11 Amendments of Erik BÁNKI related to 2012/0192(COD)
Amendment 189 #
Proposal for a regulation
Article 2 – paragraph 2 – point 2 – point a
Article 2 – paragraph 2 – point 2 – point a
(a) the investigational medicinal products are not authorised for marketing;
Amendment 190 #
Proposal for a regulation
Article 2 – paragraph 2 – point 2 – point b
Article 2 – paragraph 2 – point 2 – point b
(b) according to the protocol of the clinical studytrial, the investigational medicinal products are not used in accordance with the terms of the marketing authorisation of the Member State concerned or the marketing authorisation granted by the Commission;
Amendment 191 #
Proposal for a regulation
Article 2 – paragraph 2 – point 2 – point c
Article 2 – paragraph 2 – point 2 – point c
Amendment 194 #
Proposal for a regulation
Article 2 – paragraph 2 – point 2 – point d
Article 2 – paragraph 2 – point 2 – point d
(d) the decision to prescribuse the investigational medicinal products is taken together with the decision to include the subject in the clinical studytrial;
Amendment 195 #
Proposal for a regulation
Article 2 – paragraph 2 – point 2 – point e
Article 2 – paragraph 2 – point 2 – point e
Amendment 204 #
Proposal for a regulation
Article 2 – paragraph 2 – point 3 – point a
Article 2 – paragraph 2 – point 3 – point a
(a) the investigational medicinal products are authorised for marketing;
Amendment 211 #
Proposal for a regulation
Article 2 – paragraph 2 – point 3 – point b
Article 2 – paragraph 2 – point 3 – point b
(b) according to the protocol of the clinical trial, the investigational medicinal products are used in accordance with the terms of the marketing authorisation or their use is a standard treatment in any of the Member States concerned;
Amendment 212 #
Proposal for a regulation
Article 2 – paragraph 2 – point 3 – point c
Article 2 – paragraph 2 – point 3 – point c
Amendment 216 #
Proposal for a regulation
Article 2 – paragraph 2 – point 5
Article 2 – paragraph 2 – point 5
(5) ‘Investigational medicinal product’: a medicinal productpharmaceutical form of an active substance or a placebo which is being tested or used as a reference, including as a placebo, in a clinical trial;
Amendment 344 #
Proposal for a regulation
Article 7 – paragraph 3 – subparagraph 3 a (new)
Article 7 – paragraph 3 – subparagraph 3 a (new)
The Member State may extend the time limits referred to in paragraphs 2 and 3 with a further 15 days for the purpose of consulting with ethics committees.
Amendment 371 #
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
1. Member States shall ensure that the persons validating and assessing the application do not have conflicts of interest, are independent of the sponsor, the institution of the trial site and the investigators involved, as well as free of any other undue influence. The curriculum vitae and declaration of interests of the persons validating and assessing the application shall be published on the EU portal.