Getting to grips with the new European Union pharmacovigilance legislation.

摘要

On 31 December 2010, major changes to the legislation covering pharmacovigilance in the European Union (EU) were published in the Official Journal. This was the culmination of a process started by the Commission soon after the withdrawal of Vioxx in late 2004. It began with an assessment of the existing pharmacovigilance system following which there was a public consultation in 2006. This led to proposals from the Commission being put forward in December 2008. Since that time, it has been taken through the legislative process, finally clearing the European Parliament in September 2010 and the European Council in December 2010. In principle, most of what was put forward by the Commission have survived, but there have been numerous changes of wording, many of them amplifications.