Renewing Marketingmarketing Authorisationsauthorisations for medicines

1. Overview 

TheThis guidance provides information on how to renew marketing authorisations (MA) for products granted through different routes in the UK following the agreement of the Windsor Framework arrangements for human medicines. It also includes guidance for 5-year renewal of full authorisation and the annual renewal of a conditional marketing authorisation (CMA). 

The Medicines and Healthcare products Regulatory Agency (MHRA) acts acts as the regulator for products placed on the market in Northern Ireland.Ireland (NI). There are some different requirements for products placed on the market in the UK with respect to Great Britain (England, Scotland, Wales) and Northern Ireland.Ireland. 

Renewals

New arrangements for convertedhuman Centrallymedicines Authorisedcome Productsinto (CAPS)

CAPS convertedeffect from EU1 toJanuary UK MAs will2025, bereflecting treatedthe asagreement ifon theyhuman weremedicines grantedas onpart theof date the correspondingWindsor EU MA wasFramework. granted.From Thethat renewal date willall staymedicines licensed in the same.

PleaseUK referwill tobe Guidanceauthorised onby Convertingthe CentrallyMHRA Authorisedunder Productthe (CAPS)Human toMedicines UK MAs.Regulations 2012. 

Your MAs remainProducts inthat forcefall untilunder athe decisionEU’s hascentralised beenprocedure madethat onwere yourpreviously renewalautomatically applications.

Renewalsgranted submittedby for MAs grantedthe throughEU mutualin recognitionNI (MR)(as ora decentralisedcentrally (DC)authorised procedures

Allproduct holders(CAP)) ofwill existingno marketinglonger authorisationsbe (MAs),authorised orin applicantsthis for MAs withmanner. applicationsInstead, submittedthese byproducts 1will Januarybe 2021authorised andUK-wide under reviewnational withinUK arequirements decentralisedby orthe mutualMHRA. These recognitionproducts procedurewill withbe UKknown as acategory CMS1 willproducts haveunder aUK choicelaw. onProducts howwhich todo managenot theirfall marketingunder authorisations/applications.

Referthis tocategory thewill guidancebe onknown handlingas ofcategory decentralised2. 

2. andRenewal mutualof recognitiona procedures.

marketing authorisation 

TheAn defaultMA positionwill isbe tovalid maintainfor a5 UKyears widefrom marketingthe date of authorisation and retainmarket UKauthorisation inholders respect(MAH) ofshould Northerncontinue Irelandto (UK(NI)submit (UKrenewal inapplications respect9 ofmonths Northernbefore Ireland)expiry, asunless athe CMS.application Inis thisbeing case,submitted via the authorisationInternational willRecognition continueProcedure to be a UK wide MA(IRP with). For Northernadvice Irelandon asthis aprocedure CMSplease andsee Greatbelow, Britaintogether alignedwith with,further butguidance noton partInternational of,Recognition the DCP/MRP.Procedure. 

WhereOnce thisan appliesapplication anyhas pendingbeen applicationssubmitted willfor berenewal, processedthe toauthorisation conclusionwill afterremain 1in Januaryforce 2021until asthe MR/DCMAH renewalsis informed usingof the relevantdecision MR/DCon procedures led by the RMS.application.  

NewThe applicationsauthorisation formay a renewal of the MA should be submittedrenewed viafor the DCP/MRP andan ifunlimited approvedperiod wouldor, applywhere tothere theare UKpharmacovigilance widegrounds authorisationwhich withrequire Greatit, Britainfor implementinga theperiod Europeanof decision5 unlessyears, the MHRA notifiesafter thewhich MAHone withinfurther 30renewal daysapplication ofmay the RMS decision that the decision cannot be accepted in Great Britain.made. 

InThe thisrequirements case,for athe separate MA forcontent Greatrenewal Britainsubmissions would need to bethe issued.MHRA Otherfor optionsproducts includeauthorised havingin separate MAs forthe UK(NI)UK aswill CMS,remain andaligned Greatwith Britain.current RenewalEU applicationssubmission forrequirements, Greatdependent Britain MAs willon bethe processedroute viaof theauthorisation, purelyas nationaldetailed route.below. 

If

2.1 you’veRenewal submittedof renewals for MAs granted throughfor thecategory  DCP/MRP and1 doproducts 

Renewal notapplications getfor acategory decision before 1 Januaryproducts 2021,should yoube willsubmitted not need to resubmitthe them.

IfMHRA abut finalcontinue decisionto hasinclude beenthe madeelements oncurrently yourset renewalout but it hasn’t been processed in the UKEU beforeguidance 1for Januaryrenewals 2021,in the MHRA will implement the agreedEU outcome.centralised procedure.  

WhereThis aalso finalapplies decisionto has not been made, the MHRA will ensure that the renewal processapplications issubmitted concludedvia and processed by the appropriateIRP route.(see below). 

Renewals

2.2 submittedRenewal fromof 1MAs Januaryfor 2021

Youcategory should2 continueproducts  

2.2.1 toApplications submitsubmitted yourvia renewalthe applicationsmutual 9recognition monthsand beforedecentralised theyprocedure expire.

(MRDCP) 

TheRenewal requirementsapplications for renewalcategory submissions2 will remain the same for products authorisedwhich inare thewithin UK and should include the sameMRDCP documentswith currentlyNorthern requiredIreland inas thea EUconcerned asmember detailedstate in(CMS) theshould followingcontinue guidance,to dependentbe onsubmitted thein natureline ofwith the authorisation:

• CAPrequirements renewalsfor and annual reassessments
• Renewalsrenewals for products authorised through through MRP or  or DCP procedures procedures

. 

