Activities of Giulia MOI related to 2014/0257(COD)
Shadow opinions (1)
OPINION on the proposal for a regulation of the European Parliament and of the Council on veterinary medicinal products
Amendments (55)
Amendment 39 #
Proposal for a regulation
Recital 7 a (new)
Recital 7 a (new)
(7a) This regulation aims at ensuring a high level of protection of both animal and human health while securing the protection of the environment. The precautionary principle should be applied and this Regulation should ensure that industry demonstrates that pharmaceutical substances or veterinary medicinal products produced or placed on the market have no harmful effects on human or animal health nor any unacceptable effects on the environment.
Amendment 97 #
Proposal for a regulation
Article 2 – paragraph 2
Article 2 – paragraph 2
2. In addition to the products referred to in paragraph 1, Chapter VI shall also apply to active substances, intermediate products and excipientactive substances used as starting materials in veterinary medicinal products.
Amendment 128 #
Proposal for a regulation
Article 7 – paragraph 2 – point b
Article 7 – paragraph 2 – point b
(b) information about risk mitigation measures to limit antimicrobial resistance development related to the use of veterinary medicinal product, including that the product is not to be used as a routine prophylactic measure in food producing animals, unless specifically authorised by CVMP.
Amendment 135 #
Proposal for a regulation
Article 9 – paragraph 1 – introductory part
Article 9 – paragraph 1 – introductory part
1. The immediate packaging of a veterinary medicinal product shall contain only the following information: only be required to contain the information set out below. Additional information consistent with Article 30 may be included where space allows.
Amendment 141 #
Proposal for a regulation
Article 10 – paragraph 1 – point f
Article 10 – paragraph 1 – point f
(f) requirement to use take-back schemes for veterinary medicinal products forspecific precautions relating to the disposal of unused veterinary medicinal products or waste materials derived from the use of such products and, if appropriate, additional precautions as regarding hazardous waste disposal of unused veterinary medicinal products or waste materials derived from the use of such products reference to any appropriate collection system in place;
Amendment 154 #
Proposal for a regulation
Article 16 – paragraph 5
Article 16 – paragraph 5
5. The clinical information of the summary of the product characteristics (as defined in Article 30(1)(c), excluding point (vi)) of the generic veterinary medicinal product shall be identical to that of the reference veterinary medicinal product. However, thatis requirement shall not apply to: (a) those parts of the summary of the product characteristics of the reference veterinary medicinal product that refer to indications or pharmaceutical forms which are still covered by patent law or protection of technical documentation (Articles 33 to 36) at the time when the generic veterinary medicinal product is authorised or (b) a subsequent amendment of the reference medicinal product.
Amendment 160 #
Proposal for a regulation
Article 17 – paragraph 1 – introductory part
Article 17 – paragraph 1 – introductory part
By way of derogation from Article 7(1)(b) an application for a marketing authorisation for a veterinary medicinal product containing a combination of active substances that have eachwhere one or more have already been used in authorised veterinary medicinal products, but have not hitherto been authorised in that combination (‘combination veterinary medicinal product'’) shall satisfy the following criteria:
Amendment 161 #
Proposal for a regulation
Article 17 – paragraph 1 – point b
Article 17 – paragraph 1 – point b
(b) the applicant can demonstrate that the veterinary medicinal product icontains a combination ofwith at least one reference veterinary medicinal products as referred to in Article 16(1)(b);
Amendment 162 #
Proposal for a regulation
Article 17 – paragraph 1 – point d
Article 17 – paragraph 1 – point d
(d) where needed, appropriate documentation on the safety of that combination is provided.
Amendment 163 #
Proposal for a regulation
Article 19 – paragraph 1
Article 19 – paragraph 1
By way of derogation from Article 16(1)(b), an applicant for a marketing authorisation for a generic veterinary medicinal product shall not be required to provide the documentation on safety and efficacy if he demonstrates in the form of a letter of access that he is allowed to use the documentation on safety and efficacy referred to in Article 7(1)(b) which is available forfor which he has a relevant letter of access to the documentation of the reference veterinary medicinal product.
Amendment 175 #
Proposal for a regulation
Article 30 – paragraph 1 – point c – point vi
Article 30 – paragraph 1 – point c – point vi
(vi) frequency and seriousness of adverse events or reactions,
Amendment 176 #
Proposal for a regulation
Article 30 – paragraph 1 – point c – point viii
Article 30 – paragraph 1 – point c – point viii
(viii) known interaction with other medicinal products and other known forms of interaction,.
