Windsor Framework key date - 1 Jan 2025! (and 30 September 2024)

As I settle back into work having been away on holiday with my family, I can't help slightly shuddering at the passing of time. How is it September already? And don't get me started on it being 2024.

After we left the EU (which feels like yesterday), the UK and EU experienced predictable issues relating to the movement of medicines between the EU (as shriveled by Brexit), 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. But the reality was that 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 Ireland and Malta.

Some interim measures were put in place on both sides to avoid adverse consequences for 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. The best official UK sources for medicines-related information include:

• https://www.gov.uk/government/news/windsor-framework-medicines-announcement
• https://www.gov.uk/government/publications/labelling-and-packaging-of-medicinal-products-for-human-use-following-agreement-of-the-windsor-framework
• https://www.gov.uk/government/publications/uk-wide-licensing-for-human-medicines
• Medicines and Healthcare products Regulatory Agency (filecamp.com)
• Medicines and Healthcare products Regulatory Agency (filecamp.com)

Also, the Irish medicines regulator, the HPRA, has published a useful Q&A, which gives a good summary of the EU perspective. See Brexit - Latest Information (hpra.ie). The official EU-level guidance is found here: Brexit-related guidance for companies | European Medicines Agency (EMA) (europa.eu) - see, in particular, the Q&A on Regulation (EU) 2023/1182. For the keen among you, the regulation is here: Regulation - 2023/1182 - EN - EUR-Lex (europa.eu).

The deadline of 1 Jan 2025 was already extended once, so it is best to assume it won't be extended again.

Authorisation

Due to the application of EU law with respect to NI, certain medicines for the NI market need to be authorised centrally by the European Commission. The MHRA is not permitted to authorise them (EU centralised procedure authorisation is mandatory for some products and optional for others under EU law if the medicines are within scope). But that is going to change. From 1 Jan 2025, the MHRA can and will authorise products what would previously have needed to go (or could optionally have gone) through the EU centralised procedure. For those products, the applicant or existing MAH will get a "PL" licence covering the UK. Simple.

You can't apply for a PLGB after 31 Dec 2024.

If you have PLGB, PLNI or UK-wide MAs, then things will happen and you need to plan or it.

• PLGB - This will automatically convert to a PL covering the UK. The MHRA can decide to cancel a PLGB by 31 Dec 2024, in which case this won't happen. 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.
• PLNI and PLNI/PLGB - 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) with respect to the product (this is specific to the Mutual Recognition Procedure or the Decentralised Procedure (MRP/DCP) and involves notifying the Reference Member State (RMS)). 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, the guidance is less clear, but you will need to apply for a PL and make sure you request the cancellation of your PLNI (you will only get a PL once the PLNI is dead).
• UK-wide MA (old MRP/DCP products) - Pre-exit UK-wide licences granted through routes such as the MRP/DCP can continue under the EU procedures while the differing UK and EU requirements have not caused divergence (e.g. different packaging requirements). If you need to change UK packaging, then you would need to withdraw NI from the EU procedure. The MHRA would then manage the existing UK-wide MA as a standalone PL. Where the MAH currently holds a PLGB and a MRP/DCP PLNI, 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). The PLNI prefix will still be used and, unlike PLGB, will denote limited territorial coverage.

The MHRA has sought to reassure stakeholders by stating that UK meds will still be available in the EU under EU specials rules. The HPRA has clarified in relation to new UK packaging that:

"The supply of packs from NI to IE as exempt medicinal products (EMPs) under Article 5(1) of EU Directive 2001/83/EC will therefore also no longer be permitted where the packs have been placed on the market in NI i.e. in UK or NI labelled packs."

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 (i.e. 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.

From 1 Jan 2025, the UK RMP must have been authorised for at least 8 years in the UK (or GB prior to 1 January 2025).

If you decide to carry on with a PLNI under the MRP/DCP (as described above), you can still refer to a European reference product.

Packaging

Stated in the briefest possible way, you will need different packaging for products destined for the UK and EU (joint packs will not be allowed). This starts on 1 Jan 2025 and the MHRA has published guidance on labelling to help MAHs and distributors to prepare. There are changes coming, and some chunky guidance to read, but on the bright side UK labelling and packaging requirements will be unified across GB and NI.

New packs of UK products placed on the market from 1 Jan 2025 must state "UK only" conspicuously, clearly and legibly anywhere on the outer packaging; the idea being to stop UK products entering the EU. This applies to all UK medicines. The general MHRA guidance on labelling and packaging applies (Best practice in the labelling and packaging of medicines - GOV.UK (www.gov.uk)). The MHRA has stated that the UK only label must be at least 7-point font and in line with Article 5 of EU Regulation 2023/1182.

A sticker can be used to meet the "UK only" requirement until 30 June 2025; after that it must be printed directly on the packaging. The MHRA expects the site named on the relevant MA to apply the sticker before QP certification. Be careful not to obscure other required elements of the packaging and make sure the new stickered packaging is notified to the MHRA.

Products heading to NI will not need to have the safety measures required under the EU Falsified Medicines Directive. In fact, they must not have the FMD 2-D barcodes or serialisation numbers (specifically, those that have been uploaded to the EU data repositories), but they should still have anti-tamper devices. Existing FMD features can be covered or removed.

All artwork changes related to the Windsor Framework 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.

Other topics

There are still plenty of things to think about, but the resources linked above contain some useful guidance on the following topics:

• Parallel imports.
• Specials.
• Inner packaging.
• Traditional herbal and homeopathic medicinal products.
• Products released before 1 Jan 2025 (with or without "UK only"). Generally, the changes do not affect packs in existing packaging already on the UK market or within supply chains.
• Optional UK 2-D barcodes and serial numbers.
• The CAP bridging mechanism.
• Equivalent EU packaging updates for CAPs.
• Repackaging or relabelling for other reasons, triggering variation requirements.
• Effect on sunset clause timing.
• Effect on regulatory data protection periods.
• References to the UK in EU parallel distribution notices.
• EU Article 57 reporting.
• Continuing EU pharmacovigilance reporting.
• Source of product for pivotal studies used in generic/hybrid applications.
• International Recognition Procedure (IRP) to bring CAP products to the UK after 1 Jan 2025 and for generic variations where EU reference products have been used.
• NIMAR.
• Continued use of MRP/DCP for EU MAH access to the NI market.
• Batch testing and release.

Thoughts

Momentous changes like those arising from Brexit and then the Windsor Framework will always generate significant volumes of additional work for businesses, even when those implementing the changes for the State try hard to make it easy. Hopefully, you will have engaged early and made lots of changes already so the next few months are just about minor adjustments and checks. If you haven't, you're probably not alone.

Looking back at the negotiation and Brexit and the Windsor Framework, it was difficult and took a long time. It's all very complex, and the law and regulatory guidance reflects that. This is the tip of the iceberg of Brexit law.

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

(Just some friendly commentary to help understanding and awareness. Not legal advice and not to be relied on. My own thoughts only.)