Guidance for new Marketing Authorisation assessment routes in the UK following Brexit: Unfettered Access Procedure for marketing authorisations approved in Northern Ireland

In the penultimate of our series of posts analysing the new access routes developed in the UK, Nasos Kipentzoglou takes a deeper dive into the Unfettered Access Procedure for marketing authorisations approved in Northern Ireland

Unfettered Access Procedure for marketing authorisations approved in Northern Ireland

Summary

Unfettered Access Procedure (UAP) for marketing authorisations approved in Northern Ireland describes a new marketing application procedure where manufacturers holding a marketing authorisation approved in Northern Ireland (NI) can seek recognition in Great Britain (GB) under certain qualifying conditions.

Timetable

The Medicines and Healthcare products Regulatory Agency (MHRA) intends to determine applications for recognition within 67 days of the validation of application although the vast majority of GB marketing authorisations (MA) should be approved after the first round of assessment (by day 42). The MHRA states that if issues are identified during the assessment, they should be resolved within the 67-day timeline without a clock-stop. In the case of Major Objections or requirement for substantial amendments to the product information, then the application will be moved to the standard National Procedure timetable (150-days).

Application process

There are certain eligibility criteria that applicants should meet in order to apply for a GB MA under the UAP, such as:

The relevant MA holder is established in Northern Ireland and
The relevant product placed on the market in Great Britain must be a Qualifying Northern Ireland Good (QNIG)

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 Northern Ireland, 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. However, this is not required if the MHRA was sent the dossier with a Northern Ireland application.

The Working Document Folder should include:

All iterations of the CHMP/RMS/NI assessment reports and End of Procedure documents for the initial MA application and subsequent variations
The proposed product information
The MA grant letter as approved in NI

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:

Clearly stating the regulatory route (UAP) and the relevant procedure number for the Northern Ireland Marketing Authorisation
A list of any product information differences between the proposed product information and the one approved in Northern Ireland
A list of all the CHMP/RMS/NI assessment reports 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 UAP application to the one approved in Northern Ireland

Implications for manufacturers

The MHRA with the ‘Unfettered Access Procedure’ will offer the opportunity to MA holders in Northern Ireland to seek recognition in Great Britain through an accelerated process. The UAP offers to manufacturers a 67-day turnaround; however, the MHRA states that the vast majority will be approved by day 42 (first round of assessment). Crucially, manufacturers need to meet specific eligibility criteria (e.g., the MA holder being established in Northern Ireland) and being compliant with all UK regulatory requirements.

Article published 8 April 2021.