1 Amendments of Holger KRAHMER related to 2008/0257(COD)
Amendment 58 #
Proposal for a regulation – amending act
Article 1 - point 11
Article 1 - point 11
Regulation EC/726/2004
Article 27 – paragraph 1
Article 27 – paragraph 1
1. The Agency shall monitor selected 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. The Agency shall monitor all medical literature for reports of suspected adverse reactions to medicinal products for human use containing well-established active substances.