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

| Procedures, Regulatory Operations: eCTD and Submissions, UK

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: [email protected]

Alternatively, you can schedule a free 30 minutes meeting HERE

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NEWS | Important Update for Clinical Trial Sponsors

October 3, 2024

The transition period for the EU Regulation on Clinical Trials on medicinal products for human use (CTR, 536/2014) is approaching its conclusion, with a final

Curso | Novedades en el Entorno Telemático Europeo. Implementación de ISO IDMP.

October 1, 2024

El objetivo del curso es ofrecer una actualización de la normativa y los sistemas telemáticos para la gestión de la información de los medicamentos de uso humano con las autoridades sanitarias.

EVENT| CPHI congress

September 13, 2024

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About

Team

Partners

CSR

Careers

NEW timelines for ECDRP!

Search

Filter by category

Related news and events

NEWS | Important Update for Clinical Trial Sponsors

Curso | Novedades en el Entorno Telemático Europeo. Implementación de ISO IDMP.

EVENT| CPHI congress

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