NEW timelines for ECDRP!

Before 31 December 2023, where a Committee for Medicinal Products for Human Use (CHMP) positive opinion has been received, you can continue to submit your ECDRP Marketing Authorisation Application (MAA) or variations to MHRA. MHRA will continue to review these applications via the current ECDRP process.

Before 31 December 2023, where a Committee for Medicinal Products for Human Use (CHMP) positive opinion has been received, you can continue to submit your ECDRP Marketing Authorisation Application (MAA) or variations to MHRA. MHRA will continue to review these applications via the current ECDRP process.
April 20, 2023

The European Commission Decision Reliance Procedure (ECDRP) has been extended to 31 December 2023

From 1 January, 2024, a new international recognition framework will be in place.

If you are looking to apply for a MA in Great Britain via the EC Decision Reliance Procedure, get in touch with us to get to know the requirements and timelines!

You can contact us at: info@asphalion.com

Alternatively, you can schedule a free 30 minutes meeting HERE

 

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