Activities of Margarita DE LA PISA CARRIÓN related to 2023/0132(COD)
Shadow opinions (1)
OPINION on the proposal for a directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC
Amendments (153)
Amendment 22 #
Proposal for a directive
Recital 3
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 39 #
Proposal for a directive
Recital 12
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 48 #
Proposal for a directive
Recital 18 a (new)
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 64 #
Proposal for a directive
Recital 49
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 70 #
Proposal for a directive
Recital 50
Recital 50
(50) The establishment ofo 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 74 #
Proposal for a directive
Recital 50 a (new)
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 76 #
Proposal for a directive
Recital 51 a (new)
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 84 #
Proposal for a directive
Recital 53
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 101 #
Proposal for a directive
Recital 61
Recital 61
Amendment 105 #
Proposal for a directive
Recital 62
Recital 62
Amendment 144 #
Proposal for a directive
Recital 74
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 172 #
Proposal for a directive
Article 1 – paragraph 2
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 industrially prepared or manufactured by a method involving an industrial process.
Amendment 175 #
Proposal for a directive
Article 1 – paragraph 6
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 176 #
Proposal for a directive
Article 1 – paragraph 6 a (new)
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 188 #
Proposal for a directive
Article 2 – paragraph 4
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 192 #
Proposal for a directive
Article 2 – paragraph 5
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 196 #
Proposal for a directive
Article 2 – paragraph 6
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 public repository of that data.
Amendment 205 #
Proposal for a directive
Article 2 – paragraph 8
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 209 #
Proposal for a directive
Article 3 – paragraph 2
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 210 #
Proposal for a directive
Article 3 – paragraph 3
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 consequenceswill 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 orofficiatly 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 235 #
Proposal for a directive
Article 4 – paragraph 1 – point 39
Article 4 – paragraph 1 – point 39
(39) ‘medicinal'Prescription' means a prescription’ means any for a medicinal prescriptionoduct 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 238 #
Proposal for a directive
Article 4 – paragraph 1 – point 61 a (new)
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 244 #
Proposal for a directive
Article 6 – paragraph 6 a (new)
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 248 #
Proposal for a directive
Article 11 – paragraph 1
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 249 #
Proposal for a directive
Article 11 – paragraph 1 a (new)
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 250 #
Proposal for a directive
Article 12
Article 12
Amendment 261 #
Proposal for a directive
Article 16 – paragraph 1
Article 16 – paragraph 1
1. A marketing authorisation shall be required for radionuclidepharmaceuticals 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 262 #
Proposal for a directive
Article 16 – paragraph 2
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, kitsusing an authorised kit for radiopharmaceutical preparation in combination with a radionuclide or radionuclide precursgenerators in accordance with the manufacturer's instructionssummary of product characteristics of the kit ('kit-radiolabelling').
Amendment 270 #
Proposal for a directive
Article 18 – paragraph 3
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 documentationevidence 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 271 #
Proposal for a directive
Article 18 – paragraph 4
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 authoritiesy shall recognise the results of the assessment of compliance of the medical device part of that integral combinationconcerned 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
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 276 #
Proposal for a directive
Article 22 – paragraph 1
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 280 #
Proposal for a directive
Article 22 – paragraph 2 – point c
Article 22 – paragraph 2 – point c
(c) persistent, mobile and toxic (PMT), very persistent and very mobile (vPvM);
Amendment 282 #
Proposal for a directive
Article 22 – paragraph 2 – point c a (new)
Article 22 – paragraph 2 – point c a (new)
(c a) very persistent and very mobile (vPvM);
Amendment 291 #
Proposal for a directive
Article 22 – paragraph 3
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 295 #
Proposal for a directive
Article 22 – paragraph 4
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 antimicrobialbiotic taking into account, where relevant, the existing international standards that have established predicted no effect concentration (PNECs) specific for antibiotics.
