The Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) contains new legal provisions on veterinary pharmacovigilance.

These aim to focus on continuous signal management based on adverse event data in the ‘Union Pharmacovigilance Database’ and cover pharmacovigilance inspections and the maintenance of pharmacovigilance master files.  

To support marketing authorisation holders in complying with their pharmacovigilance obligations, EMA will provide a guideline on veterinary good pharmacovigilance practices (VGVP guideline), which will replace the current guidelines on veterinary pharmacovigilance from 28 January 2022. 

A draft VGVP guideline is available for public consultation, composed of six modules:

The VGVP guideline will supersede the currently applicable guidelines on veterinary pharmavocigilance on 28 January 2022.

Stakeholders should send any comments to by 5 September 2021 using the feedback form linked within the draft guideline (one form per module).