UK-EU Northern Ireland Deal Reinstates ‘Single UK Market For Medicines’
Under the landmark “Windsor Framework” agreed by the UK and the EU, medicines will take the “green lane” from Great Britain to Northern Ireland, while the UK regulator will have UK-wide responsibility for all drug approvals. In addition, the provisions of the EU Falsified Medicines Directive will no longer apply in Northern Ireland.
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Numerous political and legislative procedures will be needed before new rules on the UK-wide approval of new medicines and their marketing in Northern Ireland can be implemented.
As heated discussions continue on the future of the protocol that keeps Northern Ireland within the EU’s single market, the UK government has been urged to ensure concerns over medicines supply are addressed before “rushing to get a deal done.”
The burden of having to produce separate product packs for Great Britain and Northern Ireland is among a number of concerns raised by industry executives at a recent hearing in the House of Lords.