Marketing Authorisation HoldersApplications (MAHs)(MAAs) maymade seekthrough recognitionthe inUnfettered GreatAccess BritainProcedure of(UAP) ashould Marketingbe Authorisationrecognised (MAby MHRA) approvedfor inGreat NorthernBritain Ireland.

This(England, routeScotland -and theWales) Unfetteredwithin Access67 Proceduredays (of MAA validation, unless Major Objections are identified.

Eligibility

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.

ReferFind toout more in our guidance on conditions for eligibility of unfettered access, and definitions of qualifying Northern Ireland goods.

TheWe intentionalso ishave thatguidance acceptableexplaining Marketingwhat Authorisationgoods Applicationsqualify (MAAs)as shouldNorthern beIreland recognised by the MHRA for Great Britain (England, Scotland and Wales) within 67 days of MAA validation, unless Major Objections are identified.goods.

How to apply

If theyour company does not have a 5-digit company number, to allow registration on the MHRA Submissions Portal, thenyou this should beemail requested from Reference.Data@mhra.gov.uk. Ato PLGBrequest numberone.

You can then beget obtainedyour PLGB number through MHRA Submissions or by emailing PLNumberAllocation@mhra.gov.uk priorbefore toyou submission.submit your application.

You can find out more in our guidance about the MHRA submission portal.

The entire dossier should be submitted to the MHRA as one electronic Common Technical Document sequence through MHRA Submissions. It must be submitted 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.questions.

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 again for the UAP MAA.

TheYour 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.Ireland

You should use our eAF and cover letter tool to determine what information you need to include in your application. If you do not include the correct information your application will not be validated.

It is anticipated that the Marketing Authorisation Holder (MAH) for an application submitted via the unfettered access procedure is the same company or belongs to the same (legal) group of companies as the MAH in the European or UKMA(NI) procedure. This is to ensure that the MAH in 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.

These measures are intended to provide reassurance to the Licensing Authority that the MAHs of licences authorised via the reliance route are able to keep legislative and safety information up-to-date to ensure that a positive benefit:risk balance is maintained throughout the validity of the MA.

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.ukRIS.NA@mhra.gov.uk if you have any questions about submitting your application.

Find out more about orphan designation

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:

• Clearlyclearly state the regulatory route as UAP to ensure appropriate handling, including the relevant procedure number for the Northern Ireland MA
• Includeinclude 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
• Includeinclude a declaration that the proposed product information is identical to that approved in the Northern Ireland MA,MA, and that the product information in Microsoft Word format has been included with the submission
• Ifif 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
• Indicateindicate 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
• Ifif 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
• Includeinclude a declaration that the proposed Risk Management Plan (RMP) is identical to RMP in Northern Ireland/European Union.Union
• Statestate 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

TheFees will be payable for each submission. You can find out more about the fees we charge in the guidance MHRA fees.

Use the Fees Calculator to work out what the fee for your submission will attractbe.

You can find out more about how pay your fees in our guidance Make a feepayment to MHRA.

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,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. ItWe isanticipate anticipated that this will be necessary only on rare occasions.