The European Medicines Agency (EMA) has published a draft revision of its guideline on veterinary good pharmacovigilance practices (VGVP) for pharmacovigilance systems, quality management systems, and pharmacovigilance system master files (PSMFs), aiming to address common inspection findings and questions from marketing authorisation holders (MAHs). The revision, dated 16 July 2026 and released for public consultation on 27 July 2026, introduces clarifications on partial MAH transfers, back-up arrangements for the Qualified Person responsible for Pharmacovigilance, performance indicators, audit requirements, and subcontracting of pharmacovigilance tasks. A new appendix provides additional guidance on PSMF content, particularly annexes listing contracts and task delegations, based on EU inspectors' experience.
The revision is based on pharmacovigilance inspectors' experience, common inspection findings, and requests for clarification from MAHs. No concept paper was created as the revision is not considered a new guideline or a significant revision. The scope of the public consultation is limited to the proposed changes, which are provided in track-changes mode to facilitate review.
Key changes include alignment of the introduction with other VGVP modules, guidance on partial MAH transfers (e.g., when a marketing authorisation is transferred at national level in only one Member State without being transferred in all concerned Member States), and clarification of back-up arrangements for the Qualified Person. The revision also provides guidance on performance indicators and audit requirements for the PSMF main body and annexes, in line with published Q&A. For subcontracting, the text clarifies that MAH entities and third parties involved in the pharmacovigilance system should be clearly stated, with roles and responsibilities defined, including for co-marketing of separately authorised veterinary medicinal products that are identical except for their invented names.
The revision impacts MAHs, who will need to update their PSMFs and quality management systems to comply with the clarified requirements, potentially increasing administrative burden. Veterinary pharmacovigilance inspectors will benefit from clearer standards, facilitating consistent enforcement. The changes aim to improve the quality and consistency of pharmacovigilance data, ultimately benefiting animal health and public health by ensuring better monitoring of veterinary medicinal products. The public consultation period allows stakeholders to provide feedback before the guideline is finalised.