When will the Windsor Framework for Northern Ireland be implemented and what happens next?

How long will the Windsor Framework take to implement?

That is difficult to say, Parliament has started debating the issue but this shows that as yet no timetable is available or that a full scoping of what legislation needs amending has been completed.

Changes to the Human Medicines Regulations must be made by a Statutory Instrument Unpicking all the post Brexit changes, amending legislation and updating the MHRA EU Exit guidance is a significant piece of work for MHRA and Government Legal Services and needs some form of stakeholder consultation to be conducted.

As an illustration as to how long this might take the EU amended EC 2001/83 with DIRECTIVE (EU) 2022/642 on 12 April 2022. This introduced the concept of CAP Bridging where if the UK was first to approve a Marketing Authorisation for a PLGB that was subject to the Centralised Procedure ahead of the EMA, then it could be supplied to Northern Ireland. There were conditions from the EU that supply was a temporary measure for up to 6 months and the product concerned must not be made available in the EU.

As yet there is no UK legislation implemented to reflect EU Directive 2022/642 or guidance on .gov.uk for Market Authorisation Holders (MAH) and wholesalers on this topic.

At this point with the new proposal this is likely to no longer be required.

What is a realistic date for implementation? (UPDATED)

DHSC have advised the target date is January 2025

What happens in the meantime?

Current legislation remains in place and Licence Holders are obliged to continue to follow the rules on supply to and within Northern Ireland. It’s highly unlikely any guidance will be put out that says the Regulations no longer apply prior to adoption of the Windsor Framework.

However while there may be a pragmatic view taken as to the level of enforcement that is appropriate if elements of the regulations will be replaced imminently, I would certainly advise business as usual to be the default option on supplies to NI until the law changes.

The use of NIMAR for supply in case of shortages will need to continue and wholesalers will need to remain mindful not to supply PLGB packs to NI.

FMD verification system will also remain in place and MAHs will have to continue to upload serialisation data to EMVO.

The position of SecurMed and their staff is uncertain. I know and have met many of the team at SecurMed and finding out FMD is to be disapplied with presumably no notice must be incredibly challenging.

I can foresee that end users are likely to stop using the system for verification and decommissioning almost immediately with the message that FMD will cease in NI. That is a real shame as SecurMed and DHNI had just started a training programme for Pharmacists on understanding and using the FMD system.

So shortly the UK will be one of the few developed countries with no medicines verification system in place to prevent falsified medicines getting to the licensed supply chain. It will be interesting to see what the DHSC consultation of a future UK FMD system will be. It is understood further details of the government’s intentions will be published early in 2023.