Pharmacovigilance guidance

This page lists the European Medicines Agency's guidance documents relating to pharmacovigilance of veterinary medicines.

The main body of guidance on veterinary pharmacovigilance can be found in the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) and Commission Implementing Regulation (EU) 2021/1281. The guidance on this page is complementary to these Regulations.

For veterinary international conference on harmonisation (VICH) guidance on pharmacovigilance see Veterinary International Conference on Harmonisation (VICH).

Pharmacovigilance system

A pharmacovigilance system enables the collection, monitoring, assessment and evaluation of information related to adverse events. Marketing authorisation holders (MAH) are required to develop a pharmacovigilance system and provide a detailed description of it as part of their Marketing authorisation application (MAA).

Requirements for a detailed description of the pharmacovigilance system and how the information should be presented in a MAA:

Article 8(1)(c) of Regulation EU 2019/6 requires a summary of the applicant’s pharmacovigilance system master file to be included in the marketing authorisation application, which, in accordance with  Article 23 of Commission Implementing Regulation 2021/1281, shall include the following elements: 

• The pharmacovigilance system master file reference number.
• The pharmacovigilance system master file location.
• Name, contact details and place of operation of the QPPV.
• A signed statement from the marketing authorisation holder and the QPPV that the QPPV has the necessary means to fulfil the tasks and responsibilities requested by Regulation (EU) 2019/6.
• The type of record management system used for adverse events reports including the name of the database, if applicable.

Further guidance is available in the following modules of the guideline on veterinary good pharmacovigilance practices (VGVP guideline): 

• Guidance applicable from 28 January 2022

Surveillance of EudraVigilance Veterinary data

The following guidance documents are available:

• Recommendation on pharmacovigilance surveillance and signal detection of veterinary medicinal products;
• Recommendation for the basic surveillance of EudraVigilance veterinary data;