【中英文对照版】药品经营和使用质量监督管理办法.docx

药品经营和使用质量监督管理办法MeasuresfortheQualitySupervisionandAdministrationoftheDistributionandUseofMedicinalProducts制定机关：国家市场监督管理总局发文字号：国家市场监督管理总局令第84号公布日期：2023.09.27施行日期：2024.01.01效力位阶：部门规章法规类别：药品管理IssuingAuthority：StateAdministrationforMarketRegulationDocumentNumber：OrderNo.84oftheStateAdministrationforMarketRegulationDateIssued：09-27-2023EffectiveDate：01-01-20241.evelofAuthority：DepartmentalRulesAreaofLaw：PharmaceuticalAdministration药品经营和使用质量监督管 理办法MeasuresfortheQualitySupervisionand（2023年9月27日国家市 场监督管理总局令第84号 公布自2024年1月1日起 施行）第一章总则第一条为了加强药品 经营和药品使用质量监督管 理，规范药品经营和药品使 用质量管理活动，根据中AdministrationoftheDistributionandUseofMedicinalProducts(IssuedbyOrderNo.84oftheStateAdministrationforMarketRegulationonSeptember27,2023andshallcomeintoforceonJanuary1,2024)Chapter I GeneralProvisionsArticle1TheseMeasuresaredevelopedinaccordancewiththePharmaceuticalAdministrationLawofthePeople,sRepublicofChina(hereinafterreferredtoastheTharmaceuticalAdministrationLawn),theVaccineAdministrationLawofthePeople,sRepublicofChina,theRegulationsontheImplementationofthePharmaceuticalAdministrationLawofthePeople'sRepublicofChina,andotherlawsandadministrativeregulations,forthepurposesofstrengtheningthequalitysupervisionandadministrationoftheDistributionanduseofmedicinalproducts,andregulatingtheadministrativeactivitiesforthequalityofdistributionanduseofmedicinalproducts.Article2TheadministrationofthequalityofdistributionanduseofmedicinalproductsanditssupervisionandadministrationactivitieswithintheterritoryofthePeople'sRepublicofChinashallcomplywiththeseMeasures.Article3Thosewhocarryoutwholesaleorretailactivitiesofmedicinalproductsshallobtainapprovalofthemedicalproductsadministrativedepartment,obtainamedicinalproductsdistributionlicenseaccordingtothelaw,andstrictlycomplywiththeIaws5regulations,rules,standardsandnorms.Aholderofmedicinalproductsmarketingauthorizationmaysellthemedicinalproductsforwhichamedicinalproductregistrationcertificatehasbeenobtainedonitsown,orentrustsaletoamedicinalproductsdistributionenterprise.However,aholderofmedicinalproductsmarketingauthorizationcarryingoutmedicinalproductsretailactivitiesshallobtainamedicinalproductsdistributionlicense.华人民共和国药品管理法 （以下简称药品管理 法）中华人民共和国疫 苗管理法中华人民共和 国药品管理法实施条例等 法律、行政法规，制定本办 法。第二条在中华人民共 和国境内的药品经营、使用 质量管理及其监督管理活 动，应当遵守本办法。第三条从事药品批发 或者零售活动的，应当经药 品监督管理部门批准，依法 取得药品经营许可证，严格 遵守法律、法规、规章、标 准和规范。药品上市许可持有人可以自 行销售其取得药品注册证书 的药品，也可以委托药品经 营企业销售。但是，药品上 市许可持有人从事药品零售 活动的，应当取得药品经营 许可证。其他单位从事药品储存、运 输等相关活动的，应当遵守 本办法相关规定。Otherentitiescarryingoutstorage,transportationandotherrelatedactivitiesofmedicinalproductsshallcomplywiththerelevantprovisionsoftheseMeasures.Article4Amedicalinstitutionshallestablishamedicinalproductsqualitymanagementsystemandberesponsibleforthequalitymanagementofmedicinalproductsduringthewholeprocessofpurchase,storageanduseofitsmedicinalproducts.Whereradioactivemedicinalproductsandothermedicinalproductsunderspecialadministrationareused,relevantlicensesforuseshallbeobtainedinaccordancewiththerelevantprovisions.MedicinalproductsusingentitiesotherthanmedicalinstitutionsshallcomplywiththeprovisionsoftheseMeasuresonthequalitymanagementofmedicinalproductsinthewholeprocessofpurchase,storageanduseofmedicinalproductsbymedicalinstitutions.Article5Holdersofmedicinalproductsmarketingauthorization,medicinalproductsdistributionenterprisesandmedicalinstitutionsshallcomplywiththeunifiedstandardsandnormsfortraceabilityofmedicinalproductsdevelopedbytheNationalMedicalProductsAdministration,establishandimplementthemedicinalproducttraceabilitysystem,providetraceabilityinformationinaccordancewiththeprovisions,andensuretraceabilityofmedicinalproducts.Article6TheNationalMedicalProductsAdministrationshallberesponsibleforthequalitysupervisionandadministrationofthedistributionanduseofmedicinalproductsacrossthecountry,andguidethequalitysupervisionandadministrationofthedistributionanduseofmedicinalproductsbythemedicalproductsadministrativedepartmentsofprovinces,autonomousregionsandmunicipalitiesdirectlyundertheCentralGovernment.第四条医疗机构应当 建立药品质量管理体系，对 本单位药品购进、储存、使 用全过程的药品质量管理负 责。使用放射性药品等特殊 管理的药品的，应当按规定 取得相关的使用许可Q医疗机构以外的其他药品使 用单位，应当遵守本办法关 于医疗机构药品购进、储 存、使用全过程的药品质量 管理规定。第五条药品上市许可 持有人、药品经营企业和医 疗机构等应当遵守国家药品 监督管理局制定的统一药品 追溯标准和规范，建立并实 施药品追溯制度，按照规定 提供追溯信息，保证药品可 追溯Q第六条国家药品监督 管理局主管全国药品经营和 使用质量监督管理工作，对 省、自治区、直辖市药品监 督管理部门的药品经营和使 用质量监督管理工作进行指 导。省、自治区、直辖市药品监督管理部门负责本行政区域Themedicalproductsadministrativedepartmentsofprovinces,autonomousregionsandmunicipalitiesdirectlyundertheCentralGovernmentshallberesponsibleforthequalitysupervisionandadministrationofthedistributionanduseofmedicinalproductswithintheirrespectiveadministrativeregions,thelicensing,inspectionandpunishmentofmedicinalproductwholesaleenterprisesandheadquartersofmedicinalproductsretailchains,andtheinspectionandhandlingofthesalesactivitiesofholdersofmedicinalproductsmarketingauthorization;andguidethequalitysupervisionandadministrationofthedistributionanduseofmedicinalproductsbythedepartmentsresponsibleformedicinalproductsupervisionandadministrationofthepeople'sgovernmentsatthedistrictedcitylevelandcountylevel(hereinafterreferredtoastheedicalproductsadministrativedepartmentsatthemunicipalandcountyleve,)accordingtotheirduties.Themedicalproductsadministrativedepartmentsatthemunicipalandcountylevelshallberesponsibleforthequalitysupervisionandadministrationofthedistributionanduseofmedicinalproductswithintheirrespectiveadministrativeregions,andthelicensing,inspectionandpunishmentofmedicinalproductsretailenterprises,aswellastheinspectionandpunishmentofthequalityofuseofmedicinalproducts.TheStateAdministrationforMarketRegulationshall,inaccordancewiththerelevantprovisions,strengthentheguidanceofthecomprehensivelawenforcementteamformarketregulation.内药品经营和使用质量监督 管理，负责药品批发企业、 药品零售连锁总部的许可、 检查和处罚，以及药品上市 许可持有人销售行为的检查 和处罚；按职责指导设区的 市级、县级人民政府承担药 品监督管理职责的部门（以 下简称市县级药品监督管理 部门）的药品经营和使用质 量监督管理工作。市县级药品监督管理部门负 责本行政区域内药品经营和 使用质量监督管理，负责药 品零售企业的许可、检查和 处罚，以及药品使用环节质 量的检查和处罚。