ForThe purely national UK-wide authorisations, the requirements set out in the the CMDh Bestbest Practicepractice Guideguide on processing renewals in the the MRP/DCP should should also be followedfollowed. As the MAH has the obligation to keep the dossier up to date throughout the lifecycle of the medicinal product no submission of the consolidated dossier is expected.

By default, the consolidated file may be reduced to a cover letter from the MAH accompanied by an application form (without annexes). The cover letter should include include:

• confirmation that no new data areis available that changes, or would result in a re-evaluation of, the benefit/risk balance and that the product information is up to date with current scientific knowledge (or otherwise a commitment to update the product information by the appropriate variation within 3-months3 months of the finalisation of the renewal), and renewal)

• a declaration that full documentation is available for submission on request.request

No Withinchanges to the MA particulars can be made in the standard renewal procedure,procedure. 

The nodefault changesposition to maintain a UK wide marketing authorisation aligned with the MAMR procedure and UK in respect of Northern Ireland (UK(NI)) particularsas cana CMS will be made.

Renewalsretained forunless Great-Britain-onlythere MAsare UK-specific requirements which fallare withinnot aligned with the scopeMR ofposition. theIn centralisedthis procedurecase shouldMAHs followwill thebe submissionrequired requirementsto setwithdraw outNI infrom CAPthe renewalsprocedure and annualthe reassessments.existing UK-wide MA will then be managed as a standalone national UK authorisation.  

2.2.2 Applications for standalone UK-wide authorisations 

FeesRenewal applyapplications for standalone national UK-wide authorisations for category 2 products should be submitted to the firstMHRA 5-yearbut renewalincluding the elements required as part of a MA whichrenewal wasapplications grantedin forthe aMRDCP.

The newsubmission activeof substance.a Whereconsolidated thisdossier appliesis itnot shouldexpected and may be clearlyreduced statedto ina cover letter from the coverMAH letter.accompanied Detailsby onan feesapplication areform included(without below.annexes).

Annual

The renewalcover ofletter Conditionalshould Marketing Authorisations

include:

• Youconfirmation shouldthat continueno new data is available that changes, or would result in a re-evaluation of, the benefit/risk balance and that the product information is up to submitdate yourwith renewalcurrent applicationsscientific forknowledge conditional MAs 6(or monthsotherwise beforea theycommitment expire.to update the product information by the appropriate variation within 3-months of the finalisation of the renewal)

• Seea guidancedeclaration onthat converting CAPS tofull UK MAsdocumentation is available for advicesubmission on convertedrequest

No EU MAschanges to the MA which particulars werecan grantedbe asmade conditional MAs.in the standard renewal procedure. Any changes must be made via a variation procedure. 

ForFees Greatapply Britain MAs yourfor applicationthe shouldfirst be5-year submittedrenewal toof the MHRAa MA, which whowas willgranted considerfor thea applicationnew active substance. Where this applies it should be clearly stated in accordancethe withcover newletter.  

3. regulationAnnual 66Brenewal of a conditional marketing authorisation 

With the Humanexception Medicinesof Regulationsapplications 2012.submitted via IRP, MAHs should continue to submit renewal applications for conditional MAs 6 months before they expire. 

There is no application form for a renewal of a conditional conditional MA and and the application form for a 5-year renewal of an an MA is is not applicable.

Applications Your application should include a cover letter accompanied by the same documents as currently required by the EU.EU renewal annual re-assessment marketing authorisation.

The application must include an interim report on the fulfilment of the obligations to which the conditional marketing authorisation is subject.subject. 

There are no fees for the renewal of a conditional renewals.MA. 

Recognition

4. International recognition route

for renewals 

WhereIn anorder identicalto renewaluse applicationIRP (forfor eitherrenewals a MA or(including athe conditional MAannual renewal of conditional MAs)), hasapplications beencan submittedbe fordelayed until the correspondingreference centralisedregulator productassessment is completed, and the renewaldecision applicationavailable canto be submittedincluded forwith the Great Britain-MA.submission. 

WhereThe thisMA routewill isremain usedvalid, itand mustthe application should be clearlysubmitted indicatedas insoon as possible to the cover-letterMHRA and evidenceno oflater acceptancethan provided60 (thedays CHMPfollowing opinion)the togetherfinal withassessment abeing copyavailable offrom the finalreference assessmentregulator.

However, reportin andthe anyevent updatesthat e.g.the track-changereference ofregulator anyfor updatedthe productMA informationmakes shoulda berecommendation submitted.

Forat renewalsany relyingpoint onduring atheir EUassessment decision,(whether aprovisional copyor offinal) that the Commissionbalance Decisionof mustbenefits alsoand berisks submittedis .no beforelonger thefavourable, renewalthere canmust be concluded.

Whereno theredelay havein beennotifying changesthe toMHRA theof Patientthis Informationinformation.

As Leafletwith (PIL)other aslifecycle partchanges ofit theis renewal,expected athat fullthe colouroriginal mock-upRR ofis theused leafletfor mustrenewal beapplications submittedand where thethis product is marketed.changed justification should be provided. 

Where the application is for a first 5-year renewal of a a MA which which was granted for a new active substance, a reduced fee of £747 applies for the recognition route.route.  

5. Renewals for for MAs granted granted via unfettered accessaccess 

Where youa haveMAH ahas Greatan Britain-only MA granted granted via the Unfetteredunfettered Accessaccess route, an application to renew the the MA should should be submitted in line with the above guidance.guidance for category 2 products.

Where the the MA has has remained in line with the EU or Northern Ireland Ireland MA we, the MHRA will accept the same renewal application as submitted to the EU and a reduced fee will be applied.applied. 

Changes

6. toFurther fees

information 

TheFor newfurther feesinformation, willcontact be:variationqueries@mhra.gov.uk. 

• £9,682