Detail of outcome
From 1 January 2024, the EC Decision Reliance Procedure (ECDRP) will be replaced by the new International Recognition procedure (IRP).
We have analysed all responses and considered the feedback received alongside existing commitments to end the ECDRP. While we recognise feedback that the ECDRP has been a useful process, the ECDRP was always intended to be a temporary procedure. We are confident that the new IRP will prove a suitable replacement, enabling the MHRA to recognise decisions from a range of trusted regulators, including the European Commission, to allow the MHRA to make the most of the expertise and decision-making of trusted regulatory partners to streamline assessments. We intend to proceed to introduce legislation to amend the HMRs to remove regulation 58(4C), reflecting the end of ECDRP on 31 December 2023.
We welcome the engagement we have received with the consultation and appreciate the constructive and considered responses. We intend to publish the full consultation response shortly.
As the United Kingdom (UK) exited the EU, the MHRA introduced a mechanism that allowed the agency to rely on European Commission (EC) decisions when considering application for a UK marketing authorisation to authorise medicinal products. This procedure, known as the European Commission Decision Reliance Procedure (ECDRP), is due to come to an end December 31, 2023.
We welcome the views of patients, pharmaceutical and biotechnology researchers, developers, manufacturers and suppliers, clinicians, other healthcare professionals and the wider public to help shape our approach to ending ECDRP.
This consultation is being carried out jointly with the Department of Health in Northern Ireland.