Notice on initial administrative approval for domestic specialuse cosmetics.docx
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Noticeoninitialadministrativeapprovalfordomesticspecialusecosmetics
Noticeonregistrationofimportedhealthfoodproducts(incl.fromHongKong,MacaoandTaiwan)
2013-12-05
I.Projectname:
healthfoodapproval
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