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European Commission (EC) Decision Reliance Procedure for determination of a MAA by MHRA.

Read time: 1 mins
Published:24th Apr 2021
MHRA Explanatory Note: For a period of two years from 1 January 2021, when determining an application for a Great Britain Marketing Authorisations (MA), the MHRA may rely on a decision taken by the European Commission (EC) on the approval of a new MA in the centralised procedure.Great Britain refers to England, Scotland and Wales.This route – the EC Decision Reliance Procedure (ECDRP) - is available to MAs approved via the centralised procedure.

The intended operation of the ECDRP is submission of the Marketing Authorisation Application (MAA) to the MHRA immediately on receipt of a positive Committee for Medicinal Products for Human Use (CHMP) opinion, although applications can be submitted any time after the approval of a European Union Marketing Authorisation. The MHRA aims to determine the Great Britain MA as soon as possible after EC approval. A delay in submission may affect the delivery of a decision within the 67-day timeline. When a submission is made to the MHRA within 5 days of CHMP positive opinion, the date of CHMP positive opinion will be designated Day 0 of the ECDRP, and the MHRA will aim to determine the Great Britain MA as soon as possible after EC approval, and by Day 67 at the latest provided that EC decision has been received. If the application is submitted more than 5 days after the CHMP positive opinion, Day 0 of the ECDRP will be the date of MAA validation, and determination may be delayed.

Condition: Cardiovascular Events
Type: drug

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