Veterinary good pharmacovigilance practices (VGVP)

Veterinary good pharmacovigilance practices (VGVP) are a set of measures to facilitate pharmacovigilance for veterinary medicines in the European Union (EU) / European Economic Area (EEA). They apply to marketing-authorisation holders, the European Medicines Agency (EMA) and medicines regulatory authorities in EU Member States.

VGVP cover veterinary medicines authorised centrally via the Agency as well as medicines authorised at national level.

As of 28 January 2022, the VGVP guideline superseded previous EU guidance on pharmacovigilance for veterinary medicines.

VGVP modules

Draft guideline on veterinary good pharmacovigilance practices (VGVP) Module: Signal Management - Revision 1

Draft: consultation open Consultation dates: 18/09/2026 to 18/12/2026 Reference Number: EMA/522332/2021 Rev.1 Summary:

This guideline has been revised to reflect the current approach to the signal management process. The guideline provides general guidance on scientific and quality aspects of signal management for veterinary medicinal products (VMPs), and describes the roles, responsibilities and procedural aspects of the EU signal management process for VMPs.

Comments should be provided using this template. The completed comments form should be sent to [e-mail] 

Guideline on veterinary good pharmacovigilance practices (VGVP) - Module: Collection and recording of suspected adverse events for veterinary medicinal products

Adopted Reference Number: EMA/306663/2021 Legal effective date: 28/01/2022 Summary:

This module of the guideline on veterinary good pharmacovigilance practices (VGVP) brings together general guidance for marketing authorisation holders, national competent authorities and the Agency on the requirements, roles, activities and procedures related to collection and recording of suspected adverse events for veterinary medicinal products occurring within the EU/EEA or in third countries.

Guideline on veterinary good pharmacovigilance practices (VGVP) - Module: Signal Management

Adopted Reference Number: EMA/522332/2021 Legal effective date: 28/01/2022 Summary:

This module of the guidelines on veterinary good pharmacovigilance practices (VGVP) brings together general guidance for marketing authorisation holders, national competent authorities and the European Medicines Agency (the “Agency”) regarding signal management for veterinary medicinal products authorised in the European Union (EU).

Concept paper for the revision of the guideline on veterinary good pharmacovigilance practices (VGVP) Module: Signal Management (EMA/522332/2021)

Draft: consultation closed Consultation dates: 13/02/2026 to 15/03/2026 Reference Number: EMA/CVMP/PhVWP/31941/2026 Summary:

The guideline on veterinary good pharmacovigilance practices (VGVP) Module: Signal Management (EMA/522332/2021) was initially adopted in November 2021 and came into effect in January 2022. The current 2021 version of the document makes reference to future revisions, should these be warranted by the experience gained by all stakeholders involved in the signal management process. This concept paper addresses the need for a thorough revision of the guideline, applying the experience gained with the implementation of Regulation (EU) 2019/6 on the signal management process.

Comments should be provided using this template. The completed comments form should be sent to [e-mail]

Guideline on veterinary good pharmacovigilance practices (VGVP) - Module: Veterinary pharmacovigilance communication

Adopted Reference Number: EMA/63454/2021 Legal effective date: 28/01/2022

Guideline on veterinary good pharmacovigilance practices (VGVP) - Module: Pharmacovigilance systems, their quality management systems and pharmacovigilance system master files

Adopted Reference Number: EMA/595115/2021 Legal effective date: 28/01/2022 Summary:

This module of the guidelines on veterinary good pharmacovigilance practices (VGVP) addresses the basic requirements on the pharmacovigilance system, its integral quality management system and the pharmacovigilance system master file that marketing authorisation holders for veterinary medicinal products authorised in the European Union (EU) should establish and maintain.

Draft guideline on veterinary good pharmacovigilance practices (VGVP) - Module: Pharmacovigilance systems, their quality management systems and pharmacovigilance system master files - Revision 1

Draft: consultation open Consultation dates: 27/07/2026 to 24/09/2026 Reference Number: EMA/INS/PhV/68655/2026 Summary:

The Guideline on veterinary good pharmacovigilance practices (VGVP) – Module on Pharmacovigilance systems, their quality management systems and pharmacovigilance system master files was adopted in November 2021 and came into effect on 28 January 2022. Revision 1 of the guideline is based on the experience of pharmacovigilance inspectors, common inspection findings, and questions and requests for clarification received from marketing authorisation holders. The proposed changes affect:

• Section 1 – Introduction
• Section 2 – Pharmacovigilance
• Section 2.1 – Qualified person responsible for pharmacovigilance
• Section 2.2.2 – Performance indicators
• Section 2.2.3 – Audits
• Section 2.2.7 – Quality management system requirements for pharmacovigilance tasks contracted or subcontracted by the marketing authorisation holder

In addition, an appendix has been added to provide further guidance on the content of the pharmacovigilance system master file (PSMF), particularly the annexes. This reflects experience gained from pharmacovigilance inspections and addresses requests from marketing authorisation holders for more guidance on the information to include in each annex. No concept paper was prepared for this revision, as it does not constitute either a new guideline or a significant revision of the existing guideline. The scope of the public consultation is limited to the proposed changes, which are provided in track changes to facilitate review. Comments should be submitted using the dedicated template. The completed comments form should be sent to [e-mail], with [e-mail] copied (in cc:).

