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On 19 June 2025, the Government published its paper on 鈥楶rotecting Animal Health: 皇冠体育app Government鈥檚 Approach to Veterinary Medicines in Northern Ireland鈥�.

This guidance sets out the steps that businesses need to take to continue to market their products in Northern Ireland from 1 January 2026.

Marketing Authorisation Holders (MAH) must be based in Northern Ireland or an EU Member State in order to market a veterinary medicine in Northern Ireland.

If you hold a Marketing Authorisation (MA) valid in Northern Ireland (either an Northern Ireland only MA (Vm xxxxx/3xxx) or a UK-wide MA (Vm xxxxx/4000)) and are based in Great Britain, you must apply to vary your authorisation(s) to change the Marketing Authorisation Holder to an EU or Northern Ireland based legal entity. If you do not change your holder to an EU or Northern Ireland based legal entity, you will not be able to supply to Northern Ireland after 31 December 2025.

For UK wide authorisations (Vm xxxxx/4000), if you do not plan to vary your MA and therefore cease supply to Northern Ireland, but wish to maintain your Great Britain approval, you must submit a variation to remove the Northern Ireland aspect which will incur a fee.

This will result in a change of your MA number to a Great Britain only authorisation number. Labels will need to be updated to reflect the change to a Great Britain only authorisation within 12 months.

Marketing Authorisation Holders are also reminded that if they are unable to supply medicines to any part of the UK, including Northern Ireland, this must be reported to the VMD as soon as possible.

Variation applications will take up to 30 days to approve from receipt of a valid application. Variations must be submitted by 1 October 2025 and applications must be approved by 31 December 2025.

We encourage you to submit any variations well ahead of the deadline to allow efficient processing of applications. We also encourage you to discuss your submission strategies with us in advance of submitting your applications. Meeting requests should be sent via email to [email protected]

Application process to change legal entity聽

Changing the legal entity of the MAH is a Variation Requiring Assessment 鈥� Reduced (VRA), (category U.I.z.a) dealt with on a national basis. A change in legal entity will result in a change to the 鈥榗ompany number鈥�, which forms part of a product鈥檚 Vm number and splitting out of any existing Great Britain and Northern Ireland shared Vm4000 numbers.聽

When submitting a change of legal entity variation, you must ensure no other variation procedures are in progress or submitted during the legal entity variation assessment. You will need to provide:聽

• confirmation that no other aspect of the dossier has changed
• evidence that a variation to replace or change an existing Summary of the Pharmacovigilance System Master File (PSMF) has been submitted, or an explanation as to why no variation is necessary
• formal letters of transfer of ownership from the current and acceptance from the proposed聽MAH
• proof of establishment of the new MAH 鈥� unless they already hold MAs for veterinary medicines

For a Great Britain and Northern Ireland MA to remain aligned, the MAH will need to remain the same for Northern Ireland and Great Britain upon approval of your application(s).聽 MAHs based in Northern Ireland or the EU are able to hold an MA in Great Britain, as well as a Marketing Authorisation granted in accordance with the Windsor Framework in Northern Ireland.

We ask that grouped applications contain a maximum of eight veterinary medicines per application.

Please note that MAs for Great Britain and Northern Ireland are separate, even if they share MA numbers.

Each medicine within a veterinary medicine range should be considered independently, when counting the number of veterinary medicines to be varied within an application.

Placing on the market聽

Veterinary medicines that have already been placed on the market in Northern Ireland (including from Great Britain) before 1 January 2026, may continue to be sold and supplied in Northern Ireland.

For a veterinary medicine to be considered to have been placed on the market in Northern Ireland, the following criteria must have been met:

• 皇冠体育app veterinary medicine must have been released onto the market before 1 January 2026 by a Qualified Person (QP) in the UK or the EU; and
• 皇冠体育appre must have been an offer or agreement (either written or verbal) for the transfer of ownership of the medicine to a legal entity in Northern Ireland. This may include transfer of stock for sale or supply to different legal entities within the same company group.

Veterinary medicines in Great Britain or the EU that meet the above criteria before 1 January 2026 but have not yet been physically delivered may still be supplied to Northern Ireland after that date.

From 1 January 2026, Northern Ireland authorised veterinary medicines from Great Britain can only be supplied by the holder of a Manufacturing Authorisation (ManA) granted in accordance with the Windsor Framework who must then ensure each batch of product is tested, to confirm that it meets its required specification before being released to the market by a Northern Ireland or EU-based Qualified Person.

This does not apply to veterinary medicines authorised in Northern Ireland and imported directly from the EU or veterinary medicines sourced by vets for use under the cascade / the Veterinary Medicines Internal Market Scheme.

More details on manufacturing requirements are available on Apply to manufacture authorised veterinary medicines or exempt products for small pet animals - GOV.UK.