进口化妆品申报资料及要求 英文版XXXX年新版.docx
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进口化妆品申报资料及要求 英文版XXXX年新版.docx
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进口化妆品申报资料及要求英文版XXXX年新版
ApplicationdossiersforadministrativelicensingofimportedcosmeticrequiredbySFDA
PARTONE:
Importedcosmeticsclassification
TheimportedcosmeticsaredividedintotwomajorcategoriesbySFDA:
importedcosmeticforparticularpurpose,andimportedcosmeticfornon-particularpurpose.ThedetaileddescriptionabouttheclassificationissetforthinAppendix3.
PARTTWO:
Administrativelicensingofimportedcosmeticforparticularpurpose
Administrativelicensingofimportedcosmeticforparticularpurposeforthefirsttime,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-particularpurpose
Administrativelicensingofimportedcosmeticfornon-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:
Theprocessflowdiagramofadministrativelicensingofimportedcosmetic
PARTFIVE:
Charge
ThereisnochargeinadministrativelicensingofimportedcosmeticbySFDA
Appendix1
Thedetaileddescriptionabouttheapplicationdossiersforadministrativelicensingofimportedcosmeticforparticularpurpose
1.Thedossiersshouldbeprovidedfollowingthelist,
2.Fillouttheapplicationformundertheinstructionoftheformnotices,
Applicationformforadministrativelicensingshouldbefilledoutbythemanufacturingenterprisesofimportedcosmetic,ortheauthorizerofthemanufacturingenterprises,ortheauthorizedagencyfortheadministrativelicensinginChina.Indicationsshouldbewritteninthesealplaceoftheletterofassurancefrommanufacturingenterprisesincaseofnoofficialseals.
LetterofcommitmentinapplicationformshouldbesignedbythelegalpersonoftheauthorizedagencyfortheadministrativelicensinginChina,ortheauthorizerofthelegalperson,withofficialsealontheletter.
Whensigninginthepowerofattorney,anotarizedcopyandChinesecopyshouldbeprovided,theconsistentoftheChinesecopywiththeoriginaloneshouldbenotarizedsimultaneously.AccordingtotherequirementsinArticle24of“TheRequirementsOfTheApplicationDossiersForAdministrativeLicensingOfCosmetic”(shortforTheRequirementsOfTheDossiers),theoriginalofthepowerofattorneyandthenotarizedcopyshouldbeprovidedwhiletheapplication,andawrittenexplanationoftheproduct’snameintheoriginalofthepowerofattorney.ThecontentofthesignatureinthepowerofattorneyshouldnotbecontainedbythecontentofthecertificateofauthorizationfromtheapplicantinChina.
3.Theproductformulashouldcontaintheconfirmationoftheformulaissuedbytheinspectionagencywithlicense,andthedateoftheconfirmationshouldbeconsistentwiththeapplicationdate.
4.Requirementsinqualitycontrolshouldcontaintherequirementsconductedbytheoriginalmanufacturer(foreignlanguageandtheChinesecopy),andaletterofcommitmentdeclaringtheproductsmeettherequirementsin"HygienicStandardforCosmetics".
5.Incaseofnoproductdirectionsordirectionsprintedonthecontainers(suchaslipstickandliprougesatcompactsize),therelevantexplanationshouldbemadeinthePackagingPart.
6.ThecertificateofanalysisandrelevantdossiersissuedbytheinspectionagencywhichmustberecognizedandacceptedbySFDA,orthecertificateofanalysisonSPF,PFAorPAvalueissuedbyabroadlaboratoryshouldmeettherequirementsasfollows,
1)Applicationformforinspection;
2)Notificationofacceptanceforinspection;
3)Directionoftheproduct;
4)Health&Safetytestingreport(microorganism,sanitarychemistryandtoxicology);
5)Thedossiersasfollowsshouldbeprovidedincaseofexisting:
①Humansafetytestingreport(skinpatchtest,humantrials);
②SPF、PFAorPAvaluereports;
③Additionalreports(suchasAsbestosinspectionreport).
(2)TheapplicationdossierscontainingSPF,PFAorPAvaluereportsissuedbyabroadlaboratory,theadditionaldossiersasfollowsshouldbeprovidedsimultaneously:
1)IncaseofthatthelaboratoryhasbeenrecognizedandacceptedbySFDA,theauthenticationcertificateshouldbeprovided;2)Incaseofnoauthenticationcertificate,GCPcertificateorGLPcertificateshouldbeprovided;3)Additionaldossierswhichareconduciveforqualifying.
Incaseofthatthereportsissuedbyabroadlaboratoryareprovidedforthefirsttime,theoriginalreport,orthecopywhichisnotarizedbythelocalembassyorrelevantassociationsfromthecountry(region)ofmanufacturer.Thecopyofthereportwouldbeallowedinthere-applicationafterhavingbeenrecognizedandacceptedbySFDA.
Theoriginalreportissuedbyabroadlaboratoryshouldbeprovided.Theoriginalreportofatleastoneproductshouldbeprovidedincaseofseriesproducts,thecopyonesofotherproductsareallowed,andtheproductnameintheoriginalreportshouldbepointed.
Thecertificateoftherelationshipbetweentheinspectingsampleandthereportissuedbytherelevantlaboratoryshouldbeprovided,whilethereportofabroadlaboratoryisprovidedintheapplicationdossiers.
Incaseofthattherelationshipbetweentheinspectingsampleandthereporthasbeenclearlystatedinthereport(suchastheproductnamehasbeennotedinthereport,andthenameofthesampleisconsistentwiththeproductname),thecertificateofaboveisneedless.
7.Thecertificateofmanufacturingandmarketingfromthecountry(region)whichtheproductsaremanufacturedorthecountry(region)oforiginshouldmeettherequirementsasfollows,
(1)Thecertificateshouldbeissuedbytheregulatoryauthoritiesorrelevantassociations.Thecopyofthecertificateisallowedincaseofwithouttheoriginallone.Thecopyofthecertificateshouldbenotarizedbylocalembassyortheregulatoryauthorities.
(2)Thecertificateshouldcontainthenameofproduct,nameofmanufacturer,nameoftheregulatoryauthoritywhichissuesthecertificate,andtheofficialsealorthesignatureoflegalperson(orauthorizer)shouldbeonthecertificate.
(3)Thenameofproductandmanufacturershouldbeconsistentwiththeapplicationdossiers.Incaseofcontractman
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