25 Amendments of James NICHOLSON related to 2014/0257(COD)
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 130 #
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 188 #
Proposal for a regulation
Recital 56 a (new)
Recital 56 a (new)
(56a) In order to ensure that the lines of distribution and the supply of veterinary medicines are not restricted, where Member States have a legally defined, professionally qualified animal medicines advisor, they shall continue to prescribe and supply certain veterinary medicines;
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 231 #
Proposal for a regulation
Article 4 – paragraph 1 – point 7 a (new)
Article 4 – paragraph 1 – point 7 a (new)
(7a) 'antimicrobial' means an active substance of synthetic or natural origin which destroys microorganisms, suppresses their growth or their ability to reproduce in animals or humans;
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 357 #
Proposal for a regulation
Article 21 – paragraph 2
Article 21 – paragraph 2
2. By way of derogation from Article 5(2), a marketing authorisation for a limited market shall be granted for a period of 35 years. Following this period it should be renewed and remain valid for an indefinite period unless risks to animal or public health or the environment are detected.
Amendment 368 #
Proposal for a regulation
Article 22 – paragraph 1 – point c
Article 22 – paragraph 1 – point c
(c) a requirement to conduct post- authorisation studiessupply post- authorisation data based on post- authorisation studies deemed necessary on the basis of risk-benefit assessment, and on data collected from use in the field.
Amendment 432 #
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 447 #
Proposal for a regulation
Article 35 – paragraph 1
Article 35 – paragraph 1
1. Where the first marketing authorisation application relating to 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 period of the protection provided for in that Article shall be prolonged by 12 years for each additional target species, in the original dossier, or provided that the variation has been submitted at least 3 years before the expiration of the protection period laid down in Article 34(1)(a) or (d).
Amendment 452 #
Proposal for a regulation
Article 35 – paragraph 2
Article 35 – paragraph 2
2. Where the first marketing authorisation relating to 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 period of the protection provided for in Article 34(1)(a) or (d) shall be prolonged by 4 years.
Amendment 463 #
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 498 #
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.
Amendment 657 #
Proposal for a regulation
Article 82 – paragraph 1
Article 82 – paragraph 1
1. Before the expiry of the period of validity of 35 years, marketing authorisations for a limited market granted in accordance with Article 21 shall be re- examined on application from the marketing authorisation holder. After the initial re-examination, it shall be re- examined every 5 yearsremain valid for an indefinite period.
Amendment 731 #
Proposal for a regulation
Article 109 – title
Article 109 – title
Retail of prescription only veterinary medicinal products or active substances, with anabolic, anti-infectious, anti- parasitic, anti-inflammatory, hormonal or psychotropic veterinary medicinal productproperties
Amendment 737 #
Proposal for a regulation
Article 109 – paragraph 1
Article 109 – paragraph 1
1. Only manufacturers, wholesale distributors and retailers authorised specifically to do so in accordance with applicable national law shall be allowed to supply and purchase prescription only veterinary medicinal products which have anabolic, anti- infectious, anti-parasitic, anti- inflammatory, hormonal or psychotropic properties or substances which may be used as veterinary medicinal products having those properties.
Amendment 742 #
Proposal for a regulation
Article 109 – paragraph 3 – subparagraph 1 – introductory part
Article 109 – paragraph 3 – subparagraph 1 – introductory part
Those manufacturers and suppliers shall keep detailed records of the following information in respect of each purchase and sale transaction of prescription only veterinary medicinal products:
Amendment 897 #
Proposal for a regulation
Article 124 – paragraph 2
Article 124 – paragraph 2
2. The prohibition laid down in paragraph 1 shall not apply to advertising to persons permitted to prescribe or, supply or use veterinary medicinal products.