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For a period of 3 years from 1 January 2021, when determining an application for a Great Britain Marketing Authorisations (MA), the MHRA may rely on a decision taken by the European Commission (EC) on the approval of a new MA in the centralised procedure.

Great Britain refers to England, Scotland and Wales.

This route the EC Decision Reliance Procedure (ECDRP) - is available to MAs approved via the centralised procedure.

The intended operation of the ECDRP is submission of the Marketing Authorisation Application (MAA) to the MHRA immediately on receipt of a positive Committee for Medicinal Products for Human Use (CHMP) opinion, although applications can be submitted any time after the approval of a European Union Marketing Authorisation.

The MHRA aims to determine the Great Britain MA as soon as possible after EC approval. A delay in submission may affect the delivery of a decision within the 67-day timeline.

How to apply

If the Applicant intends to apply for an MA in Great Britain via the EC Decision Reliance Procedure they should inform the MHRA at the earliest opportunity by emailing ECDRP@mhra.gov.uk.

If the company does not have a 5-digit company number, to allow registration on the MHRA Submissions Portal, then this should be requested from Reference.Data@mhra.gov.uk. A PLGB number can then be obtained through MHRA Submissions or by emailing PLNumberAllocation@mhra.gov.uk prior to submission.

Letter of intent

To facilitate scheduling, prior to receiving a positive CHMP opinion, companies should submit a letter of intent to submit an ECDRP to the MHRA at least 4 weeks before submission of the ECDRP MAA. This should be submitted to the ECDRP mailbox once a positive CHMP opinion is anticipated, for example after receiving confirmation that no major concerns remain.

The letter should state when the company intends to submit the application and should be accompanied by all iterations of the CHMP assessment reports that have been received to date.

The letter should also state whether the company intends to apply for an orphan designation in Great Britain. Fees will be payable only after the dossier is received and not during this pre-procedure stage.

MAA Submission

On receipt of the positive CHMP opinion, or as soon as possible after this date, the ECDRP MAA should be submitted to the MHRA as one electronic Common Technical Document sequence through MHRA Submissions.

The submission should include the entire dossier as reviewed by the CHMP (and approved by the EC if the EC decision has already been received), including the full responses to CHMP questions.

The Working Documents Folder should include:

• all iterations of the CHMP assessment reports and the CHMP opinion for the initial MAA and any subsequent variations,
• the proposed product information in Microsoft Word format.

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.

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 ECDRP to ensure appropriate handling, including the relevant procedure number for the centralised MAA.
• include a declaration of conformity of the Great Britain application with the dossier that received a positive opinion from the CHMP (and was approved by the EC if the EC decision has already been received), including approved variations.
• include a declaration that all iterations of the CHMP 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 identical to that which received a positive opinion from the CHMP (and was approved by the EC if the EC decision has already been received), and that the product information in Microsoft Word format has been included with the submission.
• 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 Applicants and Restricted Parts of the ASMF, including approved variations and all iterations of the assessment reports on the Applicants and Restricted Parts.
• include a declaration that the proposed Risk Management Plan (RMP) is identical to RMP which received a CHMP positive opinion (and was approved by the EC if the EC decision has already been received).
• state any conditions associated with the Marketing Authorisation.

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