Activities of Sajjad KARIM related to 2012/0192(COD)
Shadow opinions (1)
OPINION on the proposal for a regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
Amendments (11)
Amendment 88 #
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – introductory part
Article 6 – paragraph 4 – subparagraph 1 – introductory part
The reporting Member State shall submit Part I of the assessment report, including its conclusion, to the sponsor and to the other Member States concerned within the following time periods, which shall include periods for initial assessment, for joint assessment and for consolidation of the final report:
Amendment 90 #
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – point a
Article 6 – paragraph 4 – subparagraph 1 – point a
(a) within 10 days from the validation date for low-intervention clinical trials; the time for the joint assessment and for consolidation by Member States concerned and reporting Member State shall not be shorter than 5 days.
Amendment 92 #
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – point b
Article 6 – paragraph 4 – subparagraph 1 – point b
(b) within 25 days from the validation date for clinical trials other than low- intervention clinical trials; the time for the joint assessment and for consolidation by Member States concerned and reporting Member State shall not be shorter than 10 days.
Amendment 94 #
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – point c
Article 6 – paragraph 4 – subparagraph 1 – point c
(c) within 30 days from the validation date for any clinical trial with an advanced therapy investigational medicinal product; the time for the joint assessment and for consolidation by Member States concerned and reporting Member State shall not be shorter than 10 days.
Amendment 96 #
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 2
Article 6 – paragraph 4 – subparagraph 2
For the purposes of this Chapter, the assessment date shall be the date on which the assessment report is submitted to the other Member States concerned and the reporting date shall be the date when the final assessment report is submitted to the sponsor and to the other Member States concerned.
Amendment 97 #
Proposal for a regulation
Article 6 – paragraph 5
Article 6 – paragraph 5
5. Until the assessment date, any the reporting Member State shall develop and circulate to the Member States concerned an initial assessment report. Until 2 days before the reporting date, Member States concerned may communicate to the reporting Member State and all other Member States concerned any considerations relevant to the application. The reporting Member State shall take those considerations duly into account in finalising the assessment report.
Amendment 99 #
Proposal for a regulation
Article 6 – paragraph 6 a (new)
Article 6 – paragraph 6 a (new)
6a. The reporting Member State may also extend the time referred to in paragraphs 4 and 6 a further 60 days for trials involving Advanced Therapy Medicinal Products or other novel therapies, for the purpose of consulting with expert committees
Amendment 100 #
Proposal for a regulation
Article 6 – paragraph 6 – subparagraph 1
Article 6 – paragraph 6 – subparagraph 1
The reporting Member State, and only the reporting Member State, may, between the validation date and the assessmentreporting date, request additional explanations from the sponsor, taking into account the considerations referred to in paragraph 5.
Amendment 101 #
Proposal for a regulation
Article 6 – paragraph 6 – subparagraph 2
Article 6 – paragraph 6 – subparagraph 2
For the purpose of obtaining those additional explanations, the reporting Member State may suspextend the time period referred to in paragraph 4 for a maximum of 120 days for low-intervention clinical trials and for a maximum of 230 days for trials other than low-intervention clinical trials.
Amendment 102 #
Proposal for a regulation
Article 6 – paragraph 6 – subparagraph 3
Article 6 – paragraph 6 – subparagraph 3
Amendment 103 #
Proposal for a regulation
Article 6 – paragraph 7
Article 6 – paragraph 7
7. The sponsor may at its own initiative change the content of the application only between the validation date and the assessmentreporting date and only for duly justified reasons. In this case, the reporting Member State may, depending on the extent of the change to the content of the application, suspend the period referred to in paragraph 4 for a maximum of 60 days.