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UK MHRA: Guidance on Renewing Marketing Authorisations & Implementation of Med Dev. Future Regime

Recently (28, July 2023) the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Renewing Marketing Authorisations for medicines" that is designed to guide on how to renew marketing authorisations for products granted through different routes and at different times.

This guidance gives clear directions and emphasizing early planning, streamlined documentation, and collaborative communication, the MHRA aims to ensure a smooth and efficient renewal process.

As per the guidance Renewals for converted Centrally Authorised Products (CAPS) from EU to UK MAs will be treated as if they were granted on the date the corresponding EU MA was granted. The renewal date will stay the same.

The holder of an existing marketing authorization (MA), or the applicant for a MA with an application submitted by 1 January 2021 and under review under a decentralised or mutual recognition procedure with UK as a CMS, will have a choice as to how to manage their marketing authorisations/applications.

For products authorised in the UK, renewal applications need to be submitted nine months before they expire, and the requirements for renewal submissions will remain the same.

Please refer to the following guidance for more details on the documents required in the EU.

The MHRA also released a standard "Implementation of Medical Devices Future Regime" aiming for core aspects of the future regime for medical devices to apply from 1 July 2025. The response outlined the intended regulatory reform including the transitional arrangements for CE and UKCA marked devices placed on the Great Britain market.


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