Amendment 321 #
Proposal for a directive
Article 23 – paragraph 2
Article 23 – paragraph 2
2. The Agency shall set the scientific criteria for the identification of the medicinal products as potentially harmfulthat 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 336 #
Proposal for a directive
Recital 74
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 370 #
Proposal for a directive
Article 42 – paragraph 5 a (new)
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 372 #
Proposal for a directive
Article 43 – paragraph 4
Article 43 – paragraph 4
4. The competerelevant authority ofin the Member State may consider and decide upon additional evidence available, independently from the data submitted byhas 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 productThe 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
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 377 #
Proposal for a directive
Article 47 – paragraph 1 – point d
Article 47 – paragraph 1 – point d
Amendment 384 #
Proposal for a directive
Article 51 – paragraph 1 – point e
Article 51 – paragraph 1 – point e
(e) is an antimicrobial for systemic use; or
Amendment 386 #
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 390 #
Proposal for a directive
Article 56 – paragraph 3 – subparagraph 1
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 392 #
Proposal for a directive
Article 56 – paragraph 3 – subparagraph 1
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 397 #
Proposal for a directive
Article 56 – paragraph 9
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 402 #
Proposal for a directive
Article 1 – paragraph 6
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)
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 418 #
Proposal for a directive
Article 58 – paragraph 1
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 428 #
Proposal for a directive
Article 63 – paragraph 3
Article 63 – paragraph 3
3. Member States may decidshall ensure that the package leaflet shall be maderospectus is available in paper format orand electronically, 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 format 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 441 #
Proposal for a directive
Article 2 – paragraph 4
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 445 #
Proposal for a directive
Article 63 – paragraph 5
Article 63 – paragraph 5
Amendment 448 #
Proposal for a directive
Article 2 – paragraph 5
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 454 #
Proposal for a directive
Article 63 – paragraph 6
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 457 #
Proposal for a directive
Article 2 – paragraph 6
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 public repository of that data.
Amendment 464 #
Proposal for a directive
Article 63 – paragraph 7
Article 63 – paragraph 7
7. Wheren the package leaflet is maderospectus is available electronically, the individual International Directorate’s right to privacy shall be ensurguaranteed. Any technology givproviding 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 individualmonitoring of persons, nor shall it be used for commercial purposes., including advertising and marketing activities
Amendment 469 #
Proposal for a directive
Article 63 – paragraph 7 a (new)
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 472 #
Proposal for a directive
Article 2 – paragraph 8
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 475 #
Proposal for a directive
Article 66 – paragraph 3 – point a
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)
Article 66 – paragraph 3 – point a a (new)
(a a) Pharmaceutical form
Amendment 477 #
Proposal for a directive
Article 66 – paragraph 3 – point b
Article 66 – paragraph 3 – point b
(b) the methodroute of administration;
Amendment 481 #
Proposal for a directive
Article 3 – paragraph 2
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 481 #
Proposal for a directive
Article 67 – paragraph 6
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 repositoriesy system referred to paragraph 2, second subparagraph, point (in the second subparagraph of paragraph 2, letter e).
