5 Amendments of Paul BRANNEN related to 2014/0257(COD)
Amendment 165 #
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 pervalid for an unlimited period of time, unless risks to animal health, public health and protectiodn of 3 yearsthe environment (‘signal management process’) are detected.
Amendment 346 #
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 417 #
Proposal for a regulation
Article 116 – paragraph 3 – point b a (new)
Article 116 – paragraph 3 – point b a (new)
(ba) if there is no product as referred to in point (a), a veterinary medicinal product prepared extemporaneously in accordance with the terms of a veterinary prescription by a person authorised to do so under national legislation.
Amendment 435 #
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 use, prescribe or supply veterinary medicinal products.
Amendment 843 #
Proposal for a regulation
Article 116 – paragraph 1 – point b a (new)
Article 116 – paragraph 1 – point b a (new)
(ba) if there is no product as referred to in point (a), a veterinary medicinal product which does not contain antimicrobial agents, prepared extemporaneously in accordance with the terms of a veterinary prescription by a person authorised to do so under national legislation;