Activities of Elisabeth KÖSTINGER related to 2014/0257(COD)
Plenary speeches (1)
Veterinary medicinal products (A8-0046/2016 - Françoise Grossetête) DE
Amendments (10)
Amendment 44 #
Proposal for a regulation
Recital 17
Recital 17
(17) However, there may be situations where no suitable authorised veterinary medicinal product is available. In those situations, by way of exception, veterinarians should be allowed to prescribe other medicinal products to the animals under their responsibility in conformity with strict rules and in the interest of animal health or animal welfare only, whereby antimicrobial medicinal products for human use may be employed only subject to the issuing of a prescription by a vet and authorisation by the veterinary authority responsible for monitoring the work of the vet in question. In case of food-producing animals, veterinarians should ensure that an appropriate withdrawal period is prescribed, so that harmful residues of those medicinal products do not enter the food chain.
Amendment 119 #
Proposal for a regulation
Recital 17
Recital 17
(17) However, there may be situations where no suitable authorised veterinary medicinal product is available. In those situations, by way of exception, veterinarians should be allowed to prescribe other medicinal products to the animals under their responsibility in conformity with strict rules and in the interest of animal health or animal welfare only; in such cases antimicrobial medicinal products for human use may be employed only subject to the issuing of a prescription by a veterinarian and the granting of authorisation by the veterinary authority responsible for monitoring the work of the veterinarian in question. In case of food-producing animals, veterinarians should ensure that an appropriate withdrawal period is prescribed, so that harmful residues of those medicinal products do not enter the food chain.
Amendment 156 #
Proposal for a regulation
Recital 37 a (new)
Recital 37 a (new)
(37a) As Antimicrobial resistance to human and veterinary medicinal products is a growing health problem in the Union and worldwide there must soon also action be taken in the field of human medicine for example in the form of an instrument incentivising the development of new antibiotics for human use similar to that already proposed within this regulation.
Amendment 399 #
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. Antimicrobial medicinal products for human use may only be employed, subject to the issuing of a prescription by a veterinarian and approval by the veterinary authority responsible for monitoring the work of the veterinarian in question, if treatment with a medicinal product as referred to in letter (a)(i) or (ii) is not possible; __________________ 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 408 #
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,. Antimicrobial medicinal products for human use may be employed, subject to the issuing of a prescription by a veterinarian and approval by the veterinary authority responsible for monitoring the work of the veterinarian in question, if treatment with a veterinary medicinal product as referred to in letter (a) or (b) is not possible; or
Amendment 426 #
Proposal for a regulation
Article 118 – paragraph 1
Article 118 – paragraph 1
1. Antimicrobial medicinal products shall only be used in accordance with Articles 115 and 116 to treat conditions for which there is no other treatment available, and the proper use of which would not present a risk to public or animal health.
Amendment 819 #
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 or another Member State in accordance with Directive 2001/83/EC of the European Parliament and of the Council30 or Regulation (EC) No 726/2004. Antimicrobial medicinal products for human use may only be employed, subject to the issuing of a prescription by a veterinarian and approval by the veterinary authority responsible for monitoring the work of the veterinarian in question, if treatment with a medicinal product as referred to in point (a)(i) or (ii) is not possible; __________________ 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 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 849 #
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, o. Antimicrobial medicinal products for human use may be employed, subject to the issuing of a prescription by a veterinarian and approval by the veterinary authority responsible for monitoring the work of the veterinarian in question, if treatment with a veterinary medicinal product as referred to in point (a) or (b) is not possible. Or
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.