【中英文对照版】药品监督管理行政处罚裁量适用规则（2024）.docx

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1、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)Do

2、cumentNumber：No.112024oftheNationalMedicalProductsAdministrationDateIssued：02-21-2024EffectiveDale：08-01-20241.evelofAuthoriiy：DepartmentalRegulatoryDocumentsAreaofLaw:AdministrativePenaltyandAdministrativeReconsiderationPhannaceuticalAdministrationNoticebytheNationalMedicalProductsAdministrationofI

3、ssuingtheRulesfortheApplication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

4、实际 认真贯彻落实。Themedicinalproductsadministrationsofallprovinces,autonomousregions,municipalitiesdirectlyundertheCentralGovernment,andXinjiangProductionandConstructionCorps:TheRulesfortheApplicationofDiscretioninImposingAdministrativePenaltiesintheSupervisionandAdministrationofMedicinalProducts,asdeliber

5、atedandadoptedattheexecutivemeetingoftheNationalMedicalProductsAdministration,areherebyissuedforyourdiligentimplementationinlightofactualcircumstances.NationalMedicalProductsAdministration国家药监局February21,2024RulesfortheApplicationofDiscretioninImposingAdministrativePenaltiesintheSupervisionandAdmini

6、strationofMedicinalProductsChapterIGeneralProvisionsArticle1Forthepurposesofregulatingtheexerciseofdiscretionarypowerinimposingadministrativepenaltiesbymedicinalproductregulatorydepartmentsinaccordancewiththelaw,safeguardingandsupervisingtheimpositionofadministrativepenaltiesbymedicinalproductregula

7、torydepartments,andprotectingthelawfulrightsandinterestsofcitizens,legalpersons,andotherorganizations,theseRulesaredevelopedinaccordancewiththeAdministrativePenaltyLawofthePeoplesRepublicofChina,theMedicinalProductAdministrationLawofthePeoplesRepublicofChina,theVaccineAdministrationLawofthePeoplesRe

8、publicofChina,theRegulationontheSupervisionandAdministrationofMedicalDevices,theRegulationontheSupervisionandAdministrationofCosmetics,andotherapplicablelaws,regulations,andrelevantrules,aswellastherequirementstoimplementtherequirementsofrelevantdocumentsoftheStateCouncilandtheGuidingOpinionsonRegul

9、atingtheExerciseofDiscretionaryPowerinImposingAdministrativePenaltiesinMarketSupervisionandAdministration(No.22022,SAMR)andinlightoftheactualsupervisionandadministrationofmedicinalproducts.Article2ForthepurposesoftheseRules,“discretionarypowerinimposingadministrativepenalties“meanstheauthorityofmedi

10、cinalproduct2024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

11、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,andothercircumstancesofillegala

12、cts.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：A

13、rticle4Medicinalproductregulatorydepartmentsshallexercisediscretionarypowerinimposingadministrativepenaltiesunderthefollowingprinciples:（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,thediscretio

14、nconditionsandthetypesandextentofpenaltiesprescribedinlaws,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,andthepartiesrighttoknow,therig

15、httoparticipate,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,am

16、ongothers,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egalfacts,nature,circu

17、mstances,anddegreeofsocialharm,amongothers.（五）处罚和教育相结合原 则。兼顾惩戒、纠正违法行 为和教育公民、法人和其他 组织，引导当事人自觉守 法。(5) Principleofcombiningpenaltieswitheducation.Equalattentionshallbepaidtopenalties,correctionofillegalacts,andeducationofcitizens,legalpersons,andotherorganizations,andthepartiesshallbeguidedtoconsciousl

18、yabidebythelaw.（六）综合裁量原则。综合 考虑个案的事实、性质、情 节、社会危害程度和当事人 主客观情况等，兼顾本地区 经济社会发展状况、药品产 业高质量发展和药品安全风 险防控需要等相关因素，惩 戒违法行为，预防药品安全 风险，保护和促进公众生命 健康，实现政治效果、社会 效果和法律效果的统一。第五条国务院药品监 督管理部门制定全国统一的 行政处罚裁量规则，可以针 对特定药品监督管理行政处 罚事项的裁量制定规则或者 意见。(6) Principleofcomprehensivediscretion.Bytakingintooverallconsiderationthefacts

19、,nature,circumstances,degreeofsocialharm,thesubjectiveandobjectiveconditionsofthepartiesinvolvedinindividualcases,andinlightofrelevantfactorssuchaseconomicandsocialdevelopmentoftheregion,thehigh-qualitydevelopmentofthemedicinalproductsindustry,andtherequirementsforthepreventionandcontrolofsafetyrisk

