For two years from 01 January 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) may rely on Marketing Authorisations (MAs) approved by the European Commission (EC) via a centralised procedure when assessing an application for a Great Britain (GB) MA. The MHRA have released guidance on applying for a GB (England, Scotland and Wales only) MA through this route.
The European Commission Decision Reliance Procedure (ECDRP) aims to determine a GB MA as soon as possible after approval by the EC, hence a 67-day timeline from submission of the Marketing Authorisation Application (MAA) to a decision. When an applicant anticipates receiving a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), such as through a confirmation of no remaining major concerns, the applicant must send a ‘letter of intent to submit an ECDRP’ to the MHRA (via the ECDRP mailbox). This must occur at least 4 weeks before submitting an ECDRP MAA. This letter should include a proposed timeline for when the company intends to submit their application along with all CHMP assessment reports they have received to date. Additionally, should the company wish to apply for an orphan designation in GB, this intention should be stated in their letter.
Upon obtaining a positive opinion from the CHMP, an electronic Common Technical Document (eCTD) sequence should be submitted through MHRA submissions as soon as possible. The entire dossier as reviewed by the CHMP including all company responses to CHMP questions must be included. 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, along with a Microsoft Word document containing the proposed product information.
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 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 ECDRP 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 for applications through the ECDRP route, click here.