EUDG Enterprise and Industry wishes to consult stakeholders on legislative proposals to strengthen and rationalise the EU system of pharmacovigilance. The Commission services conducted a previous consultation, between 16 March 2006 and 12 May 2006, which sought stakeholders' views on the strengths and weaknesses of the current EU system of pharmacovigilance and how the system could be strengthened. The web-based consultation was supplemented by public workshops in April 2006, as well as, meetings with specific stakeholder groups. The consultation results were made public in February 2007 and at the same time, in response to the consultation outcome, Vice- President Verheugen announced its "Strategy to Better Protect Public Health by Strengthening and Rationalising EU Pharmacovigilance". The Strategy has two parts: 1. better implementation of the current framework and, 2. proposals for change to the legal framework. Details of both the 2006 consultation and the Strategy are available on the Commission's website.

This public consultation specifically addresses part 2 of the strategy, the proposals for changes to the legal framework. This consultation paper is organised in the following sections:

  • Section 1 introduces the consultation, explains how and by when to submit consultation responses and explains the next steps.
  • Section 2 provides a brief orientation on pharmacovigilance and the background to the strategy.
  • Section 3 presents the legislative strategy and the key proposals for legislative change.
  • Section 4 presents detailed proposals to change EU legal texts.
The public consultation is open from 4 December 2007 to 1 February 2008. Stakeholders may wish to comment on the key proposals presented in Section 3 or may prefer to comment on the detailed proposals to change EU legal texts presented in Section 4. All comments should be sent electronically to Dr Peter Arlett by 1 February 2008.

For further information, download PUBLIC CONSULTATION ON LEGISLATIVE PROPOSALS document (.pdf).