con007545.docx

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con007545

MHRAGUIDANCENOTE11

CHANGINGTHELEGALCLASSIFICATION

INTHEUNITEDKINGDOM

OFAMEDICINEFORHUMANUSE

INTRODUCTION

1.Anewmedicine,whenfirstauthorised,isusuallyrestrictedtouseundermedicalsupervisionandmadeavailableonlyonaprescription;amedicinerestrictedinthiswayisclassifiedasaPrescriptionOnlyMedicine（POM）.If,followingexperiencegainedduringuse,itcanbedemonstratedthatthemedicineissafeforusewithpharmacistsupervision,reclassificationasaPharmacyMedicine（P）maybeundertakenbyremovingtheprescriptionrequirementstoallowsaleorsupplyfromapharmacy.Iffurtherexperiencedemonstratesthataccesstoprofessionaladviceisnotrequiredforsafeuseofthemedicine,suitablepresentationsmaythenbereclassifiedasGeneralSaleList（GSL）medicinestoallowsalefromawiderrangeofretailoutlets.

2.Proceduresforchangingthelegalclassificationofamedicinehavebeenrevisedwithaviewtosimplifyingandspeedingtheprocesswhereverpossibleandprovidinggreatertransparency.Thisbookletreplacesearlieradviceonlegalandadministrativerequirementsforreclassification.Itshouldbetreatedasgeneraladviceandnotasacompleteandauthoritativestatementofthelaw.TheEuropeanguidelineonchanginglegalclassificationforthesupplyofmedicinalproductsisalsorelevantandcanbeaccessedviatheCommission’swebsiteintheRulesGoverningMedicinalProductsintheEuropeanCommunity–VolumeIIIB-Guidelines.

3.RequestsforchangeoflegalclassificationofsubstancesandassociatedpolicymattersaredealtwithbythePost-LicensingDivisionofMedicinesandHealthcareproductsRegulatoryAgency.FurtherinformationonthenewreclassificationproceduremaybeobtainedfromMrsAmandaWilliamson02070842523（adviceonapplications）orMissAmandaLawrenceon02070842366（onprocess）.

BACKGROUND

4.ThesaleandsupplyofmedicinesiscontrolledbytheMedicinesAct1968and

Directive2001/83/EC.Allmedicinesareclassifiedaccordingtooneofthethreefollowingcategories:

∙PrescriptionOnlyMedicines（POM）–availableonlyonaprescription

∙Pharmacy（P）–availableunderthesupervisionofapharmacist

∙GeneralSaleList（GSL）–availableingeneralretailoutletssuchassupermarkets.

ThepresumptionunderlawisthatallmedicinesarePunlesstheymeetthecriteriaforPOMorGSLstatus.PacksizerestrictionsforGSLproductsarelistedintheMedicines（SaleorSupply）（MiscellaneousProvisions）Regulations1980.

5.Since1April2002changesinlegislationmeanthatforalllicensedmedicines,legalstatusisdeterminedbytheMarketingAuthorisation（MA）.

6.Thereclassificationproceduresareoutlinedbelow.Iftheguidancedoesnotappeartodescribeadequatelyanyparticularcircumstancerelevanttoanapplication,pleasecontactPost-LicensingDivisionatthecontactpointslistedonpage1.ApplicantswhoareconsideringmakingareclassificationapplicationareencouragedtodiscusstheirproposalsandprospectivetimetablewithMHRApriortosubmission.ContactnumbersfordiscussionofprofessionalaspectsarelistedintheMAILbulletin,seecontactpointslistedonpage1.

PROCEDURESFORRECLASSIFICATION

TypesofApplication

7.FollowingreceiptinMHRA,applicationsarevalidatedandsiftedonatriagebasis.Thereclassificationprocessdependsonthetypeofapplication.AmajorchangerequiringCommitteereferralwillbeallocatedtotheCOMPLEXprocedureandachangenotrequiringCommitteereferralwillbeallocatedtotheSTANDARDprocedure.A“me-too”applicationbasedonananalogousproduct,whichhasalreadycompletedthereclassificationprocedure,maybedealtwithsimplyasavariation.Forthesepurposes,ananalogousmedicinalproductisamedicinalproduct,whichhasaUnitedKingdommarketingauthorisationoraCommunitymarketingauthorisationandwhich—

（a）hasthesameactiveingredient,routeofadministrationanduse;

（b）hasthesamestrengthorahigherstrength;

（c）hasthesamedosageordailydosage,orahigherdosageordailydosage;and

（d）isforsaleorsupplyatthesamequantityoragreaterquantity,

asthemedicinalproductinrelationtowhichtheapplicationismade.

Fees

8.Inlinewiththesenewcategories,anewfeestructurehasbeenputinplace.AhigherfeeispayableonallComplexapplicationsrequiringcommitteereferral.ForaStandardapplicationthefullfeeisleviedbutwheretheMHRAaresatisfiedthattheclassificationdoesnotneedtobeconsideredbytherelevantcommittee,halfthefeewillberefunded.

Ifthereisananalogousproductwiththatclassification（seeabove）,aStandardTypeIIvariationfeewillbepayable.

