GVP Pharmacovigilance: What They Are and How They Work in a Company

Good Vigilance Practices (GVPs) are the European guidelines that define how a pharmaceutical company must manage the safety of its medicines after marketing authorisation. As the source document states: “When discussing GVP pharmacovigilance, we are referring to a set of European guidelines that define how a pharmaceutical company must manage the safety of its medicines after they have received marketing authorisation.” Good Vigilance Practices (GVPs) were introduced as part of the European pharmacovigilance legislation adopted in 2010 and implemented in July 2012.

GVP Modules I to XVI

Below are the core GVP modules exactly as they are numbered and titled:

• Module I: Pharmacovigilance systems and their quality

• Module II: The Pharmacovigilance System Master File (PSMF)

• Module III: Pharmacovigilance inspections

• Module IV: Pharmacovigilance system audits

• Module V: Risk management systems, including the Risk Management Plan (RMP)

• Module VI: Collection, management, and reporting of suspected adverse reaction reports

• Module VII: The Periodic Safety Update Report (PSUR)

• Module VIII: Post-Authorisation Safety Studies (PASS)

• Module IX: Signal management

• Module X: Additional monitoring

• Module XV: Safety communication

• Module XVI: Risk minimisation measures

Note: Modules XI–XIV no longer exist as standalone chapters; their content has been incorporated into other EMA guidance documents. The GVP framework also includes product‑ and population‑specific annexes (for example, vaccines, biologicals, paediatrics, pregnancy and breastfeeding).