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.

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As of 28 January 2022, the VGVP guideline superseded previous EU guidance on pharmacovigilance for veterinary medicines.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

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

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

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.

The completed comments form should be sent to [e-mail].

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

AdoptedLegal effective date: 28/01/2022Reference Number: EMA/522332/2020Summary:

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).

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

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

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

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

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.

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

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

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

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

Eudravigilance Veterinary - Best Practice Guide (EVV BPG)

This document provides guidance to all registered user organisations and their individual users (EVWEB and Gateway users) that record suspected adverse event reports (AERs) in the Union pharmacovigilance database, EudraVigilance Veterinary (EVV).

Eudravigilance Veterinary - Best Practice Guide

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

Consultation dates: 05/07/2021 to 05/09/2021Draft: consultation closedReference 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

Consultation dates: 05/07/2021 to 05/09/2021Draft: consultation closedReference 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

Consultation dates: 05/07/2021 to 05/09/2021Draft: consultation closedReference 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

Consultation dates: 05/07/2021 to 05/09/2021Draft: consultation closedReference 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

Consultation dates: 05/07/2021 to 05/09/2021Draft: consultation closedReference 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 closedReference 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