6 Amendments of Christofer FJELLNER related to 2012/0192(COD)
Amendment 120 #
Proposal for a regulation
Recital 20 a (new)
Recital 20 a (new)
(20a) Before a marketing authorisation has been obtained, clinical trial data should be considered commercially confidential. Once a marketing authorisation is obtained, it should be presumed that data contained in the marketing authorisation dossier may contain some confidential and commercially sensitive information.
Amendment 442 #
Proposal for a regulation
Article 25 – paragraph 6
Article 25 – paragraph 6
6. CData, from clinical trial datas conducted on patients, submitted in an application dossier shall be based on clinical trials which have been registered prior to their start in a public register which is a primary registry or data provider of the international clinical trials registry platform of the World Health Organisation.
Amendment 443 #
Proposal for a regulation
Article 25 – paragraph 6
Article 25 – paragraph 6
6. Clinical trial data submitted in an application dossier shall be based on clinical trials which have been registered prior to their start in a public register which is a primary registry of the international clinical trials registry platform of the World Health Organisation.
Amendment 517 #
Proposal for a regulation
Article 33 – title
Article 33 – title
Notification of the start of the clinical trial and of the end of the recruitment of subjects
Amendment 519 #
Proposal for a regulation
Article 33 – paragraph 2 – subparagraph 1
Article 33 – paragraph 2 – subparagraph 1
Amendment 520 #
Proposal for a regulation
Article 33 – paragraph 2 – subparagraph 2
Article 33 – paragraph 2 – subparagraph 2