6 Amendments of Catherine STIHLER related to 2013/0402(COD)
Amendment 57 #
Proposal for a directive
Recital 9 a (new)
Recital 9 a (new)
(9a) For the purposes of this Directive, and in accordance with Regulation (EU) No 536/2014 of the European Parliament and of the Council1a, in general the data included in a clinical study report should not be considered commercially confidential once a marketing authorisation has been granted, the procedure for granting the marketing authorisation has been completed or the application for marketing authorisation has been withdrawn. In addition, the main characteristics of a clinical trial, the conclusion on Part I of the assessment report for the authorisation of a clinical trial, the decision on the authorisation of a clinical trial, the substantial modification of a clinical trial, and the clinical trial results including reasons for temporary halt or early termination, in general, should not be considered a trade secret. ________________ 1aRegulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use (OJ L 158, 27.5.2014, p. 1).
Amendment 82 #
Proposal for a directive
Article 2 – paragraph 1 – point 1 – point c a (new)
Article 2 – paragraph 1 – point 1 – point c a (new)
(ca) its disclosure is not in the public interest or is not required or allowed under Union or Member State law.
Amendment 99 #
Proposal for a directive
Article 3 – paragraph 2 – point f
Article 3 – paragraph 2 – point f
Amendment 107 #
Proposal for a directive
Article 2 – point 1 – point c a (new)
Article 2 – point 1 – point c a (new)
(ca) its disclosure is not in the public interest or is not required under Union or Member State law.
Amendment 138 #
Proposal for a directive
Article 4 – paragraph 2 – point c a (new)
Article 4 – paragraph 2 – point c a (new)
(ca) its disclosure is required under Union or national law;
Amendment 157 #
Proposal for a directive
Article 6 – paragraph 1 – point c a (new)
Article 6 – paragraph 1 – point c a (new)
(ca) ensures that the trade secret holder has responsibility for proving that the information in question is a trade secret and that this information has been acquired unlawfully.