Amendment 179 #
Proposal for a regulation
Article 30 – paragraph 1 – point c – point xiii
Article 30 – paragraph 1 – point c – point xiii
(xiii) special conditions for use, including restrictions on the use of antimicrobials in order to limit the risk of development of antimicrobial resistance, and specifying that the product is not to be used as a routine preventative measure in food producing animals,
Amendment 181 #
Proposal for a regulation
Article 30 – paragraph 1 – point e – point viii
Article 30 – paragraph 1 – point e – point viii
(viii) requirement to use take-back schemes for veterinary medicinal products forspecific precautions relating to the disposal of unused veterinary medicinal products or waste materials derived from the use of such products and, if appropriate, additional precautions regarding hazardous waste disposal of unused veterinary medicinal products or waste materials derived from the use of such products reference to any appropriate collection system in place;
Amendment 205 #
Proposal for a regulation
Article 2 – paragraph 2
Article 2 – paragraph 2
2. In addition to the products referred to in paragraph 1, Chapter VI shall also apply to active substances, intermediate products and excipientactive substances used as starting materials in veterinary medicinal products.
Amendment 217 #
Proposal for a regulation
Article 34 – paragraph 1 – point c
Article 34 – paragraph 1 – point c
(c) 1820 years for veterinary medicinal products for bees;
Amendment 219 #
Proposal for a regulation
Article 34 – paragraph 1 – point d
Article 34 – paragraph 1 – point d
(d) 146 years for veterinary medicinal products for animal species other than listed in paragraph 1(a) and (c).
Amendment 230 #
Proposal for a regulation
Article 35 – paragraph 2
Article 35 – paragraph 2
2. Where a variation is approved in accordance with Article 65 extending the marketing authorisation to a another species not listed in Article 34(1)(a), the period of the protection provided for in Article 34 shall be prolonged by 46 years.
Amendment 235 #
Proposal for a regulation
Article 35 – paragraph 3
Article 35 – paragraph 3
3. The period of the protection of the first marketing authorisation prolonged by any additional periods of protection due to any variations or new authorisations belonging to the same marketing authorisation ( ' 'overall period of the protection of technical documentation ' ') shall not exceed 1820 years.
Amendment 301 #
Proposal for a regulation
Article 9 – paragraph 1 – introductory part
Article 9 – paragraph 1 – introductory part
1. The immediate packaging of a veterinary medicinal product shall contain only the following information:only be required to contain the information set out below. Additional information consistent with Article 30 may be included where space allows.
Amendment 311 #
Proposal for a regulation
Article 10 – paragraph 1 – point f
Article 10 – paragraph 1 – point f
(f) requirement to use take-back schemes for veterinary medicinal products forspecific precautions relating to the disposal of unused veterinary medicinal products or waste materials derived from the use of such products and, if appropriate, additional precautions as regarding hazardous waste disposal of unused veterinary medicinal products or waste materials derived from the use of such products reference to any appropriate collection systems already in place;
Amendment 313 #
Proposal for a regulation
Article 73 – paragraph 2 – point d
Article 73 – paragraph 2 – point d
Amendment 317 #
Proposal for a regulation
Article 74 – paragraph 1
Article 74 – paragraph 1
1. The Agency shall establish and maintain a Union database on pharmacovigilance of veterinary medicinal products (the ‘pharmacovigilance database')’), linked with the Product database. The Union database shall be the sole point of receipt for adverse events submitted by the MAHs.
Amendment 318 #
Proposal for a regulation
Article 74 – paragraph 2
Article 74 – paragraph 2
2. The Agency shall, in collabornsultation with the Member States and, the Commission, and interested parties, draw up the functional specifications for the pharmacovigilance database.
Amendment 320 #
Proposal for a regulation
Article 74 – paragraph 3
Article 74 – paragraph 3
3. The Agency shall ensure that information reported to the pharmacovigilance database is uploaded and made publicly accessible in accordance with Article 75.
Amendment 322 #
Proposal for a regulation
Article 76 – paragraph 2
Article 76 – paragraph 2
2. Marketing authorisation holders shall record in the pharmacovigilance database all adverse events which were reported to them by healthcare professionals and animal holders and that occurred within the Union or in a third country with regard to their authorised veterinary medicinal products, within 30 days following the receipt of the adverse event report. Different requirements shall apply for adverse events observed in clinical trials.
Amendment 324 #
Proposal for a regulation
Article 76 – paragraph 3
Article 76 – paragraph 3
3. CIn the event of a serious safety concern, competent authorities may, on their own initiative or on request from the Agency, request the marketing authorisation holder to collect specific pharmacovigilance data, in particular regarding the use of a veterinary medicinal product in specified animal species, in the context of public and animal health, safety of the persons administering the product, and the protection of the environment. The authority shall state in detail the reasons for the request and inform other competent authorities and the Agency thereof.
