European Medicines Agency releases good pharmacovigilance practice modules for public consultation

The European Medicines Agency, on 22 February 2012, released the first batch of modules on good pharmacovigilance practices (GVP) for public consultation until 18 April 2012. The release of these modules is a key deliverable of the 2010 pharmacovigilance legislation, which will apply from July 2012. The remaining nine draft modules making up the entire GVP package are under development and will be released for consultation later in the year.

EMA: Guidelines on good pharmacovigilance practices (GVP): Introductory cover note to the public consultation of the first seven modules http://www.ema.europa.eu/docs/en_GB/document_library/Other/2012/02/WC500123145.pdf

---