The UK MHRA has published guidance on the Unfettered Access Procedure (UAP) for marketing authorisations approved in Northern Ireland.
What is the the Unfettered Access Procedure (UAP)?
Marketing Authorisation Holders (MAHs) may seek recognition in Great Britain (GB) of a Marketing Authorisation (MA) approved in Northern Ireland (NI).
This route, known as the the Unfettered Access Procedure (UAP).
The UAP is available to Marketing Authorsiations (MAs) approved in NI via which procedures?
It is available to MAs approved in NI via European procedures (centralised, mutual recognition or decentralised procedures) or via the Northern Ireland National route.
What are the conditions for the eligibility of the UAP?
The conditions for eligibility of the UAP are that the MAH must be established in Northern Ireland, and that the product to be placed on the market in Great Britain must be a Qualifying Northern Ireland Good.
The intention is that acceptable Marketing Authorisation Applications (MAAs) should be recognised by the MHRA for Great Britain (England, Scotland and Wales) within 67 days of MAA validation, unless Major Objections are identified.
How to apply for a Marketing Authorisation via the UAP
Prior to submission, an Applicant should first email Reference.Data@mhra.gov.uk if this is the company’s first application, and then must apply for a PLGB number through MHRA Submissions or by emailing PLNumberAllocation@mhra.gov.uk.
What documentation should be included in the Marketing Authorisation Application?
The entire dossier as approved for marketing in Northern Ireland, including the full company responses to the Committee for Medicinal Products for Human Use (CHMP)/Reference Member State (RMS)/Concerned Member State (CMS) questions, should be submitted to the MHRA as one electronic Common Technical Document sequence through MHRA Submissions.
If the entire dossier has already been submitted to the MHRA as NI, and no changes are required for the UAP MAA dossier, the dossier need not be submitted for the UAP MAA.
The Working Documents Folder should include:
- all iterations of the CHMP/RMS/Northern Ireland 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 Northern Ireland.
What is required if an orphan designation is sought?
- If an orphan designation is sought, the GB Orphan Drug Designation Application Form should be submitted in module 1.2 of the eCTD.
- Email IPUenquiries@mhra.gov.uk if you have any questions about submitting your application.
What happens in cases where a submission triggers paediatric requirements?
- For submissions which will trigger paediatric requirements, applicants should ensure the latest European Union and/or GB-PIP/waiver opinion/decision or class waiver decision is included in the dossier.
- If the application has been subject to a European Union or GB 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.
What information should be included in the cover letter accompanying an MAA application?
The cover letter accompanying the application should:
- Clearly state the regulatory route as UAP to ensure appropriate handling, including the relevant procedure number for the Northern Ireland MA.
- Include a declaration:
- of conformity of the Great Britain application with the dossier approved for marketing in Northern Ireland, including approved variations.
- that all iterations of the CHMP/RMS/Northern Ireland assessment reports and End of Procedure documents have been submitted. These assessment reports should also be listed.
- that the proposed product information is identical to that approved in the Northern Ireland MA, and that the product information in Microsoft Word format has been included with the submission.
- If an orphan designation is sought, confirm that the Great Britain Orphan Drug Designation Application Form has been submitted in module 1.2 of the eCTD.
- 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 GB-PIP compliance check and confirm whether any PIP studies were due to initiate or complete since compliance verification.
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
The submission will attract a fee.
What is the assessment procedure?
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. It is anticipated that the vast majority of GB MAs will be approved at this point.
Any issues identified during assessment will be communicated, and should be resolvable within the 67-day timetable without clock-stop.
What happens If major objections are raised?
If Major Objections are identified or substantial amendments to the product information are necessary, the timetable will move to the standard National Procedure timetable. It is anticipated that this will be necessary only on rare occasions.
Source: MHRA website