KYB CHINA(2004年12月9日中华人民共和国国务院、中华人民共和国中央军事委员会令第425号公布 2025年4月5日中华人民共和国国务院、中华人民共和国中央军事委员会令第805号修订)
(Promulgated by Decree No. 425 of the State Council of the People's Republic of China and the Central Military Commission of the People's Republic of China on December 9, 2004, and revised by Decree No. 805 of the State Council of the People's Republic of China and the Central Military Commission of the People's Republic of China on April 5, 2025)
总 则
General Provisions
为了加强军队药品管理，根据《中华人民共和国药品管理法》和其他有关法律规定，制定本办法。
These Measures are formulated in accordance with the Drug Administration Law of the People's Republic of China and other relevant legal provisions to strengthen military drug management.
军队药品研制、生产(含配制，下同)、储备、供应、使用和监督管理活动，适用本办法。
These Measures apply to drug research, production (including preparation, the same below), storage, supply, use, and supervision activities within the military.
军队药品管理工作坚持中国共产党的领导，贯彻习近平强军思想，坚持风险管理、全程管控、军地协同的原则，科学严格监管，保障药品的安全、有效、可及。
Military drug management shall adhere to the leadership of the Communist Party of China, implement Xi Jinping's thinking on strengthening the military, adhere to the principles of risk management, full-process control, and military-local coordination, and conduct scientific and strict supervision to ensure the safety, efficacy, and accessibility of drugs.
在中央军事委员会领导下，中央军事委员会后勤保障部负责组织指导军队药品监督管理工作，具体工作由中央军事委员会后勤保障部负责卫生工作的业务部门承办；中央军事委员会机关其他部门按照职责分工做好与药品有关的监督管理工作。
Under the leadership of the Central Military Commission, the Logistics Support Department of the Central Military Commission is responsible for organizing and guiding military drug supervision and management, with specific work undertaken by the business department in charge of health work under the Logistics Support Department of the Central Military Commission; other departments of the Central Military Commission shall perform drug-related supervision and management duties according to their respective responsibilities.
军队团级以上单位后勤保障部门负责本系统、本单位药品监督管理工作以及药品安全突发事件应对工作；同级机关其他部门按照职责分工做好与药品有关的监督管理工作。
The logistics support departments of military units at or above the regiment level shall be responsible for drug supervision and management within their respective systems and units, as well as for responding to drug safety emergencies; other departments at the same level shall perform drug-related supervision and management duties according to their respective responsibilities.
中央军事委员会后勤保障部负责卫生工作的业务部门与国务院药品监督管理部门和省、自治区、直辖市人民政府药品监督管理部门建立注册审评、联合监管、专业培训、信息通报等工作协调机制，协同开展药品监督管理工作。
The business department in charge of health work under the Logistics Support Department of the Central Military Commission shall establish coordination mechanisms with the drug regulatory department of the State Council and the drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government for registration review, joint supervision, professional training, information notification, and other matters, and shall carry out drug supervision and management in a coordinated manner.
国务院药品监督管理部门和县级以上地方人民政府承担药品监督管理职责的部门，按照本办法规定履行相应的药品监督管理职责。
The drug regulatory department of the State Council and the departments responsible for drug supervision and management at or above the county level in local people's governments shall perform corresponding drug supervision and management duties in accordance with these Measures.
军队药品专业技术机构依法承担军队药品监督管理所需的审评、检验、核查、监测与评价等工作。
Military drug professional and technical institutions shall undertake the review, inspection, verification, monitoring, and evaluation work required for military drug supervision and management in accordance with the law.
军队单位应当按照国家和军队药品追溯有关标准和规范加强管理，实现药品可追溯。
Military units shall strengthen management in accordance with national and military drug traceability standards and specifications to achieve drug traceability.
军队单位应当按照国家和军队药物警戒有关规定，对药品不良反应及其他与用药有关的有害反应进行监测、识别、评估和控制。
Military units shall, in accordance with national and military pharmacovigilance regulations, monitor, identify, assess, and control adverse drug reactions and other harmful reactions related to drug use.
