Guidance to end-users in Ireland

Introduction

The Windsor Framework is a post-Brexit legal agreement between the EU and the UK and will have an impact on several areas including medicines. It is due to come into effect on 1 January 2025, on condition that certain written guarantees being given by the UK Government to the EU are provided before then.

Some of the changes due to be introduced by the Windsor Framework at the end of this year will have an impact from an FMD perspective throughout Europe, particularly in countries like Ireland that have strong traditional links with the UK.

What will change in the UK due to the Windsor Framework?

FMD will no longer apply in Northern Ireland from 1 January 2025, having already been disapplied in the rest of the UK at the time of Brexit. The UKNI medicines verification system will cease to operate and the data in it will be deleted. Pharmacies, hospitals and wholesalers in Northern Ireland will be disconnected from the EU FMD system and will no longer have to scan packs.

The Medicines and Healthcare products Regulatory Agency (MHRA) has advised companies in the UK that 2D barcodes may remain on UK packs after FMD ceases to apply, as well as anti-tampering devices. In addition, all packs placed on the UK market from 1 January 2025 must be labelled as ‘UK Only’, however we expect that it will take some time before packs with this additional text appear in Ireland.

How will the Windsor Framework have an impact in Ireland? 

FMD still applies across the EU post Windsor Framework, and FMD obligations for pharmacies and hospitals in Ireland are unchanged.

The key impact of the Windsor Framework relates to UK packs that move into EU markets. Some of the changes introduced by the Windsor Framework will have an impact from an FMD perspective in Ireland where the UK is a source of exempt medicinal products (EMPs) (also known as unlicensed medicines, or ULMs).

Currently most EMPs/ULMs sourced from the UK do not generate alerts when scanned in Ireland, as the data for these packs in the UK system can be retrieved via the Irish Medicines Verification System (IMVS). After the disconnection of the UK system, all UK packs bearing 2D barcodes that are scanned here will generate an alert, as the pack data will no longer be available to the IMVS to verify the pack.  The Irish Medicines Verification Organisation (IMVO) has worked closely with the Department of Health, Health Products Regulatory Authority (HPRA), the PSI, the Pharmacy Regulator, and colleagues in other national medicines verification organisations and the European Medicines Verification Organisation (EMVO) over the last 18 months to assess and mitigate the impact of the Windsor Framework from an FMD perspective in Ireland. Some of the issues identified have been resolved by way of changes to the system, however, it is not technically possible to prevent UK packs from generating alerts when scanned from 1 January 2025 onwards.

Guidance on how to manage UK packs from 1 January 2025

The following guidance has been agreed with the HPRA, PSI and Department of Health:

  • As flagged above, it is expected that most UK packs supplied as EMPs/ULMs in Ireland will continue to carry 2D barcodes and the only way to avoid an alert with these packs is not to scan them.
  • If you inadvertently do scan a UK pack, you will get an amber or red alert message on your FMD software. Notwithstanding this, you may supply the pack unless:
    • You have overriding concerns that a falsified medicine is involved or believe the pack has been interfered with; or
    • The pack has expired. Your FMD software may not be able to flag that the pack is expired because of the UK system having been disconnected.
  • Always check the anti-tampering device on the pack (if there is one). If you have any reason to believe the pack has been interfered with, please report this to the HPRA as a product quality defect and do not supply the pack. Email qualitydefects@hpra.ie to report this.

Webinars

Throughout October and November we have been hosting a series of Windsor Framework webinars for pharmacies and hospitals. The slides and recording for these webinars are available here.

In October and November we hosted a Windsor Framework webinar for wholesalers and one for Marketing Authorisation Holders (MAHs). The slides and recordings are available here for wholesalers and here for MAHs.

FAQs

Q1. What is the Windsor Framework (WF)?

The Windsor Framework is a post-Brexit legal agreement between the EU and the UK and will have an impact on several areas including medicines. It is due to come into effect on 1 January 2025, on condition that certain written guarantees being given by the UK Government to the EU are provided before then.

Some of the changes due to be introduced by the Windsor Framework at the end of this year will have an impact from an FMD perspective throughout Europe, particularly in countries like Ireland that have strong traditional links with the UK.

Q2. When does the Windsor Framework come into effect?

It is due to come into effect on 1 January 2025, on condition that certain written guarantees being given by the UK Government to the EU are provided before then.  

Q3. What will change in the UK due to the Windsor Framework?

FMD will no longer apply in Northern Ireland from 1 January 2025, having already been disapplied in the rest of the UK at the time of Brexit. The UKNI medicines verification system will cease to operate and the data in it will be deleted. Pharmacies, hospitals and wholesalers in Northern Ireland will be disconnected from the EU FMD system and will no longer have to scan packs. 

Q4. Will UK packs continue to have 2D barcodes and anti-tampering devices?

The Medicines and Healthcare products Regulatory Agency (MHRA) has advised companies in the UK that 2D barcodes may remain on UK packs after FMD ceases to apply, as well as anti-tampering devices. In addition, all packs placed on the UK market from 1 January 2025 must be labelled as ‘UK Only’, however we expect that it will take some time before packs with this additional text appear in Ireland.

Q5. How will the Windsor Framework have an impact in Ireland?

FMD still applies across the EU post Windsor Framework, and FMD obligations for pharmacies and hospitals in Ireland are unchanged.

The key impact of the Windsor Framework relates to UK packs that move into EU markets. Some of the changes introduced by the Windsor Framework will have an impact from an FMD perspective in Ireland where the UK is a source of exempt medicinal products (EMPs) (also known as unlicensed medicines, or ULMs).

Currently most EMPs/ULMs sourced from the UK do not generate alerts when scanned in Ireland, as the data for these packs in the UK system can be retrieved via the Irish Medicines Verification System (IMVS). After the disconnection of the UK system, all UK packs bearing 2D barcodes that are scanned in Ireland will generate an alert, as the pack data will no longer be available to the IMVS to verify the pack. 

Q6. What actions have been taken to mitigate the effects of the Windsor Framework from an FMD perspective in Ireland?

IMVO has worked closely with the Department of Health, Health Products Regulatory Authority (HPRA), the PSI, the Pharmacy Regulator and colleagues in other national medicines verification organisations and the European Medicines Verification Organisation (EMVO) over the last 18 months to assess and mitigate the impact of the Windsor Framework from an FMD perspective in Ireland. Some of the issues identified have been resolved by way of changes to the system, however, it is not technically possible to prevent UK packs from generating alerts when scanned from 1 January 2025 onwards. 

Q7. How should UK packs be managed in pharmacies and hospitals after 1 January 2025?

The following guidance has been agreed with the HPRA, PSI and Department of Health: 

  • It is expected that most UK packs supplied as ULMs in Ireland will continue to carry 2D barcodes and the only way to avoid an alert with these packs is not to scan them.  
  • If you inadvertently do scan a UK pack, you will get an amber or red alert message on your FMD software. Notwithstanding this, you may supply the pack unless: 
    • You have overriding concerns that a falsified medicine is involved or believe the pack has been interfered with; or 
    • The pack has expired. Your FMD software will not be able to flag that the pack is expired because of the UK system having been disconnected. 
  • Always check the anti-tampering device on the pack (if there is one). If you have any reason to believe the pack has been interfered with, please report this to the HPRA as a product quality defect and do not supply the pack. Email qualitydefects@hpra.ie to report this. 

Q8. Where can I get more information about the Windsor Framework?

More information about the Windsor Framework can be found at the following links: