26 Amendments of Ulrike MÜLLER related to 2014/0257(COD)
Amendment 105 #
Proposal for a regulation
Article 4 – paragraph 1 – point 11 – introductory part
Article 4 – paragraph 1 – point 11 – introductory part
(11) ‘benefit-risk balance’ means an evaluation of the positive effects of the veterinary medicinalrisk of damage to animal health caused by the absence of the product in relation to the following risks relating to the use of that product:
Amendment 122 #
Proposal for a regulation
Recital 18
Recital 18
(18) Member States should be able to allow exceptional use of veterinary medicinal products without a marketing authorisation where it is necessary to respond to Union listed diseases or new diseases and where the health situation in a Member State so requires.
Amendment 132 #
Proposal for a regulation
Article 8 – paragraph 2 – point b a (new)
Article 8 – paragraph 2 – point b a (new)
(ba) a provisional maximum residue limit has been established for the tested product.
Amendment 138 #
Proposal for a regulation
Article 9 – paragraph 1 – point g a (new)
Article 9 – paragraph 1 – point g a (new)
(ga) a barcode containing all the information listed in paragraph 1, points (a) to (g), and enabling this information and the information contained in the package leaflet to be provided electronically in a readable form and in all languages at the place of treatment, and making the data available for other documentation systems through standard interfaces.
Amendment 143 #
Proposal for a regulation
Article 10 – paragraph 1 – point g a (new)
Article 10 – paragraph 1 – point g a (new)
(ga) waiting times.
Amendment 148 #
Proposal for a regulation
Article 12 – paragraph 1 a – point m a (new)
Article 12 – paragraph 1 a – point m a (new)
(ma) the barcode referred to in Article 9(1)(ga).
Amendment 149 #
Proposal for a regulation
Article 12 – paragraph 3
Article 12 – paragraph 3
3. The package leaflet shall be written and designed to be clear, readable and understandable, in terms that are comprehensible to the general public.
Amendment 153 #
Proposal for a regulation
Article 16 – paragraph 2
Article 16 – paragraph 2
2. For the purpose of this Section, where the active substance consists of salts, esters, ethers, isomers and mixtures of isomers, complexes or derivatives differing from the active substance used in the reference veterinary medicinal product, it shall be considered to be the same active substance as that used in the reference veterinary medicinal product, unless it differs significantly in respect of properties with regard to safety or, efficacy and residue behaviour. Where it differs significantly in respect of those properties, the applicant shall submit additional information in order to prove the safety and/or efficacy of the various salts, esters or derivatives of the authorised active substance of the reference veterinary medicinal product.
Amendment 155 #
Proposal for a regulation
Recital 37
Recital 37
(37) In order to preserve as long as possible the efficacy of certain antimicrobials in the treatment of infections in humans, it may be necessary to reserve those antimicrobials for humans onlythose antimicrobials should be used on a tightly restricted basis. Therefore it should be possible to decide that the use of certain antimicrobials, following the scientific recommendations of the Agency, should not be available on the market in the veterinary sectorbe made contingent on the existence of an antibiogram which shows that the antimicrobial in question is essential to the treatment of a given animal disease.
Amendment 189 #
Proposal for a regulation
Article 32 – paragraph 1 – point c
Article 32 – paragraph 1 – point c
(c) the product is a zootechnical veterinary medicinal product or a performance enhancer, and the applicant has not sufficiently demonstrated the benefits of the product to the animal health and welfare or public health;
Amendment 191 #
Proposal for a regulation
Article 32 – paragraph 1 – point g
Article 32 – paragraph 1 – point g
(g) risk for public health in case of development ofoutweighs the risk of damage to antimicrobial resistance outweighs the benefitsal health caused by the absence of thea product to animal health;
Amendment 196 #
Proposal for a regulation
Article 32 – paragraph 2
Article 32 – paragraph 2
Amendment 198 #
Proposal for a regulation
Article 32 – paragraph 3
Article 32 – paragraph 3
Amendment 203 #
Proposal for a regulation
Article 32 – paragraph 4
Article 32 – paragraph 4
Amendment 208 #
Proposal for a regulation
Article 33 – paragraph 3
Article 33 – paragraph 3
3. Any marketing authorisation or variation to the terms of a marketing authorisation differing from the previously granted marketing authorisation only with regard to strengths, pharmaceutical forms, administration routes or presentations shall be regarded as the same marketing authorisation as the one previously granted for the purpose of applying the rules of the protection of technical documentation.
Amendment 221 #
Proposal for a regulation
Article 34 – paragraph 2 a (new)
Article 34 – paragraph 2 a (new)
2a. The period shall be extended in line with the prolongation periods provided for in Article 35 where the veterinary medicinal product has been authorised for more than one species.
Amendment 225 #
Proposal for a regulation
Article 35 – paragraph 1
Article 35 – paragraph 1
1. Where 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, 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).
Amendment 356 #
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.
Amendment 400 #
Proposal for a regulation
Article 115 – paragraph 1 – point a – point iii
Article 115 – paragraph 1 – point a – point iii
(iii) a medicinal product for human use authorised in the Member State concerned in accordance with Directive 2001/83/EC of the European Parliament and of the Council30 or Regulation (EC) No 726/2004; if no medicinal product as referred to in letter (a)(i) or (ii) can be used. __________________ 30 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
Amendment 409 #
Proposal for a regulation
Article 116 – paragraph 1 – point c
Article 116 – paragraph 1 – point c
(c) a medicinal product for human use authorised in the Member State concerned in accordance with Directive 2001/83/EC or under Regulation (EC) No 726/2004, or in cases where an authorised veterinary medicinal product as referred to in letters (a) and (b) cannot be used.
Amendment 422 #
Proposal for a regulation
Article 32 – paragraph 2
Article 32 – paragraph 2
Amendment 425 #
Proposal for a regulation
Article 32 – paragraph 3
Article 32 – paragraph 3
Amendment 655 #
Proposal for a regulation
Article 82 – paragraph 1
Article 82 – paragraph 1
1. Before the expiry of the period of validity of 3 years, mMarketing 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 years.
Amendment 769 #
Proposal for a regulation
Article 110 – paragraph 3 a (new)
Article 110 – paragraph 3 a (new)
3a. Methaphylactic use of antibiotics may be allowed in cases where the diagnosis of clinical disease has been established or the agent responsible for subclinical disease has been identified by appropriate testing.
Amendment 829 #
Proposal for a regulation
Article 115 – paragraph 1 a (new)
Article 115 – paragraph 1 a (new)
1a. Homoeopathic veterinary medicinal products may be given to non-food producing animals by way of derogation from paragraph 1.
Amendment 864 #
Proposal for a regulation
Article 116 – paragraph 3 a (new)
Article 116 – paragraph 3 a (new)
3a. By way of derogation from paragraphs 1 to 3, homoeopathic veterinary medicinal products may be administered to treat food-producing animals under the responsibility of the veterinarian provided that they exclusively contain active ingredients listed in Table 1 of Regulation (EU) No 37/2010 as substances for which no maximum limit needs to be set.