Amendment 331 #
Proposal for a regulation
Article 77 – paragraph 6
Article 77 – paragraph 6
6. The marketing authorisation holder shall not communicate information regarding adverse events and potential pharmacovigilance concerns to the general public in relation to the veterinary medicinal product without giving prior notification of his intention to the competent authority or authorities having granted the marketing authorisation or to the Agency where the marketing authorisation was granted in accordance with the centralised authorisation procedure.
Amendment 332 #
Proposal for a regulation
Article 78 – paragraph 1 – point a
Article 78 – paragraph 1 – point a
(a) elaborating and maintaining a detailed description of the pharmacovigilance system used by the marketing authorisation holder with respect to the veterinary medicinal product for which the authorisation has been granted (‘pharmacovigilance system master file’) for all products under their responsibility;
Amendment 333 #
Proposal for a regulation
Article 78 – paragraph 1 – point b
Article 78 – paragraph 1 – point b
(b) allocating reference numbers to the pharmacovigilance system master file and communicating the relevant reference number of the pharmacovigilance master file of each product to the product database for each product;
Amendment 340 #
Proposal for a regulation
Article 16 – paragraph 5
Article 16 – paragraph 5
5. The clinical information in the summary of the product characteristics (as defined in Article 30(1)(c), excluding point (vi)) of the generic veterinary medicinal product shall be identical to that of the reference veterinary medicinal product. However, that requirement shall not apply to those parts of the summary of the product characteristics of the reference veterinary medicinal product that refer to indications or pharmaceutical forms which are still covered by patent law at the time when the generic veterinary medicinal product is authorised.:
Amendment 341 #
Proposal for a regulation
Article 16 – paragraph 5 – point a (new)
Article 16 – paragraph 5 – point a (new)
(a) those parts of the summary of the product characteristics of the reference veterinary medicinal product that refer to indications or pharmaceutical forms which are still covered by patent law or arrangements for the protection of technical documentation (Articles 33 to 36) at the time when authorisation is granted for the generic veterinary medicinal product or
Amendment 342 #
Proposal for a regulation
Article 16 – paragraph 5 – point b (new)
Article 16 – paragraph 5 – point b (new)
(b) any subsequent changes to the reference medicinal product.
Amendment 348 #
Proposal for a regulation
Article 17 – paragraph 1 – introductory part
Article 17 – paragraph 1 – introductory part
By way of derogation from Article 7(1)(b) an application for a marketing authorisation for a veterinary medicinal product containing a combination of active substances that have eachone or more of which have already been used in authorised veterinary medicinal products, but have not hitherto been authorised in that combination (‘combination veterinary medicinal product’) shall satisfy the following criteria:
Amendment 349 #
Proposal for a regulation
Article 17 – paragraph 1 – point b
Article 17 – paragraph 1 – point b
(b) the applicant can demonstrate that the veterinary medicinal product icontains a combination ofwith at least one reference veterinary medicinal products as referred to in Article 16(1)(b);
Amendment 350 #
Proposal for a regulation
Article 17 – paragraph 1 – point d
Article 17 – paragraph 1 – point d
(d) where necessary, appropriate documentation on the safety of that combination is provided.
Amendment 351 #
Proposal for a regulation
Article 19 – paragraph 1
Article 19 – paragraph 1
By way of derogation from Article 16(1)(b), an applicant for a marketing authorisation for a generic veterinary medicinal product shall not be required to provide the documentation oin safety and efficacy if he demonstrates in the form of a letter of access that he is allowed to use the documentation on safety and efficacy referred to in Article 7(1)(b) which is availablerespect of which he has a relevant letter of access to the documentation for the reference veterinary medicinal product.
Amendment 397 #
Proposal for a regulation
Article 115 – paragraph 1 – introductory part
Article 115 – paragraph 1 – introductory part
1. By way of derogation from Article 111, where there is no authorised veterinary medicinal product in a Member State for a condition affecting a non-food producing animal, the veterinarian responsible may, under his/her direct personal responsibility and in particular to avoid causing unacceptable suffering, exceptionally treat the animal concerned with the following, with the exception of anticrobial products used as routine prophylactic measure, unless specifically authorised by the CVMP:
Amendment 401 #
Proposal for a regulation
Article 30 – paragraph 1 – point c – point viii
Article 30 – paragraph 1 – point c – point viii
(viii) known interaction with other medicinal products and other known forms of interaction,
Amendment 407 #
Proposal for a regulation
Article 30 – paragraph 1 – point e – point viii
Article 30 – paragraph 1 – point e – point viii
(viii) requirement to use take-back schemes for veterinary medicinal products forspecific precautions relating to the disposal of unused veterinary medicinal products or waste materials derived from the use of such products and, if appropriate, additional precautions regarding hazardous waste disposal of unused veterinary medicinal products or waste materials derived from the use of such products reference to any appropriate collection system in place;
Amendment 420 #
Proposal for a regulation
Article 116 – paragraph 4 – subparagraph 1
Article 116 – paragraph 4 – subparagraph 1
The Commission may, by means of implementing acts, establish a list of veterinary medicinal products authorised in the Union for use in terrestrial animals which can be used for treatment of food- producing animals of an aquatic species in accordance with paragraph 1. This provision is strictly limited to closed aquatic systems with specific waste water treatment facilities. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
Amendment 437 #
Proposal for a regulation
Article 125 – paragraph 1
Article 125 – paragraph 1
1. Competent authorities shall performensure common controls of manufacturers, importers, marketing authorisation holders, wholesale distributors and suppliers of the veterinary medicinal products regularly, on a risk- basis, in order to verify that the requirements as set out in this Regulation are complied with.
