3 Amendments of Marian-Jean MARINESCU related to 2008/0257(COD)
Amendment 15 #
Proposal for a regulation – amending act
Recital 5
Recital 5
(5) In order to allow all competent authorities to receive and access, at the same time, pharmacovigilance information for medicinal products for human use authorised in the Community, and share it, the Eudravigilance database should be maintained and strengthened as the single point of receipt of such information. Member States should therefore not impose on marketing authorisation holders any additional reporting requirements. Instead, the Eudravigilance database should simultaneously notify the relevant Member States of reports submitted by market authorisation holders. In order to ensure the high quality of information, Member States should support the development of the expertise of national and regional pharmacovigilance centres. National competent authorities should collect the reports from those centres and should then transfer data to the Eudravigilance database. The database should be fully accessible to the Member States, the Agency and the Commission, and accessible to an appropriate extent to marketing authorisation holders and the public.
Amendment 21 #
Proposal for a regulation – amending act
Article 1 – point 11
Article 1 – point 11
Regulation (EC) No 726/2004
Article 24 – paragraph 1 – subparagraph 1
Article 24 – paragraph 1 – subparagraph 1
1. The Agency, in collaboration with the Member States and the Commission, shall set up and maintain a database and data processing network (hereinafter ‘the Eudravigilance database’) to collate pharmacovigilance information regarding medicinal products authorised in the Community and to allow competent authorities to access the information at the same time and to share it. Member States should support the development of the expertise of national and regional pharmacovigilance centres. National competent authorities should collect the reports from those centres and should then transfer data to the Eudravigilance database.
Amendment 23 #
Proposal for a regulation – amending act
Article 1 – point 11
Article 1 – point 11
Regulation (EC) No 726/2004
Article 24 – paragraph 2 – subparagraph 2 a (new)
Article 24 – paragraph 2 – subparagraph 2 a (new)
The Agency shall work together with healthcare professional organisations and patient and consumer organisations to define ‘the appropriate level of access’.