Consultation on end to the European Commission Decision Reliance Procedure
This is a consultation on a statutory instrument to amend the Human Medicines Regulations 2012 to remove the provision which provides the legal basis to the European Commission Decision Reliance Procedure (ECDRP).
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.