Unfettered Access Procedure for marketing authorisations approved in Northern Ireland

Marketing Authorisation Holders (MAHs) may seek recognition in Great Britain of a Marketing Authorisation (MA) approved in Northern Ireland.

This route - the Unfettered Access Procedure (UAP) - is available to MAs approved in Northern Ireland via European procedures (centralised, mutual recognition or decentralised procedures) or via the Northern Ireland National route.

Refer to guidance on conditions for eligibility of unfettered access, and definitions of qualifying Northern Ireland goods.

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

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.

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 Northern Ireland, 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.

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 IPUenquiries@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 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
• Include a declaration 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
• Include a declaration 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 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 Applicant’s and Restricted Parts of the ASMF, including approved variations and all iterations of the assessment reports on the Applicant’s and Restricted Parts
• Include a declaration that the proposed Risk Management Plan (RMP) is identical to RMP in Northern Ireland/European Union.
• State any conditions associated with the Marketing Authorisation

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.

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 Great Britain 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.

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.