Guidance for new Marketing Authorisation assessment routes in the UK following Brexit: European Commission (EC) Decision reliance procedure

Guidance for new Marketing Authorisation assessment routes in the UK following Brexit: European Commission Decision reliance procedure

In the third of our series of posts analysing the new access routes developed in the UK, Nasos Kipentzoglou looks at the European Commission Decision reliance procedure

European Commission Decision reliance procedure

Summary

European Commission (EC) Decision Reliance Procedure describes a new MA procedure for the UK through which the MHRA may rely on EC approvals under the EU centralised procedure. The EC Decision reliance procedure (ECDRP) will be available for two years from 1 January 2021. The intended operation of the ECDRP is the 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.

Timetable

The MHRA aims to determine GB MAs under the ECDRP as soon as possible and suggested that a delay in submission may affect the 67-day timeline. There is the possibility that the MHRA may make major objections or require significant amendment of the product information, which will move the application on to the standard National procedure timetable. The MHRA anticipates that this would be on rare occasions. Other reasons that may cause delay include an incomplete dossier or missing assessment reports.

The timetable can vary depending on when the application is made in relation to the EMA’s Committee for Medicinal Products for Human Use (CHMP) opinion. If the submission is made within five days of the CHMP opinion, then a 67-day timetable applies from the date of the CHMP opinion (provided the EC decision has been received). If the application is made more than five days after the CHMP opinion, then the timetable starts on the date that the MHRA validates the application, and determination may be delayed.

The MHRA promises to raise concerns relating to approvability at the earliest opportunity with the applicant. The guidance states that issues identified during the assessment will be communicated by day 46 and the MHRA expects to be able to resolve those issues without affecting the overall 67-day timetable.

For orphan medicines, the Applicant is also responsible for confirming the COMP (Committee on Orphan Medicinal Products) decision using the ECDRP mailbox. Any delay in providing these confirmations will impact the timing of the UK application determination.

Application Process

MHRA sets out the steps that applicants must do to apply for a GB MA under the ECDPR.

If this is a first-time application, then applicants must apply for a PLGB number through MHRA Submissions. Prior to an anticipated positive opinion from CHMP, applicants should submit a letter of intent including:

A statement that the applicant intends to submit an ECDRP application to the MHRA
The intended timing of the application, which should be at least four weeks before submission of the ECDPR MAA
Disclosure of all iterations of the CHMP assessment reports
A statement confirming whether the applicant intends to apply for orphan designation in the UK

Fees will be payable only after the dossier is received and not during this pre-procedure stage.

On receipt of the positive CHMP opinion, an application for the GB MA should be submitted to the MHRA any time after EU approval. The application should be submitted to the MHRA as a single eCTD (containing the entire dossier, including responses to CHMP questions) using MHRA Submissions. The dossier is not required if it has already been submitted to the MHRA as part of a NI application and no changes are required for ECDPR MAA.

The applicant should include in the Working Document Folder:

All iterations of the CHMP assessment reports and opinion for the initial centralised procedure application and any subsequent variations
The proposed product information in MS Word Format

To apply for UK orphan designation, applicants will need to include the Great Britain Orphan Drug Designation Application Form in module 1.2 of the eCTD.

For submissions that will trigger paediatric requirements:

Applicants must include in the dossier the latest EU and/or GB-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

Applications must be accompanied by a cover letter that should include information such as:

The relevant ECDRP procedure number
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 (CHMP) 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 ECDRP application to the Commission approval, and the related CHMP assessment and opinion on which it is based

Finally, the applicant is also required to confirm:

The relevant Commission decision by providing the decision letter on the day of receipt
Any applicable decision of the EMA’s Committee on Orphan Medicinal Products

Implications for manufacturers

The MHRA with the ECDRP scheme, which will operate for two years until the end of 2022, will offer the possibility for manufactures to apply for a GB marketing authorisation as soon as possible after the CHMP opinion. This is a critical step for manufacturers who will have the chance to align the GB assessment procedures with those of the EU. The process enables an opportunity to run parallel advice and enhance early dialogue with NICE. This is a critical step to maximise the opportunity to successfully navigate potential technology assessments with NICE and accelerate access.

Article published 22 March 2021.