EU Good Pharmacovigilance Practices (GVP)
The EU good pharmacovigilance practices — a modular set of guidelines (Modules I-XVI plus product/population-specific considerations) governing the safety surveillance of medicines across their lifecycle: the pharmacovigilance system and its master file, risk management plans, ICSR management, signal management, and post-authorisation safety studies.
Marketing authorisation holders and competent authorities operating pharmacovigilance systems for EU-authorised medicines. Operated through EudraVigilance and the QPPV role.
- 01A defined pharmacovigilance system with a QPPV and a maintained PSMF
- 02Risk management plans proportionate to the product safety profile
- 03ICSR collection and expedited/periodic submission via EudraVigilance
- 04A documented signal-management process with defined timelines
Modules have been revised individually since first publication in 2012; several (e.g. Module VI) were updated to reflect ISO/ICH E2B(R3) ICSR standards.
EU GVP Modules: frequently asked questions
Quick answers to common questions about EU GVP Modules.
What is EU GVP Modules?
EU GVP Modules — EU Good Pharmacovigilance Practices (GVP) — is a guidance issued by the European Medicines Agency (European Union). The EU good pharmacovigilance practices — a modular set of guidelines (Modules I-XVI plus product/population-specific considerations) governing the safety surveillance of medicines across their lifecycle: the pharmacovigilance system and its master file, risk management plans, ICSR management, signal management, and post-authorisation safety studies.
Who does EU GVP Modules apply to?
Marketing authorisation holders and competent authorities operating pharmacovigilance systems for EU-authorised medicines. Operated through EudraVigilance and the QPPV role.
What are the key requirements of EU GVP Modules?
EMA EU GVP Modules requires, among other things: A defined pharmacovigilance system with a QPPV and a maintained PSMF; Risk management plans proportionate to the product safety profile; ICSR collection and expedited/periodic submission via EudraVigilance; A documented signal-management process with defined timelines.
When was EU GVP Modules last updated?
The current version of EU GVP Modules dates from January 2017. Modules have been revised individually since first publication in 2012; several (e.g. Module VI) were updated to reflect ISO/ICH E2B(R3) ICSR standards.
Live openFDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.
Track the standards that move
When EU GVP Modules — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.