Unfettered Accessaccess Procedureprocedure for marketing authorisations approved in Northern Ireland

1. Overview

MarketingUntil Authorisationand Applicationsincluding 31 December 2024, marketing authorisation applications (MAAs) made through the Unfettered Access Procedure (UAP) shouldrelying beon recogniseda bycurrent MHRAmarketing authorisation issued for GreatNorthern BritainIreland (England,(NI) Scotlandshould andbe Wales)recognised by the MHRA for GB within 6770 days of MAA validation, unless Majormajor Objectionsobjections are identified.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 a 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.   

Eligibility2. Eligibility 

UAP is is available to MAs approved in NorthernNI Ireland via European procedures (centralised, mutual recognition or decentralised procedures) or via the Northernnational IrelandNI Nationalroute.   

Following route.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. 

FindEuropean outUnion moreauthorisations issued by the European Commission following application through the European Medicines Agency’s (EMA) centralised procedure will cease to be valid in ourNI guidancefrom onthat conditionsdate. Therefore they cannot be used as the basis for eligibilitya new application using the principle of unfettered access.access.  See guidance on: 

• We UK-wide alsolicensing 

• Moving havequalifying guidancegoods explainingfrom whatNorthern goodsIreland qualifyto asthe rest of the UK 

• Definition of qualifying Northern Ireland goods. 

3. How to applyapply 

IfIn youraccordance companywith doesRegulation 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,number to allow registration on the the MHRA submissions Submissionsportal, Portal, you should email email Reference.Data@mhra.gov.uk to to request one.one. 

YouThe cancompany number is then used to get youra PLGBPL number through the MHRA Submissions Submissions or by emailing  PLNumberAllocation@mhra.gov.uk before beforesubmitting youan submit your application.application. 

YouFurther caninformation findis outavailable more in our guidance abouton the the MHRA submission submission portal.. 

The entire dossier should be submitted to the the MHRA as as one one electronic Common Technical Document sequence sequence through through MHRA Submissions. Submissions.The Itdossier submitted under UAP must be submittedthe same as approvedthe forcurrently marketingapproved MA in NorthernNI, Ireland, 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)), questions.as appropriate. 

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

YourThe Workingworking Documentsdocuments Folderfolder should include:include: 

• all iterations of the CHMP/CHMP opinion, RMS/Northern Irelandor national NI assessment reports and Endend-of-procedure of Procedure documents for the initial MAA and subsequent variations,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,format 

• the MA grant letter as approved in Northern Ireland

YouApplicants should use our the eAF and and cover letter tool to to determine what information youis needneeded to include in yourthe application.application, Iffor yousuccessful dovalidation. 

Cover notletter 

The includecover theletter correctaccompanying informationthe your application will not be validated.should: 

• Itclearly isstate anticipated that the Marketingregulatory Authorisationroute Holderas UAP to (MAH)ensure forappropriate anhandling, applicationincluding submitted via the unfetteredrelevant access procedure isnumber for the sameNI companyMA 

• include ora belongsdeclaration toof theconformity same (legal) group of companies as the MAHUK application inwith the Europeandossier orapproved UKMA(NI)for procedure.marketing This is to ensure that the MAH in canNorthern fulfilIreland, theincluding submissionapproved requirementsvariations 

• include asa welldeclaration asthat all ofiterations their legal obligations as holder of marketingthe authorisationCHMP/RMS/Northern (MA),Ireland suchassessment asreports theand obligationsend-of-procedure stateddocuments inhave Regulationsbeen 74submitted and- 75these ofassessment thereports Humanshould Medicinesalso Regulationsbe 2012 (HMRs).listed 

• Ininclude exceptionala circumstances,statement providedto anconfirm applicantwhether canthe demonstrateproposed andproduct provideinformation writtenis assuranceidentical to that allapproved in the legalNI obligationsMA canor bewhether metit athas submission,been duringamended thefor assessmentUK process(in and throughout the lifecase of theapplications MA,that itare mayrequired be possible to acceptcite an application from a thirdreference partymedicinal applicant.

  Theseproduct measures(RMP) arethe intendedproposed toproduct provideinformation reassuranceshould toalign thewith Licensing Authority that the MAHscited ofRMP) 

• include licencesa authoriseddeclaration viathat the relianceproduct route are able to keep legislative and safety information up-to-datein toMicrosoft ensureWord thatformat ahas positivebeen benefit:riskincluded balancewith is maintained throughout the validity of the MA.submission 

  Orphan designation

• Ifif an orphan designation is sought, theconfirm Greatthat Britainthe OrphanUK Drugorphan Designationdrug Applicationdesignation Formapplication shouldform behas been submitted in module 1.2 of the the eCTD. 

• indicate Emailwhether RIS.NA@mhra.gov.ukpaediatric ifrequirements youwill havebe anytriggered, questionsand aboutif submittingso, yourthat application.

  Findthe outpaediatric moreinformation aboutis orphanincluded designation

  Paediatricin requirements

  Forthe submissionsdossier which- willthe triggerapplicant paediatricshould requirements,indicate applicantsif shouldthis ensureapplication thehas latestbeen Europeansubject Unionto and/ora  GreatUK Britain--PIP/waiver compliance opinion/decisioncheck orand classconfirm waiverwhether decisionany PIP studies iswere includeddue into theinitiate dossier.or complete since compliance verification 

• Ifif the applicationprocedure hasincludes beenan ASMF, subjectinclude to a Europeandeclaration Unionthat orthe ASMF holder Greathas Britainsubmitted compliancethe checkapplicant’s theand outcomerestricted documentsparts shouldof bethe ASMF, includedincluding inapproved thevariations dossier.