20、sofmedicinalproducts,illegalactsshallbepunishedtopreventthesafetyrisksofmedicinalproducts,andprotectandpromotepublichealthtoensuretheunityofpolitical,social,andlegaleffects.Article5ThemedicinalproductregulatorydepartmentoftheStateCouncilshalldevelopuniformnationalrulesfordiscretioninimposingadminist

21、rativepenaltiesandmaydeveloprulesoropinionsonthediscretionofadministrativepenaltymattersinthesupervisionandadministrationofspecificmedicinalproducts.省级药品监督管理部门应当根据本规则，结合本地区实Medicinalproductregulatorydepartmentsattheprovinciallevelshall,inaccordancewiththeseRules际，制定本辖区的行政处罚 裁量基准，可以针对特定药 品监督管理行政处罚事项的

22、 裁量制定意见市、县级药品监督管理部门 可以在法定范围内，对上级 药品监督管理部门制定的行 政处罚裁量基准适用的标 准、条件、种类、幅度、方 式、时限予以合理细化量 化。andinlightofactualcircumstancesintheregion,developthebasicstandardsfordiscretioninimposingadministrativepenaltiesintheirrespectivejurisdictions,andmaydevelopopinionsonthediscretionofadministrativepenaltymattersinthe

23、supervisionandadministrationofspecificmedicinalproducts.Medicinalproductregulatorydepartmentsatmunicipalandcountylevelsmay,withinthestatutoryscope,rationallyspecifyandquantifytheapplicablestandards,conditions,types,extent,methods,andtimelimitofthebasicstandardsfordiscretioninimposingadministrativepe

24、naltiesdevelopedbymedicinalproductregulatorydepartmentsathigherlevels.对同一行政处罚事项，上级 药品监督管理部门已经制定 行政处罚裁量基准的，下级 药品监督管理部门原则上应 当直接适用。下级药品监督 管理部门细化量化的行政处 罚裁量基准不得超出上级药 品监督管理部门划定的阶次 或者幅度。Forthesameadministrativepenaltymatter,ifthemedicinalproductregulatorydepartmentatahigherlevelhasdevelopedthebasicstandard

25、sfordiscretioninimposingadministrativepenalties,themedicinalproductregulatorydepartmentatalowerlevelshalldirectlyapplysuchstandardsinprinciple.Thebasicstandardsfordiscretioninimposingadministrativepenaltiesspecifiedandquantifiedbythemedicinalproductregulatorydepartmentatalowerlevelshallnotexceedthed

26、egreeorextentdefinedbythemedicinalproductregulatorydepartmentatahigherlevel.第二章裁量情形ChapterIlCircumstancesforDiscretion第六条行使行政处罚 裁量权，应当依据违法事 实、性质、情节和社会危害 程度等因素，并综合考虑下 列情形：Article6Thediscretionarypowerinimposingadministrativepenaltiesshallbeexercisedaccordingtosuchfactorsasthefacts,nature,circumstance

27、s,anddegreeofsocialharmofthe川egalacts,whilecomprehensivelyconsideringthefollowingcircumstances:(1)Theage,intelligence,andmentalhealthoftheparty.（一）当事人的年龄、智力及精神健康状况；(2)Thedegreeofsubjectivefaultoftheparty.（二）当事人的主观过错程度；(3)Thefrequency,area,scope,andtimeoftheillegalact.（三）违法行为的频次、区域、范围、时间；(4)Specificm

28、ethodsandmeansoftheillegalact.（四）违法行为的具体方法、手段；(5) Risksoftheproductsinvolvedinthecase.(6) Quantityandamountofillegalincomeorillegalproperty.(7) Theharmfulconsequencesandsocialimpactcausedbytheillegalact.(8) Theremedialmeasurestakenbythepartyfortheillegalactandtheireffectivenessinaddressingtheillegal

29、act.(9) Othercircumstancesprescribedbylaws,regulations,orrules.（五）涉案产品的风险性;（六）违法所得或者非法财物的数量、金额；（七）违法行为造成的损害后果以及社会影响；（八）当事人对违法行为所采取的补救措施及效果；（九）法律、法规、规章规定的其他情形。Article7Aheavieradministrativepenalty,generaladministrativepenalty,lighterormitigatedadministrativepenalty,ornoadministrativepenaltyshallbeimp

