With just 10 weeks left for Northern Ireland medicines suppliers to comply with the Windsor Framework post-Brexit agreement between the UK and EU, the British Generic Manufacturers Association has raised the alarm over potential supply interruptions that could be caused by requirements that come into effect on 1 January 2025.
Generics Industry Sounds Alarm Over Northern Ireland Requirements As Deadline Looms
‘UK Only’ Labeling And Biological Testing Threaten Supply Ahead Of 1 January 2025
With a looming deadline of 1 January 2025 for firms supplying Northern Ireland to comply with the Windsor Framework, UK generics and biosimilars association the BGMA has warned of potential supply interruptions due to requirements that include a “UK only” label for all packs as well as UK-based batch testing for biologicals.

More from Biosimilars & Generics
The FDA’s accelerated approval draft guidance has left stakeholders seeking clarification of the process for determining a surrogate marker or intermediate clinical endpoint is reasonably likely to confirm clinical benefit.
The UK branded drug industry is calling for adjustments to be made to the UK voluntary scheme framework for branded medicines, after the payment rate increased to 22.9% for 2025. Meanwhile, the generics industry says the scheme is functioning “as intended” and opposes any changes.
Teva was forced to delist its ProAir HFA inhaler patents from the FDA’s Orange Book by mid-March after the Federal Circuit denied its petition for en banc rehearing. Will the Supreme Court listen?
The development could highlight the power of competitive market forces over government price controls or suggest Medicare price negotiation is enhancing competitive market forces.
More from United Kingdom
Payers and health technology assessment bodies in the Netherlands, Germany and Italy are either unwilling to use real-world data in assessments or cannot due to their existing frameworks, say representatives from Gilead Sciences and Autolus Therapeutics.
The Clinical Trials Regulation was “supposed to harmonize” requirements in the EU, but instead it is giving some countries the chance to get ahead by offering faster approval timelines, notes Telethon’s head of regulatory affairs.
The government wants to raise the statutory scheme payment rate for newer branded medicines from 15.5% to 32.2%, after sales data for Q2 and Q3 2024 showed “higher than expected newer medicines sales growth.”