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  1. Healthcare & Life Sciences
  2. United Kingdom: UKs MHRA announces extension of the European Commission Decision Reliance Procedure (ECDRP)

United Kingdom: UKs MHRA announces extension of the European Commission Decision Reliance Procedure (ECDRP)

27 Jan 2023    1 minute read
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Sectors Healthcare & Life Sciences

In brief

The MHRA lifted some extra burden from the industry by extending the European Commission Decision Reliance Procedure (ECDRP) by 12 months until 31 December 2023. The ECDRP was introduced following Brexit and is available to medicines approved via the EU centralized procedure.


Contents

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

The MHRA also announced that from 1 January 2024, a new international recognition framework will be in place, which will have regard to decisions already made by the European Medicines Agency/European Commission and certain other regulators.

MHRA, in its announcement, said that “Our aim is to extend the countries whose assessments we will take account of, increasing routes to market in the UK.”

The Association of British Pharmaceutical Industry (ABPI) responded positively to the MHRAs announcement noting that it minimizes the burden on companies and that it will allow MHRA to develop a new international framework.

 

For further information, please talk to Elina Angeloudi, Jaspreet Takhar or Julia Gillert from our London office

Contact Information
Julia Gillert
Of Counsel at BakerMcKenzie
London
Read my Bio
julia.gillert@bakermckenzie.com
Jaspreet Takhar
Senior Associate
London
Read my Bio
jaspreet.takhar@bakermckenzie.com
Elina Angeloudi
Associate
London
Elina.Angeloudi@bakermckenzie.com

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