Notice on initial administrative approval for domestic specialuse cosmeticsWord文档格式.docx

Notice on initial administrative approval for domestic specialuse cosmeticsWord文档格式.docx

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II.Contentoflicensing:

Registrationofimportedhealthfoodproducts（incl.fromHongKong,MacaoandTaiwan）

III.Basisforimplementation:

"

People'

sRepublicofChinaFoodHygieneLaw,"

ProvisionsforHealthFoodRegistration（Interim）"

"

FocusesforAcceptanceandInspectionofHealthFoodExaminationandApproval"

IV.Fees:

Nocharge

V.Quantityrestrictions:

Noquantitylimitforthelicensing

VI.Listofapplicationdocuments:

Datanumber

（1）Importedhealthfoodregistrationapplicationform;

Datanumber

（2）Copiesofapplicant’sIDcard,businesslicenseorlegallyregisteredcertificatesofotherinstitutions;

Datanumber（3）Retrievalinformation（retrievedfromCFDAgovernmentwebsitedatabase）provingthatthegenericnamesofthehealthfoodsbeingapplieddon’toverlapwiththenamesofproductsalreadyregistered;

Datanumber（4）Letterofguaranteeensuringnon-infringementofpatentsalreadyobtainedbyothers

InformationNumber（five）Providetrademarkregistrationcertificates（unregisteredtrademarkscandowithout）;

Datanumber（6）Productdevelopmentreport（includingresearchanddevelopmentideas,featureselectionprocess,theexpectedfunctions,etc.）;

Datanumber（7）Productformulation（APIsandexcipients）andformulabasis;

Datanumber（8）Functionalcomponents/Characteristicingredients,contentsandfunctionalcomponents/testingmethodsofcharacteristicingredients;

Datanumber（9）Productionprocessdiagramanddetaileddescription,andtheassociatedresearchdata;

Datanumber（10）Productqualitystandardsandpreparationexplanations（includingqualitystandardsofAPIsandexcipients）;

Datanumber（11）Types,names,qualitystandardsandselectionbasisofpackagingmaterialsindirectcontactwiththeproduct;

Datanumber（12）Thetestingreportissuedbythetestinginstitutionsandrelatedinformation;

Datanumber（13）Samplesofproductlabelsandpackageinserts;

Datanumber（14）TechnicalrequirementsandConfirmationformofsuccessfuluploadoftechnicalrequirements;

Datanumber（15）Otherinformationthathelpsproductreview;

Datanumber（16）twosamplesofminimumunopenedsalespackage;

Datanumber（17）IfthefunctionsarenotwithinthescopeofCFDAannounceditems,relevantdocumentsshallbeprovidedasrequired;

Datanumber（18）CertifyingdocumentsissuedbyrelatedinstitutionsofthecountryorregionoforiginprovingGMPcomplianceofthemanufacturer

Datanumber（19）Forregistrationaffairsrunbyoverseasmanufacturer’sPermanentRepresentativeinChina,acopyofthe"

registrationcertificateofoverseasenterprise’spermanentChineserepresentativeoffices"

shallbeprovided;

forregistrationaffairsrunbydomesticagenciesentrustedbyoverseasmanufacturers,theapplicantshallprovidetheoriginalnotarizedcertificateofentrustmentandcopiesofbusinesslicenseoftheagenciesentrusted;

Datanumber（20）Documentsprovingthattheproducthasbeenmarketedmorethanayearintheproducingcountry（region）,whichshallbenotarizedbynotaryinstitutionsoftheproducingcountry（region）andconfirmedbytheChineseEmbassyinthecountry;

Datanumber（21）Product-associatedstandardsissuedbytheproductproducingcountry（region）orinternationalorganizations;

Datanumber（22）Realsamplesofthepackaging,labels,packageinsertsforproductsmarketedintheproducingcountry（region）,whichshallbeattachedtothecorrespondingentriesintheapplicationform;

Datanumber（23）Threeconsecutivebatchesofsamples,thenumberofwhichshalltripletheamountrequiredfortesting.

VII.Requirementsforapplicationdossier:

（I）Generalrequirementsforthedossier:

1.Thefirstpageofthedossiersisalistoftheapplicationdocuments,whichshallbearrangedinorderrequiredbythe"

attachedinformation"

in"

Healthfoodregistrationapplicationform"

.Eachdossiershallhaveacoverpageindicatingthenameoftheproductandtheapplicant,andthedossiertitleshallbemarkedattheupperrightcorner.Thedossiershallbedistinguishablewithclearmarkers,andthenameandserialnumberofthedossiershallbeindicated.Thefullsetofdossiershallbepunchedandboundintoabook.

2.TheapplicationdossiershallbeprintedinA4sizepaper（Chinesecharactersnotlessthanfont-sizejunior4inSongtypeface,Englishnotlessthanfont-size12）,thecontentsshallbecomplete,clear,withoutalteration.

3.Registrationapplicationfornewproductsshallprovide1originaland8copiesofapplicationdossier.Copiesshallbefullyidenticalwiththeoriginalandshallremainintactandclear.

4.Exceptforthe"

Importedhealthfoodregistrationapplicati