对在军队药品研制、生产、储备、供应、使用和监督管理工作中做出突出贡献的单位和个人，按照国家和军队有关规定给予表彰、奖励。
Units and individuals that have made outstanding contributions to military drug research, production, storage, supply, use, and supervision and management shall be commended and rewarded in accordance with national and military regulations.
药品储备与供应
Drug Storage and Supply
军队实行战备药品储备制度。
The military shall implement a system of drug reserves for combat readiness.
中央军事委员会后勤保障部与国务院有关部门建立军队战备药品和国家储备药品调用协作机制，保障发生战争以及重大灾情、疫情或者其他突发事件时药品应急使用需要。
The Logistics Support Department of the Central Military Commission shall establish a coordination mechanism with relevant departments of the State Council for the use of military combat readiness drugs and national reserve drugs to ensure the emergency use of drugs in the event of war, major disasters, epidemics, or other emergencies.
军队建立军队基本药物目录，提高基本药物的储备和供给能力，满足军队人员伤病防治基本用药需求。
The military shall establish a military essential drug list to enhance the reserve and supply capacity of essential drugs and meet the basic drug needs for the prevention and treatment of injuries and diseases among military personnel.
军队医疗机构、药材供应保障机构应当从药品上市许可持有人或者具有药品生产、经营资格的企业购进药品；但是，购进未实施审批管理的中药材除外。
Military medical institutions and drug supply support institutions shall purchase drugs from drug marketing authorization holders or enterprises with drug production or business qualifications; however, this does not apply to the purchase of Chinese medicinal materials that are not subject to approval management.
军队医疗机构、药材供应保障机构购进药品，应当建立并执行进货检查验收制度，验明药品合格证明和其他标识，有真实、完整、可追溯的药品购进记录。
When purchasing drugs, military medical institutions and drug supply support institutions shall establish and implement a system for inspection and acceptance upon receipt, verify the drug's qualification certificates and other markings, and maintain true, complete, and traceable drug purchase records.
药品购进记录应当注明药品的通用名称、剂型、规格、产品批号、有效期、上市许可持有人、生产企业、供货单位、购进数量、购进价格、购进日期以及国务院药品监督管理部门规定的其他相关内容。
Drug purchase records shall indicate the generic name, dosage form, specification, batch number, expiration date, marketing authorization holder, manufacturer, supplier, quantity purchased, purchase price, purchase date, and other relevant content as required by the drug regulatory department of the State Council.
军队医疗机构、药材供应保障机构应当制定和执行药品保管制度，采取必要的冷藏、防冻、防潮、防虫、防鼠等措施，保证药品质量。
Military medical institutions and drug supply support institutions shall formulate and implement a drug storage system, taking necessary measures such as refrigeration, freeze protection, moisture protection, pest control, and rodent control to ensure drug quality.
军队药材供应保障机构应当按照划定区域和指定任务，负责军队单位所需药品的供应保障。
Military drug supply support institutions shall be responsible for the supply of drugs required by military units within designated areas and assigned tasks.
军队药材供应保障机构不得向地方单位和人员供应药品；因发生重大灾情、疫情或者其他突发事件等原因，确需向地方单位和人员供应的，应当经中央军事委员会后勤保障部批准。
Military drug supply support institutions shall not supply drugs to local units or individuals; if supply to local units or individuals is truly necessary due to major disasters, epidemics, or other emergencies, approval from the Logistics Support Department of the Central Military Commission shall be obtained.
军队药材供应保障机构从事药品供应保障活动，应当取得中央军事委员会后勤保障部负责卫生工作的业务部门核发的军队药材供应许可证；无军队药材供应许可证的，不得供应药品。
Military drug supply support institutions engaged in drug supply activities shall obtain a military drug supply license issued by the business department in charge of health work under the Logistics Support Department of the Central Military Commission; without a military drug supply license, they shall not supply drugs.
