Key Deadlines for the Windsor Framework: what you need to know about medicine regulations

After the UK left the EU, the UK and EU faced challenges moving medicines between the EU, Great Britain and Northern Ireland. The "no hard border" situation meant that the UK was required to comply with EU legal requirements with respect to NI.

However, a significant quantity of important medicines flowed from the EU to GB and then onwards to NI, so the changing regulatory requirements were a problem. Similar problems were experienced by certain other EU countries historically dependent on GB medicines, such as the Republic of Ireland and Malta. Some interim measures were put in place to protect individuals in NI and the dependent EU countries. Then some tense discussions were had about a permanent solution to the problem and the result was the Windsor Framework, which has an important deadline approaching fast!

The main medicines legislation relating to the Windsor Framework is:

• From the UK perspective, the Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024, which made changes to the Human Medicines Regulation 2012
• From the EU perspective, Regulation (EU) 2023/1182, which made changes to Directive 2001/83/EC and Regulation 726/2004

The MHRA has been proactive as follows:

• It has published detailed guidance and related Q&A documents relating to the licensing and packaging changes arising from the Windsor Framework. Helpfully, the guidance is all held in a collection page
• It held a webinar on 19 September 2024, a recording of which it has promised to publish

Also, the Irish medicines regulator, the HPRA, has published a useful Q&A, which gives a good summary of the EU perspective. The official EU-level guidance is published on the EMA's Brexit web page - the Q&A on Regulation (EU) 2023/1182 is particularly useful.

This is a complex topic, and there is a lot to get your head around. 1 Jan 2025 is a looming deadline that has already been extended once, so it is best to assume it won't be extended again.

Authorisation

From 1 Jan 2025, the MHRA can and will authorise products that would previously have needed to go (or could optionally have gone) through the EU centralised procedure managed by the EMA. For those products, the applicant or existing MAH will get a 'PL' licence covering the UK and 'PLGB' licences will not be available.

PLGB licences will automatically convert to full UK coverage. No action is required unless you want it cancelled. If it survives, you will still have a 'PLGB' prefix but it doesn't mean the licence is limited to GB.

If you have a PLNI and a PLGB and want to keep UK coverage, then you need to take action to cancel the PLNI. Send your request to the MHRA by 30 September 2024. You also need to withdraw NI as a Concerned Member State (CMS) under the EU Mutual Recognition Procedure or Decentralised Procedure (MRP/DCP). If you don't take action, the PLNI will survive and the PLGB will be cancelled.

If you only have a PLNI, but you want to convert to UK coverage, you would need to cancel the PLNI before you can get UK coverage.

Legacy UK-wide licences based on MRP/DCP can continue under the EU procedures unless the requirements have diverged (e.g. different packaging requirements). If you need to change UK packaging, then you would need to withdraw NI from the EU procedure. It is possible for the MAH to cancel the PLGB and manage the PLNI through the MRP/DCP only (but you would of course lose GB coverage).

Generics

In generic applications and approvals, the generic is linked to a reference medicinal product (the originator product that it is a generic version of; the RMP). For generics based on EU centrally authorised products (CAPs), a UK generic application will need to refer to the EU CAP until 31 Dec 2024. After that, it needs to refer to a UK RMP (ie one with a PL number or a PLGB based on a CAP which is then converted as described above).

Reference to EU products will not be possible (unless you are carrying on with a MRP/DCP PLNI).

From 1 Jan 2025, the UK RMP must have been authorised for at least eight years in the UK (or GB prior to 1 January 2025).

Packaging

Starting from 1 Jan 2025, you will need different packaging for products destined for the UK and EU (joint packs will not be allowed), and UK labelling and packaging requirements will be unified across GB and NI.

New UK packs must state 'UK only' conspicuously, clearly and legibly anywhere on the outer packaging The general MHRA guidance on labelling and packaging applies, and the UK only label must be at least 7-point font and in line with Article 5 of Regulation 2023/1182.

A sticker can be used to meet the 'UK only' requirement until 30 June 2025. The MHRA expects the site named on the relevant MA (not the wholesaler) to apply the sticker before QP certification. The new stickered packaging must be notified to the MHRA.

Products heading to NI must not have EU Falsified Medicines Directive safety measures, specifically 2-D barcodes or serialisation numbers that have been uploaded to the EU data repositories.

All artwork changes must be notified to the MHRA by 31 Dec 2024. The MHRA has provided some options for MAH's, which allow the MAH to decide between speed and fees, and depend on whether consequential changes (such as removing details concerning other territories) are also required. Artwork changes for live applications also need to be notified to the MHRA.

Thoughts

Major State-State changes like those in the Windsor Framework will always generate significant volumes of additional work for international businesses, even if those States try to make it easy. Whether you started your preparation early or late, you're not alone. It was clear at the MHRA's webinar that there are questions needing answers. See the list in my other article.

At this stage, it is important to discuss and implement any remaining contract changes with distributors, contract manufacturers and packagers, with negotiation positions getting more strained as the deadlines approach. If you find yourself in a tight spot, then think more broadly about the relationship and what could bolster your position.

If you would like to discuss this article or would like to discuss how we might be able to assist you, please contact Harry Jennings in our Pharmaceuticals and Life Sciences team on 07789 533122, or complete the form below.