From that date, new rules on the labelling and packaging of medicines will come into effect across the United Kingdom, including Northern Ireland, under the Windsor Framework. These rules will prohibit prescription medicines in Northern Ireland from being labelled with European Union (EU) safety features. The requirements of the EU Falsified Medicines Directive (FMD) for medicines marketed and supplied in Northern Ireland will no longer apply. All medicines supplied to the UK market, including Northern Ireland, must be labelled "UK Only" from this date and must not be sold into the EU.
Previously, Northern Ireland had various exemptions, including for medicine labelling, allowing products to be marked for both the Irish (EU) and Northern Irish/UK markets. However, the Windsor Framework sets out Northern Ireland’s full separation from the EU single market, referred to as "NIXIT."
These new regulations will apply to medicines produced after 31 December 2024. For products manufactured before this date and intended for the Northern Ireland market, the EU’s unique identifier must be removed or covered, and such products can remain on sale until their expiry date. The "UK Only" label can be added using stickers until 30 June 2025, after which it must be printed directly on the packaging. Other safety and packaging requirements, such as the display of expiry dates and batch numbers, will remain unchanged, in accordance with UK law.