军队人员需要接种的疫苗，由军队疾病预防控制机构按照国家规定的疫苗采购渠道向疫苗上市许可持有人采购；对未纳入国家组织采购的疫苗，可以按照军队采购有关规定向疫苗上市许可持有人采购。疫苗上市许可持有人应当按照采购合同约定，向军队疾病预防控制机构或者其指定的军队单位供应疫苗。
Vaccines required for inoculation of military personnel shall be procured by military disease prevention and control institutions from vaccine marketing authorization holders through the vaccine procurement channels prescribed by the state; for vaccines not included in the state-organized procurement, they may be procured from vaccine marketing authorization holders in accordance with military procurement regulations. Vaccine marketing authorization holders shall supply vaccines to military disease prevention and control institutions or the military units designated by them in accordance with the procurement contract.
军队疾病预防控制机构和军队其他相关单位从事疫苗储存、运输活动的，应当严格遵守国家有关规定，保证疫苗质量。
Military disease prevention and control institutions and other relevant military units engaged in vaccine storage and transportation shall strictly comply with relevant state regulations to ensure vaccine quality.
军队医疗机构药事管理
Pharmacy Management of Military Medical Institutions
军队医疗机构应当配备经过国家或者军队资格认定的药师或者其他药学技术人员，负责本单位的药品管理、处方审核和调配、合理用药指导等工作。
Military medical institutions shall be staffed with pharmacists or other pharmaceutical technical personnel who have passed national or military qualification certification, responsible for drug management, prescription review and dispensing, and rational drug use guidance within their units.
军队医疗机构应当坚持安全有效、经济合理的用药原则。
Military medical institutions shall adhere to the principles of safe, effective, and economical drug use.
军队医疗机构配制制剂，应当取得中央军事委员会后勤保障部负责卫生工作的业务部门核发的军队医疗机构制剂许可证。
Military medical institutions that prepare preparations shall obtain a Military Medical Institution Preparation License issued by the health work department of the Logistics Support Department of the Central Military Commission.
军队医疗机构配制的制剂，应当是本单位临床需要而市场上没有供应或者任务急需但市场供应不足的品种，并应当取得中央军事委员会后勤保障部负责卫生工作的业务部门或者军兵种负责卫生工作的业务部门核发的制剂批准证明文件；但是，法律对配制中药制剂另有规定的除外。
Preparations prepared by military medical institutions shall be varieties that are clinically needed by the unit but not available on the market, or urgently needed for missions but in short supply on the market, and shall obtain a preparation approval certificate issued by the health work department of the Logistics Support Department of the Central Military Commission or the health work department of the service or branch; however, laws otherwise provide for the preparation of traditional Chinese medicine preparations.
军队医疗机构配制的制剂应当在本单位使用。经中央军事委员会后勤保障部负责卫生工作的业务部门或者军兵种负责卫生工作的业务部门批准，可以在指定的军队医疗机构之间调剂使用。
Preparations prepared by military medical institutions shall be used within the unit. With the approval of the health work department of the Logistics Support Department of the Central Military Commission or the health work department of the service or branch, they may be transferred for use among designated military medical institutions.
军队医疗机构配制的制剂，不得在市场上销售。
Preparations prepared by military medical institutions shall not be sold on the market.
发生重大灾情、疫情以及其他突发事件或者临床急需而市场上没有供应时，经中央军事委员会后勤保障部负责卫生工作的业务部门和国务院药品监督管理部门或者省、自治区、直辖市人民政府药品监督管理部门批准，医疗机构配制的制剂可以在指定的军队医疗机构和地方医疗机构之间调剂使用。
In the event of major disasters, epidemics, or other emergencies, or when there is an urgent clinical need but no supply on the market, with the approval of the health work department of the Logistics Support Department of the Central Military Commission and the drug regulatory department of the State Council or the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government, preparations prepared by medical institutions may be transferred for use between designated military medical institutions and local medical institutions.
