Decentralised and mutual recognition reliance procedure for marketing authorisations
Guidance on the decentralised and mutual recognition reliance procedure (MRDCRP) for marketing authorisation applications including information on how to apply.
This guidance is valid for Established Medicines applications submitted before 1 January 2024 only. For submissions after 1 January 2024 please refer to International Recognition Procedure.
The MHRA has the power to have regard to Marketing Authorisations (MAs) approved in EU Member States (or Iceland, Liechtenstein, Norway) through decentralised and mutual recognition procedures with a view to granting the MA in the UK or Great Britain (England, Scotland and Wales).
The intention is that acceptable MAs should be granted within 67 days of MAA validation.
Eligibility
This route – the MRDC Reliance Procedure (MRDCRP) - can be used to apply for a UK MA [PL] or for a Great Britain MA [PLGB].
The MRDCRP is not available to products with MAs in EU Member States (or Iceland, Liechtenstein, Norway) granted only through National Procedures.
How to apply
If your company does not have a 5-digit company number, to allow registration on MHRA Submissions , you should email Reference.Data@mhra.gov.uk to request one.
You can then get your PLGB number through MHRA Submissions or by emailing PLNumberAllocation@mhra.gov.uk before you submit your application.
You can find out more in our guidance about the MHRA submission portal.
The entire dossier should be submitted to the MHRA as one electronic Common Technical Document sequence through MHRA Submissions. It must be submitted as approved for marketing in the EU Member States (or Iceland, Liechtenstein, Norway), including the full company responses to Reference Member State (RMS)/Concerned Member States (CMS) questions.
The Working Documents 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 in Microsoft Word format
- the MA grant letter as approved in the RMS
You should use our eAF and cover letter tool to determine what information you need to include in your application. If you do not include the correct information your application will not be validated.
It is anticipated that the Marketing Authorisation Holder (MAH) for an application via the MRDCRP route is the same company or belongs to the same (legal) group of companies as the MAH in the European procedure. This is to ensure that the MAH can fulfil the submission requirements as well as all of their legal obligations as holder of a marketing authorisation (MA), such as the obligations stated in Regulations 74 and 75 of the Human Medicines Regulations 2012 (HMRs).
In exceptional circumstances, provided an applicant can demonstrate and provide written assurance that all the legal obligations can be met at submission, during the assessment process and throughout the life of the MA, it may be possible to accept applications from third parties.
These measures are intended to provide reassurance to the Licensing Authority that the MAHs of licences authorised via the reliance route are able to keep legislative and safety information up-to-date to ensure that a positive benefit:risk risk balance is maintained throughout the validity of the MA.
Orphan designation
If an orphan designation is sought, the Great Britain Orphan Drug Designation Application Form should be submitted in module 1.2 of the eCTD. Email RIS.NA@mhra.gov.uk if you have any questions about submitting your application.
Find out more about orphan designation.
Paediatric requirements
For submissions which will trigger paediatric requirements, applicants should ensure the latest European Union and/or Great Britain-PIP/waiver opinion/decision or class waiver decision is included in the dossier.
If the application has been subject to a European Union or Great Britain compliance check the outcome documents should be included in the dossier. The applicant should also indicate any parallel, ongoing or previous applications containing paediatric data relevant for the full PIP compliance verification (if applicable). An overview table 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.
Cover letter
The cover letter accompanying the application should:
- clearly state the regulatory route as MRDCRP to ensure appropriate handling, including the relevant MR/DC procedure number
- include a declaration of conformity of the UK/Great Britain application with the dossier approved for marketing in EU Member States (or Iceland, Liechtenstein, Norway), including approved variations
- include a declaration that all iterations of the RMS assessment reports and End of Procedure documents have been submitted. These assessment reports should also be listed
- include a declaration that the proposed product information is in line with that approved in the EU Member States (or Iceland, Liechtenstein, Norway), and that the product information in Microsoft Word format has been included with the submission. The applicant should list all differences between the proposed product information and that approved in the EU Member States (or Iceland, Liechtenstein, Norway)
- confirm that the Great Britain Orphan Drug Designation Application Form has been submitted in module 1.2 of the eCTD, if an orphan designation is sought
- indicate whether paediatric requirements will be triggered, and if so, that the paediatric information is included in the dossier. The applicant should indicate if this application has been subject to a European Union or Great Britain-PIP compliance check and confirm whether any PIP studies were due to initiate or complete since compliance verification.
- if the procedure includes an ASMF, include a declaration that the ASMF Holder has submitted the Applicant’s and Restricted Parts of the ASMF, including approved variations and all iterations of the assessment reports on the Applicant’s and Restricted Parts
- include a declaration that the proposed Risk Management Plan (RMP) is identical to the RMP approved in EU Member States (or Iceland, Liechtenstein, Norway)
- state any conditions associated with the Marketing Authorisation
If it is found during the assessment phase that the dossier is incomplete or assessment reports have been omitted, this will be raised as a Point for Clarification, and may cause a delay to the 67-day timetable.
Fees
Fees will be payable for each submission. You can find out more about the fees we charge in the guidance MHRA fees.
You can find out more about how pay your fees in our guidance Make a payment to MHRA.
Assessment
All applications will be assessed to ensure they comply with UK regulatory requirements, including those related to:
- Great Britain Reference Medicinal Products
- product name
- labelling
- patient information legibility
- supply status
- controlled drug scheduling where necessary
- paediatric and orphan medicine requirements, where relevant
The first round of assessment should be completed by Day 42, at which point the MA will be granted if no concerns are raised.
Any points will be sent as a Request for Further Information (RFI) and the clock will be stopped for up to 28 days to give the Applicant the opportunity to respond. If there are no outstanding points at Day 65 the MA will be granted within 67 days of MAA validation.
Major objections
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.
Updates to this page
Published 4 January 2021Last updated 23 February 2021 + show all updates
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Updated information around how to get a 5-digit company number.
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First published.