5 Amendments of Martin HÄUSLING related to 2014/0256(COD)
Amendment 19 #
Proposal for a regulation
Recital 6 a (new)
Recital 6 a (new)
(6a) Advances in alternative testing require the creation of a validation framework capable of adapting to new developments in this field, particularly in relation to the recognition and evaluation of in silico testing.
Amendment 20 #
Proposal for a regulation
Recital 6 b (new)
Recital 6 b (new)
(6b) Animal testing currently plays a key regulatory and scientific role in the development of medicines, and is subject to Directive 2010/63/EU relating to the replacement, reduction or refinement of animal testing.
Amendment 25 #
Proposal for a regulation
Article 1 – point 5 a (new)
Article 1 – point 5 a (new)
Regulation (EC) No 726/2004
Article 6 – paragraphs 4 a and 4 b (new)
Article 6 – paragraphs 4 a and 4 b (new)
(5a) In Article 6, the following paragraphs are added: "4a. The Agency shall verify that applicants for marketing authorisations have acted in accordance with Article 13(1) of Directive 2010/63/EU. 4b. The Agency shall develop a framework for the validation of in silico models and take into consideration the opportunities presented by in silico concepts developed in toxicology aiming for predictive medicine. These can be based on human-relevant computer or cellular models, pathways of toxicity, or adverse outcome pathways."
Amendment 31 #
Proposal for a regulation
Article 1 – point 10 a (new)
Article 1 – point 10 a (new)
Regulation (EC) No 726/2004
Article 57 – paragraph 1– subparagraph 2 – points t a, t b and t c (new)
Article 57 – paragraph 1– subparagraph 2 – points t a, t b and t c (new)
(10a) In subparagraph 2 of Article 57(1), the following points are added: "(ta) co-ordination of the provision of information on active substances of veterinary medicinal products authorised under community procedures, for the purpose of implementing a review system (Monograph system); (tb) assisting Member States in providing information on active substances of veterinary medicinal products authorised under procedures other than the community procedures, for the purpose of implementing a review system (Monograph System); (tc) 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 should be presented in an easily understandable manner."
Amendment 34 #
Proposal for a regulation
Article 1 – point 11 a (new)
Article 1 – point 11 a (new)
Regulation (EC) No 726/2004
Article 57 – paragraph 2 a (new)
Article 57 – paragraph 2 a (new)
(11a) In Article 57, the following paragraph is added: "2a. The database according to point (tc) of paragraph 1 of this Article contains data on physico-chemical, ecotoxicological and behavioural properties of the active substance and its respective metabolites. The database lists information of all veterinary medicines marketed in the Union. Therefore, 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) 2015/xxx of the European Parliament and of the Council1a+. ___________________________ 1aRegulation (EU) 2015/xxx of the European Parliament and of the Council of ... on veterinary medicinal products (OJ L ...). ' + OJ: please insert the number and in the footnote, the number, date and OJ reference of Regulation in document COD 2014/0257."