Veterinary pharmacovigilancepharmacovigilance vétérinaire
Veterinary pharmacovigilance is the monitoring of adverse effects of veterinary medicines after they are placed on the market, based mainly on spontaneous reports from professionals and animal owners.
According to ANSES, the surveillance system has existed in France since 2002, and online reporting since 2010. Reports are recorded and assessed by marketing authorisation holders, by ANSES (Anses-ANMV) and by the Lyon veterinary pharmacovigilance centre. Vets send more than 90% of the reports.
Article 81 of Regulation (EU) 2019/6 requires the marketing authorisation holder to run a signal management process. If that process shows a change in the benefit-risk balance or a new risk, the holder must notify it without delay and no later than 30 days to the competent authorities or the Agency. The holder also records the results in the pharmacovigilance database at least once a year. Implementing Regulation (EU) 2021/1281 sets out good pharmacovigilance practice.
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See also
- ANSES ANSES is the French public agency for health and safety expertise, created on 1 July 2010; its ANMV department regulates veterinary medicines.
- ANMV The ANMV is the department of ANSES, based in Fougères, that acts as France’s competent authority for veterinary medicines.
- AMM The AMM is the marketing authorisation a veterinary medicine needs before it can be sold, granted in France by the ANMV or at EU level by the European Commission.