The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a final call to marketing authorisation holders to ensure they are prepared to comply with the Windsor Framework arrangements for medicines ahead of the 31 December deadline.
The MHRA outlined that the “vast majority” of companies have already submitted updated artwork to ensure compliance with the Framework, under which the regulator will be responsible for licensing all medicines on the market in Northern Ireland (NI) on a UK-wide basis.
The Framework, agreed between the UK and EU in February 2023, is aimed at securing the long-term stability of medicines supply to NI.
From 1 January 2025, all medicines for the UK market must carry a ‘UK Only’ label or sticker to show that they are only for sale within the UK and not in countries inside the EU. To support the transition, medicines released to the market before 1 January will still be allowed to be supplied without the new labelling until they reach their expiry date.
The European Medicines Agency and the European Commission were previously responsible for approving new medicines for supply in NI under a process known as the EU Centralised Procedure.
This, according to the MHRA, created a risk of fewer medicines being available in NI than in Great Britain, and meant that supply to NI could be discontinued if companies chose not to maintain two different labels and packs.
A number of other changes will also be implemented under the new arrangements, including the removal of the EU Falsified Medicines Directive safety features in NI.
Julian Beach, MHRA interim executive director, healthcare quality and access, said: “I would like to thank the large proportion of marketing authorisation holders who have submitted their updated artwork already.
“We’re now on the home stretch, with… a month before the new medicines arrangements of the Windsor Framework are put into practice, providing a solution to the supply of medicines into NI. Any companies that still need to submit updated artwork should do so as soon as possible, and ahead of releasing products on the market in the new year.”