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.
Communications to animal healthcare professionals on important new safety information
Information on the data-processing network and database for managing and analysing information on suspected adverse reactions of veterinary medicines
The European medicines regulatory network's plan for handling safety-related incidents involving authorised veterinary medicines
Guidance for marketing authorisation holders and applicants
Guidance and information on veterinary safety signal management
Guidance on the safety monitoring of veterinary medicines in the EU / EEA
Annual summaries of safety-monitoring activities for veterinary medicines in a calendar year between 2003 and 2019
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
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.
Procedural note for interim measures regarding notification of pharmacovigilance alerts by marketing authorisation holders under Regulation (EU) 2019/6 (PDF/86.75 KB)
First published: 27/01/2022
Annex to interim measures regarding notification of pharmacovigilance alerts by marketing authorisation holders under Regulation (EU) 2019/6: contact points (PDF/153.8 KB)
First published: 27/01/2022
Last updated: 31/03/2023