Pharmacovigilance of Veterinary Medicines in Great Britain
Explanation of what Pharmacovigilance means and who is responsible.
Applies to England, Scotland and Wales
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What is pharmacovigilance
The World Health Organization has defined pharmacovigilance as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. This principle also applies to veterinary medicines.
Adverse effects may be undesirable side effects, such as adverse reactions, or a medicine may not work as expected, known as a lack of expected efficacy. The effects may be seen, for example, in the animal being treated, in other animals, the person handling the medicine or in the environment.
Veterinary pharmacovigilance legislation
Statutory Instrument 2013 Number 2033, the Veterinary Medicines Regulations 2013, hereinafter referred to as the VMR, sets out the legal framework for the pharmacovigilance of veterinary medicines in Great Britain (GB).
Although Part 8 of Schedule 1 of the VMR contains the majority of pharmacovigilance provisions in the legislation, you can find other requirements directly relevant to the conduct of pharmacovigilance in other Schedules and Parts of the VMR.
This guidance document applies to all products authorised in Great Britain. All products authorised in Northern Ireland are required to follow the EU acquis and therefore should follow the guidance set out in EudraLex Volume 9B. Notwithstanding, specifically for reporting of adverse events cases occurring in Northern Ireland, guidance provided by this document should be followed and these reports should continue to be submitted to the VMD.
Who is responsible for pharmacovigilance
The Veterinary Medicines Directorate (VMD) is the Competent Authority (CA) of the United Kingdom for veterinary pharmacovigilance. The VMR describes the obligation of Marketing Authorisation Holders (MAHs) for the establishment and maintenance of a pharmacovigilance system.
We will cooperate with MAHs, sharing all relevant information, so that all parties can continue to develop pharmacovigilance systems capable of achieving animal and public health protection, irrespective of the routes of authorisation of their veterinary medicines.
Intensive exchange of information between the MAH and the CA, as well as procedures to avoid duplication, whilst maintaining confidentiality, ensures the quality of the systems and data. Each MAH must ensure that it has an adequate pharmacovigilance system in place. Where appropriate, a risk management system must also be in place. This assures that the MAH takes responsibility and liability for its products on the market and can take appropriate action, when necessary.
We will continually check the safety profile of the veterinary medicines available on our territory, act where necessary, checking that MAHs fulfil their pharmacovigilance obligations. We are responsible for the pharmacovigilance of all UK-held veterinary medicine Marketing Authorisations (MAs) (this includes UK-wide, GB-only and NI-only MAs). MAHs are legally responsible for MAs held in the UK.
We use internationally agreed veterinary terminology, (VeDDRA) and other related terminology to exchange adverse event information with MAHs and other interested parties. You can find information about these terminologies on the website of the European Medicines Agency.
This guidance has been prepared by the VMD and is specifically related to pharmacovigilance concerning veterinary medicines. It should be noted that this guidance will be regularly reviewed and updated.
Last updated 8 June 2022 + show all updates
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Revision of guidance, attachment title Adverse event reporting - section 14 Considerations on prioritisation of signals.
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Full review and major amendments including addition of section for Requirement for Pharmacovigilance System Master File, amendments to sections on PSUR, Considerations on serious and non-fatal adverse events and prioritisation of signals and changes of references from UK to GB.
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First published.