30、osedonthepartyinlightofthefacts,nature,circumstances,anddegreeofsocialharmofanillegalact.第七条对当事人实施的违法行为，按照违法行为的事实、性质、情节和社会危害程度，分别给予从重行政处罚、一般行政处罚、从轻或者减轻行政处罚、不予行政处罚。从重行政处罚是指在依法可 以选择的处罚种类和处罚幅 度内，适用较重、较多的处 罚种类或者较高的处罚幅 度。从轻行政处罚是指在依法可 以选择的处罚种类和处罚幅 度内，适用较轻、较少的处 罚种类或者较低的处罚幅 度。减轻行政处罚是指适用法定Impositionofaheavie

31、radministrativepenaltymeansapplyingheavierandmoretypesofpenaltiesorimposingahigherlevelofpenaltywithinthetypesandextentofpenaltiesthatcanbechoseninaccordancewiththelaw.Impositionofalighteradministrativepenaltymeansapplyinglighterandfewertypesofpenaltiesorimposingalowerlevelofpenaltywithinthetypesand

32、extentofpenaltiesthatcanbechoseninaccordancewiththelaw.行政处罚最低限度以下的处 罚种类或者处罚幅度，包括 在违法行为应当受到的一种 或者几种处罚种类之外选择 更轻的处罚种类，或者在应 当并处时不并处，也包括在 法定最低罚款限值以下确定罚款数额。Impositionofamitigatedadministrativepenaltymeansapplyingthetypeofpenaltyorextentofpenaltybelowtheminimumstatutorylevel,includingchoosingalightertypeof

33、penaltyfromoneormoretypesofpenaltiestobeimposedornotimposingadditionalpenaltywhenitisrequired,anddeterminingtheamountoffinebelowthestatutoryminimumfinelimit.不予行政处罚是指因法定原 因对符合处罚条件的违法行 为不给予行政处罚。一般行政处罚是指当事人违 法行为不具备法律、法规、 规章及本规则规定的从重行 政处罚、从轻或者减轻行政 处罚、不予行政处罚情形， 应当在法定处罚幅度中限给 予行政处罚。Exemptionfromadministrat

34、ivepenaltymeansthatnoadministrativepenaltyisimposedonanillegalactthatmeetsthepenaltyconditionsduetostatutoryreasons.Impositionofageneraladministrativepenaltymeansanadministrativepenaltywhichshallbeimposedwithinthemediumrangeoflegalpenalties,ifheavier,lighter,mitigated,ornoadministrativepenaltyshallb

35、eimposedaccordingtoanylaw,regulation,rule,ortheseRules.第八条当事人有下列 情形之一的，应当给予从重 行政处罚：Article 8 Whereapartyfallsunderanyofthefollowingcircumstances,aheavierpenaltyshallbeimposedinaccordancewiththelaw:（一）以麻醉药品、精神药 品、医疗用毒性药品、放射 性药品、药品类易制毒化学 品冒充其他药品，或者以其 他药品冒充上述药品的；(1) Thepartypassesoffanarcoticdrug,psych

36、otropicsubstance,poisonoussubstanceformedicaluse,radiopharmaceutical,orpharmaceuticalprecursorchemicalasanyotherdrug,orpassesoffanyotherdrugasanyoftheaforesaiddrugs.（二）生产、销售、使用假 药、劣药、不符合强制性标 准或者不符合经注册的产品 技术要求的第三类医疗器 械，以孕产妇、儿童、危重 病人为主要使用对象的；(2) Thepartyproduces,sells,orusescounterfeitorinferiordrugs,

37、orClass-Illmedicaldevicesthatfailtomeetthecompulsorystandardsortheregisteredtechnicalrequirementsforproducts,whicharemainlyusedbypregnantwomen,children,andcriticallyillpatients.（三）生产、销售、使用的 生物制品、注射剂药品属于 假药、劣药的；(3) Thebiologicalproductsordrugsforinjectionproduced,sold,andusedbythepartyarecounterfeita

38、ndinferiordrugs.（四）生产、销售、使用假 药、劣药，不符合强制性标 准或者不符合经注册备案的 产品技术要求的医疗器械， 造成人身伤害后果的；(4) Thepartyproduces,sells,orusescounterfeitorinferiordrugs,ormedicaldevicesthatfailtomeetthecompulsorystandardsorfailtocomplywiththeregisteredandfiledtechnicalrequirementsforproducts,thuscausingpersonalinjury.（五）生产、销售、使用假

