MHRA release guidance on the decentralised and mutual recognition reliance procedure for marketing authorisations

Following the end of the transition period, the Medicines and Healthcare products Regulatory Agency (MHRA) have released guidance on how to obtain a marketing authorisation (MA) in the United Kingdom (UK) or Great Britain (GB) using the decentralised and mutual recognition reliance procedure (MRDCRP).

The MHRA has the authority to inspect MAs approved in European Union (EU) member states through decentralised and mutual recognition procedures with the aim of granting an MA in the UK or GB. This route is known as the MRDCRP and the MHRA strives to have acceptable approvals within 67 days of the MA application (MAA). It is important to note that the MRDCRP is not available to products with MAs granted in EU member states through a National Procedure only.

Applicants must first apply for a product licence (PL) based on whether they require it for the UK or just GB (England, Scotland and Wales only). If it is their first application then the company should email Reference.Data@mhra.gov.uk. The company must then submit one electronic Common Technical Document (eCTD) sequence containing the entire dossier as approved for marketing in the EU member states including company responses to Reference Member State (RMS)/Concerned Member State (CMS) questions. Additionally, the Working Documents Folder must include:

  • All versions of the RMS/CMS assessment reports and End of Procedure documents for the initial MAA and any successive variations
  • The proposed product information in Microsoft Word format
  • The MA grant letter as approved in the RMS

Additional components for the application may be required in the case of:

  • Orphan designation – the Great Britain Orphan Drug Designation Application Form should be submitted in module 1.2 of the eCTD.
  • Paediatric requirements – applicants should ensure the latest EU and/or GB Paediatric Investigation Plan (PIP), waiver decision or class waiver decision is included in the submission. If the application has been subjected to an EU or GB compliance check, the outcome documents should be included. If the applicant has any ongoing or previous applications containing paediatric data relevant for full PIP compliance verification, then an overview of the PIP results indicating in which application(s) they were/are going to be submitted, status of the application(s) as well as their location in the present application must be included.

A cover letter must also be included, clearly stating the regulatory route as MRDCRP and declaring conformity with the mandatory requirements of this process and indications of any additional components (such as including an application for Orphan Drug Designation).

For full details on the process of applying for the MRDCRP, click here.