure with a view to the purchase of medicinal products. 2. A joint procurement procedure as referred to in paragraph 1 shall be preceded by a Joint Procurement Agreement between the parties determining the practical arrangements governing that procedure and the decision-making process with regard to the choice of the procedure, the joint procurement assessment as referred to in paragraph 3, point (c), the assessment of the tenders and the award of the contract. 3. The joint procurement procedure referred to in paragraph 1 of this Article shall comply with the following conditions: (a) participation in the joint procurement procedure is open to all Member States, European Free Trade Association States and Union candidate countries, as well as the Principality of Andorra, the Principality of Monaco, the Republic of San Marino and the Vatican City State, by way of derogation from Article 165(2) of Regulation (EU, Euratom) 2018/1046; (b) the rights and obligations of the countries referred to in point (a) that do not participate in the joint procurement are respected, in particular those relating to the protection and improvement of human health; (c) before the launch of a joint procurement procedure, the Commission prepares a joint procurement assessment which shall indicate the general envisaged conditions of the joint procurement procedure, including as regards possible restrictions to parallel procurement and negotiation activities by the participating countries for the medicinal product in question during the specific joint procurement procedure; that assessment shall take into account the need to ensure security of supply of medicinal products concerned to the participating countries. Based on the joint procurement assessment and the relevant information provided therein, such as on envisaged price ranges, manufacturers, delivery time frames and the proposed deadline for decision on participation, the parties to the Joint Procurement Agreement shall express their interest in participating at an early stage. Those parties to the Joint Procurement Agreement which have expressed their interest shall subsequently decide on their participation in the joint procurement procedure under the conditions jointly agreed with the Commission, taking into account the information proposed in the joint procurement assessment; (d) the joint procurement does not affect the internal market, does not constitute discrimination or a restriction of trade and does not cause distortion of competition; and (e) the joint procurement does not have any direct financial impact on the budget of the countries referred to in point (a) that do not participate in the joint procurement. 4. The Commission shall, in liaison with the Member States, ensure coordination and the exchange of information between the entities organising and participating in any action, including, but not limited to, joint procurement procedures for and development, stockpiling, distribution and donation of medicinal products, under different mechanisms established at Union level, in particular under: (a) stockpiling under rescEU referred to in Article 12 of Decision No 1313/2013/EU; (b) Regulation (EU) 2016/369; (c) the Pharmaceutical Strategy for Europe; (d) the EU4Health Programme established by Regulation (EU) 2021/522; (e) Regulation (EU) 2021/697 of the European Parliament and of the Council (34); and (f) other programmes and instruments supporting biomedical research and development at Union level for enhanced capacity and readiness to respond to cross-border threats and emergencies, such as measures adopted under Regulation (EU) 2022/2372. 5. The Commission shall inform the European Parliament about procedures concerning the joint procurement of medicinal products and, upon request, grant access to the contracts that are concluded as a result of those procedures, subject to the adequate protection of business secrecy, commercial relations and the interests of the Union. The Commission shall communicate information to the European Parliament regarding sensitive documents in accordance with Article 9(7) of Regulation (EC) No 1049/2001

Amendment 72 #

Proposal for a directive
Recital 50

Amendment 720 #

Proposal for a directive
Article 175 – paragraph 2 – point d a (new)

Amendment 721 #

Proposal for a directive
Article 177 – paragraph 1 – subparagraph 1 (new)

Amendment 722 #

Proposal for a directive
Article 177 – paragraph 1 – point b a (new)

(b a) are antibiotics

Amendment 723 #

Proposal for a directive
Article 177 – paragraph 2

2. Medicinal products may be advertised to the general public where, by virtue of their composition and purpose, they are intended and designed for use without the intervention of a ~~medical practit~~health professioneral for diagnostic purposes or for the prescription or monitoring of treatment, with the advice of the pharmacist~~, if necessary~~.