军队特需药品管理
Management of Military Special Drugs
军队特需药品，是指军队用于防治战伤和军事特殊环境引发疾病，以及满足军事行动特定作业人员需求的药品。
Military special drugs refer to drugs used by the military for the prevention and treatment of war injuries and diseases caused by special military environments, as well as to meet the needs of specific operational personnel during military operations.
投入生产的军队特需药品应当经过注册，取得中央军事委员会后勤保障部负责卫生工作的业务部门核发的批准证明文件。
Military special drugs put into production shall be registered and obtain an approval certificate issued by the health work department of the Logistics Support Department of the Central Military Commission.
从事军队特需药品生产活动的单位，应当取得中央军事委员会后勤保障部负责卫生工作的业务部门核发的军队特需药品生产与配制许可证；其中，地方生产单位取得军队特需药品生产与配制许可证后，应当向所在省、自治区、直辖市人民政府药品监督管理部门备案。
Units engaged in the production of military special drugs shall obtain a Military Special Drug Production and Preparation License issued by the health work department of the Logistics Support Department of the Central Military Commission; among them, local production units, after obtaining the Military Special Drug Production and Preparation License, shall file with the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where they are located.
军队特需药品研制单位委托生产军队特需药品的，应当与符合条件的生产单位签订委托协议和质量协议，并对生产活动进行监督，确保军队特需药品质量安全。
If a military special drug research and development unit entrusts the production of military special drugs, it shall sign an entrustment agreement and a quality agreement with a qualified production unit, and supervise the production activities to ensure the quality and safety of the military special drugs.
军队特需药品应当在军队内部使用；地方单位因特殊情况需要购进军队特需药品的，应当经国务院药品监督管理部门或者省、自治区、直辖市人民政府药品监督管理部门审核，并经中央军事委员会后勤保障部负责卫生工作的业务部门同意。
Military special drugs shall be used within the military; if a local unit needs to purchase military special drugs due to special circumstances, it shall be reviewed by the drug regulatory department of the State Council or the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government, and approved by the health work department of the Logistics Support Department of the Central Military Commission.
军队特需药品需要转化为民用药品的，应当经中央军事委员会后勤保障部负责卫生工作的业务部门审核，由国务院药品监督管理部门按照药品上市注册有关规定办理。
If military special drugs need to be converted into civilian drugs, they shall be reviewed by the health work department of the Logistics Support Department of the Central Military Commission, and the drug regulatory department of the State Council shall handle the matter in accordance with the relevant provisions on drug marketing registration.
中央军事委员会后勤保障部负责卫生工作的业务部门与国务院药品监督管理部门建立技术支持协作机制，为军队特需药品的审评、检验、核查、监测与评价等工作提供支撑。
The health work department of the Logistics Support Department of the Central Military Commission and the drug regulatory department of the State Council shall establish a technical support cooperation mechanism to provide support for the review, inspection, verification, monitoring, and evaluation of military special drugs.
监 督 管 理
Supervision and Management
军队后勤保障部门应当对军队药品研制、生产、储备、供应、使用等活动进行监督检查，并对军队特需药品、医疗机构制剂以及国家有特殊管理规定的药品实施重点监督检查。
Military logistics support departments shall conduct supervision and inspection on the research and development, production, storage, supply, and use of military drugs, and shall implement key supervision and inspection on military special drugs, medical institution preparations, and drugs subject to special state management.
中央军事委员会后勤保障部负责卫生工作的业务部门制定军队药品质量抽查检验计划，组织对军队单位生产、储备、供应、使用的药品以及委托生产的军队特需药品进行抽查检验。药品质量抽查检验结果按照规定向军队有关单位和地方有关药品监督管理部门通报。
The health work department of the Logistics Support Department of the Central Military Commission shall formulate a plan for random inspection and testing of military drug quality, and organize random inspection and testing of drugs produced, stored, supplied, and used by military units, as well as military special drugs produced under entrustment. The results of drug quality random inspection and testing shall be notified to relevant military units and local drug regulatory departments in accordance with regulations.
