Getting ready for the Windsor Framework: ensuring continuity of UK medicines supply beyond 1 January 2025

This article first appeared in the Pink Sheet and can be accessed here. 

Blog post by Rick Greville, Director ABPI Wales Cymru & Distribution Supply Chain, Andy Collier, Regulatory Policy Manager and Ross Maclagan, Distribution and Supply Chain Policy Manager. 

There are increased complexities associated with potential regulatory divergence between the UK and the EU when the Medicines and Healthcare products Regulatory Agency takes over responsibility for UK-wide new drug approvals from January 2025. 

The Windsor Framework, agreed between the UK and the EU in February 2023, is expected to be fully implemented on 1 January 2025. The agreement seeks to resolve some of the issues with the Northern Ireland Protocol identified by businesses and communities, but the new framework does not entirely replace all the protocol’s provisions.

The new Labour government has continued progress towards implementation of the Windsor Framework. Just before the summer parliamentary recess, updates were made to the Human Medicines Regulations (HMR) legislation to enable the implementation of the framework.

What is new for medicines?

The Windsor Framework ensures that the MHRA, the UK’s sovereign medicines regulator, will be responsible for licensing innovative medicines in Northern Ireland (NI) as well as the rest of the UK. At present, pan-EU centralized marketing authorizations issued by the European Commission apply to NI. These new provisions will only apply to medicines, with medical devices not in scope.

The Windsor Framework requires a reclassification of medicines supplied to the UK, with a new two-category system being introduced under which some UK medicines will remain subject to certain EU regulations:

• Category 1 encompasses medicines that were previously within the mandatory or voluntary scope of the EU’s centralized authorization procedure . From 1 January 2025, these will become UK national licences regulated by the MHRA and subject to UK law.
• Category 2 medicines are those which meet none of the criteria for Category 1, and will remain subject to certain EU legal requirements. These include aspects of pharmacovigilance such as the submission of Periodic Safety Update Reports (PSURs), Post Authorization Safety Studies (PASS) and Safety Referrals.

While this reclassification is necessary for the government to comply with the requirements of the Windsor Framework agreement, the ABPI believes it adds complexity and there may be other consequences as a result of regulatory divergence over time.

Where companies have large and diverse portfolios, a two-category system might create a complex landscape as different products may be subject to different regulations.

Additionally, it is currently unclear what future divergence between UK and EU regulations will look like, and whether this will add even further complexity. Both the MHRA and the Department of Health and Social Care (DHSC) have stated that mechanisms will shortly be introduced that provide a forum for the UK and EU to discuss any issues of divergence in regulations. However, further details on this are yet to be published.

Preparing for implementation

Many of the changes brought about by the Windsor Framework do not apply to products already on the market in Great Britain (GB) and NI. For example, licensed medicines packed and released for distribution before 1 January 2025 can remain unchanged and in circulation until expiry.

From January next year, medicines must be labelled "UK Only" to prevent the inadvertent flow of UK products from Northern Ireland to the EU.

A number of other changes to existing procedures that are intended to protect the integrity of the EU market will also go live in January, including the removal of the requirement for packs released after 1 January 2025 to be uploaded to the European Medicines Verification System (EMVS).

Flexibilities to support companies in the transition

The ABPI and other trade associations successfully advocated for a number of flexibilities to be in place to support companies in managing this transition. These include:

• Products labelled "UK only" can be released to the GB market (but not NI) ahead of 1 January 2025.
• Companies can update their products through any regulatory opportunity, self-certification and a new procedure that delays parts of the process by 12 months to ease regulatory burden.
• Labelling updates can be completed through UK-licensed repacking sites, and packs are not required to return to the licensed/original place of manufacture for this to take place.

The MHRA continues its phased work of updating guidance materials with support from trade associations. We know from conversations with ABPI members that they are progressing their obligations depending on the nature of their product portfolio and planned labelling notifications as well as engagements with the MHRA. The ABPI continues to support member companies and encourages them to notify us of any issues or challenges.