39、 药、劣药，经处理后再犯； 生产、销售、使用不符合强 制性标准或者经注册的产品 技术要求的医疗器械，经处 理后三年内再犯的；(5) Thepartyproduces,sells,orusescounterfeitorinferiordrugsonceagainafterbeingpunishedforsuchanact;orproduces,sells,orusesanymedicaldevicesthatfailtomeetthecompulsorystandardsortheregisteredtechnicalrequirementsforproductsonceagainwithint

40、hreeyearsafterbeingpunishedforsuchanact.（六）在自然灾害、事故灾(6) Duringtheperiodofanaturaldisaster,accident,难、公共卫生事件、社会安 全事件等突发事件发生时 期，生产、销售、使用用于 应对突发事件的药品系假 药、劣药，或者用于应对突 发事件的医疗器械不符合强 制性标准或者不符合经注册 备案的产品技术要求的；publichealthincident,socialsecurityincident,oranyotheremergency,thedrugsproduced,sold,orusedforemerge

41、ncyresponsearecounterfeitorinferiordrugs,orthemedicaldevicesusedforemergencyresponsefailtocomplywithcompulsorystandardsorfailtosatisfytheregisteredandfiledtechnicalrequirementsforproducts.（七）因药品、医疗器械违 法行为受过刑事处罚的；(7) Thepartyhasbeencriminallypunishedforillegalactsrelatedtomedicinalproductsandmedicald

42、evices.（八）法律、法规、规章规 定的其他应当从重行政处罚 情形。(8) Anyothercircumstancewhereaheavieradministrativepenaltyshallbeimposedinaccordancewithlaws,regulations,andrules.第九条当事人有下列 情形之一的，可以依法从重 行政处罚：Article 9 Whereapartyfallsunderanyofthefollowingcircumstances,aheavieradministrativepenaltymaybeimposedinaccordancewiththe

43、law:（一）药品有效成份含量不 符合规定，足以影响疗效 的，或者药品检验无菌、热 原（如细菌内毒素）、微生 物限度、降压物质不符合规 定的；涉案医疗器械属于植 入类医疗器械的；(1) Thecontentofactiveingredientsofadrugfailstocomplywiththerelevantrequirements,whichmayaffectthecurativeeffect,orthedruginspectionsonsterility,pyrogen(suchasbacterialendotoxin),microbiallimit,orantihypertensiv

44、esubstancesfailtosatisfytherelevantrequirements;orthemedicaldevicesinvolvedareimplantablemedicaldevices.（二）生产、销售、使用的 急救药品属于假药、劣药 的；(2) Thefirst-aiddrugsproduced,sold,orusedarecounterfeitorinferiordrugs.（三）涉案产品主要使用对象为孕产妇、儿童或者其他(3) Thedrugsinvolvedareprimarilyintendedforusebypregnantwomen,children,oro

45、therspecificgroupsofpeople.特定人群的;（四）生产经营未经注册或 者备案的药品、医疗器械、 化妆品或者未经许可从事生 产经营活动，且涉案产品风 险性高的；(5) The party incites, coerces, or induces any other person to commit an illegal act.(6) The party knowingly sells or uses any illegal product.(7) The party has received any administrative penalty for the same

46、type of illegal acts within one year.（五）教唆、胁迫、诱骗他 人实施违法行为的；（六）明知属于违法产品仍 销售、使用的；（七）一年内因同一性质违 法行为受过行政处置的；(4) Thepartyproducesordistributesanydrugs,medicaldevices,orcosmeticsthathavenotbeenregisteredorfiled,orengagesinproductionordistributionactivitieswithoutpermission,andtheproductsinvolvedarehighlyri

47、sky.（A）违法行为持续六个月 以上或者在两年内实施违法 行为三次以上的；（九）拒绝、逃避监督检 查，伪造、销毁、隐匿有关 证据材料，或者擅自动用查 封、扣押、先行登记保存物 品的；（十）阻碍或者拒不配合行 政执法人员依法执行公务或 者对行政执法人员、举报 人、证人、鉴定人打击报复 的；（十一）被药品监督管理部(8) Theillegalacthaslastedforsixormoremonthsortheviolatorhascommittedillegalactsthreeormoretimeswithintwoyears.(9) Thepartyrefusesorevadessuper

48、visionandinspection,forges,destroys,orconcealsrelevantevidentiarymaterials,orusesitemsplacedunderseal,impounded,orregisteredandpreservedinadvancewithoutpermission.(10) Thepartyobstructsorrefusestocooperatewithadministrativelawenforcementofficers*lawfulperformanceofdutiesorretaliatesagainstanyadministrativelawenforcementofficer,informant,witness,orexpertwitness.(11) Thepartyisorderedbythemedicin