The Windsor Framework allows the UK to regulate medicines in Northern Ireland, ending the EU's role. From 2025, UK-wide licensing and 'UK only' packaging will apply.
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 . 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. '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. It included an agreement that manufacturers could produce a single medicines pack for the whole of the UK, including Northern Ireland
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