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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鈥痶he MHRA鈥痜or GB within 70 days of MAA validation, unless major objections are identified.听听

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 a听UK-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.听听听

2. Eligibility听

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

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.听

European Union authorisations issued by the European Commission following application through the European Medicines Agency鈥檚 (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.听 See guidance on:听

• 听UK-wide licensing听

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

• 听

3. How to apply听

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.听听听

For companies who do not have a 5-digit company number to allow registration on the鈥�MHRA鈥痵ubmissions portal, email鈥�Reference.Data@mhra.gov.uk鈥痶o request one.听

The company number is then used to get a PL number through the鈥�MHRA鈥疭ubmissions or by emailing 鈥�PLNumberAllocation@mhra.gov.uk鈥痓efore submitting an application.听

Further information is available in guidance on the鈥�MHRA鈥痵ubmission portal.听

The entire dossier should be submitted to the鈥�MHRA鈥痑s one鈥�鈥痵equence through鈥�MHRA鈥疭ubmissions. 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.听

If the entire supporting dossier (modules 1 鈥� 5) has already been submitted to the鈥�MHRA鈥痑s the competent authority for NI, and no changes are required for the鈥�UAP鈥疢AA dossier, the dossier need not be submitted again for the鈥�UAP鈥疢AA 鈥� only module 1 needs to be updated and submitted.听

The working documents folder should include:听

• 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听

• the MA grant letter as approved in Northern Ireland

Applicants should use the鈥�eAF鈥痑nd cover letter tool鈥痶o determine what information is needed to include in the application, for successful validation.听

Cover letter听

The cover letter accompanying the application should:听

• clearly state the regulatory route as鈥�UAP鈥痶o ensure appropriate handling, including the relevant procedure number for the NI MA听

• include a declaration of conformity of the UK听application with the dossier approved for marketing in Northern Ireland, including approved variations听

• 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听

• 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)听

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

• if an orphan designation is sought, confirm that the UK orphan drug designation application form has been submitted in module 1.2 of the鈥�eCTD听

• 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听 UK -PIP鈥痗ompliance check and confirm whether any鈥�PIP鈥痵tudies were due to initiate or complete since compliance verification听

• if the procedure includes an鈥�ASMF, include a declaration that the鈥�ASMF鈥痟older has submitted the applicant鈥檚 and restricted parts of the鈥�ASMF, including approved variations and all iterations of the assessment reports on the applicant鈥檚 and restricted parts

• include a declaration that the proposed risk management plan is identical to鈥痶he risk management plan鈥痑pproved for NI听

• state any conditions associated with the marketing authorisation听

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).听

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.听

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

4. Orphan designation听

If you are seeking an orphan designation is, submit the UK orphan drug designation application form in module 1.2 of the鈥�eCTD. Email鈥�RIS.NA@mhra.gov.uk鈥痜or any questions about submitting an application.听

Find out more about鈥�orphan designation.听

5. Paediatric requirements听

For submissions which will trigger paediatric requirements, applicants must ensure the latest UK-PIP/waiver decision or class waiver decision is included in the dossier.听

If the application has been subject to a UK compliance check, the outcome documents must听 be included in the dossier.听

The applicant should also indicate any parallel, ongoing or previous applications containing paediatric data relevant for the full鈥�PIP鈥痗ompliance verification (if applicable). An overview table of the鈥�PIP鈥痳esults, 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.听

For more information, see guidance on paediatric requirements.听

6. Fees听

Fees will be payable for each submission. The fees charged are set out in guidance on MHRA鈥痜别别蝉.听

Find out more about how to pay your fees in guidance on how to make a payment to鈥�MHRA.听

7. Assessment听

All applications will be assessed to ensure they comply with UK regulatory requirements, including those related to:听

• reference medicinal products听 (a UK or EU reference medicinal product is acceptable)听

• product name听

• labelling听

• patient information legibility听

• supply status听

• controlled drug scheduling where necessary听

• paediatric and orphan medicine requirements, where relevant听

If we find 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 70-day timetable.听

The first round of assessment should be completed by Day 42. We anticipate that the vast majority of MAs will be approved at this point.听

Any issues identified during assessment will be communicated and should be resolvable within the 70-day timetable without clock-stop.听

8. Major objections听

If we identify major objections, or substantial amendments to the product information are necessary, the timetable will move to the standard national procedure timetable. We anticipate that this will be necessary only on rare occasions.听