Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 726/2004 as regards pharmacovigilance

The general policy objectives of the proposals to amend Directive 2001/83/EC and Regulation (EC) No 726/2004 are in line with the overall objectives of the EU pharmaceutical legislation. These are intended to ensure the proper functioning of the internal market for medicinal products for human use and to better protect health of EU citizens.

Following this line, the proposals aim specifically to address weaknesses identified in the EU pharmacovigilance system and provide for more transparency and efficiency of the system in cases where safety concerns are identified.

EUR-Lex: COM(2012)051: Follow the progress of this document through the decision-making procedure http://eur-lex.europa.eu/legal-content/EN/HIS/?uri=COM:2012:051:FIN

European Commission: COM(2012)52: Proposal for a Directive of the European Parliament and of the Council amending Directive 2001/83/EC as regards pharmacovigilance http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2012:0052:FIN:EN:PDF

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