6 Amendments of Paul RÜBIG related to 2012/0192(COD)
Amendment 116 #
Proposal for a regulation
Article 14 – paragraph 1 – subparagraph 2
Article 14 – paragraph 1 – subparagraph 2
The application may be submitted in any Member State only after the notification date of the initial authorisation decision.
Amendment 117 #
Proposal for a regulation
Article 14 – paragraph 3 – point a
Article 14 – paragraph 3 – point a
(a) 2510 days from the date of submission of the application referred to in paragraph 1 for low-intervention clinical trials;
Amendment 118 #
Proposal for a regulation
Article 14 – paragraph 3 – point b
Article 14 – paragraph 3 – point b
(b) 325 days from the date of submission of the application referred to in paragraph 1 for clinical trials other than low- intervention clinical trials;
Amendment 119 #
Proposal for a regulation
Article 14 – paragraph 3 – point c
Article 14 – paragraph 3 – point c
(c) 430 days from the date of submission of the application referred to in paragraph 1 for any clinical trial with an advanced therapy investigational medicinal product.
Amendment 121 #
Proposal for a regulation
Article 14 – paragraph 5
Article 14 – paragraph 5
5. Between the date of submission of the application referred to in paragraph 1 and the expiry of the relevant time period referred to in paragraph 3, tThe additional Member State concerned may communicate to the reporting Member State any considerations relevant to Part 1 of the application within the timelines laid down in paragraph 3 starting from the date of submission referred to in paragraph 1.
Amendment 122 #
Proposal for a regulation
Article 14 – paragraph 6 – subparagraph 1
Article 14 – paragraph 6 – subparagraph 1
The reporting Member State, and only the reporting Member State, may, between the date of submission of the application referred to in paragraph 1 and the expiry of the relevant time period referred towithin the timelines specified in paragraph 35, request additional explanations from the sponsor concerning Part I of the assessment report, taking into account the considerations referred to in paragraph 5.