Veterinary pharmacovigilance inspections: Q&As

The European Medicines Agency (EMA) and the Pharmacovigilance Inspectors Working Group provides guidance on veterinary pharmacovigilance obligations in the form of questions and answers (Q&As).

These Q&As are based on the Pharmacovigilance Inspectors Working Group's interpretation of Volume 9B of The Rules Governing Medicinal Products in the European Union – Guidelines on Pharmacovigilance for Medicinal Products for Veterinary Use.

Minimum expectations for marketing authorisation holders (MAHs) in implementing pharmacovigilance agreements with other parties involved in fulfilling veterinary pharmacovigilance obligations

Minimum expectations for the pharmacovigilance training of staff in veterinary pharmaceutical companies

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