Good Pharmacovigilance Practices

Good Pharmacovigilance Practices

Good pharmacovigilance practices (GPVP/GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU). GVP apply to marketing-authorisation holders, the European Medicines Agency and medicines regulatory authorities in EU Member States. They cover medicines authorised centrally via the Agency as well as medicines authorised at national level.

Guideline on GVP

The guideline on GVP is divided into chapters that fall into two categories:

• modules covering major pharmacovigilance processes;
• product- or population-specific considerations.

Each chapter is developed by a team consisting of experts from the European Medicines Agency and from EU Member States.

The guideline on GVP is a key deliverable of the 2010 pharmacovigilance legislation. 

Modules covering major pharmacovigilance processes

GVP modules I to XVI cover major pharmacovigilance processes and the development of this set of guidance is concluded. The module numbers XI, XII, XIII and XIV stay void, as their planned topics have been addressed by other guidance documents on the Agency’s website.

Module I – Pharmacovigilance systems and their quality systems

Module II – Pharmacovigilance system master file

Module III – Pharmacovigilance inspections

Module IV – Pharmacovigilance audits Module V – Risk management systems

Module V – Risk management systems

Module VI – Management and reporting of adverse reactions to medicinal products

Module VII – Periodic safety update report

Module VIII – Post-authorisation safety studies (PASS)

Module IX – Signal management

Module X – Additional monitoring

Module XV – Safety communication

Module XVI– Risk minimisation measures - Selection of tools and effectiveness indicators