VMD Information Hub
This is the Hub for all the Veterinary Medicines Directorate's communications on current and future regulatory changes.
VMD Information Hub
This is the Hub for all the Veterinary Medicines Directorate鈥檚 communications on current and future regulatory changes.
You can sign up to receive聽email alerts聽for all our news and announcements through 伊人直播 to make sure you get the latest information as soon as it becomes available. In addition to this we have a mailing list for those in your organisation only interested in receiving updates made to the Hub and other regulatory related information. To register email postmaster@vmd.gov.uk.
Supply of Veterinary Medicines to Northern Ireland from 1 January 2026
New rules governing the distribution of veterinary medicines in Northern Ireland will apply from 1 January 2026.
On 19 June 2025, the Government published its paper 鈥楶rotecting Animal Health: The Government鈥檚 Approach to Veterinary Medicines in Northern Ireland鈥.
This paper sets out progress in safeguarding the ongoing supply of veterinary medicines in Northern Ireland, and the steps that the Government will take to support this.
The following guidance accompanies the Paper and provides further technical guidance on supplying veterinary medicines in Northern Ireland:
- Guidance for Marketing Authorisation holders
- Guidance for Wholesalers / Retailers
- Veterinary Medicine Health Situation Scheme
- Veterinary Medicines Internal Market Scheme
We welcome your feedback, please send your comments to聽windsorframework@vmd.gov.uk
Great Britain legislation now in force
The Veterinary Medicines (Amendment etc.) Regulations 2024, which amend the Veterinary Medicines Regulations 2013 in respect of Great Britain, are now in force.
You can find the legislation here: .
The Regulations contain transitional provisions for certain requirements, set out in , for which we have created an explainer which you can find in the table below.
We have published updated guidance documents to reflect the amendments introduced by the new Regulations, which can be found on our collection page Veterinary Medicines Guidance.
If you have any questions about the new Regulations or feedback on the guidance, please contact us at vmr@vmd.gov.uk.
Authorisation requirements
As a result of the mitigations put in place in February 2021 (set out below), many of the changes introduced by the amended Regulations to veterinary medicine approval processes are already implemented.
From 17 May 2024, the following additional changes relevant to Marketing Authorisation Holders take effect:
Renewals
Marketing Authorisations are no longer subject to renewal and are valid indefinitely. For those Marketing Authorisations that were due to be renewed after 17 May further renewal applications will not be required. Exceptional MAs continue to be required to be reassessed annually.
Marketing Authorisations for Parallel Import (MAPI)
MAPIs are no longer provided for in the amended Regulations.聽 Existing authorisations remain in effect for the UK, however applications for new MAPIs will not be accepted.
Authorisation application fees
For applications validated after 17 May the amended fees set out in Great Britain and Northern Ireland will apply. For all applications you will be invoiced based on the legislation in force on the date of invoicing.
Labelling for authorised veterinary medicines
From 29 April new labelling requirements are in effect. More information can be found in the Product Information Template guidance.
Reporting supply issues
From 17 May, MA holders are obliged to report any identified supply problems as soon as reasonably practical. To do so, email a completed supply issue report form to supply@vmd.gov.uk.
Explainers to accompany the Great Britain changes
Explainer subject | Summary |
---|---|
Fee changes in the VMR | Explainer for the pharmaceutical industry on the implementation of the Veterinary Medicines Regulations relating to fees for applications and authorisations for veterinary medicines |
Implementation explainer: Pharmacovigilance | Explainer for the pharmaceutical industry on the implementation of Pharmacovigilance requirements from the date of the new VMR. |
Mitigation explainer: Labelling text - Product Information Templates for Veterinary Medicines (SPC and QRD Text) | Explainer on product information templates to be used by applicants and Marketing Authorisation Holders (MAHs) of veterinary medicines. |
Explainer: transitional provisions in new Regulations | Explainer for businesses and persons regulated by the Veterinary Medicines Regulations 2013, as amended, on the transitional provisions included in the amending legislation: the Veterinary Medicines (Amendment etc.) Regulations 2024. |
Updates to this page
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Updated to add technical guidance for Marketing Authorisation Holders, Wholesalers and Retailers on supplying veterinary medicines to Northern Ireland from 2026.
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Placeholder for the VMR 2013, as amended, Pharmacovigilance Implementation Explainer.
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Added Explainer regarding Fee changes to the VMR.
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Additional notes relating to authorisation requirements including; MAPI, fees, labelling, reporting supply issues.
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Added section; New legislation to come into force on 17 May
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Revised Draft pdf added for Pharmacovigilance of Veterinary Medicines in GB with BRR template.
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Updated Mitigation explainer: Labelling text - Product Information Templates
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Draft Guidance attachments have been added for: * Marketing authorisations for veterinary medicines * Registrations for veterinary homeopathic remedies (VHR) * Technical annex * Variations to a veterinary marketing authorisation or homeopathic remedy * Exemption from authorisation for medicines for small pet animals * The cascade: prescribing unauthorised medicines
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Updated to include Draft guidance reflecting changes to the VMR.
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Removed references to Northern Ireland Protocol - now referred to as the Windsor Framework.
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The Northern Ireland section under The Windsor Framework has been updated.
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Updated to take into account of The Windsor Agreement.
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European Commission Statement 19 December 2022 added: three-year extension to the grace period for veterinary medicines until 31 December 2025.
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Northern Ireland update: Introduction of the Northern Ireland Protocol Bill
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Updated to include information specifically for Vets in Northern Ireland. There is no change to the current cascade steps.
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Update concerning Northern Ireland: EU Regulation 2019/6 and EU Regulation 2019/4 will not be implemented in Northern Ireland.
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Northern Ireland update following Government statement 17 December
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Explainer text added regarding the Government announcement about the 'standstill' arrangements for Northern Ireland.
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Explainer text added regarding the Government announcement about maintaining the 鈥渟tandstill鈥 arrangements.
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links updated to expliners
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Hub revamp - DM 1738370
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End of Transition Period Information Hub launched
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Recognition of MAH location, manufacturing sites and authorised personnel update
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Added information on the Border Operating Model
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Post-Transition period action deadlines extended
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First published.