Consultation on end to the European Commission Decision Reliance Procedure

Consultation opened on 30 August 2023. Closing date 27 September 2023.


A UK wide public consultation launched today on amending the Human Medicines Regulations 2012 to remove the power for the Medicines and Healthcare Products Regulatory Agency (MHRA) to rely on the European Commission Decision Reliance Procedure (ECDRP) when approving a medicine for the GB market. The consultation will run for 4 weeks and is facilitated by virtue of the primary powers contained in the Medicines and Medical Devices Act 2021 (MMDA). The Department of Health in Northern Ireland is the appropriate authority for the making of human medicines regulations in respect of NI, reflecting the fact that medicines are a devolved matter in Northern Ireland, and therefore consultation responses will be shared with the Department as outlined in the consultation document.

Consultation description

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.  Offering a shortened assessment procedure for products that have already gone through the EU procedures, helps avoid duplication and costs for manufacturers, and makes the most efficient use of the MHRA resource.  This procedure, known as the ECDRP, is due to come to an end on December 31, 2023.

The MHRA are now in a position to implement a more considered approach to their assessments. The proposal will only apply to medicines approved for the GB market, as until the implementation of the Windsor Framework, medicines for the Northern Ireland market must follow the EU acquis as per the Northern Ireland Protocol.  The MHRA will continue to work with the Department to mitigate against any potential regulatory divergence in the short term until the implementation of the Windsor Framework.

The consultation document can be accessed via the link below:

Share this consultation

Back to top