Amendment 724 #

Proposal for a directive
Article 177 – paragraph 4

4. The prohibition contained in paragraph 1 shall not apply to vaccination campaigns ~~carried out by the industry and~~ approved by the competent authorities of the Member States.

Amendment 725 #

Proposal for a directive
Article 177 – paragraph 4

4. The prohibition contained in paragraph 1 shall not apply to vaccination campaigns ~~carried out by the industry and~~ approved by the competent authorities of the Member States.

Amendment 726 #

Proposal for a directive
Article 185 – paragraph 1 – point b

(b) any supply of samples shall be in response to a written or electronic request, signed and dated, from the persons qualified to prescribe or supply medicinal products;

Amendment 727 #

Proposal for a directive
Article 185 – paragraph 1 – point g

(g) no samples of medicinal products containing substances classified as antibiotic, psychotropic or narcotic within the meaning of international conventions may be supplied.

Amendment 728 #

Proposal for a directive
Article 188 – paragraph 5 – introductory part

Amendment 729 #

Proposal for a directive
Article 188 – paragraph 5 – point d

(d) distributors of medicinal products or manufacturers or distributors of active substances located in third countries;

Amendment 73 #

Proposal for a directive
Recital 50 a (new)

(50 a) The development of medical products in underserved therapeutic areas can greatly increase the quality of life for patients. In that regard, elements such as acute or chronic side effects, in particular in relation to the toxicity of a product, as well as the ability of patients to perform regular life activities, the presence of pain and the management of co-morbidities should be considered in the assessment of improving quality of life. Improving quality of life can allow patients to return to job or education, which can not only bear a significant positive effect on the individual patient, but can also alleviate costs to society arising from productivity losses. Furthermore, novel medicinal products which have significant positive impacts on the quality of life of a patient can also alleviate the burden on family and carers, in particular as regards paediatric patients. This will in turn also have a societal impact in areas such as labour shortages and fiscal budgets.

Amendment 730 #

Proposal for a directive
Article 188 – paragraph 15 a (new)

15 a. The Agency shall draw up guidelines on the use of the Union database.

Amendment 731 #

Proposal for a directive
Article 195 – paragraph 2

2. The competent authorities of the Member States or, in the case of centralised marketing authorisation, the Commission may suspend~~, revoke~~ or vary a marketing authorisation if a serious risk to the environment or, including public health, has been identified and not sufficiently addressed by the marketing authorisation holder, with the exception of medicinal products authorised before 30 october 2005 to avoid restricting patients' access to existing treatments. Should the environmental risks, which also encompass public health dangers, surpass the therapeutic benefits for the intended patients and if these risks are not adequately reducible, the relevant Member State authorities or the Commission may revoke the marketing authorization of the holder.

Amendment 732 #

Proposal for a directive
Article 195 – paragraph 2

2. The competent authorities of the Member States or, in the case of centralised marketing authorisation, the Commission may suspend~~, revoke~~ or vary a marketing authorisation if a serious risk to the environment or, including public health, has been identified and not sufficiently addressed by the marketing authorisation holder. The competent authorities of the Member States or, in the case of a centralised marketing authorisation, the Commission may revoke a marketing authorisation in such cases only if it deems that those risks clearly outweigh the loss of positive therapeutic effects of the medicinal product for the concerned patient population and the risks cannot be mitigated following a decision of suspension or modification.

Amendment 733 #

Proposal for a directive
Article 195 – paragraph 2

Amendment 734 #

Proposal for a directive
Article 195 – paragraph 2

Amendment 735 #

Proposal for a directive
Article 195 – paragraph 2

Amendment 736 #

Proposal for a directive
Article 195 – paragraph 3

3. A marketing authorisation may also be suspended, revoked or varied where the particulars supporting the application as provided for in Articles 6, 9 to 14 or Annexes I to V are incorrect or have not been amended in accordance with Article 90, or where any conditions referred to in Articles 44, 45 and 87 have not been fulfilled or where the controls referred to in Article 191 have not been carried out.