军队医疗机构、科研机构、药材供应保障机构发现药品有疑似质量问题的，应当按照规定送交军队药品专业技术机构进行质量检验。
If military medical institutions, research institutions, or drug supply support institutions discover suspected quality problems with drugs, they shall submit the drugs to a military professional drug technical institution for quality inspection in accordance with regulations.
军队药品专业技术机构应当根据抽查检验任务和军队有关单位提出的药品质量检验需求，对相关药品进行质量检验，及时出具检验结论。
Military professional drug technical institutions shall conduct quality inspection on relevant drugs based on random inspection tasks and drug quality inspection needs raised by relevant military units, and issue inspection conclusions in a timely manner.
军队药品专业技术机构不得收取药品质量检验费用，抽查检验所需样品由其自行购买。
Military professional drug technical institutions shall not charge fees for drug quality inspection; the samples required for random inspection shall be purchased by themselves.
对药品质量检验结论有异议的，可以自收到药品质量检验结论之日起7日内向原军队药品专业技术机构或者其上一级药品专业技术机构申请复验。受理复验的军队药品专业技术机构应当在规定的时间内作出复验结论。
If there is any objection to the drug quality inspection conclusion, a re-inspection may be applied to the original military professional drug technical institution or its superior drug technical institution within 7 days from the receipt of the drug quality inspection conclusion. The military professional drug technical institution that accepts the re-inspection shall issue a re-inspection conclusion within the specified time.
对在军队医疗机构使用且有证据证明可能危害人体健康的药品及其有关材料，军队医疗机构应当立即停用，采取封存管控等措施，并逐级上报至中央军事委员会后勤保障部负责卫生工作的业务部门处理；其中，从地方单位购进的药品，由中央军事委员会后勤保障部负责卫生工作的业务部门协调国务院药品监督管理部门或者省、自治区、直辖市人民政府药品监督管理部门按照国家有关规定处理。
For drugs and related materials used in military medical institutions that have evidence suggesting they may endanger human health, the military medical institution shall immediately stop using them, take measures such as sealing and controlling them, and report level by level to the health work department of the Logistics Support Department of the Central Military Commission for handling; among them, for drugs purchased from local units, the health work department of the Logistics Support Department of the Central Military Commission shall coordinate with the drug regulatory department of the State Council or the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government for handling in accordance with relevant state regulations.
军队医疗机构、药材供应保障机构、特需药品研制单位和生产单位，应当经常考察本单位所生产、供应、使用的药品质量、疗效和不良反应。发现疑似不良反应的，应当按照国家和军队有关规定报告并采取风险控制措施。
Military medical institutions, drug supply support institutions, and special-needs drug research and production units shall regularly examine the quality, efficacy, and adverse reactions of the drugs they produce, supply, or use. When suspected adverse reactions are discovered, they shall report in accordance with national and military regulations and take risk control measures.
中央军事委员会后勤保障部负责卫生工作的业务部门和军兵种负责卫生工作的业务部门应当对军队医疗机构配制的制剂和军队特需药品组织评估，发现疗效不确定、不良反应大或者因其他原因危害人体健康的，应当注销其批准证明文件。
The health work business department of the Logistics Support Department of the Central Military Commission and the health work business departments of the services and arms shall organize evaluations of preparations made by military medical institutions and military special-needs drugs. If it is found that the efficacy is uncertain, adverse reactions are severe, or other reasons endanger human health, the approval certificate shall be revoked.
已被注销批准证明文件的军队医疗机构配制的制剂和军队特需药品，不得生产、供应、使用；已经生产的，由批准部门组织回收并监督销毁。
Preparations made by military medical institutions and military special-needs drugs whose approval certificates have been revoked shall not be produced, supplied, or used; those already produced shall be recalled and supervised for destruction by the approving department.
任何单位和个人不得以军队单位或者军队人员的名义、形象或者利用军队装备、设施等从事药品商业宣传。
No unit or individual may engage in commercial promotion of drugs using the name or image of a military unit or military personnel, or using military equipment or facilities.
