18 Amendments of Julie GIRLING related to 2014/0257(COD)
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 192 #
Proposal for a regulation
Recital 57
Recital 57
(57) The illegal sale of veterinary medicinal products to the public via the Internet may represent a threat to public and animal health, as falsified or substandard medicines may reach the public in this way. It is necessary to address this threat. Account should be taken of the fact that specific conditions for supply of medicinal products to the public have not been harmonised at Union level and, therefore,. To minimise the risks to animal and human health, the online sale of antimicrobials should be prohibited. Member States may impose conditions for supplying medicinal products to the public within the limits of the Treaty.
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 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 716 #
Proposal for a regulation
Article 108 – paragraph 1
Article 108 – paragraph 1
1. Persons permitted to supply veterinary medicinal products in accordance with Article 107(1) may offer veterinary medicinal products, including those subject to veterinary prescription but excluding antimicrobials, by means of information society services in the meaning of Directive 98/34/EC of the European Parliament and of the Council28 to natural or legal persons established in the Union under the condition that those medicinal products comply with the legislation of the destination Member State. __________________ 28 Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (OJ L 204, 21.7.1998, p. 37).
Amendment 725 #
Proposal for a regulation
Article 108 – paragraph 6
Article 108 – paragraph 6
6. The Agency shall set up a website providing information on the common logo. The Agency's website shall explicitly mention that the websites of Member States contain information on persons authorised to offer veterinary medicinal products for sale at a distance to the public by means of information society services in the Member State concerned. The Agency's website shall also link to the page on the website of the responsible body in each Member State which lists that Member State's authorised retailers.
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.