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《application form for imported drug supplementary registretion 进口药品补充申请表格》由会员上传分享，免费在线阅读，更多相关内容在行业资料-天天文库。
1、StateFoodandDrugAdministrationDrugSupplementaryRegistrationApplication–forForeignApplicantsEntryNumber:AcceptanceNo:StatementWeguarantee:①ThisapplicationcomplieswithlawsandregulationssuchasDrugAdministrationLawofThePeople’sRepublicofChina,ImplementingRegulationoftheDrugAdministrationLawofThePeo
2、ple’sRepublicofChina,andDrugRegistrationRegulation;②Thecontentofapplicationform,thesubmittedinformationandthesamplesaretrueandlegal,withoutinfringinganyother’srights.Anymethodsanddataisresultsofresearchandthedrugtestsconductedonthedrugs;②Theaccompaniedelectronicversionisinperfectaccordancewitht
3、heprintedversion.Wewilltakeallthelegalconsequencesofanyfalsestatements.OtherStatementItemsinParticularThat:ApplicationItems1TheApplicationfor:Importregistration2Drugcategory:3whetherOTCornot:4Statusoftheinitialregistration:5Registrationcategory:〇SupplementalapplicationstobeapprovedbySFDA:□Appli
4、cationforDrugApprovalNumberofanewdrugbytheNewDrugCertificateholderofthedrug.□UseofthenameoftheTradeNameofdrugs.□AdditionalindicationsorfunctionsofTCMornaturaldrug,ortheindicationapprovedinChinaforchemicaldrugorbiologicalproducts.□Changeintheusageordosageofthedrugs,orthegroupofpatienttousethedru
5、g,butwithoutchangeinrouteofadministration.□Changeofstrengthofdrugs□Changeofthesupplementiveintheformulaofthedrugs,wherethereisamedialrequirementforit.□Achangeinthedrugmanufacturetechnologyandprocessaffectingdrugquality.□Amendmentofdrugregistrationstandards.□Substituteorremovalofthedrugmateriall
6、istedinformulaofNationalDrugStandardsastoxicorendangered.□Changeoftheimmediatepackingmaterialorcontaineroftheimportdrugs,domesticinjection,ophthalmologic,spray,powderAerosol,InhalerandSpray.Useofnewimmediatepackingmaterialorcontainer.□Applicationforcombinedpackingofdrug.□Thetransferofnewdrugtec
7、hnology.□AdditionoramendmentofitemsininsertsheetofTCMornaturaldrug,suchaspharmacologyandtoxicology,clinicaltrialandPharmacokinetic.□Achangeinitemswithintheimportdrugregistrationcertificate,suchasnameofthedrug,drugenterprisename,re
