The Windsor Framework ("WF") as implemented by Regulation (EU) 2023/1182 removes the option for jointly labelled medicines to be marked as NI/GB/UK. The Framework will be directly applicable for medicines for human use from 1st January 2025 and UK medicines will be required to be labelled as "UK only". The HPRA published a helpful updates from an Irish regulatory perspective, including a first post on 25 May 2023 regarding implications for Marketing Authorisation Holders ("MAHs") supplying medicines to the Irish market and the expiry of the existing exemptions. This was followed by guidance in the form of Questions and Answers for Stakeholders, which were updated most recently on 25 October 2024.
What is the significance of the Windsor Framework for medicines on the Irish market?
Currently, a number of national and centralised products are jointly labelled for both the IE and NI/GB/UK markets. From 1 January 2025, UK medicines will be required to carry the words "UK only" on the outer packaging. The 'UK only' label may be covered over with a label on non-prescription medicines as long as the label is permanently attached to the outer carton/bottle and cannot be removed. Over-labelling must be conducted in a site that holds a valid manufacturer's authorisation, and businesses may provide updated mock-ups to the HPRA by way of an article 61(3) application.
Pre Windsor approved (joint) packaging released in Ireland may continue to be released using the same pre-approved packaging with UK information. Any batches of joint labelled IE/UK medicines, which are batch released for the IE /UK markets, before 31st December 2024 may remain on the market until the expiry date of the medicines.
Products placed on the Northern Ireland and Great Britain markets after this date will carry the words "UK only" on the outer packaging and will be prohibited from carrying the 2-D matrix serialisation safety feature required by the Falsified Medicines Directive. However, Marketing Authorisation Holders must also ensure that their labelling is updated to remove all NI/UK administrative details by 31st December 2027.
Products Manufactured and Released in Northern Ireland
As indicated in the Notice to Stakeholders issued by the European Commission and the European Medicines Agency, batch release of medicines by a qualified person of an importer/manufacturer established in NI have been recognised in the EU to prevent shortages of medicinal products and ultimately to ensure a high level of public health protection1. These derogations will expire for Ireland on 31st December 2024 and all medicines released to the Irish market thereafter will need to be EU regulatory compliant. However, qualified personnel may use quality control data generated in the UK prior to 11 pm on 31st December 2024, to batch release products for the Irish market in 2025.
Conclusion
The Windsor Framework is due to be implemented in Regulation (EU) 2023/1182 and is applicable from 1 January 2025, this will alter the required labelling on all medicines in the Republic of Ireland, Northern Ireland and the United Kingdom.
Footnote
1 Directives 2001/20/EC and 2001/83/EC were amended to provide for temporary derogations for medicinal products supplied to Cyprus, Ireland, Malta and Northern Ireland.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