国家市场监督管理总局按照 有关规定加强市场监管综合 执法队伍的指导。第七条国家药品监督 管理局制定药品经营质量管 理规范及其现场检查指导原 则。省、自治区、直辖市药 品监督管理部门可以依据本 办法、药品经营质量管理规Article7TheNationalMedicalProductsAdministrationshalldevelopthequalitymanagementspecificationsforthedistributionofmedicinalproductsandtheguidingprinciplesforonsiteinspection.Themedicalproductsadministrativedepartmentsofprovinces,autonomousregionsandmunicipalitiesdirectlyundertheCentralGovernmentmaydevelopdetailedinspectionrulesinaccordancewiththeseMeasures5thequalitymanagementspecificationsforthedistributionofmedicinalproductsandtheguidingprinciplesforon-siteinspection,andinlightoftheactualcircumstancesoftheirrespectiveadministrativeregions.Chapter II BusinessPermitArticle8Anentitycarryingoutmedicinalproductwholesaleactivitiesshallmeetthefollowingconditions:(1) Ithasthequalitymanagementinstitutionandpersonnelappropriatetoitsbusinessscope;anditslegalrepresentative,primarypersonincharge,personinchargeofquality,personinchargeofqualitymanagementdepartment,etc.meettheprescribedconditions.(2) Ithaslegallycertifiedpharmacistsandotherpharmaceuticaltechnicians.(3) Ithasself-operatedwarehouses,businesspremises,facilitiesandequipmentcommensuratewithitsbusinessvarietyandscale,andtherearemodernlogisticsfacilitiesandequipmenttorealizeoperationofmedicinalproductswarehousing,transmission,sorting,shelvinganddeliveryinitswarehouses.范及其现场检查指导原则， 结合本行政区域实际情况制 定检查细则。第二章经营许可第八条从事药品批发 活动的，应当具备以下条 件：（一）有与其经营范围相适 应的质量管理机构和人员； 企业法定代表人、主要负责 人、质量负责人、质量管理 部门负责人等符合规定的条 件；（二）有依法经过资格认定 的药师或者其他药学技术人 员；（三）有与其经营品种和规 模相适应的自营仓库、营业 场所和设施设备，仓库具备 实现药品入库、传送、分 拣、上架、出库等操作的现 代物流设施设备；（四）有保证药品质量的质 量管理制度以及覆盖药品经 营、质量控制和追溯全过程(4) Ithasaqualitymanagementsystemensuringthequalityofmedicinalproductsandaninformationmanagementsystemcoveringthewholeprocessofdistribution,qualitymanagementandtraceabilityofmedicinalproducts,anditsatisfiestherequirementsofthequalitymanagementspecificationsforthedistributionofmedicinalproducts.medicinal product shall set up a headquarters to retail stores. TheArticle 9 Anentitycarryingoutretailchainbusinessactivitiesmedicinalproductretailchainconductunifiedmanagementofheadquartersofamedicinalproductretailchainshallmeettheconditionsstipulatedinitems(1),(2)and(4)ofArticle8oftheseMeasures,andhavewarehouses,distributionsitesandfacilitiesthatmayguaranteethequalityofmedicinalproductsandbecompatiblewithitsbusinessvarietiesandscale.Article 10 Anentitycarryingoutmedicinalproductretailactivitiesshallmeetthefollowingconditions:(1) Anentitydistributingprescriptionmedicinalproductsandclass-Anon-prescriptionmedicinalproductsshall,inaccordancewiththeprovisions,appointlegallycertifiedpharmacistsorotherpharmaceuticaltechniciansappropriatetothebusinessscopeandvariety.Anentitythatonlydistributesclass-Bnon-prescriptionmedicinalproductsmayappointmedicinalproductsalespersonnelwhohavepassedtheexaminationorganizedbythemedicalproductsadministrativedepartmentsatthedistrictedcitylevel.的信息管理系统，并符合药 品经营质量管理规范要求。第九条从事药品零售 连锁经营活动的，应当设立 药品零售连锁总部，对零售 门店进行统一管理。