Medicines ‘Must Not Fall Off The Radar’ In Northern Ireland Protocol Talks
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.”
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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.
Industry representatives told a House of Lords committee about continuing Brexit-related problems such as the extra work involved in checking compliance with the EU Falsified Medicines Directive and the drawbacks of a proposed “dual regulatory regime.”
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.