Module 18 - Drug Device Combinations and Other Technologies

30/11/2023

Recognition of Centralised, Decentralised and MRP

• For two years from 1 January 2021, Great Britain will adopt decisions taken by the European Commission on the approval of new MAs • UK submission should include all iterations of the CHMP assessment report and applicants declaration regarding same dossier • UK will also be able to take into account authorisation decisions made by other member states • UK submission should include all information submitted to RMS, all iterations of RMS assessment report and declaration regarding same dossier • GB applications should be submitted following completion of the EU procedure

The Organisation for Professionals in Regulatory Affairs

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Brexit Guidances

https://www.gov.uk/government/collections/new guidance-and-information-for-industry-from-the-mhra

Take Home message:

UK intends to accept reviewed healthcare products from all major jurisdictions - Chiefly EU, US and concentrate on reviewing high technology medical products. Chief driver – Medicines and Medical devices shortage + UK is good at innovation

The Organisation for Professionals in Regulatory Affairs

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