药品零 售连锁总部应当具备本办法 第八条第一项、第二项、第 四项规定的条件，并具备能 够保证药品质量、与其经营 品种和规模相适应的仓库、 配送场所和设施设备。第十条从事药品零售 活动的，应当具备以下条 件：（一）经营处方药、甲类非 处方药的，应当按规定配备 与经营范围和品种相适应的 依法经过资格认定的药师或 者其他药学技术人员。只经 营乙类非处方药的，可以配 备经设区的市级药品监督管 理部门组织考核合格的药品 销售业务人员；（二）有与所经营药品相适 应的营业场所、设备、陈 列、仓储设施以及卫生环 境；同时经营其他商品（非 药品）的，陈列、仓储设施 应当与药品分开设置；在超(2) Ithasthebusinesspremises,equipment,displayandstoragefacilitiesandasanitaryenvironmentsuitableforthemedicinalproductsdistributed;whereanentityconcurrentlydistributesothercommodities(non-medicinalproducts),itsdisplayandstoragefacilitiesshallbesetupseparatelyfrommedicinalproducts;andanentitycarryingoutmedicinalproductretailactivitiesatsupermarketsandotherplacesshallhaveanindependentbusinessarea.(3) Ithasqualitymanagementinstitutionorpersonnelsuitableforthemedicinalproductdistributed,anditslegalrepresentative,primarypersonincharge,personinchargeofquality,etc.,meettheprescribedconditions.(4) Ithasaqualitymanagementsystemguaranteeingthequalityofmedicinalproducts,andaninformationmanagementsystemsatisfyingtherequirementsforqualitymanagementandtraceability,andsatisfiestherequirementsofthequalitymanagementspecificationsforthedistributionofmedicinalproducts.Article11Fortheestablishmentofamedicinalproductsdistributionenterprise,afterobtainingabusinesslicense,anapplicationforamedicinalproductsdistributionlicenseshallbefiledwithandthefollowingmaterialsshallbesubmittedtothelocalmedicalproductsadministrativedepartmentabovethecountylevel:(1) TheApplicationforaMedicinalProductsDistributionLicense.(2) Theinformationofthequalitymanagementinstitutionandrelevantmaterialsontheeducationalbackgroundandworkexperienceoftheprimarypersonincharge,personinchargeofquality,andpersoninchargeofthequalitymanagementdepartment.市等其他场所从事药品零售 活动的，应当具有独立的经 营区域；（三）有与所经营药品相适 应的质量管理机构或者人 员，企业法定代表人、主要 负责人、质量负责人等符合 规定的条件；（四）有保证药品质量的质 量管理制度、符合质量管理 与追溯要求的信息管理系 统，符合药品经营质量管理 规范要求。第十一条开办药品经 营企业，应当在取得营业执 照后，向所在地县级以上药 品监督管理部门申请药品经 营许可证，提交下列材料：（一）药品经营许可证申请 表；（二）质量管理机构情况以 及主要负责人、质量负责 人、质量管理部门负责人学 历、工作经历相关材料；（三）药师或者其他药学技(3) Thequalificationcertificatesofpharmacistsorotherpharmaceuticaltechniciansandtheiremploymentdocuments.(4) Thematerialsrelatedtothemodeandscopeofdistributingmedicinalproducts.(5) Therulesandregulationsonqualitymanagementofmedicinalproductsandthelistofdisplay,storageandotherkeyfacilitiesandequipment.(6) Theinformationonbusinesspremises,equipment,storagefacilitiesandsurroundinghealthenvironment,layoutplansforbusinesspremisesandwarehouses,andmaterialsrelatedtopropertyrightsoruserightsofhouses.术人员资格证书以及任职文 件；（四）经营药品的方式和范 围相关材料；（五）药品质量管理规章制 度以及陈列、仓储等关键设 施设备清单；（六）营业场所、设备、仓 储设施及周边卫生环境等情 况，营业场所、仓库平面布 置图及房屋产权或者使用权 相关材料；(7) Othermaterialsasprescribedinlawsand(七)法律、法规规定的其regulations.他材料。Anapplicantshallberesponsiblefortheauthenticityofallthecontentsoftheapplicationmaterials.Anapplicantshallmarkthetradesecrets,informationnotdisclosed,orconfidentialbusinessinformationintheapplicationmaterials,andindicatethebasisaccordingtotherelevantrulesofthestate.申请人应当对其申请材料全 部内容的真实性负责。