Bulkfeesareapplicablewhenthesameapplicantmakesthesamechangestomorethanoneproductatthesametime,havingthesameactive（s）.

Consultationandadvice

9.Publicconsultationwithinterestedpartiesfora4or6weekperiod（6weeksforComplexapplications）willtakeplaceatdifferentpointsinthetwoprocedures.ConsultationwilltakeplaceimmediatelyintheStandardprocedureandwillbebasedontheapplicant's'ReclassificationSummary'（seebelow）.IntheComplexprocedure,publicconsultationwillonlytakeplaceaftertheadviceofthecommitteehasbeensoughtandtheyhaverecommendedthatreclassificationshouldtakeplace.Aflow-chartshowingthestepsinvolvedinreclassificationisprovidedinAppendix2.

10.Theadvisorycommitteeisinvitedtocommentonstraightforward（Standard）applicationsduringthepublicconsultationperiod.Complexapplicationsaresubmittedforadviceinthefirstinstanceandreleasedforconsultationfollowingpositiveadvice.Standardapplicationsonwhichissueshavebeenraisedinconsultationmayalsorequirecommitteeadvice.ThereisarightofappealtotheMedicinesCommission（MC）onapplicationsrefused.

StandardProcedure

11.Thisprocesswillgenerallytakeupto120calendardays,notincludingtheconsultation.Validapplicationswillbesubmittedimmediatelyforconsultation,viatheMHRAwebsite,tointerestedpartiesincludingmembersoftherelevantcommittees.Interestedpartieswillbenotifiedofnewconsultations.

12.ApplicationswillonlybesubmittedforformalreviewbytheadvisorycommitteeifissuesareraisedasaresultoftheconsultationprocessorofthereviewofthesupportingdatabytheMHRASecretariat.MembersoftherelevantcommitteemayalsorequestthatthefullapplicationbereferredtoanothercommitteeortoMC.Suchcommitteereferralwill,ofnecessity,lengthenthetimetofinaldetermination.Theapplicantmayalsobeapproachedforadditionalinformationinrelationtospecificconcernsandanysuchactionwouldagainincreasethetimerequiredtodeterminetheapplication.

13.Upondetermination,theapplicantwillbeinformedoftheoutcome.Favourabledecisionsonapplicationswillbeimplementeddependingonwhattypeofapplicationwassubmitted,byincludingthenewlegalclassificationinthegrantofthenewMA,therenewedMAorthevariationtotheexistingMA.ReclassifiedproductswillthenbelistedinthenextavailableMedicinesActInformationLetter（MAIL）andontheMHRAwebsite.

14.Inthecaseofapplicationsnotapproved,thereasonsforthedecisionwillbenotifiedtotheapplicantwhowillalsoreceivetheassessmentreport.ApplicantswillbegiventheopportunitytoappealbywrittenrepresentationtoMC.

ComplexApplications

15.Thisprocesswillgenerallytakeupto180calendardays,notincludingtheconsultation.ApplicationswillbeassessedbytheMHRASecretariat,andsubmittedtotherelevantcommitteeforconsideration.

16.Ifreclassificationisrecommended,consultationwilltakeplacewithinterestedpartiesviatheMHRAwebsiteonarollingcycleasandwhenapplicationsaremade.Providedthatnooutstandingissuesremainfollowingtheconsultationprocedure,actionasintheStandardprocedurewillbeinstigated.Notificationandopportunityforappealwillbegivenifreclassificationisnotrecommended.

Applicationsnotsupportedbydata

17.Followon“metoo”reclassifications（notsupportedbyfulldata）forproductswhereananalogousproducthasalreadybeenreclassifiedaredealtwithbythevariationprocedure.Thereisnopublicconsultationorreferraltotheadvisorycommitteefortheseapplications.

Timetables

18.Applicationsmaybemadeatanytimeduringtheyear.Therearecertainconstraintsontheprocessimposedbythetimingofmeetingsoftherelevantcommitteeandanyothercommitteeinvolved;MHRAwillstrivetomeetthetime-scalesindicatedbutthesecannotbeguaranteed.

Formofapplication

19.ApplicationscanbemadebybothMAholdersandbyotherinterestedparties.

ApplicationsfromMAholdersshouldbemadeaspartofanewMAapplication,arenewalapplicationoravariationapplicationmadeintheusualway.Itshouldbenotedthat,asclassificationisdeterminedonanationalbasis,thepositionofMAsdeterminedviatheMutualRecognition（MR）proceduremayrequirespecialconsiderationandapplicantsareadvisedtodiscusswithMHRAatanearlystage.

20IfanapplicantwishestoretainaPOMproductwithoutsomeoftherestrictionsproposedforthePproduct,anewMAapplicationratherthanavariationmustbemadeforthePproduct.TheapplicantwillthenhaveseparatelicencesforthePOMandPproducts.MAholdersareremindedthatwhereproductsofidenticalcompositionexistasbothPOMandPproducts,withdifferentindications,thetwoproductsmustbedistinguishablebynamesinceitwouldgiverisetosafetyconcernsforthetwoproductstoexistunderidenticalnames.TheseprinciplesalsoapplytoPtoGSLswitches.

21.Foranyo