药品说明书和标签管理(英文版)---24号令

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1、ProvisionsforDrugInsertSheetsandLabels(SFDADecreeNo.24)TheProvisionsforDrugInsertSheetsandLabels,adoptedattheexecutivemeetingoftheStateFoodandDrugAdministrationonMarch10,2006,isherebypromulgatedandshallgointoeffectasofJune1,2006.ShaoMingliCommissionerofSFDAMarch15,2006Prov

2、isionsforDrugInsertSheetsandLabelsChapterIGeneralProvisionsArticle1TheProvisionsareenactedwithaviewtoregulatingdruginsertsheetsandlabelsinaccordancewiththeDrugAdministrationLawofthePeople'sRepublicofChinaandtheRegulationsforImplementationoftheDrugAdministrationLawofthePeop

3、ledRepublicofChina.Article2TheinsertsheetsandlabelsofdrugsmarketedwithintheterritoryofthePeopledRepublicofChinashallmeettherequirementsoftheProvisions.Article3DruginsertsheetsandlabelsshallbereviewedandapprovedbytheStateFoodandDrugAdministration・Adrugshallbelabeledonthebas

4、isofitsinsertsheet.Thecontentofthelabelshallbewithinthescopeoftheinsertsheet.Anywordsandmarkswithimpliedtherapeuticeffects,misleadinginformationonusage,orinappropriatepromotionoftheproductshallnotbeprinted・Article4Adruglabelshallbeprintedonoraffixedtothedrugpackage,andnoot

5、herwrittenwords,audioand/orvisualmaterialsorotherinformationareattachedtointroduceorpublicizetheproductortheenterprise.Aninsertsheetshallbeattachedtothesmallestpackageprovidedbythedrugmanufacturerformarketing.Article5Thewordingindruginsertsheetsandlabelsshallbescientific,s

6、tandardizedandaccurate.Theinsertsheetofanon-prcscriptiondrugshallbewrittenintelligiblyandconvenientforpatientstojudge,chooseandusethedrugontheirown.Article6Inthelabelorinsertsheet,thelettersorcharactersshallbeclearandeasytoberecognizedandthemarksshallbeclearanddistinctive.

7、Thelabelandinsertsheetshallhavenoprintfadedandshallnotbeaffixedunsteadily.Anyadditionormodificationshallnotbemadebymeansofpasting,cuttingoraltering・Article7DruginsertsheetsandlabelsshallbewritteninstandardizedChinesecharacterspublishedbytheNationalLanguageCommission.Thever

8、sionsinotherlanguagesshallcomplywiththeChineseversion・Article8Withtheaimtoprotectpubliche