Introduction
The MHRA has issued new guidance on the labelling and packaging of medicinal products for human use in the UK (including Northern Ireland) following the agreement of the Windsor Framework. The Windsor Framework sets out the long-term arrangements for the supply of medicines into Northern Ireland and will ensure that medicines can be licensed on a UK-wide basis by the MHRA. From 1st January 2025, joint EU/UK packs can no longer enter the supply chain. The guidance introduces a number of new measures which will come into effect on 1st January 2025.
Windsor Framework Key Changes
Medicines in the UK (including Northern Ireland) already authorised or falling within the scope of the Centralised Procedure will be removed from the Centralised Procedure and will be authorised separately by the MHRA. The MHRA will publish additional guidance on the licensing process that will cover the transition of these licences.
The EU Falsified Medicines Directive will no longer apply to products to be sold on the UK (including Northern Ireland) market, therefore these products will no longer bear the safety features (anti-tampering device and serialisation) required by the EU Directive.
Products to be sold on the UK (including Northern Ireland) market must be clearly labelled ‘UK only’. This will enable medicines to use the same packaging and labelling across the UK and will preclude the onward movement of these products into the EU member states.
MAH Notification to MHRA
MAHs are required to make a submission to the MHRA to add the ‘UK only’ statement to their packaging. MAHs can use any available regulatory opportunity, except Type 1A variations, to submit the artwork change in conjunction with another application, such as a variation, and no additional fees will apply.
Submission Deadlines
For UK-wide product licences (PL) and GB-only product licences (PLGB), the submission can be made now, while for NI-only product licences (PLNI) the submission can be made from the publication date of the new licensing guidance. For all licence types, the latest submission date is 31st December 2024, and implementation of the new labelling is mandatory from 1st January 2025.
Transition Period
MAHs are permitted to over-sticker their products with the ‘UK only’ statement for a 6-month transition period until 30th June 2025.
If you require any assistance regarding the practical aspects of the new MHRA guidance please contact Acorn Regulatory at info@acornregulatory.com.
