Pharmacovigilance inspections for veterinary medicines

The European Medicines Agency (EMA) has developed procedures for the coordination, conduct and reporting of pharmacovigilance inspections carried out in the context of the centralised procedure for veterinary medicines.

These inspections are adopted by the Committee for Medicinal Products for Veterinary Use (CVMP). They may be routine, or triggered by issues arising during the assessment of pharmacovigilance data or by other information such as previous inspection experience.

For more information on pharmacovigilance inspections and EMA's role, please refer to the content in the human regulatory section:

• Coordination of Pharmacovigilance inspections

If you have questions regarding this content, Send a question to the European Medicines Agency

Also on this topic

• Veterinary pharmacovigilance inspections: Q&As

Inspection procedures

Union procedure on the coordination of veterinary pharmacovigilance inspections

Reference Number: EMA/INS/PhV/716593/2021 Rev 01

Union procedure on the preparation, conduct and reporting of EU veterinary pharmacovigilance inspections

Reference Number: EMA/INS/PhV/604648/2022 Rev 01

Appendix 1 - Pharmacovigilance Inspection Report template

Appendix 2 - Template for collecting information on Pharmacovigilance issues for the attention of the inspectors and assessors

Union guidance on record keeping and archiving of documents obtained or resulting from pharmacovigilance inspections

Reference Number: EMA/INS/PhV/773932/2022 – Rev 01

Procedure for the preparation of a risk-based programme for routine pharmacovigilance inspections of MAHs connected with veterinary Centrally Authorised Products (CAPs)

Adopted Reference Number: EMEA/INS/PhV/390778/2008