【中英文对照版】化妆品抽样检验管理办法（2023）.docx

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1、国家药监局关于发布化妆品 抽样检验管理办法的公告（国家药品监督管理局公告 2023年第5号）为加强化妆品监督管理，规范 化妆品抽样检验工作，根据 化妆品监督管理条例化 妆品生产经营监督管理办法 等法规、规章，国家药监局组 织制定了化妆品抽样检验管 理办法，现予公布，自2023 年3月1日起施行。国家药监局关于发布化妆品抽样检验管理办法的公告AnnouncementoftheNationalMedicalProductsAdministrationonIssuingtheMeasuresfortheAdministrationofSamplingInspectionofCosmetics【制定机

2、关】国家药品监督管理局【发文字号】国家药品监督管理局公告2023年第5号【公布日期】2023.01.11【施行日期】2023.03.01【效力位阶】部门规范性文件【法规类别】卫生综合规定Issuingauthority：OtherInslitulions,Others.AIIAdministrations(others),SlateDrugSupervision&AdministrationBureauDocumentNumber：AnnouncementNo.52023of(heNationalMedicalProductsAdministrationDateissued：01-11-202

3、3EfTectivedatet03-01-20231.evelofAuthority：DepartmentalRegulatoryDocumentsAreaofLaw：HealthandSanitationAnnouncementoftheNationalMedicalProductsAdministrationonIssuingtheMeasuresfortheAdministrationofSamplingInspectionofCosmetics(AnnouncementNo.52023oftheNationalMedicalProductsAdministration)Forthepu

4、rposesofstrengtheningthesupervisionandadministrationofcosmetics,andstandardizingsamplinginspectionofcosmetics,inaccordancewiththeRegulationontheSupervisionandAdministrationofCosmetics,theMeasuresfortheSupervisionandAdministrationofProductionandDistributionofCosmetics,andotherlawsandregulations,theNa

5、tionalMedicalProductsAdministrationhasorganizedthedevelopmentoftheMeasuresfortheAdministrationofSamplingInspectionofCosmetics,whichareherebyissuedandshallcomeintoforceonMarch1,2023.特此公告。Annex:MeasuresfortheAdministrationofSamplingInspectionofCosmeticsNationalMedicalProductsAdministrationJanuary11,20

6、23AnnexMeasuresfortheAdministrationSamplingInspectionofCosmeticsChapterIGeneralProvisions国家药监局2023年1月11日附件of化妆品抽样检验管理办法第一章总则Article1Forthepurposesofstrengtheningthesupervisionandadministrationofcosmetics,andstandardizingsamplinginspectionofcosmetics,inaccordancewiththeRegulationontheSupervisionandAd

7、ministrationofCosmetics,theMeasuresfortheSupervisionandAdministrationofProductionandDistributionofCosmetics,andotherlawsandregulations,theseMeasuresaredeveloped.Article2WithintheterritoryofthePeople,sRepublicofChina,thedepartmentresponsibleformedicalproductssupervisionandadministrationshallorganizet

8、heimplementationofsamplinginspectionofcosmeticsaccordingtotheseMeasures.附件：化妆品抽样检验管理办 法第一条为了加强化妆 品监督管理，规范化妆品抽样 检验工作，根据化妆品监督 管理条例化妆品生产经营 监督管理办法等法规、规章, 制定本办法。第二条在中华人民共 和国境内，负责药品监督管理 的部门组织实施化妆品抽样 检验工作，应当遵守本办法。第三条负责药品监督 管理的部门应当遵循科学、规 范、合法、公正的原则，组织 实施化妆品抽样检验工作，加 强对抽样、检验、异议审查和 复检、核查处置及信息公开的 全过程管理。Article3

9、Thedepartmentresponsibleformedicalproductssupervisionandadministrationshallfollowtheprinciplesofscience,standardization,legalityandjustice,organizetheimplementationofsamplinginspectionofcosmetics,andstrengthentheadministrationduringthewholeprocessofsampling,inspection,objectionreviewandre-inspection

10、,XzorifinQtinnandHicnncalanrlinfnrmatinndisclosure.Article4TheNationalMedicalProductsAdministration(uNMPAn)shallorganizeandcarryoutnationalsamplinginspectionofcosmeticseveryyear.Themedicalproductsadministrationsofprovinces,autonomousregionsandmunicipalitiesdirectlyundertheCentralGovernmentshallorgan

11、izesamplinginspectionofcosmeticswithintheirrespectiveadministrativeregionseveryyear,andundertakethetaskofnationalsamplinginspectionofcosmeticsinaccordancewiththerequirementsoftheNMPA.Thedepartmentresponsibleformedicalproductssupervisionandadministrationatthedistrictedcityorcountylevelshall,according

12、totheworkneeds,organizesamplinginspectionofcosmeticswithinitsownadministrativeregion,andundertakethetaskofsamplinginspectionofcosmeticsaccordingtotherequirementsofthedepartmentresponsibleformedicalproductssupervisionandadministrationatanexthigherlevel.Article5Cosmeticmanufacturersanddistributorsshal

13、lacceptsamplinginspectionofcosmeticsorganizedbythedepartmentsresponsibleformedicalproductssupervisionandadministrationinaccordancewiththelaw,andshallneitherinterferewith,hinderorrefusethesamplinginspectionwork,norprovidefalseinformation.第四条国家药品监督 管理局每年组织开展国家化 妆品抽样检验工作。省、自治区、直辖市药品监督 管理部门每年组织开展本行 政区域内

14、的化妆品抽样检验 工作，并按照国家药品监督管 理局的要求，承担国家化妆品 抽样检验任务。设区的市级、县级负责药品监 督管理的部门根据工作需要， 组织开展本行政区域内的化 妆品抽样检验工作，并按照上 级负责药品监督管理的部门 的要求，承担化妆品抽样检验 任务。第五条化妆品生产经 营者应当依法接受负责药品 监督管理的部门组织实施的 化妆品抽样检验，不得干扰、 阻碍或者拒绝抽样检验工作， 不得提供虚假信息。第六条化妆品抽样应 当支付抽取样品的费用。抽样 裕哈昕雪弗用垢昭国家有辛Article6Costsoftakingsamplesshallbepaidforcosmeticssampling.Ex

15、pensesrequiredforsamplinginspectionshallbeincludedinthegovernmentbudgetinaccordancewiththerelevantrulesofthestate.Article7TheNMPAshallberesponsibleforestablishinganinformationsystemfornationalsamplinginspectionofcosmeticsandstrengtheningtheinformationconstructionofsamplinginspectionofcosmetics.Chapt

16、erIlPlanningArticle8Thedepartmentsresponsibleformedicalproductssupervisionandadministrationthatorganizesamplinginspection(hereinafterreferredtoas“samplinginspectiondepartments)shallpreparesamplinginspectionplans.TheNMPAshalldevelopanannualplanfornationalsamplinginspectionofcosmeticseveryyear.Themedicalproductsadministrationsofprovinces,autonomousregionsandmunicipaliti