application form for drugre-registretion 进口药品再注册申请表格

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1、StateFoodandDrugAdministrationDrugRe-RegistrationApplication-forForeignApplicantsEntryNumber:AcceptanceNo:StatementWeguarantee:①ThisapplicationcomplieswithlawsandregulationssuchasDrugAdministrationLawofThePeople’sRepublicofChina,ImplementingRegulationoftheDrugAdministrationLawofThePeople’s

2、RepublicofChina,andDrugRegistrationRegulation;②Thecontentofapplicationform,thesubmittedinformationandthesamplesaretrueandlegal,withoutinfringinganyother’srights.Anymethodsanddataisresultsofresearchandthedrugtestsconductedonthedrugs;②Theaccompaniedelectronicversionisinperfectaccordancewitht

3、heprintedversion.Wewilltakeallthelegalconsequencesofanyfalsestatements.OtherStatementItemsinParticularThat:ApplicationItems1TheApplicationfor:Importapplication2Registrationcategory:〇Chinesetraditionalmedicine〇natureproduct〇chemicaldrug〇therapeuticBiologicalproduct〇Biologicalproductforpreve

4、ntion〇pharmaceuticsadjuvant〇invitrodiagnosticsadministratedwithdrugsDrugsInformation3GenericName:4English/Latinname:5ChinesePhoneticAlphabet:6ChemicalName:7TradeNames:8Productcategory:non-product:drugsubstance:〇Chinesetraditionaldrugmaterials〇newmedicinalpartsfromChinesetraditionaldrugmate

5、rials〇API〇activepharmaceuticalparts〇intermediateofthedrugproduct〇accessories〇othersProduct:dosageformfromchinapharmacopeiadosageformexcludedinchinapharmacopeiaSpecialdosageform9Strength:10OtheracceptedorsubmittedpreparationandStrengthatthesametime:11Packaging:immediatepackingmaterial:Packa

6、gingsize:12DateofExpiration:36months13Prescriptions(IncludingPrescriptionVolume):API/materialinTCM(Tradizionalechinesemedicine):Accessories:14IndicationsorAttendingFunctions:indicationcategory:15Whetherapplysupplementaryitemsconcurrently:16Initialapprovedregistrationcontentsandrelevantinfo

7、rmation:InitialIDLNo:Approveddate:ExpirydateofIDL:DrugspecificationNo.:17Approvedinformationofprevioussupplementaryapplication:No.AcceptanceNo.ApprovalNo.Approvedevents18TimesforApplications:〇Firsttimeapplication〇multi-timesapplicationthetimesapplication□Withd