Amendment 482 #
Proposal for a directive
Article 3 – paragraph 3
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 consequenceswill 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 orofficially 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 67 – paragraph 7 a (new)
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 500 #
Proposal for a directive
Article 80 – paragraph 4
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 Unionthe 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 licencefor 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 502 #
Proposal for a directive
Article 4 – paragraph 1 – point 28
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 505 #
Proposal for a directive
Article 81 – paragraph 1
Article 81 – paragraph 1
1. The regulatory data protection period shall be sixnine 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 513 #
Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point a
Article 81 – paragraph 2 – subparagraph 1 – point a
Amendment 523 #
Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point b
Article 81 – paragraph 2 – subparagraph 1 – point b
(b) sixeighteen 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 4 – paragraph 1 – point 33
Article 4 – paragraph 1 – point 33
(33) ‘environmental risk assessment’ means the evaluation of the riskspotential 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 antimicrobialbiotic mode of action, the ERA also encompasses an evaluation of the risk for antimicrobialbiotic resistance selection in the environment due to the manufacturing, use and disposal of that medicinal product;
Amendment 529 #
Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point c
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 initialA 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 530 #
Proposal for a directive
Article 4 – paragraph 1 – point 39
Article 4 – paragraph 1 – point 39
(39) ‘medicinal'Prescription' means a prescription’ means any for a medicinal prescriptionoduct 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 533 #
Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point d a (new)
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 536 #
Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point d b (new)
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 4 – paragraph 1 – point 61 b (new)
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 540 #
Proposal for a directive
Article 81 – paragraph 2 – subparagraph 2
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 authorisathroughout 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 542 #
Proposal for a directive
Article 81 – paragraph 2 – subparagraph 3
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 4 – paragraph 1 – point 70 a (new)
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 547 #
Proposal for a directive
Article 82
Article 82
Amendment 562 #
Proposal for a directive
Article 6 – paragraph 7 a (new)
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 566 #
Proposal for a directive
Article 11 – paragraph 1
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)
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
Article 12
Amendment 570 #
Proposal for a directive
Article 82 a (new)
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 572 #
Proposal for a directive
Article 82 b (new)
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 574 #
Proposal for a directive
Article 83 – paragraph 1 – introductory part
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 578 #
Proposal for a directive
Article 16 – paragraph 1
Article 16 – paragraph 1
1. A marketing authorisation shall be required for radionuclidepharmaceuticals 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 580 #
Proposal for a directive
Article 16 – paragraph 2
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, kitsusing an authorised kit for radiopharmaceutical preparation in combination with a radionuclide or radionuclide precursgenerators in accordance with the manufacturer's instructionssummary of product characteristics of the kit ('kit-radiolabelling').
Amendment 582 #
Proposal for a directive
Article 83 – paragraph 1 – point a
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 589 #
Proposal for a directive
Article 83 – paragraph 1 – point b
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 593 #
Proposal for a directive
Article 83 – paragraph 1 – point b a (new)
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)
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)
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 598 #
Proposal for a directive
Article 83 – paragraph 3
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 600 #
Proposal for a directive
Article 18 – paragraph 3
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 documentationevidence 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 603 #
Proposal for a directive
Article 19 – paragraph 4
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 610 #
Proposal for a directive
Article 22 – paragraph 1
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 613 #
Proposal for a directive
Article 22 – paragraph 2 – point c
Article 22 – paragraph 2 – point c
(c) persistent, mobile and toxic (PMT), very persistent and very mobile (vPvM);
Amendment 614 #
Proposal for a directive
Article 22 – paragraph 2 – point c a (new)
Article 22 – paragraph 2 – point c a (new)
(c a) very persistent and very mobile (vPvM);
Amendment 624 #
Proposal for a directive
Article 22 – paragraph 3
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 630 #
Proposal for a directive
Article 85 – paragraph 1 – point a – introductory part
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 632 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point i
Article 85 – paragraph 1 – point a – point i
(i) a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medifor commercinal products and for subsequent variationsuse;
Amendment 633 #
Proposal for a directive
Article 22 – paragraph 4
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 antimicrobialbiotic taking into account, where relevant, the existing international standards that have established predicted no effect concentration (PNECs) specific for antibiotics.
