【中英文对照版】药品监督管理行政处罚裁量适用规则（2024）.docx

药品监督管理行政处罚裁量适用规则RulesfortheApplicationofDiscretioninImposingAdministrativePenaltiesintheSupervisionandAdministrationofMedicinalProducts制定机关：国家药品监督管理局(已变更)发文字号：国药监法202411号公布日期：2024.02.21施行日期：2024.08.01效力位阶：部门规范性文件法规类别：行政处罚与行政复议药品管理IssuingAuthority:StateDrugSupervision&AdministrationBureau(replaced)DocumentNumber：No.112024oftheNationalMedicalProductsAdministrationDateIssued：02-21-2024EffectiveDale：08-01-20241.evelofAuthoriiy：DepartmentalRegulatoryDocumentsAreaofLaw:AdministrativePenaltyandAdministrativeReconsiderationPhannaceuticalAdministrationNoticebytheNationalMedicalProductsAdministrationofIssuingtheRulesfortheApplication国家药监局关于印发药品监ofDiscretioninImposingAdministrativePenaltiesin督管理行政处罚裁量适用规theSupervisionandAdministrationofMedicinal则的通知Products(No.112024Administration)oftheNationalMedicalProducts(国药监法(2024)11号)各省、自治区、直辖市和新 疆生产建设兵团药品监督管 理局：药品监督管理行政处罚裁 量适用规则已经国家药品 监督管理局局务会议审议通 过，现予印发，请结合实际 认真贯彻落实。Themedicinalproductsadministrationsofallprovinces,autonomousregions,municipalitiesdirectlyundertheCentralGovernment,andXinjiangProductionandConstructionCorps:TheRulesfortheApplicationofDiscretioninImposingAdministrativePenaltiesintheSupervisionandAdministrationofMedicinalProducts,asdeliberatedandadoptedattheexecutivemeetingoftheNationalMedicalProductsAdministration,areherebyissuedforyourdiligentimplementationinlightofactualcircumstances.NationalMedicalProductsAdministration国家药监局February21,2024RulesfortheApplicationofDiscretioninImposingAdministrativePenaltiesintheSupervisionandAdministrationofMedicinalProductsChapterIGeneralProvisionsArticle1Forthepurposesofregulatingtheexerciseofdiscretionarypowerinimposingadministrativepenaltiesbymedicinalproductregulatorydepartmentsinaccordancewiththelaw,safeguardingandsupervisingtheimpositionofadministrativepenaltiesbymedicinalproductregulatorydepartments,andprotectingthelawfulrightsandinterestsofcitizens,legalpersons,andotherorganizations,theseRulesaredevelopedinaccordancewiththeAdministrativePenaltyLawofthePeople'sRepublicofChina,theMedicinalProductAdministrationLawofthePeople'sRepublicofChina,theVaccineAdministrationLawofthePeople'sRepublicofChina,theRegulationontheSupervisionandAdministrationofMedicalDevices,theRegulationontheSupervisionandAdministrationofCosmetics,andotherapplicablelaws,regulations,andrelevantrules,aswellastherequirementstoimplementtherequirementsofrelevantdocumentsoftheStateCouncilandtheGuidingOpinionsonRegulatingtheExerciseofDiscretionaryPowerinImposingAdministrativePenaltiesinMarketSupervisionandAdministration(No.22022,SAMR)andinlightoftheactualsupervisionandadministrationofmedicinalproducts.Article2ForthepurposesoftheseRules,“discretionarypowerinimposingadministrativepenalties“meanstheauthorityofmedicinalproduct2024年2月21日药品监督管理行政处罚裁量适用规则第一章总则第一条为规范药品监督管理部门依法行使行政处罚裁量权，保障和监督药品监督管理部门行政处罚行为，保护公民、法人和其他组织的合法权益，根据中华人民共和国行政处罚法中华人民共和国药品管理法中华人民共和国疫苗管理法医疗器械监督管理条例化妆品监督管理条例等法律、法规以及有关规章规定，落实国务院有关文件和关于规范市场监督管理行政处罚裁量权的指导意见(国市监法规(2022)2号)要求，结合药品监督管理工作实际，制定本规则。第二条本规则所称行政处罚裁量权，是指药品监督管理部门实施行政处罚 时，依据法律、法规、规章 的规定，综合考虑违法行为 的事实、性质、情节和社会 危害程度等情形，决定是否 给予行政处罚、给予行政处 罚种类和幅度的权限。regulatorydepartmentstodecidewhethertoimposeadministrativepenalties,thetypeandextentofadministrativepenaltiesinaccordancewithlaws,regulations,andrulesandconsideringthefacts,nature,circumstances,degreeofsocialharm,andothercircumstancesofillegalacts.第三条药品监督管理 部门行使行政处罚裁量权， 适用本规则。法律、法规、 规章另有规定的，从其规 定。Article3TheseRulesshallapplytotheexerciseofdiscretionarypowerinimposingadministrativepenaltiesbymedicinalproductregulatorydepartments.Ifitisotherwiseprescribedinanylaw,regulation,orrule,suchprovisionsshallprevail.第四条药品监督管理 部门行使行政处罚裁量权， 应当坚持下列原则：Article4Medicinalproductregulatorydepartmentsshallexercisediscretionarypowerinimposingadministrativepenaltiesunderthefollowingprinciples:（一）合法裁量原则。依据 法定权限，符合立法目的， 符合法律、法规、规章规定 的裁量条件、处罚种类和幅 度。(1) Principleoflawfuldiscretion.Ifthelegislativepurposeiscompliedwithaccordingtothelegalauthority,thediscretionconditionsandthetypesandextentofpenaltiesprescribedinlaws,regulations,andrulesshallbemet.（二）程序正当原则。严格 遵守法定程序，充分听取当 事人的意见，依法保障当事 人的知情权、参与权和救济 权。(2) Theprincipleofstatutoryprocedures.Thestatutoryproceduresshallbestrictlyobserved,theopinionsofthepartiesshallbefullyheard,andtheparties'righttoknow,therighttoparticipate,andtherighttoreliefshallbeprotectedinaccordancewiththelaw.（三）过罚相当原则。以事 实为依据，处罚的种类和幅 度与违法行为的事实、性 质、情节、社会危害程度等 相当。(3) Principleofproportionalitybetweenfaultsandpenalties.Basedonfacts,thetypesandextentofpenaltiesshallbeproportionaltothefacts,nature,circumstances,anddegreeofsocialharm,amongothers,oftheillegalacts.（四）公平公正原则。对违 法事实、性质、情节和社会 危害程度等基本相同的违法 行为实施行政处罚时，适用 的法律依据、处罚种类和幅 度基本一致。(4) Principleoffairnessandimpartiality.Theapplicablelegalbasis,types,andextentofpenaltiesarebasicallythesamewhenadministrativepenaltiesareimposedforillegalactswithbasicallythesame川egalfact