EMA Releases GVP Modules for Public Consultation

The European Medicines Agency have today released seven of the long awaited good pharmacovigilance practice (GVP) modules for consultation. The modules outline the practical implementation of the new PV legislation that will apply from July 2012, and will make essential reading for all Marketing Authorisation Holders and other interested parties. The remaining nine modules are being developed and will be released later in 2012.

The GVP modules released today are as follows:

  • 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.

The consultation closes on 18th April 2012 and the EMA hope to finalise these modules for publication by July 2012.

More information and the draft modules can be found at the following link: