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NI medicine regulation returns to UK under Windsor Framework

Getty Images A person wearing a white lab coat holding two white boxes of medicine in each hand.Getty Images
An earlier Brexit deal meant the EU retained responsibility for regulating medicines in Northern Ireland

Full responsibility for regulating medicines in Northern Ireland has returned to the UK authorities as a result of the Windsor Framework.

The framework is the post-Brexit trade deal covering which effectively keeps Northern Ireland inside the EU's single market for goods.

From 1 January 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) could approve and license human medicines on a UK-wide basis.

Under an earlier Brexit deal, the EU retained responsibility for regulating medicines in Northern Ireland but it later conceded that it was practically and commercially unworkable.

The major practical change as a result of the new deal is that packaging for all relevant products on the UK market must now carry a "UK only" label.

That is to give the EU assurance that UK-licensed medicines being sold in Northern Ireland will not be sold in the Republic of Ireland or the wider EU.

A similar labelling arrangement for GB-standard food product being sold in Northern Ireland came into effect in 2023.

Labelling concerns

Some medicines manufacturers had raised concerns that not all suppliers would have their labelling ready but the government is not anticipating disruption.

A spokesperson said the move resolved supply issues created by the Northern Ireland Protocol.

"The Windsor Framework secures the long-term stability of medicines supply to Northern Ireland, ensuring that medicines can be licensed UK-wide and supplied in the same packaging across the UK," they added.

The supply of medicines from Great Britain to Northern Ireland has been one of the most complex post-Brexit issues and the original agreement reached in 2019 was amended several times.

The Windsor Framework, which was agreed in 2023, sought to deal with the issue once and for all.

It included an agreement that manufacturers could produce a single medicines pack for the whole of the UK, including Northern Ireland.

More elements of the Windsor Framework are expected to be implemented in 2025.

PA Media A wide shot of the exterior of Stormont/Parliament Buildings. It features a large, white-stone building with six large columns in the front with a large, wide staircase leading up to the doors.PA Media
Earlier this month, MLAs voted to continue the Windsor Framework for at least another four years

New customs processes for parcels and freight are due to come into force some time after March.

A pet travel scheme is due to be introduced in June, which will mean people from Great Britain travelling to Northern Ireland with a pet or assistance animal will need to have a pet travel document.

The document will be provided at no charge and will be valid for the lifetime of the animal.

Registration for that scheme is due to open in April.