Pharmacovigilance system (veterinary medicines)

Guidance is available from the European Medicines Agency (EMA) on pharmacovigilance system requirements for veterinary medicines and on describing the pharmacovigilance system in a marketing authorisation application. 

Marketing authorisation applicants and holders must have a pharmacovigilance system in place for monitoring and ensuring the safety of their medicines on the European market.

Guidance on pharmacovigilance system requirements

Guidance on the requirements for pharmacovigilance systems for veterinary medicines is available in the module on 'Pharmacovigilance systems, their quality management systems and pharmacovigilance system master files' of the guideline on veterinary good pharmacovigilance practices (VGVP):

• Veterinary good pharmacovigilance practices (VGVP)

Describing the pharmacovigilance system in the marketing authorisation application

Marketing authorisation holders should include a summary of their pharmacovigilance system master file (PSMF), in their marketing authorisation application.

This should contain the following details:

• PSMF reference number
• PSMF file location
• Name, contact details and place of operation of the qualified person responsible for pharmacovigilance (QPPV)
• Signed statement from the marketing authorisation holder and the QPPV that the QPPV has the necessary means to fulfil their tasks and responsibilities
• Reference to the type of record management system they are using for collecting reports of adverse events including the name of the database, if applicable

Marketing authorisation holders should promptly inform EMA of any changes to the contact details of their QPPV, to ensure that they do not miss important updates from EMA.

The legal basis for this obligation is Article 8(1)(c) of Regulation EU 2019/6 and and Commission Implementing Regulation (EU) 2021/1281