GovWire

1. Overview

Until and including 31 December 2024, marketing authorisation applications (MAAs) made through the Unfettered Access Procedure (UAP) relying on a current marketing authorisation issued for Northern Ireland (NI) should be recognised by?the MHRA?for GB within 70 days of MAA validation, unless major objections are identified.

New arrangements for human medicines come into effect from 1 January 2025, reflecting the agreement on human medicines as part of the Windsor Framework, and the MHRA will no longer issue GB-only MAs. If granted, an MA application made through UAP will result in aUK-wide MA and the NI MA will be revoked. This is because it is not possible to hold a UK MA and a NI MA simultaneously for the same product.

2. Eligibility

UAP?is available to MAs approved in NI via European procedures (centralised, mutual recognition or decentralised procedures) or via the national NI route.

Following implementation of the Windsor Framework on 1 January 2025, UAP will only be available for MAs approved in NI via the European mutual recognition or decentralised procedures. The national NI route will not be available.

European Union authorisations issued by the European Commission following application through the European Medicines Agencys (EMA) centralised procedure will cease to be valid in NI from that date. Therefore they cannot be used as the basis for a new application using the principle of unfettered access. See guidance on:

• UK-wide licensing

• Moving qualifying goods from Northern Ireland to the rest of the UK

• Definition of qualifying Northern Ireland goods

3. How to apply

In accordance with Regulation 49(3)(b)(i) of the Human Medicines Regulations 2012 (as amended) the MA holder for a submission using the unfettered access procedure must be established in Northern Ireland.

For companies who do not have a 5-digit company number to allow registration on the?MHRA?submissions portal, email?Reference.Data@mhra.gov.uk?to request one.

The company number is then used to get a PL number through the?MHRA?Submissions or by emailing ?PLNumberAllocation@mhra.gov.uk?before submitting an application.

Further information is available in guidance on the?MHRA?submission portal.

The entire dossier should be submitted to the?MHRA?as one?electronic Common Technical Document?sequence through?MHRA?Submissions. The dossier submitted under UAP must be the same as the currently approved MA in NI, including the full company responses to questions from the Committee for Medicinal Products for Human Use (CHMP)/Reference Member State (RMS)/Concerned Member State (CMS), as appropriate.

If the entire supporting dossier (modules 1 5) has already been submitted to the?MHRA?as the competent authority for NI, and no changes are required for the?UAP?MAA dossier, the dossier need not be submitted again for the?UAP?MAA only module 1 needs to be updated and submitted.

The working documents folder should include:

• all iterations of the CHMP opinion, RMS or national NI assessment reports and end-of-procedure documents for the initial MAA and subsequent variations (note that as Union authorisations will cease to be valid in NI from 1 January 2025, CHMP opinions will not be relevant for UAP applications from that date)

• the proposed product information in Microsoft Word format

• the MA grant letter as approved in Northern Ireland

Applicants should use the?eAF?and cover letter tool?to determine what information is needed to include in the application, for successful validation.

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 NI MA

• include a declaration of conformity of the UKapplication 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 statement to confirm whether the proposed product information is identical to that approved in the NI MA or whether it has been amended for UK (in the case of applications that are required to cite a reference medicinal product (RMP) the proposed product information should align with the cited RMP)

• include a declaration that the product information in Microsoft Word format has been included with the submission

• if an orphan designation is sought, confirm that the UK 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 UK -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 applicants and restricted parts of the?ASMF, including approved variations and all iterations of the assessment reports on the applicants and restricted parts

• include a declaration that the proposed risk management plan is identical to?the risk management plan?approved for NI

• state any conditions associated with the marketing authorisation

We anticipate that the marketing authorisation holder (MAH) for an application submitted via the UAP is the same company or belongs to the same (legal) group of companies as the MAH in the NI MA procedure. This is to ensure that the MAH can fulfil the submission requirements as well as all of their legal obligations as holder of marketing authorisation (MA), such as the obligations stated in Regulations 74 and 75 of the Human Medicines Regulations 2012 (HMRs).

In exceptional circumstances, provided an applicant can demonstrate and provide written assurance that all the legal obligations can be met at submission, during the assessment process and throughout the life of the MA, it may be possible to accept an application from a third party applicant who is established in NI.

These measures are intended to provide reassurance to the licensing authority that the MAHs of MAs authorised via thisroute can keep legislative and safety information up to date to ensure a positive balance of benefit and risk throughout the validity of the MA.

4. Orphan designation

If you are seeking an orphan designation is, submit the UK orphan drug desi

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