Eight EMA Finalised GVP Modules now Published

Good pharmacovigilance practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU).

The guidelines on GVP are divided into 16 modules, each of which covers one major process in pharmacovigilance. Each module is developed by a team consisting of experts from the European Medicines Agency and from EU Member States.

The modules are a key deliverable of the 2010 pharmacovigilance legislation.

The Agency published the first batch of seven modules in June 2012, after a public consultation period from February to April 2012. It released modules III and X for consultation in June 2012. The full set of 16 final modules is scheduled to be available by early 2013.

The Final GVP and remaining draft modules can be found here.