申请人应当按照国家有关规 定对申请材料中的商业秘 密、未披露信息或者保密商 务信息进行标注，并注明依 据。第十二条药品监督管 理部门收到药品经营许可证 申请后，应当根据下列情况 分别作出处理：Article12Afterreceivinganapplicationforamedicinalproductsdistributionlicense,themedicalproductsadministrativedepartmentshallhandleitrespectivelyaccordingtothefollowingcircumstances:(1) Whereanapplicationitemisnotsubjecttoamedicinalproductsdistributionlicenseinaccordancewiththelaw,theapplicantshallbenotifiedofrejectionimmediately.(2) Whereanapplicationitemisnotsubjecttothejurisdictionofthedepartmentsaccordingtothelaw,adecisiononrejectingtheapplicationshallbeimmediatelymadeandtheapplicantshallbenotifiedofapplyingtotherelevantadministrativedepartment.(3) Wherethereisanyerrorthatmaybecorrectedonthespotintheapplicationmaterials,theapplicantshallbeallowedtotakecorrectiveactiononthespot.(4) Wheretheapplicationmaterialsareincompleteorfailtosatisfytherequirementsforformalexamination,aNoticeofSupplementingandCorrectingMaterialsshallbeissuedtotheapplicantonthespotorwithinfivedays,andtheapplicantshallbenotifiedofallthecontentstobesupplementedandcorrectedatonetime.Whereitfailstonotifytheapplicantwithintheprescribedtimelimit,itshallbedeemedacceptancefromthedateofreceivingtheapplicationdocuments.(5) Wheretheapplicationdocumentsarecompleteandsatisfytherequirementsforformalexamination,ortheapplicanthassubmittedallthesupplementarydocumentsasrequired,theapplicationforamedicinalproductsdistributionlicenseshallbeaccepted.（一）申请事项依法不需要 取得药品经营许可的，应当 即时告知申请人不受理；（二）申请事项依法不属于 本部门职权范围的，应当即 时作出不予受理的决定，并 告知申请人向有关行政机关 申请；（三）申请材料存在可以当 场更正的错误的，应当允许 申请人当场更正；（四）申请材料不齐全或者 不符合形式审查要求的，应 当当场或者在五日内发给申 请人补正材料通知书，一次 告知申请人需要补正的全部 内容，逾期不告知的，自收 到申请材料之日起即为受 理；（五）申请材料齐全、符合 形式审查要求，或者申请人 按照要求提交全部补正材料 的，应当受理药品经营许可 证申请。药品监督管理部门受理或者 不予受理药品经营许可证申 请的，应当出具加盖本部门 专用印章和注明日期的受理AmedicalproductsadministrativedepartmentacceptingorrejectinganapplicationforamedicinalproductsdistributionlicenseshallissueaNoticeofAcceptanceorNoticeofRejectiontowhichthespecialsealofthedepartmentisaffixedandonwhichthedateisindicated.Article 13 Themedicalproductsadministrativedepartmentshallmakeadecisionwithin20daysfromthedateofacceptanceoftheapplication.Themedicalproductsadministrativedepartmentshall,inaccordancewiththequalitymanagementspecificationsforthedistributionofmedicinalproducts,theguidingprinciplesforon-siteinspection,thedetailedinspectionrules,andotherrelevantprovisions,organizetechnicalreviewofapplicationmaterialsandon-siteinspection.Aftertechnicalreviewandon-siteinspection,iftheconditionsaremet,permissionshallbegranted,andamedicinalproductsdistributionlicenseshallbeissuedwithinfivedaysfromthedateofmakingalicensingdecision;andwheretheconditionsarenotmet,awrittendecisiononrejectinglicenseshallbemade,andthereasonsshallbeexplained.通知书或者不予受理通知 书。第十三条药品监督管 理部门应当自受理申请之日 起二十日内作出决定。药品监督管理部门按照药品 经营质量管理规范及其现场 检查指导原则、检查细则等 有关规定，组织开展申报资 料技术审查和现场检查。经技术审查和现场检查，符 合条件的，准予许可，并自 许可决定作出之日起五日内 颁发药品经营许可证；不符 合条件的，作出不予许可的 书面决定，并说明理由。仅从事乙类非处方药零售活 动的，申请人提交申请材料 和承诺书后，符合条件的， 准予许可，当日颁发药品经 营许可证。自许可决定作出 之日起