Search
Close this search box.
Logo Asphalion

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

 

Search News & Events

  • Filter by category

Share

Related news and events

CTIS applicable | Faster Access to Clinical Trial Information in Europe

CTIS is the single-entry point for the submission and assessment of clinical trial applications in the EU. It features a public, searchable database aimed at delivering a high level of transparency. The authorisation and oversight of clinical trials are managed by EU/EEA Member States, while the EMA maintains the CTIS. The European Commission oversees the implementation of the Clinical Trials Regulation.

For further information

If you are interested in our services, or wish to get in touch for a general enquiry, please contact us for more information.

Fill the form and we will contact you as soon as possible.

You can also follow us on:

Schedule a Free Meeting

Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts. 

We will be happy to assist you!

Schedule a meeting