Coordination of pharmacovigilance inspections
The European Medicines Agency (EMA) plays an important role in the harmonisation and coordination of pharmacovigilance inspections at the Union level. It is involved in:
- preparing a risk based programme of routine pharmacovigilance inspections in relation to centrally authorised products (CAPs);
- co-ordinating pharmacovigilance inspections requested by the Committee for Medicinal Products for Human Use and the Committee for Medicinal Products for Veterinary Use;
- preparing new and revised guidance on pharmacovigilance inspections, through the work of the Pharmacovigilance Inspections Working Group;
- coordinating advice on the interpretation of pharmacovigilance requirements and related technical issues;
- developing of European Union-wide guidelines relating to pharmacovigilance inspections.
Using IRIS for GVP inspections improves efficiency by harmonising and automating processes and re-using master data held by EMA. It also simplifies retrieving and reporting data.
More information on the use of EMA's IRIS system:
Guidance for applicants/MAHs involved in GMP, GCP and GVP inspections coordinated by EMA (PDF/246.38 KB)
First published: 06/04/2022
Last updated: 12/12/2022
IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicants (PDF/4.12 MB) (updated)
First published: 04/07/2018
Last updated: 28/11/2023
EMA/444925/2018 Version 3