Pharmacovigilance (veterinary medicines)

Veterinary pharmacovigilance concerns monitoring, evaluating and improving the safety of veterinary medicines, with particular reference to adverse events in animals and human beings related to the use of these medicines. It also involves collection of information on adverse events due to off-label use and investigations of the validity of the withdrawal period and of potential environmental problems.

The veterinary pharmacovigilance system in the European Union (EU) operates with the management and involvement of national competent authorities, the European Commission and the European Medicines Agency (EMA), in collaboration with the marketing-authorisation holders for the medicines.

The Agency has a coordinating role within the EU veterinary pharmacovigilance system and provides advice to ensure the safe and effective use of veterinary medicinal products.

The Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) and Commission Implementing Regulation (EU) 2021/1281 contain new legal provisions on veterinary pharmacovigilance. They aim to reduce administrative burden on industry and regulators while reinforcing the scientific focus of safety monitoring activities.

The changes focus on the following areas:

• Continuous signal management throughout a medicine's lifecycle, based on adverse event reports in the 'Union Pharmacovigilance Database'
• Maintenance of a pharmacovigilance master file by the marketing authorisation holder describing their safety and efficacy monitoring system
• Pharmacovigilance inspections by regulators

Marketing authorisation holders no longer need to submit periodic safety update reports from 28 January 2022 as they must carry out continuous signal management instead.

A guideline on veterinary good pharmacovigilance practices (VGVP guideline) superseded previous guidelines on veterinary pharmacovigilance on 28 January 2022. Its six modules are available below.

A procedural note is also available for interim measures regarding notification of pharmacovigilance alerts by marketing authorisation holders under Regulation (EU) 2019/6.

Final VGVP modules

Draft VGVP modules and comments received

The incident management plan for medicines for veterinary use defines a strategy for the rapid and efficient handling of incidents involving safety issues relating to veterinary medicines authorised in the EU:

It outlines the procedures and management structures to:

• evaluate a potential incident;
• manage the response;
• communicate within the regulatory network and with concerned marketing authorisation holder(s);
• effect closure of the incident.

The plan was developed in 2010 to account for the experience gathered since 2004 with the crisis management plan on safety issues and to broaden its scope. It was last revised in 2022.

The recommended due dates for submitting annual statements for centrally and non-centrally authorised products (CAPs and non-CAPs) for 2023 are available below:

Marketing authorisation holders (MAHs) can find the veterinary signal assessment report template below:

MAHs should promptly inform EMA of any changes to the contact details of their qualified person responsible for pharmacovigilance (QPPV), to ensure that they do not miss important updates from EMA.

In addition to the annual pharmacovigilance bulletin, the pharmacovigilance regulatory recommendations include the changes agreed by CVMP during the year following the assessment of pharmacovigilance data for centrally authorised products. 

The document is updated monthly and is part of an ongoing effort of the Agency to accelerate and facilitate the communication to the stakeholders of regulatory actions related to the safe and efficacious use of centrally authorised products.

This section provides questions and answers on how adverse events are described in the product information - summary of product characteristics (SPC) and package leaflet (PL).