Activities of Bas BELDER 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 (15)
Amendment 36 #
Proposal for a regulation
Recital 6
Recital 6
(6) ADespite the measures that farmers take on good hygiene, feed, management and biosecurity, animals may suffer from a broad range of diseases which canneed to be prevented or treated by veterinary medicinal products for both animal health and welfare reasons. The impact of animal diseases and the measures necessary to control them can be devastating for individual animals, animal populations, animal keepers and the economy. Animal diseases transmissible to humans may also have a significant impact on public health. Therefore sufficient and effective veterinary medicinal products should be available in the Union in order to ensure high standards of animal and public health, and for the development of the agriculture and aquaculture sectors.
Amendment 46 #
Proposal for a regulation
Recital 25
Recital 25
(25) Tests, pre-clinical studies and clinical trials represent a major investment for companies which they need to make in order to submit the necessary data with the application for a marketing authorisation or to establish a maximum residue limit for pharmaceutical active substances in the veterinary medicinal product. That investment should be protected in order to stimulate research and innovation, in particular on veterinary medicinal products for minor species and antimicrobials, so that it is ensured the necessary veterinary medicinal products are available in the Union. For that reason data submitted to a competent authority or the Agency should be protected against use by other applicants. That protection should, however, be limited in time in order to allow competition.
Amendment 53 #
Proposal for a regulation
Recital 33
Recital 33
(33) Antimicrobial resistance to human and veterinary medicinal products is a growing health problem in the Union and worldwide, thus involving a common responsibility of Member States and all relevant actors. Many of the antimicrobials used in animals are also used in humans. Some of those antimicrobials are critical for preventing or treating life-threatening infections in humans. In order to fight antimicrobial resistance a number of measures should be taken. It needs to be ensured that appropriate warnings and guidance are included on the labels of veterinary antimicrobials. Use not covered by the terms of the marketing authorisation of certain new or critically important antimicrobials for humans should be restricted in the veterinary sector. The rules for advertising veterinary antimicrobials should be tightened, and the authorisation requirements should sufficiently address the risks and benefits of antimicrobial veterinary medicinal products.
Amendment 103 #
Proposal for a regulation
Article 4 – paragraph 1 – point 8 a (new)
Article 4 – paragraph 1 – point 8 a (new)
(8a) ‘antimicrobial': an active substance of synthetic or natural origin which destroys microorganisms, suppresses their growth or their ability to reproduce in animals or humans;
Amendment 202 #
Proposal for a regulation
Article 32 – paragraph 3
Article 32 – paragraph 3
3. The Commission shall be empowered to adopt delegated acts in accordance with Article 146 and based on the latest scientific advice in order to establish rules for the designation of the antimicrobials which are to be reserved for treatment of certain infections in humans in order to preserve the efficacy of certain active substances in humans. The Commission, when establishing these rules, will make decisions on appropriate risk management measures at the class, substance or even the indication level and will consider also the route of administration.
Amendment 207 #
Proposal for a regulation
Article 32 – paragraph 4
Article 32 – paragraph 4
4. The Commission shall, by means of implementing acts, designate antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2). The Commission, when establishing these rules, will make decisions on appropriate risk management measures at the class, substance or even the indication level and will consider also the route of administration.
Amendment 212 #
Proposal for a regulation
Article 34 – paragraph 1 – point b
Article 34 – paragraph 1 – point b
(b) 148 years for antimicrobial veterinary medicinal products for cattle, sheep, pigs, chickens, dogs and cats containing an antimicrobial active substance which has not been an active substance in a veterinary medicinal product authorised within the Union on the date of the submission of the application;
Amendment 223 #
Proposal for a regulation
Article 35 – paragraph 1
Article 35 – paragraph 1
1. Where the first marketing authorisation is granted for more than one species or a variation is approved in accordance with Article 65 extending the marketing authorisation to another species listed in Article 34(1)(a), the periods of the protection provided for in that Article 34 shall be prolonged by 12 years for each additional target species listed in Article 34(1)(a), provided that the variation has been submitted at least 3 years before the expiration of the protection periods laid down in Article 34(1)(a).
