Dealing With Brexit: EMA Offers Firms Advice On More Thorny Questions
The European Medicines Agency has updated its guidance on Brexit to offer companies more advice on the regulatory changes they will need to make in areas like transfers of MAs, rapporteurships and orphan designations, multi-country packs, and Article 58 opinions.
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The EU group for coordinating drug approvals through the mutual recognition and decentralized procedures has developed a non-exhaustive list of scenarios that companies with manufacturing processes in the UK may face following Brexit, and explains how to address these through appropriate variation applications.
The European Medicines Agency’s survey on industry’s preparedness for Brexit has raised serious concerns about the continued supply of 108 drugs that have manufacturing operations based solely in the UK.
The EMA is to further refocus on its core activities to help it deal with “higher than expected” staff losses due to its relocation to Amsterdam.