禁止对军队医疗机构配制的制剂、军队特需药品进行商业宣传。
Commercial promotion of preparations made by military medical institutions and military special-needs drugs is prohibited.
军队药品监督员应当参加国家或者地方药品检查员培训并取得相应资格，按照规定的职责从事军队药品监督工作。
Military drug inspectors shall participate in national or local drug inspector training and obtain corresponding qualifications, and shall engage in military drug supervision work in accordance with their prescribed duties.
地方单位或者人员认为军队单位和人员违反本办法规定的，可以向县级以上地方人民政府承担药品监督管理职责的部门检举、控告，由省、自治区、直辖市人民政府药品监督管理部门通报中央军事委员会后勤保障部负责卫生工作的业务部门，中央军事委员会后勤保障部负责卫生工作的业务部门依法组织查处和通报。
If local units or individuals believe that military units or personnel have violated these Measures, they may report or accuse to the drug regulatory department of the local people's government at or above the county level. The drug regulatory department of the provincial, autonomous region, or municipality directly under the Central Government shall notify the health work business department of the Logistics Support Department of the Central Military Commission, which shall organize investigation and handling according to law and notify the results.
军队单位或者人员认为地方单位和人员违反本办法规定的，可以向县级以上地方人民政府承担药品监督管理职责的部门检举、控告，由县级以上地方人民政府承担药品监督管理职责的部门依法组织查处和通报。
If military units or personnel believe that local units or individuals have violated these Measures, they may report or accuse to the drug regulatory department of the local people's government at or above the county level, which shall organize investigation and handling according to law and notify the results.
国家和军队对麻醉药品、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、疫苗和血液制品等有特殊管理规定的，依照其规定执行。
Where the state and the military have special management provisions for narcotic drugs, psychotropic substances, toxic drugs for medical use, radioactive drugs, precursor chemicals for drugs, vaccines, and blood products, those provisions shall prevail.
法 律 责 任
Legal Liability
未取得军队特需药品生产与配制许可证、军队药材供应许可证或者军队医疗机构制剂许可证生产、供应药品的，责令停止有关活动，没收违法生产、供应的药品和违法所得。
If anyone produces or supplies drugs without obtaining a Military Special-Needs Drug Production and Preparation License, a Military Drug Supply License, or a Military Medical Institution Preparation License, the relevant activities shall be ordered to cease, and the illegally produced or supplied drugs and illegal gains shall be confiscated.
军队医疗机构使用假药、劣药的，没收其使用的假药、劣药和违法所得，责令改正；情节严重的，有关责任人员有医疗卫生人员执业证书的，还应当吊销其执业证书。
If a military medical institution uses counterfeit or substandard drugs, the counterfeit or substandard drugs used and illegal gains shall be confiscated, and corrective action shall be ordered; if the circumstances are serious, the responsible personnel who hold a medical practitioner license shall also have their license revoked.
军队单位和人员知道或者应当知道属于假药、劣药，而利用军队设施、运输工具为其提供储存、运输等便利条件的，扣押储存、运输的药品，按照有关规定处理，并没收全部储存、运输收入。
If military units or personnel know or should know that drugs are counterfeit or substandard but use military facilities or transport vehicles to provide storage, transportation, or other convenience, the stored or transported drugs shall be seized, handled according to relevant regulations, and all storage and transportation income shall be confiscated.
伪造、变造、出租、出借、买卖军队特需药品生产与配制许可证、军队药材供应许可证、军队医疗机构制剂许可证、军队医疗机构制剂批准证明文件、军队特需药品批准证明文件的，没收违法所得；情节严重的，吊销相关许可证或者批准证明文件。
If anyone forges, alters, leases, lends, or buys or sells a Military Special-Needs Drug Production and Preparation License, a Military Drug Supply License, a Military Medical Institution Preparation License, a Military Medical Institution Preparation Approval Certificate, or a Military Special-Needs Drug Approval Certificate, the illegal gains shall be confiscated; if the circumstances are serious, the relevant license or approval certificate shall be revoked.