Amendment 231 #
Proposal for a regulation
Article 35 – paragraph 2
Article 35 – paragraph 2
2. Where the first marketing authorisation is granted for more than one species or 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 periods of the protection provided for in Article 34 shall be prolonged by 4 years for each additional target species not listed in Article 34(1)(a).
Amendment 237 #
Proposal for a regulation
Article 35 a (new)
Article 35 a (new)
Article 35 a Data protection for redevelopment of veterinary medicinal products Where the data protection period as set out in Articles 34 and 35 has elapsed, any applicant may apply for a data protection period for additional innovations to existing veterinary medicinal products, which shall amount to two years for an additional species and one year for an additional indication, additional pharmaceutical form or new withdrawal period.
Amendment 243 #
Proposal for a regulation
Article 38 – paragraph 3
Article 38 – paragraph 3
3. For veterinary medicinal products other than those listed in paragraph 2 a centralised marketing authorisation may be granted if no other marketing authorisation has been granted for the veterinary medicinal product within the Union or if the application concerns a conversion of a marketing authorisation as referred to in Article 57a.
Amendment 258 #
Proposal for a regulation
Article 49 – paragraph 1
Article 49 – paragraph 1
1. If a Member State raises, within the time period referred to in Article 46(4) or Article 48(5) its objections to the assessment report, proposed summary of product characteristics or proposed labelling and package leaflet, on grounds of a potential serious risk to human or animal health or to the environment, a detailed statement of the reasons shall be provided to the reference Member State, the other Member States and the applicant. The points of disagreement shall be referred without delay to the coordination group for mutual recognition and decentralised procedures set up by Article 142 (‘the coordination group'’) by the reference Member State.
Amendment 260 #
Proposal for a regulation
Article 49 – paragraph 4
Article 49 – paragraph 4
4. In the event of an opinion in favour of granting or amending a marketing authorisation, the reference Member State shall record the agreement of Member States, close the procedure and inform Member States and the applicant accordingly.
Amendment 270 #
Proposal for a regulation
Article 54 – paragraph 1
Article 54 – paragraph 1
1. Member States shall collect relevant and comparable data on the volume of sales and, the use of veterinary antimicrobial medicinal products and data on antimicrobial resistant organisms in animals.
Amendment 281 #
Proposal for a regulation
Article 57 a (new)
Article 57 a (new)
Article 57a Subsequent conversion into centralised marketing authorisation 1. After completion of a decentralised procedure laid down in Article 46, a mutual recognition procedure laid down in Article 48, or a marketing authorisation harmonisation procedure laid down in Article 69, the marketing authorisation holder may submit an application to convert the existing marketing authorisations for the veterinary medicinal product into a centralised marketing authorisation granted by the Commission and which shall be valid throughout the Union. 2. The application for the conversion into a centralised marketing authorisation shall be submitted to the Agency and shall include the following: (a) a list of all decisions granting marketing authorisations concerning this veterinary medicinal product; (b) a list of variations introduced since the first marketing authorisation in the Union was granted; (c) a summary report on pharmacovigilance data. 3. Within 30 days of receipt of the documents listed in paragraph 2, the Commission shall prepare a draft of the decision granting the Union marketing authorisation in conformity with the assessment report referred to in Articles 46(3), 48(4) and 69(3) or, where appropriate, an updated assessment report, summary of the product characteristics, labelling and package leaflet. 4. The Commission shall, by means of implementing acts, take a final decision on the granting of the centralised marketing authorisation. This Article shall only apply to veterinary medicinal products that have been authorised through a mutual recognition procedure, decentralised procedure or marketing authorisation harmonisation procedure after the date of the application of this Regulation.