1 Amendments of Mairead McGUINNESS related to 2008/0257(COD)
Amendment 60 #
Proposal for a regulation – amending act
Article 1 – point 11
Article 1 – point 11
Regulation EC/726/2004
Article 27 – paragraphs 1 and 2
Article 27 – paragraphs 1 and 2
1. The Agency shall monitor selectedthe medical literature for reports of suspected adverse reactions to medicinal products for human use containing certain active substances. It shall publish the list of active substances being monitored and the publications subject to this monitoring. 2. The Agency shall enter into the Eudravigilance database relevant information from the selected literature.