Application form for DrugReRegistretion 进口药品再注册申请表格.docx

Application form for DrugReRegistretion 进口药品再注册申请表格.docx

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ApplicationformforDrugReRegistretion进口药品再注册申请表格

ApplicationformforDrugRe-Registretion进口药品再注册申请表格

StateFoodandDrugAdministration

DrugRe-RegistrationApplication-forForeignApplicants

EntryNumber:

AcceptanceNo:

Statement

Weguarantee:

1ThisapplicationcomplieswithlawsandregulationssuchasDrugAdministrationLawofThePeople’sRepublicofChina,ImplementingRegulationoftheDrugAdministrationLawofThePeople’sRepublicofChina,andDrugRegistrationRegulation;

②Thecontentofapplicationform,thesubmittedinformationandthesamplesaretrueandlegal,withoutinfringinganyother’srights.Anymethodsanddataisresultsofresearchandthedrugtestsconductedonthedrugs;

2Theaccompaniedelectronicversionisinperfectaccordancewiththeprintedversion.

Wewilltakeallthelegalconsequencesofanyfalsestatements.

OtherStatementItemsinParticularThat:

ApplicationItems

1TheApplicationfor:

Importapplication

2Registrationcategory:

〇Chinesetraditionalmedicine〇natureproduct〇chemicaldrug

〇therapeuticBiologicalproduct〇Biologicalproductforprevention〇pharmaceuticsadjuvant〇invitrodiagnosticsadministratedwithdrugs

DrugsInformation

3GenericName:

4English/Latinname:

5ChinesePhoneticAlphabet:

6ChemicalName:

7TradeNames:

8Productcategory:

non-product:

drugsubstance:

〇Chinesetraditionaldrugmaterials〇newmedicinalpartsfromChinesetraditionaldrugmaterials〇API〇activepharmaceuticalparts〇intermediateofthedrugproduct〇accessories〇others

Product:

dosageformfromchinapharmacopeia

dosageformexcludedinchinapharmacopeia

Specialdosageform

9Strength:

10OtheracceptedorsubmittedpreparationandStrengthatthesametime:

11Packaging:

immediatepackingmaterial:

Packagingsize:

12DateofExpiration:

36months

13Prescriptions（IncludingPrescriptionVolume）:

API/materialinTCM（Tradizionalechinesemedicine）:

Accessories:

14IndicationsorAttendingFunctions:

indicationcategory:

15Whetherapplysupplementaryitemsconcurrently:

16Initialapprovedregistrationcontentsandrelevantinformation:

InitialIDLNo:

Approveddate:

ExpirydateofIDL:

DrugspecificationNo.:

17Approvedinformationofprevioussupplementaryapplication:

No.

AcceptanceNo.

ApprovalNo.

Approvedevents

18TimesforApplications:

〇Firsttimeapplication〇multi-timesapplicationthetimesapplication

□Withdrewbefore,date__________________reason:

______

□notapproved,date__________________reason:

______

TheApplicantandCommissionedResearchInstitutions

19.Institutions1（ForeignPharmaceuticalCompanies）:

ChineseName:

EnglishName:

LegalRepresentative:

Position:

RegisteredAddress:

CountryorRegion:

HeadofAnApplicationforRegistration:

Positions:

Tel:

Fax:

E-mail:

LegalRepresentative（Signatures）:

（DepartmentOfficialSeal）

MonthDay,Year

20.Institutions2（ImportedDrugsProductionPlant）:

ChineseName:

EnglishName:

LegalRepresentative:

Position:

RegisteredAddress:

CountryorRegion:

HeadofAnApplicationforRegistration:

Positions:

Tel:

Fax:

E-mail:

LegalRepresentative（Signatures）:

（DepartmentOfficialSeal）

MonthDay,Year

21Institutions3（ImportedDrugsForeignPackagingFactory）:

ChineseName:

EnglishName:

LegalRepresentative:

Position:

RegisteredAddress:

CountryorRegion:

HeadofAnApplicationforRegistration:

Positions:

Tel:

Fax:

E-mail:

LegalRepresentative（Signatures）:

（DepartmentOfficialSeal）

MonthDay,Year

22Institutions4（RegistrationAgencyofImportedDrugs）:

Thisagencyisresponsibleforpayment

ChineseName:

EnglishName:

OrganizationCode:

LegalRepresentative:

Position:

RegisteredAddress:

ZipCode:

ContactAddress:

ZipCode:

HeadofanApplicationforRegistration:

Position:

Contact:

Position:

Phone:

Fax:

E-mail:

phone:

LegalRepresentative（Signatures）:

（DepartmentOfficialSeal）

MonthDay,Year

23Itemslistforthisapplication:

Authorities

Afterreviewed,thetableisinlinewiththeformwiththerequest.

Authorities:

Reviewer（Signatures）Date: