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Supply of Veterinary Medicines from Great Britain to Northern Ireland

Date
June 24, 2025
Category

UK Regulations

Description

The ‘Windsor Framework’ that came into force on 1 January 2025 only applies to human medicines, so different arrangements are need for veterinary medicines. The transitional arrangements for veterinary medicines that have been applied since the UK left the EU and which have been extended year on year since then, will cease at the end of 2025.

On 19 June 2025, the U.K. Government published a paper Veterinary medicines in Northern Ireland - GOV.UK.

The following guidance accompanies the government Paper and provides further technical guidance which can be found on the VMD Information Hub - GOV.UK

  • Supplying veterinary medicines to Northern Ireland from 2026 – Guidance for Marketing Authorisation holders.
  • Supplying veterinary medicines to Northern Ireland from 2026 – Guidance for Wholesalers / Retailers.
  • Supplying veterinary medicines to Northern Ireland from 2026 – Veterinary Medicine Health Situation Scheme - Guidance.
  • Supplying veterinary medicines to Northern Ireland from 2026 – Veterinary Medicines Internal Market Scheme guidance.

The guidance for Marketing Authorisation (MA) holders states that:

“If you hold a 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.”

From 1 January 2026, Northern Ireland authorised veterinary medicines from Great Britain will need to be retested and QP certified either in Northern Ireland or in the EU.

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:

  • The 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
  • There 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.