Amendment 737 #

Proposal for a directive
Article 196 – paragraph 1 – point f

Amendment 738 #

Proposal for a directive
Article 200 – paragraph 4 – subparagraph 1

Amendment 739 #

Proposal for a directive
Article 200 – paragraph 4 – subparagraph 1

Amendment 74 #

Proposal for a directive
Recital 50 a (new)

(50 a) Progress in treatments for overlooked therapeutic areas can greatly improve patient well-being, especially through better management of side effects, daily activities, pain, and concurrent illnesses. Improvements in patient quality of life ought to facilitate their return to work or education, benefiting both individuals and society by diminishing economic strains. Moreover, novel treatments can alleviate the responsibilities of caregivers, yielding broader social advantages. Identifying these therapeutic areas and unmet needs should include discussions with stakeholders such as patients, healthcare practitioners, and industry specialists.

Amendment 740 #

Proposal for a directive
Article 201 – paragraph 1

1. Member States, in applying this Directive, shall ensure that when questions arise with regard to the regulatory status of a medicinal product, in relation to their link to substances of human origin as referred to in Regulation (EU) No [SoHO Regulation], the competent authorities of the Member States shall consult the Agency and the relevant authorities established under that Regulation. The Agency shall oversee the examination and results of inquiries and disclose pertinent information, ensuring any commercially sensitive data is removed prior to publication.

Amendment 741 #

Proposal for a directive
Article 201 – paragraph 2 a (new)

Amendment 742 #

Proposal for a directive
Article 206 – paragraph 1 – subparagraph 1

Amendment 743 #

Proposal for a directive
Article 206 – paragraph 2 – point d

Amendment 744 #

Proposal for a directive
Article 206 – paragraph 2 – point e a (new)

(e a) non-compliance with the obligations laid down in Article 58a shall be subject to the imposition of effective, proportionate and dissuasive financial penalties.

Amendment 745 #

Proposal for a directive
Article 206 – paragraph 3 a (new)

Amendment 746 #

Proposal for a directive
Article 207 – title

Collection and management of unused or expired medicinal products

Amendment 747 #

Proposal for a directive
Article 207 – paragraph 1

Amendment 748 #

Proposal for a directive
Article 207 – paragraph 1

Amendment 749 #

Proposal for a directive
Article 207 – paragraph 1

Amendment 75 #

Proposal for a directive
Recital 50 a (new)

(50 a) Advancing treatments in neglected therapeutic areas can significantly enhance patient lives, particularly by considering the management of side effects, daily functioning, pain, and co- existing illnesses. Enhancements in patient quality of life may lead to their re- engagement in work or education, benefiting both the individual and society by reducing economic burdens. Additionally, new treatments can lessen the load on caregivers, with wider social benefits. Defining these therapeutic areas and unmet needs should involve consultation with stakeholders like patients, healthcare providers, and industry experts.

Amendment 750 #

Proposal for a directive
Article 207 – paragraph 1

Amendment 751 #

Proposal for a directive
Article 207 – paragraph 1 – subparagraph 1 (new)

Member States shall promote awareness raising and educational campaigns for the general public on the environmental risks of pharmaceuticals and on how to improve disposal practices.

Amendment 752 #

Proposal for a directive
Article 207 – paragraph 1 a (new)

1a. By ... [18 months after the date of entry into force of this Directive], Member States shall draw up national plans including measures designed to: (a) monitor the rates of correct and incorrect disposal of unused and expired medicinal products; (b) inform the general public about the environmental risks associated with incorrect disposal of medicinal products, in particular those that contain substances referred to in Article 22(2); (c) inform healthcare professionals about the environmental risks associated with incorrect disposal of unused or expired medicinal products, in particular those that contain substances referred to in Article 22(2); (d) increase the rate of correct disposal of unused or expired medicinal products; and (e) designate public and private actors responsible for the collection systems referred to in paragraph 1.

