2 Amendments of Molly SCOTT CATO related to 2014/0256(COD)
Amendment 23 #
Proposal for a regulation
Article 1 – paragraph 1 – point 10 a (new)
Article 1 – paragraph 1 – point 10 a (new)
Regulation (EC) No 726/2004
Article 57 – paragraph 1 – points u, v and w (new)
Article 57 – paragraph 1 – points u, v and w (new)
(10a) In Article 57(1) the following points are added: "(u) co-ordination of the provision of information on active substances of veterinary medicinal products authorised under Union procedures, for the purpose of implementing a review system (Monograph system); (v) assisting Member States in providing information on active substances of veterinary medicinal products authorised under procedures other than the Union procedures, for the purpose of implementing a review system (Monograph System); (w) setting up a free of charge public database that lists information on active substances of veterinary medicinal products according to the review system (Monograph System), and updating on a regular basis. The respective information shall be presented in an easily understandable manner.".
Amendment 25 #
Proposal for a regulation
Article 1 – paragraph 1 – point 11 a (new)
Article 1 – paragraph 1 – point 11 a (new)
Regulation (EC) No 726/2004
Article 57 – paragraph 3 (new)
Article 57 – paragraph 3 (new)
(11a) In Article 57, the following paragraph is added: '(3) The database according to point (w) paragraph 1 of this Article, shall contain data on physico-chemical, ecotoxicological and behavioural properties of the active substance and its respective metabolites. The database shall list information on all veterinary medicines marketed in the Union. The Agency shall prepare a list of all veterinary medicines and active substances marketed in the Union in accordance with Article 51 of Regulation (EU) No .../... of the European Parliament and of the Council of ... on veterinary medicinal products (2014/0257(COD)).'.