Amendment 442 #
Proposal for a regulation
Article 34 – paragraph 1 – point c
Article 34 – paragraph 1 – point c
(c) 1820 years for veterinary medicinal products for bees;
Amendment 442 #
Proposal for a regulation
Article 125 – paragraph 4 – subparagraph 2
Article 125 – paragraph 4 – subparagraph 2
Amendment 443 #
Proposal for a regulation
Article 34 – paragraph 1 – point d
Article 34 – paragraph 1 – point d
(d) 146 years for veterinary medicinal products for animal species other than listed in paragraph 1(a) and (c).
Amendment 444 #
Proposal for a regulation
Article 125 – paragraph 6
Article 125 – paragraph 6
6. IFinal inspection reports shall be uploaded to the appropriate database, with continuous access for all competent authorities, and shall be made public.
Amendment 451 #
Proposal for a regulation
Article 35 – paragraph 2
Article 35 – paragraph 2
2. Where a variation is approved in accordance with Article 65 extending the marketing authorisation to a another species not listed in Article 34(1)(a), the period of the protection provided for in Article 34 shall be prolonged by 46 years.
Amendment 456 #
Proposal for a regulation
Article 35 – paragraph 3
Article 35 – paragraph 3
3. The period of the protection of the first marketing authorisation prolonged by any additional periods of protection due to any variations or new authorisations belonging to the same marketing authorisation ( ' 'overall period of the protection of technical documentation ' ') shall not exceed 1820 years.
Amendment 582 #
Proposal for a regulation
Article 73 – paragraph 2 – point d
Article 73 – paragraph 2 – point d
Amendment 596 #
Proposal for a regulation
Article 74 – paragraph 1
Article 74 – paragraph 1
1. The Agency shall establish and maintain a Union database on pharmacovigilance of veterinary medicinal products (the " ‘pharmacovigilance database " )’), linked with the product database. The Union database shall be the sole point of receipt for adverse events submitted by the marketing authorisation holders.
Amendment 597 #
Proposal for a regulation
Article 74 – paragraph 2
Article 74 – paragraph 2
2. The Agency shall, in collabornsultation with the Member States and, the Commission and interested parties, draw up the functional specifications for the pharmacovigilance database.
Amendment 610 #
Proposal for a regulation
Article 76 – paragraph 2
Article 76 – paragraph 2
2. Marketing authorisation holders shall record in the pharmacovigilance database all adverse events which were reported to them by healthcare professionals and animal holders and that occurred within the Union or in a third country with regard to their authorised veterinary medicinal products, within 30 days following the receipt of the adverse event report. Different requirements shall apply for adverse events observed in clinical trials.
Amendment 613 #
Proposal for a regulation
Article 76 – paragraph 3
Article 76 – paragraph 3
3. CIn the event of serious safety concerns, competent authorities may, on their own initiative or on request from the Agency, request the marketing authorisation holder to collect specific pharmacovigilance data, in particular regarding the use of a veterinary medicinal product in specified animal species, in the context of public and animal health, safety of the persons administering the product, and the protection of the environment. The authority shall state in detail the reasons for the request and inform other competent authorities and the Agency thereof.
Amendment 630 #
Proposal for a regulation
Article 78 – paragraph 1 – point a
Article 78 – paragraph 1 – point a
(a) elaborating and maintaining a detailed description of the pharmacovigilance system used by the marketing authorisation holder with respect to the veterinary medicinal product for which the authorisation has been granted (‘pharmacovigilance system master file’) for all products under their responsibility;
Amendment 632 #
Proposal for a regulation
Article 78 – paragraph 1 – point b
Article 78 – paragraph 1 – point b
(b) allocating reference numbers to the pharmacovigilance system master file and communicating the relevant reference number of the pharmacovigilance master file of each product to the product database for each product;