Pharmacovigilance (veterinary medicines)

Veterinary pharmacovigilance involves closely monitoring the safety and efficacy of veterinary medicines on the European Union (EU) market. The European Medicines Agency (EMA) has a coordinating role in the EU pharmacovigilance system and operates services and processes to support veterinary pharmacovigilance activities. EMA also provides guidance and recommendations to stakeholders on the safe and effective use of veterinary medicines.

The EU pharmacovigilance system involves continuous safety monitoring by identifying and analysing any negative effects from the use of veterinary medicines that may occur in animals. 

The system also monitors the following:

• Lack of efficacy or adverse events when a medicine is used off-label
• Adequacy of withdrawal periods
• Suspected spread of an infectious agent by a medicine
• Negative environmental effects

The system is applicable to all veterinary medicines in the EU / European Economic Area, including:

• Authorised veterinary medicines
• Registered homeopathic veterinary medicines
• Veterinary medicines exempt from authorisation under Article 5(6) of Regulation (EU) 2019/6

The CVMP Pharmacovigilance Working Party (PhVWP-V) provides advice to the Committee for Veterinary Medicinal Products (CVMP) and the Coordination group for mutual recognition and decentralised procedures for veterinary medicinal products (CMDv) on coordinating and overseeing veterinary pharmacovigilance activities in the EU / EEA.

In this section

Direct animal healthcare professional communications

Communications to animal healthcare professionals on important new safety information

EudraVigilance Veterinary

Information on the data-processing network and database for managing and analysing information on suspected adverse reactions of veterinary medicines

Incident management plan

The European medicines regulatory network's plan for handling safety-related incidents involving authorised veterinary medicines

Veterinary good pharmacovigilance practices (VGVP)

Guidance on the safety monitoring of veterinary medicines in the EU / EEA

Signal management

Guidance and information on veterinary safety signal management

Pharmacovigilance system

Guidance for marketing authorisation holders and applicants

International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH)

International guidelines on veterinary pharmacovigilance applied by EMA

Pharmacovigilance-related recommendations to product information of centrally authorised veterinary medicines

Changes to the product information proposed by the CVMP following assessment of safety data

 

Archived content

Annual bulletins on veterinary pharmacovigilance activities (2003-19) Annual summaries of safety-monitoring activities for veterinary medicines in a calendar year between 2003 and 2019

Changes introduced in 2022 by the Veterinary Medicinal Products Regulation

The Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) and Commission Implementing Regulation (EU) 2021/1281 contain specific legal provisions on veterinary pharmacovigilance.

This legal framework, which took effect in January 2022, aims 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

Since 28 January 2022, marketing authorisation holders do not need to submit periodic safety update reports. They must carry out continuous signal management instead.

Interim measures for reporting pharmacovigilance alerts

Interim measures are in place for reporting pharmacovigilance alerts until the communication module of the Union pharmacovigilance database becomes fully functional. 

This includes a list of contact points for marketing authorisation holders to report pharmacovigilance alerts, and to notify EMA and national competent authorities of other important pharmacovigilance-related matters, such as public announcements or regulatory measures in third countries.

More information:

Procedural note for interim measures regarding notification of pharmacovigilance alerts by marketing authorisation holders under Regulation (EU) 2019/6

Reference Number: EMA/CVMP/PhVWP/751940/2021

Annex to interim measures regarding notification of pharmacovigilance alerts by marketing authorisation holders under Regulation (EU) 2019/6: contact points

Reference Number: EMA/586463/2021 Rev.5

Guidance on adverse events

How to report adverse events

• Adverse event reporting in the EU

Guidance on describing adverse events in the product information 

Guidance is available on describing adverse events in the product information of veterinary medicines in the form of questions and answers in the document below.

Questions and answers on describing adverse events in the product information (summary of product characteristics (SPC) and package leaflet (PL)

Reference Number: EMA/CVMP/150343/2016-Rev.4