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1、ApplicationdossiersforadministrativelicensingofimportedcosmeticrequiredbySFDAPARTONE:ImportedcosmeticsclassificationTheimportedcosmeticsaredividedintotwomajorcategoriesbySFDA:importedcosmeticforparticularpurpose,andimportedcosmeticfornon-particularpurpose.Thedetail
2、eddescriptionabouttheclassificationissetforthinAppendix3.PARTTWO:AdministrativelicensingofimportedcosmeticforparticularpurposeAdministrativelicensingofimportedcosmeticforparticularpurposeforthefirsttime,theapplicationdossiersshouldbeprovidedasfollows,(1)Application
3、formofadministrativelicensingofimportedcosmeticforparticularpurpose,(2)ThereasonfornameoftheimportedproductsinChinese,(3)Productformula,(4)Brieflydescriptionandschematicsaboutthemanufacturingprocesses,(5)Requirementsinqualitycontroltoensurethesafetyoftheproduct,(6)
4、Originalpackagingoftheproduct(includingthedirectionandthelable).IncaseoftheproductwithaproprietarypackagingformarketinginChina,theintendedpackagingdesign(includingthedirectionandthelable)shouldbeprovidedsimultaneously.(7)Thecertificateofanalysisandrelevantdossiersi
5、ssuedbytheinspectionagencywhichmustberecognizedandacceptedbySFDA,orthecertificateofanalysisonSPF,PFAorPAvalueissuedbyabroadlaboratory,(8)Safetyevaluationdateonmaterialsthatmaybeexistinthefinishedproductswhichhavethesafetyrisk.(9)Applicationforproductsusedinnurturin
6、ghair,bodybuildingandbreast,theeffectiveconstituentandthereferenceliteraturescontainingthescientificproofsshouldbeprovide,(10)TheletterofauthorityfortheapplicantinChina(copy),whichhasbeenrecordedbySFDA,andthebusinesslicenceoftheapplicantinChina(copywithofficialseal
7、),(11)Theletterofcommitmentthattherawmaterialandthesourceoftherawmaterialinproductionshouldmeettherequirementsoftherestrictionsorprohibitionsinusinghighriskmaterialsfrombovinespongiformencephalopathy(BSE)diseaseareas,(12)Thecertificateofmanufacturingandmarketingfro
8、mthecountry(region)whichtheproductsaremanufacturedorthecountry(region)oforigin,(13)Additionaldossierswhichareconducivefortheadministrativelicensi
