From 1 January 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) will be able to license products that currently fall under the mandatory scope of the European Union’s Centralised Procedure and require a European Commission authorisation for Northern Ireland (NI). Due to implementation of the so-called Windsor Framework, MHRA will license all medicines across the whole of the UK under one UK-wide regime.
A few years ago, at the time of the Brexit, a specific Protocol on Northern Ireland was introduced with the withdrawal agreement to be able to apply specific EU legislation to and in Northern Ireland preventing a hard border between NI and Ireland. However, the Protocol caused a lot of difficulties across many sectors and on 27 February 2023 the UK government and European Commission reached an agreement, the Windsor Framework. With this agreement the trade between Great Britain (GB) and Northern Ireland will be simplified while safeguarding the EU single market. It will be made harder to supply EU countries with GB- and NI-authorised products.
The Windsor Framework will be implemented on 1 January 2025 and after implementation the MHRA will license all medicines across the whole of the UK to ensure a permanent solution for the supply and access of medicines from GB into NI.
All new and innovative medicines, orphan medicinal products, Advanced Therapy Medicinal Products (ATMPs) and paediatric medicines will be granted UK licenses.
The key components of the implementation of the Windsor Framework to note for human medicines are as follows:
MHRA will be responsible for approval and oversight of medicines for the NI market, including new and innovative products. Consequently, this means that MHRA will be responsible for all medicinal products, destined for the whole of the UK internal market.
From 1 January 2025, Marketing Authorisations (MA’s) issued via the EU Centralised Procedure are no longer valid in NI. A UK wide MA is required and the packaging should state ‘UK only’.
GB-only MA’s issued by MHRA since UK left the EU will expand to cover NI.
Disapplication of EU Falsified Medicines Directive requirements to UK packs.
EU Falsified Medicines Directive will cease to be valid from 1 January 2025 onwards in the UK. Serialisation codes used for outer packaging and registered with the European Medicines Verification Organisation (EMVO) will not be permitted in GB or NI. The codes should be removed or covered in new UK packs from January 2025. However, similar coding included in 2D barcodes and serial numbers that have not been uploaded to EMVO, can be used by MAH’s.
Concluding, there will be several scenarios applicable for new and existing MA’s in the UK from January 2025 onwards. Make sure you are prepared by checking the MHRA website or by contacting us in case you have questions or are in need of support.