The Windsor Framework Agreement – What does it mean for the trade of medicinal products across the UK?

On the 1st of January 2025, provisions of the Windsor Framework relating to the regulation, licensing, labelling and wholesale dealing of medicinal products in the UK became effective.

The Framework, initially agreed on 27 February 2023 between the UK and the EU, aimed to provide a new set of arrangements that would address difficulties in trade between the UK and Northern Ireland (NI) brought about by Brexit and the subsequent Northern Ireland Protocol. 

A significant challenge that has been posed has been the complex rules and procedures that have had to be followed by companies manufacturing medicines in the rest of the UK and transporting them to NI, as they have had to adhere to two different sets of regulatory standards. It is hoped that these newly effective provisions will better align the position on trade across the UK and ‘secure the long-term stability of medicines supply to Northern Ireland’[1]

Below we take a brief look at a few of the changes introduced by the agreement, and how these will provide an easier and more efficient channel of trade for medicinal products between the NI and the rest of the UK. 

Streamlined approval of new medicines

One of the most significant changes that the Windsor Framework has brought about is that the Medicines and Healthcare products Regulatory Agency (MHRA) will be responsible for licensing all medicines on the market in Northern Ireland under a UK-wide licence. Unless a company elects to apply for a licence in Northern Ireland only, there is now a single marketing authorisation for the whole UK, called a Product Licence (PL), which replaces separate licences for Great Britain (PLGB) and Northern Ireland (PLNI).

This change creates a distinct regulatory divide between products to be marketed in the UK and in the EU, as products intended for the UK market cannot be supplied to the EU (including Ireland) unless in compliance with regulatory pathways and relevant guidance from respective national competent authorities.

Changes to packaging requirements

A number of changes have also been made to the requirements for medicines being imported into NI from the UK. Amongst these changes is that the EU Falsified Medicines Directive (FMD) safety features will no longer apply in Northern Ireland, removing significant challenges for importers of medicinal products in the UK due to the burdensome packaging, labelling and scanning requirements imposed by the Directive.

Under the new changes, products that are only intended for the UK market will now bear ‘UK only’ designation on their packaging. Up until 30 June 2025 stickering will be permissible, however, following this the ‘UK only’ label must be included directly on the packaging (further guidance can be found here). This will ensure that products can use the same packaging and labelling across the UK, while precluding onward movement of these medicines into any part of the EU, or European Economic Area (EEA).

Conclusion

The above changes bring about a ‘green lane’ for products meant for UK distribution only, allowing companies to apply the same standards to their products for distribution across the UK, rather than having to adhere to different standards for NI and the rest of the UK. Along with the other changes effective as of 1 January 2025 (which can be found here) those noted above should reduce barriers to trade across the UK, hopefully safeguarding access to and the supply of medicines to patients in NI, whilst also protecting the EU single market.

If you’d like to discuss how the changes brought about by the Windsor Framework will affect how your business operates then get in touch with a member of our specialist healthcare and life sciences team. 

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