Activities of Corinne LEPAGE related to 2008/0257(COD)
Plenary speeches (1)
Pharmacovigilance of medicinal products (amendment of Regulation (EC) No 726/2004) - Pharmacovigilance (amendment of Directive 2001/83/EC) (debate)
Amendments (2)
Amendment 45 #
Proposal for a regulation – amending act
Article 1 – point 11
Article 1 – point 11
Regulation EC/726/2004
Article 24 – paragraph 2 – subparagraphs 2 and 3
Article 24 – paragraph 2 – subparagraphs 2 and 3
The Agency shall ensure that health-care professionals and the public have appropriate levels offull access to the Eudravigilance database, with personal data protection being guaranteed. The data held on the Eudravigilance database shall be made publicly accessible in an aggregated format together with an explanation of how to interpret the data.
Amendment 83 #
Proposal for a regulation – amending act
Article 1 - point 20 a (new)
Article 1 - point 20 a (new)
Regulation EC/726/2004
Article 107 - paragraph 1
Article 107 - paragraph 1
(20a) In Article 107, paragraph 1 shall be replaced by the following: 1. In the case of a single assessment of periodic safety update reports concerning more than one marketing authorisation in accordance with Article 107e(1) which does not include any marketing authorisation granted in accordance with Regulation (EC) No 726/2004, the coordination group shall, within 30 days of receipt of the report of the Pharmacovigilance Risk Assessment Advisory Committee, consider the report and adopt an opinion on the maintenance, variation, suspension or revocation of the marketing authorisations concerned, including a timetable for the implementation of the opinion. That opinion shall be published without delay, giving an indication of minority views.