U.K. – The UK’s medicines regulator has issued a final reminder to pharmaceutical companies that new labelling requirements will come into effect on January 1st next year, following the country’s departure from the EU.
As part of these changes, all medicines sold in the UK will be required to carry a “UK Only” label or sticker, signifying that they are not intended for sale in the EU market.
These changes are a result of the Windsor Framework, which has transferred full responsibility for regulating medicines across the entire UK back to the Medicines and Healthcare products Regulatory Agency (MHRA).
This marks a significant shift since Brexit, when the MHRA’s jurisdiction was limited to Great Britain (England, Scotland, and Wales), while the European Medicines Agency (EMA) retained authority in Northern Ireland to avoid a land border in Ireland.
The Northern Ireland Protocol (NIP) had kept Northern Ireland within the EU pharmaceutical regulatory system, causing complications such as increased costs for relabelling medicines and occasional supply issues.
The Windsor Framework aims to resolve these issues by restoring the MHRA’s jurisdiction and eliminating the need for certain EU rules, such as the unique identifier 2D barcodes on medicine packaging, which will no longer apply to medicines distributed in Northern Ireland.
Julian Beach, MHRA’s interim executive director for healthcare quality and access, reported that 90% of companies responsible for medicines sold in the UK have already updated their packaging and labelling to comply with the new mandate.
The MHRA is urging the remaining companies to submit their updated artwork promptly ahead of the new year.
Under the transition rules, medicines already on the market before January 1st will still be allowed to circulate without the new labelling until their expiry date.
However, if UK medicines are sold in the EU market through parallel trade, the European Commission has stated it will suspend the Windsor Framework and impose additional checks.
