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中华人民共和国药品管理法LAWOFTHEPEOPLE'SREPUBLICOFCHINAONTHEADMINISTRATIONOFDRUGS第一条为加强药品监督管理，保证药品质量，增进药品疗效，保障人民用药安全，维护人民身体健康，特制定本法。[Article1]Thislawhasbeendrawnupinordertostrengthendrugcontrolandadministration,ensurethequalityofdrugs,enhancetheefficacyofdrugs,guaranteesafedruguseandsafeguardthephysicalhealthofthepeople.第二条国务院卫生行政部门主管全国药品监督管理工作。[Article2]TheStateCouncildepartmentresponsibleforhealthadministrationisthebodyinchargeofnationaldrugcontrolandadministration.第三条国家发展现代药和传统药，充分发挥其在预防、医疗和保健中的作用。[Article3]TheStatedevelopsbothmodernmedicinesandtraditionalmedicines,andfullyutilizestheminthepreventionandtreatmentofdisease,aswellasinhealthcare.国家保护野生药材资源鼓励培育中药材。TheStatesafeguardsresourcesofuncultivatedmedicinalmaterialsandencouragesthecultivationofrawmaterialsusedfortraditionalChinesemedicines.第二章药品生产企业的管理CHAPTERIIADMINISTRATIONOFDRUG-PRODUCINGENTERPRISES第四条开办药品生产企业必须由所在省、自治区、直辖市药品生产经营主管部门审查同意，经所在省、自治区、直辖市卫生行政部门审核批准，并发给《药品生产企业许可证》。[Article4]Theestablishmentofadrug-producingenterprisemustbeexaminedandagreedtobythedepartmentinchargeofdrugproductionandhandlingintheprovince,autonomousregionormunicipalityunderthedirectcontroloftheCentralGovernmentinwhichtheenterpriseislocated.Itshallbesubjecttoexaminationandapprovalbythedepartmentresponsibleforhealthadministrationintheprovince,autonomousregionormunicipalityunderthedirectcontroloftheCentralGovernment,whichshallissuetheDrug-productionEnterpriseLicense.无《药品生产企业许可证》的工商行政管理部门不得发给《营业执照》。WithoutaDrug-productionEnterpriseLicense,thedepartmentadministeringindustryandcommercemaynotissueaBusinessLicense.《药品生产企业许可证》应当规定有效期，到期重新审查发证。具体办法由国务院卫生行政部门规定。TheDrug-productionEnterpriseLicenseshallstipulateitsperiodofvalidity,andattheexpiryoftheperiodtheissueofthelicenseshallbeexaminedafresh.SpecificprocedureswillbedeterminedbytheStateCouncildepartmentresponsibleforhealthadministration.第五条开办药品生产企业必须具备以下条件：[Article5]Theestablishmentofanenterprisetoproducedrugsmustsatisfythefollowingconditions:（一）具有与所生产药品相适应的药师或者助理工程师以上技术人员及技术工人。(1)Itmustemploypharmacists,technicalpersonnelabovetherankofassistantengineerandtechnicalworkersappropriatetothedrugproductioncarriedoutbytheenterprise.中药饮片加工企业没有药师或者助理工程师以上技术人员，配备熟悉药性并经县级以上卫生行政部门审查登记的药工人员。WhereanenterpriseengagedintheprocessingoftraditionalChinesemedicinedoesnothaveapharmacistortechnicalpersonnelofarankabovethatofassistantengineer,itmayusedrugindustrypersonnelwithanintimateknowledgeofdrugswhohavebeenexaminedandregisteredbyadepartmentofhealthadministrationabovethecountylevel.（二）具有与所生产药品相适应的厂房、设施和卫生环境。(2)Itmusthaveafactorybuilding,facilitiesandahygienicenvironmentappropriatetoitsproductionofdrugs.（三）具有能对所生产药品进行质量检验的机构或者人员以及必要的仪器设备。(3)Itmusthaveanorganizationorpersonnelcapableofcarryingoutqualityexaminationsonthedrugsproducedaswellasthenecessaryinstrumentsandequipment.第六条药品必须按照工艺规程进行生产，生产记录必须完整准确。[Article6]Theproductionofdrugsmustbecarriedoutinaccordancewiththecorrecttechnologicalprocedures;productionrecordsshallbekeptindetailandaccurately.中药饮片的炮制必须符合《中华人民共和国药典》,或者省、自治区、直辖市卫生行政部门制定的《炮制规范》的规定。ThepreparationofChinesemedicinesshallbeinaccordancewiththePharmacopoeiaofthePeople'sRepublicofChina,orinaccordancewiththePreparationStandardslaiddownbythedepartmentadministeringhealthinthatprovince,autonomousregionormunicipalityunderthedirectcontroloftheCentralGovernment.第七条生产药品所需的原料、辅料以及直接接触药品的容器和包装材料，必须符合药用要求。[Article7]Rawmaterialsandsupplementarymaterialsrequiredfortheproductionofdrugsaswellascontainersandpackingmaterialswhichcomeintodirectcontactwithdrugsshallmeetstandardsrequiredforpharmaceuticaluse.第八条药品出厂前必须经过质量检验；不符合标准的，不得出厂。[Article8]Beforedrugsleavethefactory,theymustpassaqualityexamination.Iftheydonotreachtherequiredstandard,theymustnotleavethefactory.第九条药品生产企业必须按照国务院卫生行政部门制定的《药品生产质量管理规范》的要求，制定和执行保证药品质量的规章制度和卫生要求。[Article9]Drug-producingenterprisesmustformulateandimplementasystemofrulesandregulationsandhygienerequirementstoguaranteethequalityofdrugsinaccordancewiththerequirementsoftheStandardsfortheAdministrationofDrug-productionQualitylaiddownbythedepartmentoftheStateCounciladministeringhealth.第三章药品经营企业的管理CHAPTERIIIADMINISTRATIONOFDRUG-HANDLINGENTERPRISES第十条开办药品经营企业必须由所在地药品生产经营主管部门审查同意，经县级以上卫生行政部门审核批准，并发给《药品经营企业许可证》。无《药品经营企业许可证》的，工商行政管理部门不得发给《营业执照》。[Article10]Theestablishmentofadrug-handlingenterprisemustbeexaminedandagreedtobythedepartmentresponsiblefordrugproductionandhandlingintheplacewheretheenterpriseissituated,andmustbeexaminedandapprovedbyahealthdepartmentatcountylevelorabove,whichwillissueaDrug-handlingEnterpriseLicense,withoutwhichthedepartmentadministeringindustryandcommercemaynotissueaBusinessLicense.《药品经营企业许可证》应当规定有效期，到期重新审查发证。具体办法由国务院卫生行政部门规定。ADrug-handlingEnterpriseLicenseshallstipulateitsperiodofvalidity,andattheexpiryoftheperiodtheissueofthelicenseshallbeexaminedafresh.SpecificprocedureswillbedeterminedbythedepartmentoftheStateCounciladministeringhealth.第十一条开办药品经营企业必须具备以下条件：[Article11]Theestablishmentofadrug-handlingenterprisemustsatisfythefollowingconditions:（一）具有与所经营药品相适应的药学技术人员。(1)Itmustemploypharmaceuticaltechniciansappropriatetothemedicin