Reporting adverse events for veterinary medicines

Veterinary pharmacovigilance collects adverse-event information after medicines are authorised. Reports can come from veterinary professionals and animal owners and pass through marketing-authorisation holders or competent authorities.

Reporting responsibilities

Veterinary medicinal products require an established and maintained pharmacovigilance system, as human medicines do. ¹ Adverse-event reporting is mandatory for veterinary pharmaceuticals and vaccines in the EU. ² Marketing-authorisation holders collect reports for their products, alongside national authorities and the European Medicines Agency. ²

Reporting routes

Local veterinarians provide adverse-event information to the marketing-authorisation holder. ³ Animal owners can also report directly to the national authority; reporting is not restricted to veterinarians. ⁴

EudraVigilance Veterinary brings together reports of serious adverse events in animals and in humans exposed to veterinary medicines. ⁵