application form for drug registretion 进口药品注册申请表格

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1、StateFoodandDrugAdministrationDrugRegistrationApplication-forForeignApplicantsEntryNumber:AcceptanceNo:StatementWeguarantee:①ThisapplicationcomplieswithlawsandregulationssuchasDrugAdministrationLawofThePeople’sRepublicofChina,ImplementingRegulationoftheDrugAdmini

2、strationLawofThePeople’sRepublicofChina,andDrugRegistrationRegulation;②Thecontentofapplicationform,thesubmittedinformationandthesamplesaretrueandlegal,withoutinfringinganyother’srights.Anymethodsanddataisresultsofresearchandthedrugtestsconductedonthedrugs;②Theacc

3、ompaniedelectronicversionisinperfectaccordancewiththeprintedversion.Wewilltakeallthelegalconsequencesofanyfalsestatements.OtherStatementItemsinParticularThat:ApplicationItems1TheApplicationfor:2Applicationfor:3Registrationcategory:4Supplementalapplicationfor:Drug

4、sInformation5GenericName:6GenericNameSource:7English/Latinname:8ChinesePhoneticAlphabet:9ChemicalName:10OtherName:11TradeNames:12Productcategory:13Strength:14OtheracceptedorsubmittedpreparationandStrengthatthesametime:15Packaging:16DateofExpiration:36months17Pres

5、criptions(IncludingPrescriptionVolume):Accessories:18Materials/AccessoriesSourceSerialNumberMaterials/AccessoriesNameApprovalNo/RegistrationNo/AcceptedNoManufacturerImplementationStandards1234567819ChineseMedicinalMaterialsStandard:20DrugsStandard:Self-madestanda

6、rdSource:Otherstandard:21IndicationsorAttendingFunctions:RelevantConditions22Patents:PatentOwnershipStatement:Westatethat:theapplicationdoesnotcausepatentinfringement.23Whetherornotinvolvedinthemanagementofspecialdrugsoringredients:24VarietyProtectionofChineseMed

7、icine:25MonitoringTimeWithSameVarietyofNewDrugs:26TimesforApplications:TheApplicantandCommissionedResearchInstitutions27.Institutions1(ForeignPharmaceuticalCompanies):ChineseName:EnglishName:LegalRepresentative:Position:RegisteredAddress:CountryorRegion:HeadofAnA

8、pplicationforRegistration:Positions:Tel:Fax:E-mail: LegalRepresentative(Signatures):(DepartmentOfficialSeal) MonthDay,Year28.Institutions2(ImportedDrugsProduct