进口化妆品申报资料及要求英文版(新版).doc

ApplicationdossiersforadministrativelicensingofimportedcosmeticrequiredbySFDAPARTONE:ImportedcosmeticsclassificationTheimportedcosmeticsaredividedintotwomajorcategoriesbySFDA:importedcosmeticforparticularpurpose,andimportedcosmeticfornon-:AdministrativelicensingofimportedcosmeticforparticularpurposeAdministrativelicensingofimportedcosmeticforparticularpurposeforthefirsttime,theapplicationdossiersshouldbeprovidedasfollows,(1)Applicationformofadministrativelicensingofimportedcosmeticforparticularpurpose,(2)ThereasonfornameoftheimportedproductsinChinese,(3)Productformula,(4)Brieflydescriptionandschematicsaboutthemanufacturingprocesses,(5)Requirementsinqualitycontroltoensurethesafetyoftheproduct,(6)Originalpackagingoftheproduct(includingthedirectionandthelable).IncaseoftheproductwithaproprietarypackagingformarketinginChina,theintendedpackagingdesign(includingthedirectionandthelable)shouldbeprovidedsimultaneously.(7)eptedbySFDA,orthecertificateofanalysisonSPF,PFAorPAvalueissuedbyabroadlaboratory,(8)Safetyevaluationdateonmaterialsthatmaybeexistinthefinishedproductswhichhavethesafetyrisk.(9)Applicationforproductsusedinnurturinghair,bodybuildingandbreast,theeffectiveconstituentandthereferenceliteraturescontainingthescientificproofsshouldbeprovide,(10)TheletterofauthorityfortheapplicantinChina(copy),whichhasbeenrecordedbySFDA,andthebusinesslicenceoftheapplicantinChina(copywithofficialseal),(11)mitmentthattherawmaterialandthesourceoftherawmaterialinproductionshouldmeettherequirementsoftherestrictionsorprohibitionsinusinghighriskmaterialsfrombovinespongiformencephalopathy(BSE)diseaseareas,(12)Thecertificateofmanufacturingandmarketingfromthecountry(region)whichtheproductsaremanufacturedorthecountry(region)oforigin,(13)