第1页共16页编号：时间：2021年x月x日书山有路勤为径，学海无涯苦作舟页码：第1页共16页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.第2页共16页第1页共16页编号：时间：2021年x月x日书山有路勤为径，学海无涯苦作舟页码：第2页共16页(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).Incaseoftheproductwithaproprietarypackagingformarketingin第3页共16页第2页共16页编号：时间：2021年x月x日书山有路勤为径，学海无涯苦作舟页码：第3页共16页China,theintendedpackagingdesign(includingthedirectionandthelable)shouldbeprovidedsimultaneously.(6)ThecertificateofanalysisandrelevantdossiersissuedbytheinspectionagencywhichmustberecognizedandacceptedbySFDA,(7)Safetyevaluationdateonmaterialsthatmaybeexistinthefinishedproductswhichhavethesafetyrisk,(8)Theletterofauthorityfortheapp...
