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EC Decision reliance procedure for GB Marketing Authorisations extended by MHRA for one year to 31 December 2023

The Medicines and Healthcare products Regulatory Agency has extended the EC Decision reliance procedure (EC DRP) to apply until 31 December 2023.

The EC DRP was introduced by the MHRA as transitional measure following the withdrawal of the United Kingdom from the European Union at the end of 2020. Applicants for a GB marketing authorisation, allowing the sale or supply of a medicinal product in Great Britain can rely in their application on a decision of the European Commission to grant a Union marketing authorisation for a medicinal product. The EC DRP may be used by applicants for marketing authorisations for generic products as well as for new active substances and also for variations if they have been approved in the EC by the centralised procedure. 

An applicant will notify the MHRA of its intention to use the EC DRP by notifying the MHRA on receipt of a positive opinion from the European Medicines Agency’s Committee for Human Medicinal Products  (CHMP) and lodging an identical dossier to that lodged with the CHMP. The MHRA will then aim to grant a GB marketing authorisation within 67 days on the condition that the EC has also acted on the positive CHMP opinion and granted a Union marketing authorisation. This should mean that innovative products are available for patients at the same time in the EU (which for pharmaceutical regulatory purposes now includes Northern Ireland) and Great Britain (i.e. England, Scotland and Wales).

The MHRA has said, in commenting on this extension, that “This essential mitigation reduces the risk of companies deprioritising Great Britain for medicines authorisation and therefore ensures patients continue to have timely access to medicines”.