Public consultation by the EU Commission in relation to the pharmacovigilance legislation
12 October 2011
The European Commission is currently conducting a public consultation in relation to the amended pharmacovigilance legislation (Regulation (EU) No 1235/2010 and Directive 2010/84/EU). The Commission has drafted several implementing measures which describe the technical requirements for marketing authorisation holders, national competent authorities and the European Medicines Agency in applying the new provisions of the legislation. The Commission seeks views and feedback from stakeholders on the measures, which are described in more detail in the concept paper.
The period of consultation ends on 7 November 2011. Please send any comments to the Commission. For details on how to that, please read the concept paper.