4 Amendments of Marisa MATIAS related to 2012/0192(COD)
Amendment 70 #
Proposal for a regulation
Article 3 – paragraph 1 – indent 1 a (new)
Article 3 – paragraph 1 – indent 1 a (new)
- the evaluation of the ethical acceptability of the clinical trial is positive;
Amendment 83 #
Proposal for a regulation
Article 5 – paragraph 5 a (new)
Article 5 – paragraph 5 a (new)
5a. The assessment report shall be submitted through the EU portal and made publicly available.
Amendment 134 #
Proposal for a regulation
Article 27a (new)
Article 27a (new)
Amendment 144 #
Proposal for a regulation
Article 34 – paragraph 3 – subparagraph 1
Article 34 – paragraph 3 – subparagraph 1
Within one year from the end of a clinical trial, the sponsor shall submit to the EU database a summary of the results of the clinical trial, whether the results are positive or negative or inconclusive.