Module 18 2021

08/02/2021

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

17

Brexit Guidances

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

The Organisation for Professionals in Regulatory Affairs

18

9