The Medicines and Healthcare Products Regulatory Agency has extended the EC Ruling Appeal Procedure (EC DRP) until 31 December 2023.
The DRP CE was introduced by the MHRA as a transitional measure following the UK’s withdrawal from the European Union at the end of 2020. Applicants for UK marketing authorisation, allowing the sale or supply of a medicinal product in Great Britain, can rely on their application for a European Commission decision granting an EU marketing authorization for a medicinal product. The CE DRP can be used by applicants for marketing authorizations for generic products as well as for new active substances and also for variations if they have been approved in the EC by the centralized procedure.
An applicant will notify the MHRA of its intention to use the DRP EC by informing the MHRA upon receipt of a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency and submitting a dossier identical to that filed with the CHMP. The MHRA will then endeavor to grant a UK Marketing Authorization within 67 days provided the EC has also acted on the positive CHMP opinion and granted a Union Marketing Authorization . This should mean that innovative products are available to patients in both the EU (which for pharmaceutical regulatory purposes now includes Northern Ireland) and Great Britain (i.e. say England, Scotland and Wales).
The MHRA stated, in commenting on this extension, that “This essential mitigation reduces the risk of companies prioritizing Britain for drug authorization and therefore ensures that patients continue to have rapid access to medicines”.