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 Volume 9B of The Rules Governing Medicinal Products in the European Union (EU): Guidelines on Pharmacovigilance for Medicinal Products for Veterinary Use.

The guidance listed on this page is complementary to that included in Volume 9B and has been organised according to the steps in the pharmacovigilance process.

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 are available in the guidance document below:

Adverse event reporting

The following guidance documents are available:

Below are 'ready-to-use' pharmacovigilance reporting forms for veterinarians and health professionals for every EU Member State, available in PDF and Word formats:

Periodic safety update reports (PSURs)

The following guidance documents are available:

In addition, templates for regulatory assessors are available :

PSUR submission contact details of national competent authorities (NCAs) can be found below:

Surveillance of EudraVigilance Veterinary data

The following guidance documents are available:

Causality assessment

Triggering pharmacovigilance investigations

Pharmacovigilance communication


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