  Theand applicantall shoulditerations alsoof indicatethe anyassessment parallel,reports ongoingon orthe previousapplicant’s applicationsand containingrestricted paediatricparts

• include dataa relevantdeclaration forthat the fullproposed PIPrisk compliancemanagement verificationplan (ifis applicable).identical Anto the overviewrisk tablemanagement ofplan approved thefor PIPNI 

• state results,any indicatingconditions inassociated whichwith application(s)the theymarketing were/areauthorisation 

We goinganticipate tothat bethe submitted,marketing statusauthorisation ofholder the(MAH) application(s),for asan wellapplication assubmitted theirvia locationthe inUAP is the presentsame applicationcompany mustor bebelongs included.

Coverto letter

Thethe coversame letter(legal) accompanyinggroup theof applicationcompanies should:

• clearlyas statethe MAH in the regulatoryNI routeMA asprocedure. UAPThis is to ensure appropriatethat handling,the includingMAH can fulfil the relevantsubmission procedurerequirements numberas forwell theas Northernall Irelandof MA
• includetheir alegal declarationobligations ofas conformityholder of themarketing Greatauthorisation Britain(MA), applicationsuch withas the dossierobligations approvedstated forin marketingRegulations in74 Northernand Ireland,75 includingof approvedthe variations IncludeHuman aMedicines declarationRegulations that2012 all(HMRs). 

  In iterationsexceptional ofcircumstances, theprovided CHMP/RMS/Northernan Irelandapplicant assessmentcan reportsdemonstrate and Endprovide ofwritten Procedureassurance documentsthat haveall beenthe submitted.legal Theseobligations assessmentcan reportsbe shouldmet alsoat besubmission, listed

• includeduring athe declarationassessment thatprocess theand proposedthroughout productthe informationlife isof identicalthe toMA, thatit approvedmay inbe thepossible Northernto Irelandaccept MA,an andapplication thatfrom thea productthird informationparty inapplicant Microsoftwho Wordis formatestablished hasin beenNI. 

  These includedmeasures withare theintended submission

• ifto anprovide orphanreassurance designationto isthe sought,licensing confirmauthority that the GreatMAHs Britainof OrphanMAs Drugauthorised Designationvia Applicationthis route Formcan haskeep beenlegislative submittedand insafety moduleinformation 1.2up ofto thedate eCTD
• indicateto whetherensure paediatrica requirementspositive willbalance beof triggered,benefit and ifrisk so,throughout that the paediatricvalidity informationof is included in the dossier.MA. 

  4. TheOrphan applicantdesignation 

  If shouldyou indicateare ifseeking thisan applicationorphan hasdesignation beenis, subjectsubmit tothe aUK Europeanorphan Uniondrug ordesignation Greatapplication Britain-PIPform compliancein checkmodule and1.2 confirmof whetherthe eCTD. Email RIS.NA@mhra.gov.uk for any PIPquestions studiesabout weresubmitting duean toapplication. 

  Find initiateout ormore completeabout orphan sincedesignation. 

  5. compliancePaediatric verification

• ifrequirements 

  For thesubmissions procedurewhich includeswill antrigger ASMF,paediatric includerequirements, aapplicants declarationmust thatensure the ASMFlatest UK-PIP/waiver Holderdecision hasor submittedclass thewaiver Applicant’sdecision andis Restrictedincluded Partsin of the ASMF,dossier. 

  If includingthe approvedapplication variationshas andbeen allsubject iterationsto ofa theUK assessmentcompliance reportscheck, on the Applicant’soutcome anddocuments Restrictedmust  Parts

• includebe aincluded declarationin that the proposeddossier. 

  The Riskapplicant Managementshould Planalso (RMP)indicate isany identicalparallel, toongoing RMPor inprevious Northernapplications Ireland/Europeancontaining Union

• statepaediatric anydata conditionsrelevant associatedfor with the Marketingfull PIP compliance Authorisation

Ifverification it(if isapplicable). foundAn duringoverview thetable assessmentof phasethe PIP results, thatindicating thein dossierwhich isapplication(s) incompletethey orwere/are assessmentgoing reportsto havebe beensubmitted, omitted,status thisof willthe beapplication(s), raisedas well as atheir Pointlocation forin Clarification,the andpresent mayapplication causemust abe delayincluded. 

For tomore theinformation, 67-daysee timetable.guidance on paediatric requirements. 

Fees6. Fees 

Fees will be payable for each submission. YouThe canfees findcharged outare moreset aboutout the fees we charge in the guidance on MHRA fees fees.. 

UseFind the Fees Calculator to work out what the fee for your submission will be.

You can find out more about how to pay your fees in our guidance Makeon how to make a payment to to MHRA.. 

Assessment7. Assessment 

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

• Great Britain

  Referencereference Medicinalmedicinal Productsproducts   (a UK or EU reference medicinal product is acceptable) 

• product namename 

• labelling

  labelling 

• patient information legibilitylegibility 

• supply statusstatus 

• controlled drug scheduling where necessarynecessary 

• paediatric and orphan medicine requirements, where relevantrelevant 

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. 

The first round of assessment should be completed by Day 42. ItWe isanticipate anticipated that the vast majority of Great Britain MAs will be approved at this point.point. 

Any issues identified during assessment will be communicated and should be resolvable within the 67-day70-day timetable without clock-stop.clock-stop. 

8. Major Objectionsobjections 

If Majorwe Objectionsidentify aremajor identifiedobjections, or substantial amendments to the product information are necessary, the timetable will move to the standard Nationalnational Procedureprocedure timetable. We anticipate that this will be necessary only on rare occasions.occasions.