14 Amendments of Marc TARABELLA related to 2014/0257(COD)
Amendment 71 #
Proposal for a regulation
Recital 56
Recital 56
(56) The conditions governing the supply of veterinary medicinal products to the public should be harmonised in the Union. Veterinary medicinal products should only be supplied by persons - where appropriate, veterinarians - who are authorised to do so by the Member State where they are established. At the same time, in order to improve access to veterinary medicinal products in the Union, retailers that are authorised to supply veterinary medicinal products by the competent authority in the Member State where they are established should be allowed to sell prescription and non- prescription veterinary medicinal products via the Internet to buyers in other Member States.
Amendment 72 #
Proposal for a regulation
Recital 56 a (new)
Recital 56 a (new)
(56a) Any ban on veterinarians supplying medicines could make it impossible for some Member States to maintain a network of veterinarians covering all of their territory. Such territorial coverage is of key importance in ensuring high- quality epidemiological monitoring of existing and emerging diseases.
Amendment 73 #
Proposal for a regulation
Recital 56 b (new)
Recital 56 b (new)
(56b) Decoupling prescription from supply does not lower the consumption of antibiotics. This is borne out by the fact that the Member States in which antibiotics consumption is highest have already decoupled prescription from supply, while the Member States that have reduced consumption the most are those in which the two are still coupled.
Amendment 109 #
Proposal for a regulation
Article 4 – paragraph 1 – point 20 – point b
Article 4 – paragraph 1 – point 20 – point b
(b) veterinary medicinal products for animal species other than cattle, sheep, pigs, chickens, dogs and cats;
Amendment 112 #
Proposal for a regulation
Article 4 – paragraph 1 – point 20 – point b a (new)
Article 4 – paragraph 1 – point 20 – point b a (new)
(ba) veterinary medicinal products for animal species the national population of which is not large enough for research and development costs to be amortised during the data protection period specified in Article 34.
Amendment 166 #
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 3 years. At the end of that period, the holder may request, in the light of scientific data and on grounds of pharmacovigilance and efficiency, that this authorisation be converted into an open-ended authorisation.
Amendment 188 #
Proposal for a regulation
Article 32
Article 32
Amendment 209 #
Proposal for a regulation
Article 34 – paragraph 1 – point a
Article 34 – paragraph 1 – point a
(a) 10 years for the veterinary medicinal products for cattle, sheep, pigs, chickens, dogs and cats;
Amendment 214 #
Proposal for a regulation
Article 34 – paragraph 1 – point b
Article 34 – paragraph 1 – point b
(b) 14 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 226 #
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 1two 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 357 #
Proposal for a regulation
Article 107 – paragraph 1
Article 107 – paragraph 1
1. The retail of veterinary medicinal products shall be conducted only by persons who are permitted to carry out such operations under national law, veterinarians where appropriate.
Amendment 361 #
Proposal for a regulation
Article 107 – paragraph 2
Article 107 – paragraph 2
2. Persons qualified to prescribe veterinary medicinal products in accordance with applicable national law, veterinarians where appropriate, shall retail antimicrobial products only for animals which are under their caresupervision and after diagnosis by a veterinarian, and only in the amount required for the treatment concerned.
Amendment 378 #
Proposal for a regulation
Article 110 – paragraph 2
Article 110 – paragraph 2
2. A veterinary prescription shall only be issued by a person qualified to do so in accordance with applicable national law, a veterinarian where appropriate and only after a veterinary diagnosis. These persons shall, by reason of their initial and continuing training, have the skills necessary to prescribe and issue veterinary medicinal products for all the species they treat.
Amendment 439 #
Proposal for a regulation
Article 125 – paragraph 1 a (new)
Article 125 – paragraph 1 a (new)
1a. To combat fraud, the competent authorities shall establish a plan for spot checks on veterinary practices and herds to verify that medicinal products held comply with quality standards.