The MHRA has published new guidance over the past few months on labelling and packaging following the agreement on the Windsor Framework. For those who are not aware, the Windsor Framework is the latest agreement between the UK and the EU which aimed among other things to finally address all the challenges posed by the Northern Ireland Protocol on the supply of medicines into Northern Ireland.
The Northern Ireland Protocol as it stood had meant that medicines entering Northern Ireland from Great Britain needed to comply with all EU regulations, which was leading to both regulatory and supply chain roadblocks with the potential to impact patients.
So, what does the new Windsor Framework mean for Medicines supply?
The Windsor Framework, which was announced on 9 June 2023, sets out a long-term solution that will allow medicines to be approved and licensed on a UK-wide basis by the Medicines and Healthcare products Regulatory Agency (MHRA), without requiring separate authorisations from the European Medicines Agency (EMA). This will enable medicines to use the same packaging and labelling across the UK, with a clearly legible ‘UK only’ label to indicate that they are not for sale in the EU. These measures will come into effect on 01 January 2025, subject to written guarantees from the UK to protect the integrity of the EU internal market.
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- All medicines in Northern Ireland currently under scope of the EU Centralised Procedure will be authorised by MHRA for the UK market, and current GB-only licences will be converted to UK-wide.
- These products will only be sold in the UK and will not be available in Ireland or elsewhere in the EU.
- Packaging for all UK-wide products must have a “UK Only” label.
- These UK-Wide packs will not include the 2D barcode safety feature required under the EU Falsified Medicines Directive (FMD).
- Joint EU/UK packs will no longer be allowed to enter the supply chain.
The Windsor Framework is expected to have significant implications for the supply of medicines in the UK and Ireland, especially for those products that are currently shared between the UK and the Republic of Ireland. The loss of safety features for medicines in Northern Ireland will mean a common pack across the UK and will reduce costs and complexity for manufacturers. However, it also means that medicines in Northern Ireland will not benefit from the enhanced protection against counterfeit and falsified products that the FMD provides. More significantly however, it will prevent joint packs between the UK and the Republic of Ireland. The Windsor Framework also stipulates that new novel medicines authorised by the EU (centralised medicines) will not be permitted on the Northern Ireland market, and only those authorised by the UK authorities will be allowed.
The Windsor Framework requires that all medicines on the Northern Ireland market must have a ‘UK only’ label on their packaging, to indicate that they are not for sale in the EU. This will mean that some manufacturers with PLGB products will need to switch to a UK-wide product with the ‘UK only’ label on all UK packs. This would require some reorganisation for manufacturers and would affect parallel trade of medicines between different markets, as products with a ‘UK only’ label would not be allowed to enter or exit the EU.
So what exactly are the new ‘UK only’ Label requirements?
- The label may be presented anywhere on the outer packaging.
- The text must be conspicuous/clear and must be at least size 7-point font.
- The “UK Only” statement can be applied via a sticker for a limited time of 6 months until 30 June 2025. After this date “UK Only” must be printed directly on to the packaging.
- The application of a ‘UK Only’ sticker will need to be completed prior to certification by a Qualified Person (QP). The stickering must be completed by the site named on the Marketing Authorisation (MA) prior to QP Certification.
- Packs released prior to 1st January 2025 can remain without the need to use a sticker or over label.
- MHRA will need to be provided with an updated mock-up of the outer packaging. This can be done as part of any variation (except Type IA variations) or through the usual self-certification route applicable for artwork updates.
From the 1st January 2025 the EU Falsified Medicines Directive (FMD) will no longer apply to Northern Ireland, and features on packs may be removed. Existing 2D barcodes, serial numbers etc. on already release packs can remain in the market. Anti-tampering features are however encouraged to remain on UK packs.
Early Implementation:
The “UK Only” label can be applied to the outer packaging before the 1st January 2025, but on packs with serialisation features.
PLGB licence packs with “UK Only” cannot be made available to the market until the 1st January 2025.
PLGB Licences will become a UK-wide licence, further MHRA guidance will follow on the necessary steps to implement this.
The Windsor Framework is intended to provide a long-term solution for the supply of medicines into Northern Ireland, while respecting both UK sovereignty and EU single market rules. However, it also poses significant challenges and changes for manufacturers, distributors, regulators, healthcare providers, and patients in both the UK and Ireland. Stakeholders should prepare for these changes well in advance of their implementation date and seek further guidance from relevant authorities (i.e. the MHRA) as it becomes available.
Orion GXP Consulting’s team of GXP experts is ready to help you review your licencing and distribution needs. If you need support, please get in touch with us today to ensure your products are safe and all regulatory requirements are in place.
Get in touch today by emailing info@oriongxp.com or by calling us IRL – 07198 10101 or UK – 0203 475 0375