Amendment 753 #

Proposal for a directive
Article 207 – paragraph 1 a (new)

By ... [18 months after the date of entry into force of this Directive], Member States shall draw up national plans including measures designed to: (a) monitor the rates of correct and incorrect disposal of unused and expired medicinal products; (b) inform the general public about the environmental risks associated with incorrect disposal of medicinal products, in particular those that contain substances referred to in Article 22(2); (c) inform healthcare professionals about the environmental risks associated with incorrect disposal of unused or expired medicinal products, in particular those that contain substances referred to in Article 22(2); (d) increase the rate of correct disposal of unused or expired medicinal products; and (e) designate public and private actors responsible for the collection systems referred to in paragraph 1.

Amendment 754 #

Proposal for a directive
Article 207 – paragraph 1 b (new)

The national plans shall be submitted to the Commission.

Amendment 755 #

Proposal for a directive
Article 207 – paragraph 1 c (new)

From ... [five years after the date of entry into force of this Directive], the Commission is empowered to adopt delegated acts in accordance with Article 215 to amend paragraph 1a of this Article by supplementing or modifying the measures provided for in that paragraph if it is necessary to minimise the environmental risks posed by incorrect disposal of unused or expired medicinal products.

Amendment 756 #

Proposal for a directive
Article 208 – paragraph 1

1. In order to guarantee independence and transparency, the Member States shall ensure that members of staff of the competent authority responsible for granting authorisations, rapporteurs and experts concerned with the authorisation and surveillance of medicinal products have no financial or other interests in the pharmaceutical industry that could affect their impartiality and their independance. These persons shall make an annual declaration of their financial interests and update them annually and whenever necessary.

Amendment 757 #

Proposal for a directive
Article 208 – paragraph 2 a (new)

2 a. The multidisciplinarity of experts may constitute a guarantee of the independence and impartiality of their work.

Amendment 758 #

Proposal for a directive
Article 208 a (new)

Article208a Fostering research, innovation and production of medicinal products in the Union 1. The Commission shall establish an strategy to foster research, innovation and production of medicinal products in the Union, based on the results published in the report defined in paragraph 2. Member States shall be encouraged to participate in this strategy. 2. By... [one year after the date of entry into force of this Directive] the Commission shall present an impact assesment evaluating potential measures to be implemented at Union level, and at a Member State level to foster research, innovation and production of medicinal products in the Union. This report shall evaluate the effect of measures such as (a) funding and push and pull incentives directed to foster research and innovation in the Union, including public and private funding for preclinical and clinical research and innovation (b) public-private partnerships in research and innovation (c) regulatory support for public research and innovation entities (d) establishment of a public medicinal product production facility for products with low commertial interests (e) incentives for production inside the Union. Proposed measures shall be in line with developing a strategic autonomy for the Union regarding medicinal products.

Amendment 759 #

Proposal for a directive
Article 215 – paragraph 2 – subparagraph 1

The power to adopt delegated acts referred to in Articles 4(2), 24(5), 25(9), 26(3), 2~~8, paragraphs 2 and 3, 27(3~~6a(4), 27(3), 28(2) and (3), 58a(1), 63(54a), 65(2), 67(2), 88(1), 92(4), 126(1), 150(3), 153(4), 161, 207(1c), 210(4) and 213 shall be conferred on the Commission for a period of five years from [OP please insert the date of the entry into force of this Directive]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.

Amendment 76 #

Proposal for a directive
Recital 51 a (new)

(51 a) Repurposing of off-patent medicines to develop new therapeutic options should also be incentived as it can expand access to patients and reduce health inequalities

Amendment 760 #

Proposal for a directive
Article 215 – paragraph 3

3. The delegation of power referred to in Articles 4(2), 24(5), 25(9), 26(3), 2~~7(3), 28, paragraphs 2 and 3~~6a(4), 27(3), 28(2) and (3), 58a(1), 63(54a), 65(2), 67(2), 88(1), 92(4), 126(1), 150(3), 153(4), 161, 207(1c), 210(4) and 213 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

Amendment 761 #

Proposal for a directive
Article 215 – paragraph 6

6. A delegated act adopted pursuant to Articles 6(2), 26(3), 24(5), 2~~8, paragraphs 2 and 3, 27(3~~6a(4), 27(3), 28(2) and (3), 58a(1), 63(54a), 65(2), 67(2), 88(1), 92(4), 126(1), 150(3), 153(4), 161, 207(1c), 210(4) and 213 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.

