进口化妆品申报资料及要求英文版.docx

进口化妆品申报资料及要求英文版.docx

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进口化妆品申报资料及要求英文版

进口化妆品申报资料及要求英文版

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.Incaseofcontractmanufacturingorotherwaysandthatthenameofmanufacturerincertificateisn