Activities of Elena Oana ANTONESCU related to 2008/0257(COD)
Plenary speeches (2)
Explanations of vote
Explanations of vote
Amendments (4)
Amendment 19 #
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. 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 in all the official languages of the European Union.
Amendment 20 #
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. However, the Member States concerned should be notified at the same time, through the Eudravigilance database, of reports sent by marketing authorisation holders. In order to ensure high-quality information, Member States should support the development of national and regional pharmacovigilance centres' expertise. The national competent authorities should collect the reports from those centres and transfer the 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 22 #
Proposal for a regulation – amending act
Recital 6
Recital 6
(6) In order to increase transparency as regards pharmacovigilance issues, a European medicines safety web-portal should be created and maintained by the Agency in all the official languages of the European Union.
Amendment 76 #
Proposal for a regulation – amending act
Article 1 –- point 14
Article 1 –- point 14
Regulation EC/726/2004
Article 61a – paragraph 1 – point b a (new)
Article 61a – paragraph 1 – point b a (new)
(ba) one representative from the Patient and Consumer’s Working Party and one representative from the Healthcare Professionals Working Group.