Getting ready for the Windsor Framework
On behalf of the MHRA and DHSC, the BIA would like to remind member companies of the preparations required in advance of the implementation of the Windsor Framework. The MHRA-DHSC communication includes sharing approaches for preparedness (see below), implementation issues and links to Windsor Framework webinars for industry.
From 1 January 2025, the MHRA will be responsible for licensing all medicines on the market in Northern Ireland (NI) under a UK-wide licence. The new arrangements will make the supply of medicines to the UK market simpler and easier. Marketing authorisation holders need to be aware of three key areas of change and take action, where necessary:
- UK-wide licencing: a UK Product Licence (PL) will replace separate licences for Great Britain and NI and cover the whole UK.
- Medicines for the UK market will need to display a ‘UK Only’ label or sticker on the pack to show that they are only for sale within the UK. Companies must submit their updated artwork by 31 December 2024.
- The EU Falsified Medicines Directive (FMD) will no longer apply in NI, bringing NI in line with GB.
