Guidance

VMD Information Hub

This is the Hub for all the Veterinary Medicines Directorate's communications on current and future regulatory changes.

From:
Veterinary Medicines Directorate
Published
31 January 2020
Last updated
19 JuneMay 20252026 — See all updates

VMD Information Hub

This is the Hub for all the Veterinary Medicines Directorate’s communications on current and future regulatory changes.

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Supply of Veterinary Medicines to Northern Ireland from 1 January 2026

New rules governing the distribution of veterinary medicines in Northern Ireland willcame applyinto effect from 1 January 2026.

On 19 June 2025, the Government published its paper ‘Protecting Animal Health: The Government’s Approach to Veterinary Medicines in Northern Ireland’.

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:

We welcome your feedback, please send your comments to 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 Veterinary Medicines (Amendment etc.) Regulations 2024 (legislation.gov.uk).

The Regulations contain transitional provisions for certain requirements, set out in Part 10, 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 takecame into 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 2024 further renewal applications willwere 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.  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 2024 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 2024 new labelling requirements arecame ininto effect. More information can be found in the Product Information Template guidance.

Reporting supply issues

From 17 May,May 2024, 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

Published 31 January 2020
Last updated 19 JuneMay 20252026 + show all updates

  2. 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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