Pharmacovigilance of Veterinary Medicinal Products in Great Britain
Explanation of what Pharmacovigilance means and who is responsible. These documents must be read with the Implementation Explainer at VMD Information Hub.
Applies to England, Scotland and Wales
Documents
Details
IMPORTANT: This guidance should be implemented alongside the Implementation explainer: Pharmacovigilance at Implementation explainer: Pharmacovigilance which includes important information on transitional requirements and timelines following the Veterinary Medicines (Amendment etc.) Regulations 2024 coming into force.
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 medicinal products.
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 (as amended), hereinafter referred to as the VMR 2013 (as amended), sets out the legal framework for the pharmacovigilance of veterinary medicinal products (VMPs) in GB.
Although Part 8 of Schedule 1 of the VMR 2013 (as amended) contains the majority of pharmacovigilance provisions in the legislation, you can find other requirements directly relevant to pharmacovigilance in other Schedules and Parts.
This guidance applies to all products authorised in GB. Products authorised in Northern Ireland (NI) are required to follow the European Union (EU) acquis. Notwithstanding, specifically for reporting of adverse events cases occurring in NI, this guidance should be followed and these reports should continue to be submitted to the VMD.
Who is responsible for pharmacovigilance
The VMD is the UK regulatory authority for veterinary pharmacovigilance.
We monitor the safety profile of the VMPs available on our territory and act where necessary, including checking that Marketing Authorisation Holders (MAHs) fulfil their pharmacovigilance obligations. We are responsible for the pharmacovigilance of all Marketing Authorisations (MAs) for VMPs in the UK, 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 Dictionary for Drug Regulatory Activities (VeDDRA) terminology 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.
We also, where appropriate, use definitions and guidelines from the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH).
The VMR 2013 (as amended) set out the obligations placed upon MAHs for the establishment and maintenance of a pharmacovigilance system. It describes MAHs complying with good veterinary pharmacovigilance practice (in paragraphs 56 and 60A) which is the minimum standards for monitoring the safety and efficacy of veterinary medicinal products authorised in the United Kingdom.
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.
This guidance has been prepared by the VMD and is specifically related to pharmacovigilance concerning veterinary medicinal products. It should be noted that this guidance will be regularly reviewed and updated.
The VMR 2013 (as amended) also details legal obligations for some products which do not have an MA. Guidance on this is available in Guidance VI Pharmacovigilance for other products.
Updates to this page
Last updated 22 August 2024 + show all updates
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Updates made to Guideline IV Signal management, including benefit-risk reports: separation of the BRR into the Benefit-Risk Submission Report (BRSR) and Pharmacovigilance Sales Submission (PSS) components, BRSR, PSS and worldwide authorisation status data submission requirements and increase to the scope of Product Group Codes.
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Updated to include the following changes: Guideline III 4.2. Off-label coding clarification; Guideline IV 1.4.1. Update to MIT list; Guideline IV 2., 3.1.1., 3.1.2., 3.1.3. Clarification of timing of signal submissions and re-submission requirements; Guideline IV 4.1. Clarification of BRR sending requirements, and non-mandatory fields for signal submissions; Guideline IV 4.2, 4.4, 4.5. Accepted documents for submission, requirement for timing of data submissions and line listings clarification; Guideline IV 4.3.3 Product Group Code additional information; Guideline IV 4.6.2., 4.6.4 Dose factor, incidence and non-EEA sales updates; Guideline V 4 and Guideline VI 2. Clarification of post-marketing study and ATC requirements.
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Updates made to Guideline IV Signal management, including benefit-risk reports.
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Updated in accordance with the VMR, as amended.
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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.