MEPs vote to strengthen and rationalize European Union pharmacovigilance system

23 September 2010

Members of the European Parliament yesterday adopted by an overwhelming majority (559 to seven) the text on the proposals for a directive and a regulation on pharmacovigilance. The proposal is the first section of the ‘pharmaceutical package’ of legislation to be adopted.

The European Commission issued proposals in late 2008 seeking to change the existing EU legislation on pharmacovigilance (provisions in Regulation (EC) No 726/ 2004 and Directive 2001/83/EC; The Pharma Letter January 12, 2009). They aim to strengthen and rationalize the system, with the overall objectives of better protecting public health, ensuring proper functioning of the internal market and simplifying the current procedures.

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