Guidance for new Marketing Authorisation assessment routes in the UK following Brexit: Decentralised and Mutual Recognition Reliance Procedure

In the fourth of our series of posts analysing the new access routes developed in the UK, Nasos Kipentzoglou takes a deeper dive into at the Decentralised and Mutual Recognition Reliance Procedure.

Decentralised and Mutual Recognition Reliance Procedure

Summary

The decentralised and mutual recognition reliance procedure (MRDCRP) describes a new possible route to UK marketing authorisation (MA) that relies on approvals through the European decentralised (DC) and mutual recognition (MR) procedures, to grant marketing authorisation in the UK or GB

Timetable

The MHRA intends to complete the first-round assessment by day 42, at which point the MA will be granted if no concerns are raised. In case that MHRA need to Request Further Information (RFI), they will contact the applicants and the clock will be stopped for up to 28 days until the applicant has the opportunity to respond.

The guidance states that acceptable MAs should be granted within 67 days of MA application validation if there are not any outstanding points. The MRDCRP is not available to products with MAs in the EU member States granted only through National Procedures. The MHRA highlights that if major objections are identified, substantial amendments to the product information are necessary, or other concerns remain outstanding at Day 65, the timetable will move to the standard National Procedure timetable (150-days).

Application process

If this is a first-time application, then applicants must apply for a Product License number in GB (PLGB) through MHRA Submissions. The entire dossier as approved for marketing in the EU Member States, including the full company responses to Reference Member State (RMS)/Concerned Member States (CMS) questions, should be submitted to the MHRA as one electronic Common Technical Document (eCTD) through MHRA Submissions.

The Working Document Folder should include:

All iterations of the RMS assessment reports and End of Procedure documents for the initial MAA and subsequent variations
The proposed product information

The MA grant letter as approved in RMS

If applicants would like to apply for an orphan designation, then the Great Britain Orphan Drug Designation Application Form should be included in the eCTD.

For submissions that will trigger paediatric requirements:

applicants must include in the dossier the latest EU and/or GB- Paediatric Investigation Plan (PIP)/ waiver opinion/ decision or class waiver decision
Applicant should include an overview table of the PIP results, indicating in which application(s) they were/are going to be submitted, the status of the application(s), as well as their location in the present application, must be included

Finally, applications must be accompanied by a cover letter that should include information such as:

the relevant Mutual Recognition/Decentralised procedure number (MR/DC)

a list of any product information differences between the proposed product information and the one approved in the EU or EEA member states
a list of all assessment reports (RMS) and End of Procedure documents that have been submitted
If an orphan designation is sought, the applicant should confirm that the relevant form has been submitted
If the application will trigger a PIP, the applicant must submit any details around compliance with the European Union or Great Britain-PIP and confirm whether any PIP studies where due to initiate or complete since compliance verification
several declarations concerning the conformance of the MRDCP application to the EU or EEA member state approval on which it is based

Implications for manufacturers

The MHRA introduced the mutual recognition and decentralised procedure (MRDCRP) which allows the MHRA to take into account MAs issued under the EU’s mutual recognition and decentralised systems. The MRDCP offers to manufacturers a 67-day turnaround, but with the possibility of a MA being issued within 42 days from the application date, making it one of the fastest routes to obtain an MA. However, the EU procedures must have resulted in a MA decision before the UK process can begin which could lead to some possible delays to the UK authorisation depending on sequencing and resourcing.

Article published 29 March 2021.