The European Medicines Agency has published the first set of finalised modules of the guideline on good pharmacovigilance practices (GVP) today.
The finalisation of these seven modules is a key deliverable of the 2010 pharmacovigilance legislation, which will apply from Monday 2 July 2012. Each of the modules covers one major process in the safety monitoring of medicines.
Module I: Pharmacovigilance systems and their quality systems;
Module II: Pharmacovigilance systems master files;
Module V: Risk management systems;
Module VI: Management and reporting of adverse reactions to medicinal products;
Module VII: Periodic safety update reports;
Module VIII: Post-authorisation safety studies;
Module IX: Signal management.
On Wednesday 27 June 2012, the Agency will be publishing two further GVP modules for public consultation. These will be:
Module III: Pharmacovigilance inspections;
Module X: Additional monitoring.
The finalised GVP modules on post-authorisation safety studies and risk management plans refer to the guide on methodological standards in pharmacoepidemiology, which is available on the website of the European Network of Centres in Pharmacoepidemiology and Pharmacovigilance (ENCePP).