Guidance for Wholesalers and Manufacturers under the Windsor Framework in the UK

Background and Purpose of the Windsor Framework

The Windsor Framework, agreed in February 2023, resolves issues related to the movement of goods, including medicines, between Great Britain (GB) and Northern Ireland (NI) following the UK's exit from the EU. It ensures patients in NI continue to access the same range of medicines as in the rest of the UK, while protecting the EU Single Market. For human medicines, the Framework introduces dual routes for placing products on the NI market: the UK-wide route (using MHRA authorisations) and the NI-only route (using EU authorisations via the EMA). The guidance applies to manufacturers, wholesalers, importers, and distributors involved in supplying medicines to NI. Wholesalers' and manufacturers' guidance following agreement of the Windsor Framework - GOV.UK

Routes for Supplying Medicines to Northern Ireland

UK-Wide Authorisation Route

Most human medicines authorised by the MHRA can be supplied to NI under the UK-wide authorisation route. This route applies to products with a UK-wide marketing authorisation (MA) or a GB-only MA that meets specific conditions. From 1 January 2025, products placed on the NI market via this route must comply with new labelling and packaging requirements to distinguish them from EU-authorised versions.

NI-Only Authorisation Route

Products authorised centrally by the EMA (via the EU route) can continue to be supplied to NI under the NI-only route. This route is used for medicines that do not have a UK-wide MA or where the MAH chooses the EU authorisation pathway for NI. These products retain EU labelling and packaging and are not subject to the new Windsor Framework labelling changes.

Labelling and Packaging Requirements (Effective 1 January 2025)

From 1 January 2025, medicines placed on the NI market via the UK-wide route must include specific labelling to indicate they are for the UK market (including NI) and not for the EU Single Market. Key requirements include:

• Addition of the statement “Not for EU/EEA supply” on the immediate and outer packaging.
• Inclusion of a 2D data matrix barcode containing the product code, serial number, batch number, and expiry date (for certain products).
• Compliance with Falsified Medicines Directive-style verification requirements where applicable.

These changes apply to new batches released after 1 January 2025; existing stock with pre-2025 labelling may remain in supply chains until depleted, subject to MHRA discretion. Parallel importers and wholesalers must ensure compliance when repackaging or relabelling. Wholesalers' and manufacturers' guidance following agreement of the Windsor Framework - GOV.UK

Supply Chain and Distribution Obligations

Wholesalers and distributors must:

• Verify that products supplied to NI comply with the applicable authorisation route and labelling requirements.
• Maintain records of the route used for each batch and ensure traceability.
• Report any non-compliant products or supply disruptions to the MHRA.
• For products moving from GB to NI, comply with the Internal Market System (IMS) requirements where applicable.

Manufacturers remain responsible for ensuring batch release and quality control align with the chosen route. No new customs declarations are required for medicines moving between GB and NI under the Framework.

Transitional and Grandfathering Provisions

Products lawfully placed on the NI market before 1 January 2025 can continue to be supplied under transitional arrangements, even if labelling does not meet the new requirements. This applies to stock held by wholesalers, pharmacies, and hospitals. The MHRA may provide case-by-case flexibility during the transition.

Practical Steps for Compliance

• Review marketing authorisations to confirm the applicable route for NI supply.
• Update labelling and packaging artwork for products using the UK-wide route.
• Implement systems to track batch routes and ensure data matrix compliance.
• Train supply chain staff on new requirements and monitor MHRA updates.
• Contact the MHRA for clarification on specific products or scenarios.

The guidance supports continued patient access in NI while minimising disruption to supply chains. It forms part of broader Windsor Framework implementation for medicines. Wholesalers' and manufacturers' guidance following agreement of the Windsor Framework - GOV.UK