Brexit Revisited – Are you prepared for the Windsor Framework?

More than 4 years after the United Kingdom’s exit from the EU in January 2020, the industry is still dealing with the impact of Brexit and the Northern Ireland Protocol. Most recently being the implementation of the Windsor Framework.

In March 2023 the EU-UK Joint Committee adopted The Windsor Framework – a political declaration which includes joint solutions on customs, agri-food, medicines, VAT and excise, as well as specific instruments designed to ensure that the voices of the people of Northern Ireland are better heard on specific issues particularly relevant to the communities there. These new arrangements are underpinned by robust safeguards to ensure the integrity of the EU’s Single Market, to which Northern Ireland has a unique access. The deadline for implementation of these regulations is January 1st 2025

What Is the Impact on Human Medicines Regulation?

The updates that are of significance to the pharmaceutical industry in the UK (Great Britain and Northern Ireland) and their shared markets, are from 1st January 2025:

• Prescription Medicines entering Northern Ireland will not display features required under the EU Falsified Medicines Directive (FMD) including 2D barcodes and serialisation numbers that are compliant with the EU FMD Directive
• New novel medicines authorised by the EU (centralised medicines) will not be permitted on the NI market, i.e., only those authorised by the UK authorities will be permitted on the NI market.
• All medicines on the UK (GB & NI) market must have the words “UK only” on the packaging.
• MHRA do expect anti-tamper devices to remain on all medicine packaging.

How does this affect your registered products?

Addition of ‘UK Only’ to the outer carton and removal of serialization data

From January 1st 2025 it will no longer be possible to have a shared pack between the UK and Ireland, or any other EU country. This may also have a greater impact on Global Export Markets or other regulated English-speaking markets to which UK packs may currently be supplied.

For example, Medsafe have advised New Zealand that the addition of ‘UK only’ may cause confusion to patients in New Zealand and may be seen as misleading or cause concern over the legitimacy of medicines supplied to New Zealand, They have advised that the MA Holder should try to design the label in a way to avoid this confusion by putting all UK specific details in a box. Over-labelling could also be considered, or if these solutions are not possible, the pack can no longer be shared. Any labels updated to meet the Windsor Framework should be notified and evaluated under an assessable change category (Labelling – G2).

If you currently have a UK pack shared with Ireland, Malta or other EU countries, they must be separated by 1st January 2025. The EU packs may remain the same, with UK/GB/NI MA numbers removed and serialisation date maintained. The HPRA does not require a submission to remove MA details from another market. The MHRA does require submission of the updated carton mock-up prior to implementation, either at the next regulatory opportunity or as a self-assessable notification.

Note that this requirement is only applicable to the outer packaging and that inner packaging components and bulk items can still be shared.

How soon do I need to act?

With production lead times of up to 6 months, we advise that you assess the impact on your mock-ups as soon as possible and submit any notifications required to ensure that the deadline can be met. The MHRA has advised that over-stickering of the ‘UK Only’ text will be allowed but just for a period of 6 months. Note that over-stickering also required proper notification to the MHRA.

The following must also be considered before implementation depending on what way your product is currently registered:

Any packs released or on the market prior to 1st January 2025 can be sold to expiry.

What does this mean for products with PLGB or PLNI numbers?

From 1st January 2025 it will no longer be possible to hold simultaneously a PL, PLGB and/or PLNI license for the same product.

Product registered with a PLGB number currently can be sold in ‘GB’ only and not Northern Ireland. From 1st January 2025 they will automatically be converted to UK-wide licenses. There will be no further change to MA number, packs will require the statement ‘UK Only’ and can be sold UK-wide including Northern Ireland.

If an MAH currently holds a PLNI and PLGB for the same product, the PLGB will become UK-Wide and the PL-NI should be cancelled. Both MHRA and any applicable RMS or the DCP/MRP procedure should be informed of this cancellation.

Where a MAH only holds a PLNI and subsequently seeks authorisation for the whole of the UK, the PLNI will need to be cancelled prior to the granting of the PL. MAHs involved in EU procedures, with NI included as a CMS, will need to notify the RMS to withdraw NI as a CMS from the procedure. This must occur before the cancellation of the PLNI and the granting of the new PL. If you do not wish to seek a whole-UK license, the PLNI can remain in place and medicine can be supplied to NI only and pack cannot be shared with EU markets.

What do I do if I still have a UK-wide license as a CMS in a DCP or MRP?

Where you still have a UK wide license registered under a DCP/MRP with Northern Ireland as a concerned member state, this can remain in place. MHRA will continue to assess as a CMS and assessment will cover the whole UK. To maintain this, the full dossier must be compliant with EU requirements for QC testing and release within the EU. If in future UK specific changes are required, UK should be withdrawn from the DCP/MRP and it will be managed as a national license.

Expiry of exemptions for reliant markets

Due to the fact that markets like Ireland, Cyprus and Malta rely heavily on the UK for supply, an exemption was put in place for these markets only until end December 2024 to allow:

• Continued batch release in GB,
• Continued QC testing in GB without the need for retesting on importation into the EU,
• Importation of an authorised medicine from GB by a wholesaler rather than the holder of a manufacturer’s authorisation,
• An exemption from the requirement under the Falsified Medicines Directive to decommission joint packs going to the UK market.

To avail of these exemptions an MAH had to inform the agency and provide a plan for the medicines after the exemption date. These exemptions will expire 31st December 2024, meaning all medicines released in Ireland, Malta and Cyprus from 1st January 2025 must be QC Tested and Released in the EU and can no longer be imported from a GB wholesaler. Shared UK packs will no longer be allowed so decommissioning will no longer be applicable.

Summary

• The deadline for implementation of the Windsor Framework and Expiry of Exemptions for reliant markets is 1st January 2025.
• If you have any markets, EU or Global, that currently share the UK pack, assess the impact of adding ‘UK Only’ and removing the serialization data and take action to resolve this in time for your first production of 2025.
• If you are currently availing of exemptions in reliant markets, immediate action is required to ensure that an EU testing and release site is registered in time for your first production of 2025.