Guideline on veterinary good pharmacovigilance practices (VGVP) - Module: Controls and pharmacovigilance Inspections

Adopted Reference Number: EMA/328998/2021 Legal effective date: 28/01/2022

Guideline on veterinary good pharmacovigilance practices (VGVP) - Module: Glossary

Adopted Reference Number: EMA/118227/2021 Legal effective date: 28/01/2022

Veterinary Union Pharmacovigilance Database - Best Practice Guide

This document has replaced the previous EudraVigilance Veterinary – Best Practice Guide and covers guidance for all registered user organisations and their individual users (EVWEB and Gateway users) that record suspected adverse event reports (AERs) in EudraVigilance Veterinary (EVV), as well as practical advice to facilitate the implementation of the following veterinary good pharmacovigilance practices (VGVP) modules: Collection and recording of suspected adverse events for veterinary medicinal products, Signal Management and Controls and pharmacovigilance Inspections.

Updates in revision 14:

Section 1.2.1 and section 1.2.4. have been updated to include advice on how to complete the field “Outcome to date” in relation to the VeDDRA term “Diagnostic cull”. 

Veterinary Union Pharmacovigilance Database - Best Practice Guide

Reference Number: EMA/371192/2021 Rev.14

Draft VGVP modules and comments received

Draft guideline on veterinary good pharmacovigilance practices (VGVP) - Module: Collection and recording of suspected adverse events for veterinary medicinal products

Draft: consultation closed Consultation dates: 05/07/2021 to 05/09/2021 Reference Number: EMA/635856/2020

Overview of comments received on 'Guideline on veterinary good pharmacovigilance practices (VGVP)’ (EMA/635856/2020) - Module: Collection and recording of suspected adverse events for veterinary medicinal products

Reference Number: EMA/367323/2021

Draft guideline on veterinary good pharmacovigilance practices (VGVP) - Module: Signal Management

Draft: consultation closed Consultation dates: 05/07/2021 to 05/09/2021 Reference Number: EMA/399713/2020

Overview of comments received on 'Guideline on veterinary good pharmacovigilance practices (VGVP)’ (EMA/399713/2020) - Module: Signal Management

Reference Number: EMA/367359/2021

Draft guideline on veterinary good pharmacovigilance practices (VGVP) - Module: Veterinary pharmacovigilance communication

Draft: consultation closed Consultation dates: 05/07/2021 to 05/09/2021 Reference Number: EMA/63454/2021

Overview of comments received on 'Guideline on veterinary good pharmacovigilance practices (VGVP)’ (EMA/63454/2021) - Module: Veterinary pharmacovigilance communication

Reference Number: EMA/373229/2021

Draft guideline on veterinary good pharmacovigilance practices (VGVP) - Module: Pharmacovigilance systems, their quality management systems and pharmacovigilance system master files

Draft: consultation closed Consultation dates: 05/07/2021 to 05/09/2021 Reference Number: EMA/257136/2021

Overview of comments received on 'Guideline on veterinary good pharmacovigilance practices (VGVP)’ (EMA/257136/2021) - Module: Pharmacovigilance systems, their quality management systems and pharmacovigilance system master files

Reference Number: EMA/367990/2021

Draft guideline on veterinary good pharmacovigilance practices (VGVP) - Module: Controls and pharmacovigilance Inspections

Draft: consultation closed Consultation dates: 05/07/2021 to 05/09/2021 Reference Number: EMA/328998/2021

Overview of comments received on 'Guideline on veterinary good pharmacovigilance practices (VGVP)’ (EMA/328998/2021) - Module: Controls and pharmacovigilance Inspections

Reference Number: EMA/368440/2021

Draft guideline on veterinary good pharmacovigilance practices (VGVP) - Module: Glossary

Draft: consultation closed Reference Number: EMA/118227/2021

Overview of comments received on 'Guideline on veterinary good pharmacovigilance practices (VGVP)’ (EMA/118227/2021) - Module: Glossary

Reference Number: EMA/367598/2021