Leonie Clarke, Chief Executive, Irish Medicines Verification Organisation
Introduction
The Irish Medicines Verification System, which was established by the EU Falsified Medicines Directive (FMD), went live five years ago and was in a use-and-learn phase until May 2022. Since then, there has been substantial progress with FMD in Ireland due to the efforts of community pharmacists to integrate it into daily operations. Scanning rates continue to increase and avoidable alerts are largely eliminated, according to Leonie Clarke MPSI, Chief Executive of the Irish Medicines Verification Organisation (IMVO).
The purpose of this article is to make pharmacists aware of the Windsor Framework, what impact it will have, and how to prepare for it.
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
The key impact of the Windsor Framework relates to UK packs that move into EU markets
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.
Preparing for the Windsor Framework
According to Leonie Clarke, the Windsor Framework is a UK-EU agreement that is outside the control of IMVO and authorities in Ireland, however, pharmacists can take steps to minimise its impact in their pharmacies and IMVO is here to support them in doing so.
IMVO is running webinars for pharmacies, hospitals, wholesalers and pharmaceutical companies between now and early December to explain the Windsor Framework and how to prepare for it. It is strongly recommended that you or a member of your staff attend one of these webinars. Details of the webinars have been circulated by email and are
also available on a dedicated Brexit page on the IMVO website at www.imvo.ie. Webinar recordings and slides will be made available on the IMVO website. In early December, printed guidance cards will be posted to every pharmacy and hospital. The IMVO service desk will be open for queries through the New Year period (including New Year’s Day) and may be contacted by phone (01- 5715320) or email (info@imvo.ie).
We appreciate that this change impacts at a particularly busy time of the year for pharmacies and hospitals, however, the effective date of 1 January 2025 was agreed by the UK and EU when they drew up the Windsor Framework.