Amendment 762 #

Proposal for a directive
Article 216 – paragraph 1

Amendment 763 #

Proposal for a directive
Annex IV – paragraph 1 – point a

(a) the name of the medicinal product, including in Braille, followed by its strength and pharmaceutical form, and, if appropriate, whether it is intended for babies, children or adults; where the medicinal product contains up to three active substances, the international non- proprietary name (INN) shall be included, unless it is already part of the name of the medicinal product, or, if one does not exist, the common name;

Amendment 764 #

Proposal for a directive
Annex VI – paragraph 1 – point 2 a (new)

(2 a) a key information section reflecting the results of consultations with patients’ organisations to ensure that the leaflet is legible, clear and easy to use;

Amendment 765 #

Proposal for a directive
Annex VI – paragraph 1 – point 8 a (new)

(8 a) for products containing substances classified based on Annex I of Regulation (EC) No 1272/2008 as persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), persistent, mobile and toxic (PMT), very persistent and very mobile (vPvM) or are endocrine active agents, a warning that improper use and disposal of the medicinal product, inter alia through toilets, contributes to deteriorating the aquatic environmen[A1] t. [A1]Justification: Patients, healthcare professionals and pharmacists must be informed of the impact on the aquatic environment of products containing PBT, vPvB, PMT and vPvM substances, as well as endocrine disruptors, so they dispose properly of products and can make informed choices between alternative treatments.

Amendment 77 #

Proposal for a directive
Recital 51 a (new)

(51 a) Repurposing of off-patent medicines to develop new therapeutic options should also be incentived as it can expand access to patients and reduce health inequalities.

Amendment 78 #

Proposal for a directive
Recital 52

Amendment 79 #

Proposal for a directive
Recital 52

Amendment 80 #

Proposal for a directive
Recital 52

(52) For the ~~initial~~ marketing authorisation application for medicinal products containing a new active substance, the submission of clinical trials that include as a comparator an evidence- based existing treatment should be incentivised, in order to foster the generation of comparative clinical evidence that is relevant and can accordingly support subsequent health technology assessments and decisions on pricing and reimbursement by Member States.

Amendment 81 #

Proposal for a directive
Recital 52 a (new)

(52 a) (51 a) Repurposing of off-patent medicines to develop new therapeutic options should also be incentivised as it can expand access in an affordable manner, providing significant benefits to patients;

Amendment 82 #

Proposal for a directive
Recital 53

Amendment 83 #

Proposal for a directive
Recital 53

(53) A marketing authorisation holder should, within its responsibilities, ensure the appropriate and continuous supply of a medicinal product throughout its lifetime ~~irrespective of whether that medicinal product is covered by a supply incentive or not~~.

Amendment 84 #

Proposal for a directive
Recital 53

(53) A marketing authorisation holder should ~~ensure the appropriate and continuous supply of a medicinal product throughout its lifetime irrespective of whether that medicinal product is covered by a supply incentive or not.~~, within the scope of its control, be responsible for ensuring the consistent and proper supply of a medicinal product throughout its lifetime,

Amendment 85 #

Proposal for a directive
Recital 53 a (new)

(53 a) It is imperative in negotiations between developers and Member States to respect and adhere to the timelines set out by Directive 89/105/EEC, to accelerate and widen the availability of innovative therapies to patients.

Amendment 86 #

Proposal for a directive
Recital 54

(54) Micro, small and medium-sized enterprises (‘SMEs’), not-for-profit entities or entities with limited experience in the Union system should benefit from additional time to market a medicinal product in the Member States where the marketing authorisation is valid ~~for the purposes of receiving additional regulatory data protection~~.

