In a dramatic development, the UK and the EU have agreed that the UK regulator, the MHRA, will be able to grant a single UK-wide approval for all medicines, including those that fall within the scope of the EU’s centralized procedure.
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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Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.