提供虚假的证明、数据、资料、样品或者采取其他不正当手段骗取军队特需药品生产与配制许可、军队药材供应许可、军队医疗机构制剂许可或者军队特需药品注册、军队医疗机构制剂注册等许可的，撤销相关许可，10年内不受理其相应申请。
If anyone provides false certificates, data, information, samples, or uses other improper means to obtain a Military Special-Needs Drug Production and Preparation License, a Military Drug Supply License, a Military Medical Institution Preparation License, or a Military Special-Needs Drug Registration or Military Medical Institution Preparation Registration, the relevant license shall be revoked, and the corresponding application shall not be accepted for 10 years.
军队医疗机构、药材供应保障机构、疾病预防控制机构从药品上市许可持有人或者具有药品生产、经营资格的企业以外的地方单位和个人购进药品的，责令改正，没收违法购进的药品和违法所得。
If a military medical institution, drug supply support institution, or disease prevention and control institution purchases drugs from local units or individuals other than drug marketing authorization holders or enterprises with drug production or business qualifications, corrective action shall be ordered, and the illegally purchased drugs and illegal gains shall be confiscated.
军队医疗机构、药材供应保障机构未按照规定建立并执行药品进货检查验收制度、药品保管制度的，责令改正，给予警告。
If a military medical institution or drug supply support institution fails to establish and implement a drug purchase inspection and acceptance system or a drug storage system as required, corrective action shall be ordered and a warning shall be given.
军队特需药品研制单位和生产单位、药材供应保障机构，未经批准向地方单位或者个人提供军队特需药品的，责令停止有关活动，限期追回药品，没收违法所得。
If a military special-needs drug research and production unit or drug supply support institution provides military special-needs drugs to local units or individuals without approval, the relevant activities shall be ordered to cease, the drugs shall be recovered within a time limit, and illegal gains shall be confiscated.
军队单位和人员，收受药品上市许可持有人、药品生产企业、药品经营企业或者其代理人给予的财物或者其他不正当利益的，没收违法所得；情节严重的，有关责任人员有医疗卫生人员执业证书的，还应当吊销其执业证书。
If military units or personnel accept property or other improper benefits from drug marketing authorization holders, drug manufacturers, drug distributors, or their agents, the illegal gains shall be confiscated; if the circumstances are serious, the responsible personnel who hold a medical practitioner license shall also have their license revoked.
军队医疗机构配制假劣制剂的，责令停止配制，没收违法配制的制剂和违法所得，吊销相关制剂批准证明文件；情节严重的，吊销军队医疗机构制剂许可证，10年内不受理其相应申请。
If a military medical institution prepares counterfeit or substandard preparations, the preparation activities shall be ordered to cease, the illegally prepared preparations and illegal gains shall be confiscated, and the relevant preparation approval certificate shall be revoked; if the circumstances are serious, the Military Medical Institution Preparation License shall be revoked, and the corresponding application shall not be accepted for 10 years.
军队医疗机构将其配制的制剂在市场上销售或者未经批准调剂使用制剂的，责令改正，没收违法销售、使用的制剂和违法所得；情节严重的，吊销军队医疗机构制剂许可证。
If a military medical institution sells its preparations on the market or uses preparations through transfer without approval, corrective action shall be ordered, the illegally sold or used preparations and illegal gains shall be confiscated; if the circumstances are serious, the Military Medical Institution Preparation License shall be revoked.
军队医疗机构、药材供应保障机构、特需药品研制单位和生产单位，未按照规定开展药品不良反应监测或者报告疑似药品不良反应的，责令改正，给予警告。
If a military medical institution, drug supply support institution, or special-needs drug research and production unit fails to carry out drug adverse reaction monitoring or report suspected adverse drug reactions as required, corrective action shall be ordered and a warning shall be given.
军队单位和人员违反本办法规定从事药品商业宣传的，责令改正，没收违法所得。
If military units or personnel engage in commercial promotion of drugs in violation of these Measures, corrective action shall be ordered and illegal gains shall be confiscated.