Amendment 87 #

Proposal for a directive
Recital 54

(54) Micro, small and medium-sized enterprises (‘SMEs’), not-for-profit entities or entities with limited experience in the Union system should benefit from additional time to ~~market~~submit an application for pricing and reimbursement for a medicinal product in the Member States where the marketing authorisation is valid ~~for the purposes of receiving additional regulatory data protection~~, and where a Member State has requested it.

Amendment 88 #

Proposal for a directive
Recital 55

Amendment 89 #

Proposal for a directive
Recital 55

Amendment 90 #

Proposal for a directive
Recital 56

Amendment 91 #

Proposal for a directive
Recital 56

(56) Member States have the possibility to waive the condition of launch in their territory for the purpose of the prolongation of data protection for market launch. This can be done through a statement of non-objection to prolong the period of regulatory data protection. This is expected to be the case particularly in situations where launch in a particular Member State is materially impossible or because there are special reasons why a Member State wishes that launch take place later. In the case where a Member State does not react to the application by the marketing authoirsation holder within the deadline provided, it shall be considered that a statement of non objection has been provided and the condition in that Member State should be waived. The Commission should ensure that marketing authorisation holders are not unduly prevented from receiving the incentives for actions beyond their control.

Amendment 92 #

Proposal for a directive
Recital 56

(56) Member States have the possibility to ~~waive the condition of launch in their territor~~request a market launch of a centrally for the purpose of the prolongation of data protection for market launch. This can be done through a statement of non-objection to prolong the period of regulatory data protection. This is expected to be the case particularly in situations where launch in a particular Member State is materially impossible or because there are special reasons why a Member State wishes that launch take place ldecentrally approved product at any time after the marketing authorisation is valid in their Member State. Subsequently, marketing authorisation holders have nine months to apply for a pricing and reimbursement in that Member State, 18 months where the marketing authorisation holder is a SME, an entitiy not engaged in economic activity or an entity with limited experience in the Union system. Alternative timelines may be agreed between the Member State and the marketing authorisation holder. Marketing authorisation holders have the right to launch a product in a Member State before beign proactively approached by that Member Stater.

Amendment 93 #

Proposal for a directive
Recital 57

Amendment 94 #

Proposal for a directive
Recital 58

(58) An alternative way of demonstrating supply relates to the inclusion of medicinal products in a positive list of medicinal products covered by the national health insurance system in accordance with Directive 89/105/EEC. The related negotiations between companies and the Member State should be conducted in good faith. Equally, to promote faster and wider access to medicines, it is critical that the timelines set out in that Directive are respected in negotiations between applicants and Member States, and that negotiations are conducted in good faith.

Amendment 95 #

Proposal for a directive
Recital 58

Amendment 96 #

Proposal for a directive
Recital 58 a (new)

(58 a) Cross-border healthcare is an important pathway for patients to access medicinal products that might otherwise not be available to them. To support access to medicinal products, in particular in the case of small patient populations or where the administration of a medicine requires special competences or infrastructure, the full implementation of Directive 2011/24/EU of the European Parliament and of the Council1a should be supported. It is important to consider in that regard all alternative paths of making available medicinal products to patients and prescribing doctors, such as named patient supply, administering of medicine via a centre of excellence, early access or compassionate use programs, and other cross-border healthcare. Competent authorities of the Member States should therefore utilise the NCAPR to exchange and share best practice regarding the implementation of cross-border access agreements and negotiations. _________________ 1a Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45).

Amendment 97 #

Proposal for a directive
Recital 58 a (new)

(58 a) Small patient populations, especially paediatric or rare disease ones, are often the most disadvantaged when it comes to access to medicines. In this regard, Directive 2011/24/EU shall be considered as an alternative pathway of making available medicinal products to patients, who need paediatric, orphan medicinal products or advanced therapy medicinal products. The medicines can be administered via a center of excellence, early access or compassionate use programs, or other cross-border healthcare services.

Amendment 98 #

Proposal for a directive
Recital 58 a (new)

Amendment 99 #