进口化妆品申报资料及要求 英文版(XXXX年新版)

ApplicationdossiersforadministrativelicensingofimportedcosmeticrequiredbySFDAPARTONE:ImportedcosmeticsclassificationTheimportedcosmeticsaredividedintotwomajorcategoriesbySFDA:importedcosmeticforparticularpurpose,andimportedcosmeticfornon-particularpurpose.ThedetaileddescriptionabouttheclassificationissetforthinAppendix3.PARTTWO:AdministrativelicensingofimportedcosmeticforparticularpurposeAdministrativelicensingofimportedcosmeticforparticularpurposeforthefirsttime,theapplicationdossiersshouldbeprovidedasfollows,(1)Applicationformofadministrativelicensingofimportedcosmeticforparticularpurpose,(2)ThereasonfornameoftheimportedproductsinChinese,(3)Productformula,(4)Brieflydescriptionandschematicsaboutthemanufacturingprocesses,(5)Requirementsinqualitycontroltoensurethesafetyoftheproduct,(6)Originalpackagingoftheproduct(includingthedirectionandthelable).IncaseoftheproductwithaproprietarypackagingformarketinginChina,theintendedpackagingdesign(includingthedirectionandthelable)shouldbeprovidedsimultaneously.(7)ThecertificateofanalysisandrelevantdossiersissuedbytheinspectionagencywhichmustberecognizedandacceptedbySFDA,orthecertificateofanalysisonSPF,PFAorPAvalueissuedbyabroadlaboratory,(8)Safetyevaluationdateonmaterialsthatmaybeexistinthefinishedproductswhichhavethesafetyrisk.(9)Applicationforproductsusedinnurturinghair,bodybuildingandbreast,theeffectiveconstituentandthereferenceliteraturescontainingthescientificproofsshouldbeprovide,(10)TheletterofauthorityfortheapplicantinChina(copy),whichhasbeenrecordedbySFDA,andthebusinesslicenceoftheapplicantinChina(copywithofficialseal),(11)Theletterofcommitmentthattherawmaterialandthesourceoftherawmaterialinproductionshouldmeettherequirementsoftherestrictionsorprohibitionsinusinghighriskmaterialsfrombovinespongiformencephalopathy(BSE)diseaseareas,(12)Thecertificateofmanufacturingandmarketingfromthecountry(region)whichtheproductsaremanufacturedorthecountry(region)oforigin,(13)Additionaldossierswhichareconducivefortheadministrativelicensing.1unopenedsampleproductfromthemarketwhichissealedbytheinspectionagencywithlicenseshouldbeprovidedsimultaneously.ThedetaileddescriptionabouttheapplicationdossiersaresetforthinAppendix1.PARTTHREE:Administrativelicensingofimportedcosmeticfornon-particularpurposeAdministrativelicensingofimportedcosmeticfornon-particularpurposeforthefirsttime,theapplicationdossiersshouldbeprovidedasfollows,(1)Applicationformofadministrativelicensingofimportedcosmeticfornon-particularpurpose,(2)ThereasonfornameoftheimportedproductsinChinese,(3)Productformula,(4)Requirementsinqualitycontroltoensurethesafetyoftheproduct,(5)Originalpackagingoftheproduct(includingthedirectionandthelable).IncaseoftheproductwithaproprietarypackagingformarketinginChina,theintendedpackagingdesign(includingthedirectionandthelable)shouldbeprovidedsimultaneously.(6)ThecertificateofanalysisandrelevantdossiersissuedbytheinspectionagencywhichmustberecognizedandacceptedbySFDA,(7)Safetyevaluationdateonmaterialsthatmaybeexistinthefinishedproductswhichhavethesafetyrisk,(8)TheletterofauthorityfortheapplicantinChina(copy),whichhasbeenrecordedbySFDA,andthebusinesslicenceoftheapplicantinChina(copywithofficialseal),(9)Theletterofcommitmentthattherawmaterialandthesourceoftherawmaterialinproductionshouldmeettherequirementsoftherestrictionsorprohibitionsinusinghighriskmaterialsfrombovinespongiformencephalopathy(BSE)diseaseareas,(10)Thecertificateofmanufacturingandmarketingfromthecountry(region)whichtheproductsaremanufacturedorthecountry(region)oforigin,(13)Additionaldossierswhichareconducivefortheadministrativelicensing.1unopenedsampleproductfromthemarketwhichissealedbytheinspectionagencywithlicenseshouldbeprovidedsimultaneously.ThedetaileddescriptionabouttheapplicationdossiersaresetforthinAppendix2.PARTFOUR:TheprocessflowdiagramofadministrativelicensingofimportedcosmeticThecopyoftheletterofauthorityandbusinesslicencearerecordedbySFDAApplicationCenterFilloutaformfromSFDAadministrativelicensingsystemonlinePARTFIVE:ChargeThereisnochargeinadministrativelicensingofimportedcosmeticbySFDAFormalexaminationbySFDAApplicationCenter,5wdReviewedbyCHFE,60wdApprovedbySFDA,20wd（Incaseofdisapprove,theapplicationdossiersareabletoberecoveredbypaperapplicationwithin6months）Appendix1Thedetaileddescriptionabouttheapplicationdossiersforadministrativelicensingofimportedcosmeticforparticularpurpose1.Thedossiersshouldbeprovidedfollowingthelist,2.Fillouttheapplicationformundertheinstructionoftheformnotices,Applicationformforadministrativelicensingshouldbefilledoutbythemanufacturingenterprisesofimportedcosmetic,ortheauthorizerofthemanufacturingenterprises,ortheauthorizedagencyfortheadministrativelicensinginChina.Indicationsshouldbewritteninthesealplaceoftheletterofassurancefrommanufacturingenterprisesincaseofnoofficialseals.LetterofcommitmentinapplicationformshouldbesignedbythelegalpersonoftheauthorizedagencyfortheadministrativelicensinginChina,ortheauthorizerofthelegalperson,withofficialsealontheletter.Whensigninginthepowerofattorney,