Amendment 641 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point iii
Article 85 – paragraph 1 – point a – point iii
Amendment 661 #
Proposal for a directive
Article 23 – paragraph 2
Article 23 – paragraph 2
2. The Agency shall set the scientific criteria for the identification of the medicinal products as potentially harmfulrisk 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 85 – paragraph 1 – point b
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 674 #
Proposal for a directive
Article 86 – paragraph 1 – subparagraph 1 a (new)
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
Article 86 – paragraph 1 – subparagraph 2
The first subis 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)
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 678 #
Proposal for a directive
Article 87 – paragraph 1 – subparagraph 1 – point c – paragraph 1
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 antimicrobialand/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 679 #
Proposal for a directive
Article 89 – paragraph 1
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 680 #
Proposal for a directive
Article 92 – paragraph 3
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 707 #
Proposal for a directive
Article 166 – paragraph 1 – point c
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
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 713 #
Proposal for a directive
Article 167 – paragraph 1
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 720 #
Proposal for a directive
Article 175 – paragraph 2 – point d a (new)
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 722 #
Proposal for a directive
Article 177 – paragraph 1 – point b a (new)
Article 177 – paragraph 1 – point b a (new)
(b a) are antibiotics
Amendment 723 #
Proposal for a directive
Article 42 – paragraph 1 – subparagraph 5 a (new)
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 723 #
Proposal for a directive
Article 177 – paragraph 2
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 practithealth 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
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 727 #
Proposal for a directive
Article 43 – paragraph 4
Article 43 – paragraph 4
4. The competerelevant authority ofin the Member State may consider and decide upon additional evidence available, independently from the data submitted byhas 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 727 #
Proposal for a directive
Article 185 – paragraph 1 – point g
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 43 – paragraph 5
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 734 #
Proposal for a directive
Article 195 – paragraph 2
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 759 #
Proposal for a directive
Article 47 – paragraph 1 – point d
Article 47 – paragraph 1 – point d
Amendment 774 #
Proposal for a directive
Article 51 – paragraph 1 – point e
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
Article 51 – paragraph 1 – point e
(e) is an antimicrobial for systemic use; or
Amendment 802 #
Proposal for a directive
Article 56 – paragraph 3 – subparagraph 1
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 808 #
Proposal for a directive
Article 56 – paragraph 9
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 #
Proposal for a directive
Article 56 – paragraph 9
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 1264 #
Proposal for a directive
Article 85 – paragraph 1 – point a – introductory part
Article 85 – paragraph 1 – point a – introductory part
(a) studies, and trials and other activities conductneeded to generate data for an application, for:
Amendment 1270 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point i
Article 85 – paragraph 1 – point a – point i
(i) a marketingmedical authoriszation of generic, biosimilar, hybrid or bio-hybrid medifor comercinal products and for subsequent varizations;
Amendment 1288 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point iii
Article 85 – paragraph 1 – point a – point iii
Amendment 1325 #
Proposal for a directive
Article 85 – paragraph 1 – point b
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 1349 #
Proposal for a directive
Article 86 – paragraph 1 – subparagraph 1
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 1351 #
Proposal for a directive
Article 86 – paragraph 1 – subparagraph 1 a (new)
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 1356 #
Proposal for a directive
Article 87 – paragraph 1 – subparagraph 1 – point c – paragraph 1
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 antimicrobialand/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 1367 #
Proposal for a directive
Article 92 – paragraph 3
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 1446 #
Proposal for a directive
Article 166 – paragraph 1 – point c
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
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 1452 #
Proposal for a directive
Article 167 – paragraph 1
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 1464 #
Proposal for a directive
Article 175 – paragraph 2 – point d a (new)
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 1479 #
Proposal for a directive
Article 177 – paragraph 1 – point b a (new)
Article 177 – paragraph 1 – point b a (new)
(b a) are antibiotics.
Amendment 1481 #
Proposal for a directive
Article 177 – paragraph 1 – point b a (new)
Article 177 – paragraph 1 – point b a (new)
(b a) are antibiotics
Amendment 1487 #
Proposal for a directive
Article 177 – paragraph 2
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 practithealth 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
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 practithealth professioneral for diagnostic purposes or for the prescription or monitoring of treatment, with the advice of the pharmacist, if necessary.
Amendment 1496 #
Proposal for a directive
Article 177 – paragraph 4
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
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 1514 #
Proposal for a directive
Article 185 – paragraph 1 – point g
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
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 1547 #
Proposal for a directive
Article 195 – paragraph 2
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). .