缅甸药品注册原文

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UNIONOFMYANMAR

MinistryofHealth

DepartmentofHealth

FoodandDrugAdministration

35,MinKyaungStreet,DagonTownship,Yangon,Myanmar.

(Phone.95-1-245332)

InitialapplicationforRegistration

AnapplicationforregistrationofdrugmustbesubmittedtotheDepartmentofHealth,FoodandDrugAdministrationintheoriginalprescribedform(Form1Registration).Form(1)isavailableatonehundredkyatseachatofficeoftheFoodandDrugAdministration.

Separateregistrationhastobeappliedforpharmaceuticalpreparationsofdifferentstrengthordifferentdosageform.Forparenteralpreparationstheserequirementisapplicablealsotodifferentpacksize.

Form1mustbefilledoutintypeprint.Enclosuressubmittedtogetherwithapplicationformshallbemarkedwithproperreference.Aformwhichisfilledincompletelyorimproperlywillnotbeaccepted.

Form(1)mustalsobeaccompaniedwithtwosetsofdocumentsoncompleteinformationofdrugs.(SeeAnnex-Ifortypeofdocumentationrequired).Documentshavetobesubmittedinfileinanorderaslistedin"DocumentsRequiredforRegistrationofDrugs."Alistofdocumentssubmittedshouldbeshownonthefirstsheetofthefile.

Anapplicationwithincompletedocumentationwillnotbeaccepted.

(a)Anapplicationmustbesubmittedinpersonbyanauthorizedrepresentative

ofownerofdrug.(Productlicenceholderatcountryoforigin)Anyapplicationmadebymailorfacsimileormeansotherthaninperson,willnotbeaccepted.AnauthorizedrepresentativehastobearesidentinMyanmar.

(b)Shouldanauthorizationforrepresentationbegrantedtothelocalcompany,therepresentativehastobeacompanyemployeeauthorizedtoserveasacontactperson.

RegistrationassessmentfeesmusthavebeenremittedtoMyanmarForeignTradeBank(MFTB)infavourofDrugAdvisoryCommitteeAccountN.(91892)whensubmissionoftheapplicationformismade.

(a)IfitisanapplicationforregistrationofdrugsmanufacturedoutsideMyanmar.

TheFoodandDrugAdministrationwillissue"ApprovalforimportationofofDrugSamples"(AnnexII)afterreceivingapplication.Thedrugsamplesasspecifiedintheapprovalshallthenbeimportedintothecountry.TeholderoftheapprovalshallcomplynotonlywiththeconditionsstipulatedintheapprovalbutalsowiththeregulationsofCommerceandCustomsDepartment.

(b)AsperMinistryofHealthNotification3/93dated5-8-93paragraph5,priorapprovalshallbeobtainedfromFoodandDrugAdministrationforimportationofsampledrug.FortheimportationofsampledrugwithoutpriorapprovaloftheFDA,theFDAwillnotissueapprovalcertificate.

(a)Thefollowingkindofdrugsamplesarenormallyrequired.

Drugsamplesthequantityofwhichissufficientforclinicaltrialonsixtypatients.Forcertainrarediseasesfewernumbersofsamplesmaybeacceptable.

Samplesforlaboratoryanalysis

Samplesforretention.

(b)Forthetotalnumbersofsampledrugstobesubmitted,pleaserefertoFDAcircular1/97(a)"Requiredquantitiesofsampledrugsforregistration"(AnnexIII)

(c)Alldrugsamplesmustbeaccompaniedwiththeirrespectiveanalyticalreport(thecertificateofanalysis).Thenameanddesignationofanofficialwhosignsthereportmustbestated.Thephotocopyofreportisnotacceptable.

Theevaluationprocessforregistrationwillbestartedonlywhenalltherequirementsforregistrationapplicationhavebeenmet;viz:(a)remittanceofRegistrationAssessmentFees,(b)completesetofdocuments,(c)sufficientquantityofdrugsamples.

(a)Whenthedrugisapprovedforregistration,theapplicantwillbenotifiedtoremit200.00UnitedStatesdollarasRegistrationFees.ThenotificationwillbemadeonlyonthenoticeboardofFDA.

(b)FailuretoremitRegistrationFeeswithin90daysfromthedateofintimationwillconstituteforgoingofanapplicationbyanapplicant.Ifsohappens,neithertheRegistrationAssessmentFeesremittednorregistrationdocumentsanddrugsampleswillbereturned.

Failuretomakeafollow-upofanapplicationbyanapplicantformorethansixmonthsfromthedateofremittanceofassessmentfees,willbetakenasforgoingofanapplication.

TheRegistrationCertificate(FormII)willbeissuedonlywhentheacknowledgementofreceipt,ofpaymentsissubmitted,issuedbyMFTBsubmitted.

Thesubmitteddossiersarenotreclaimableincaseofrejectionofapplication.

UpdatingChangestoRegisteredDrugs

UpdatingchangestoregistereddrugsshallbemadeonlywiththeapprovalofFoodandDrugAdministration.

Forthispurpose,theholderofRegistrationCertificateshallapplyforVariationofRegistration;toFDA,stating(a)reasonforchange.

(b)relevantdataorfindingsfromstudiesonwhichisbasedthejustificationofchange.

(c)significanteffectofchangestothespecificationsofdrug.

Thefollowingshallbesubmittedtogetherwiththeapplication:

Theattestationbycountry'sdrugregulatoryauthoritytoapprovalofsuchchanges.Iftheregulatoryauthority'sattestationcannotbeprovided,explainthereasonforit.

AphotocopyofRegistrationCertificateofdrug.

(a)Whenitisdecidedtoapproveofchanges,US$100fees

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willbeleviedonanapplicant.TheDrugAdvisoryCommitteemaywaivethisrequirementifitbelievesthatchangeisofbenefittopublicasregtardsquality,safetyandefficacyofdrugs.

(b)AnoriginalRegistrationCertificatemustthenbesubmittedtomakeapprovedamendmentsonthecertificate.

RenewalofRegistration

Applicationforrenewalofregistrationshallbesubmitted90daysbeforethevalidityoftheregistrationterminates.Failuretoadheretothe90daysrequirementmayresultindisruptionofcontinuedvalidityofregistration.

Applicationshallbesubmittedinthesameannerasprescribedforapplicationforregistrationofdrug.

Thedrugsamplesforclinicaltrialarenormallynotrequired.Howeverifthesituationwarrantstherepeat-clinicaltrial,thesampleswillbeasked.Thesamplesforlaboratoryanalysisandforretentionarestillrequired.PleaserefertoFDAcircular1/97b"Requiredquantitiesofsampledrugforanalysisandretention."(AnnexIV)

Thedocumentaryrequirementisthesameasthatofaninitialapplication(SeeTypeofdocumentsrequiredforregistrationAnnexI).Informationprovided,however,hastobeupdated.Newfindingswhichhadnotbeensubmittedinaninitialapplicationhavetobesubmittedtoo.

RegistrationAssessmentfeesmusthavebeenremittedtotheDrugAdvisoryCommitteeAccountNo.91892atthetimeofapplicationofrenewalofregistration.Whentherenewalofregistrationisapprovedof,twohundredUnitedStatesdollarmustberemittedasRegistrationFees.

Uponapprovalofrenewing,newRegistrationNumberwillbedesignated,whichshallmaketheoldRegistrationNumbervoid.

Failuretoapplyforrenewalofregistrationshallresultininvalidationofregistrationwitheffectfromthedateofexpiryofthecertificate.

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