违反本办法规定，有下列情形之一的，应当撤销相关许可：
In violation of these Measures, under any of the following circumstances, the relevant license shall be revoked:
(一)不符合条件而批准进行军队特需药品、医疗机构制剂临床试验；
(1) Approval for clinical trials of military special-needs drugs or medical institution preparations is granted without meeting the conditions;
(二)不符合条件而颁发军队特需药品批准证明文件、医疗机构制剂批准证明文件；
(2) Issuing approval certificates for military special-needs drugs or preparation approval certificates for medical institutions despite non-compliance with conditions;
(三)不符合条件而颁发军队特需药品生产与配制许可证、军队药材供应许可证、军队医疗机构制剂许可证。
(3) Issuing licenses for the production and preparation of military special-needs drugs, military pharmaceutical supply licenses, or military medical institution pharmacy licenses despite non-compliance with conditions.
军队药品专业技术机构违反本办法规定，有下列行为之一的，责令改正，给予警告，没收违法所得；情节严重的，撤销其检验资格：
If a military drug technical institution violates these Measures by committing any of the following acts, it shall be ordered to correct, given a warning, and have its illegal gains confiscated; if the circumstances are serious, its inspection qualification shall be revoked:
(一)违规收取检验费用；
(1) Charging inspection fees in violation of regulations;
(二)出具虚假检验报告；
(2) Issuing false inspection reports;
(三)其他弄虚作假行为。
(3) Other fraudulent acts.
对军队单位和人员违反本办法规定的处罚，由军队有关部门按照职责权限作出决定；撤销许可、吊销许可证或者批准证明文件的，由原批准、发证的部门作出决定。
Penalties for violations of these Measures by military units and personnel shall be decided by the relevant military departments within their respective authority; revocation of permits, licenses, or approval certificates shall be decided by the original approving or issuing department.
地方单位和人员违反本办法规定的，依照《中华人民共和国药品管理法》等法律、行政法规的有关规定给予处罚。
Violations of these Measures by local units and personnel shall be penalized in accordance with the Drug Administration Law of the People's Republic of China and other relevant laws and administrative regulations.
军队单位和人员、国家机关及其工作人员在军队药品管理工作中滥用职权、玩忽职守、徇私舞弊，或者有其他违反本办法规定行为的，对负有责任的领导人员和直接责任人员，依法依规给予处分。
If military units and personnel, or state organs and their staff, abuse their power, neglect their duties, engage in malpractice for personal gain, or otherwise violate these Measures in military drug administration, the responsible leaders and directly responsible personnel shall be given sanctions in accordance with laws and regulations.
违反本办法规定，构成犯罪的，依法追究刑事责任。
Violations of these Measures that constitute a crime shall be subject to criminal liability in accordance with the law.
附 则
Supplementary Provisions
本办法所称军队医疗机构，包括军队医院、部队卫生机构、派驻门诊医疗机构和干休所门诊部等单位。
For the purposes of these Measures, military medical institutions include military hospitals, military unit health organizations, stationed outpatient medical institutions, and outpatient departments of rest homes for retired cadres.
本办法所称军队药品专业技术机构，是指军队设置的药品仪器监督检验总站、药品仪器监督检验站以及承担药品监测和评价任务的军队医疗机构、科研机构等单位。
For the purposes of these Measures, military drug technical institutions refer to the military drug and instrument supervision and inspection stations, drug and instrument supervision and inspection stations, and military medical institutions and scientific research institutions that undertake drug monitoring and evaluation tasks.
军队战备药品、医疗机构制剂、特需药品的具体管理办法，由中央军事委员会后勤保障部制定。
Specific measures for the management of military combat readiness drugs, medical institution preparations, and special-needs drugs shall be formulated by the Logistics Support Department of the Central Military Commission.
中国人民武装警察部队的药品管理工作，适用本办法。
These Measures shall apply to the drug administration of the Chinese People's Armed Police Force.
本办法自2025年6月1日起施行。
These Measures shall come into force on June 1, 2025.