手机版
第八章药品商标和广告的管理
CHAPTER VIII ADMINISTRATION OF DRUG TRADEMARKS AND ADVERTISING
第四十一条除中药材、中药饮片外，药品必须使用注册商标；未经核准注册的，不得在市场销售。
[Article 41] With the exception of Chinese medicinal materials and Chinese medicines sliced and prepared for decoction, drugs must use a registered trademark and may not be sold on the market until examined and approved for registration.
注册商标必须在药品的包装和标签上注明。
The registered trademark must be clearly shown on the package and label of the drug.
第四十二条药品广告必须经省、自治区、直辖市卫生行政部门审查批准；未经批准的，不得刊登、播放、散发和张贴。
[Article 42] An advertisement for a drug must be examined and approved by the department of the province, autonomous region or municipality under the direct control of the Central Government responsible for administering health; unless it is approved, it may not be published, broadcast, distributed or displayed on a poster.
第四十三条外国企业在我国申请办理药品广告，必须提供生产该药品的国家（地区）批准的证明文件、药品说明书和有关资料。
[Article 43] Where a foreign enterprise applies to advertise a drug in this country, it must submit documents proving approval of the drug from the country (or place) of its production, a written description of the drug and relevant material.
第四十四条药品广告的内容必须以国务院卫生行政部门或者省、自治区、直辖市卫生行政部门批准的说明书为准。
[Article 44] The contents of an advertisement for a drug must be in accordance with the explanatory booklet approved by the department of the State Council administering health or the department of the province, autonomous region or municipality under the direct control of the Central Government administering health.
第九章药品监督
CHAPTER IX DRUG CONTROL
第四十五条县级以上卫生行政部门行使药品监督职权。
[Article 45] Departments administering health above the county level exercise the power of supervision over drugs.
县级以上卫生行政部门，可以设置药政机构和药品检验机构。
Departments administering health at above county level may establish drug administration bodies and drug inspection bodies.
第四十六条县级以上卫生行政部门设药品监督员。药品监督员由药学技术人员担任，由同级人民政府审核发给证书。
[Article 46] Departments administering health at above county level will appoint Drug Controllers. Drug Controllers will be appointed from those holding the position of pharmaceutical technicians; they shall be examined, and a certificate will be issued by the People's Governments at that level.
第四十七条药品监督员有权按照规定对辖区内的药品生产企业、药品经营企业和医疗单位的药品质量进行监督、检查、抽验，必要时可以按照规定抽取样品和索取有关资料，有关单位不得拒绝和隐瞒。
[Article 47] A Drug Controller has the power, in accordance with regulations, to control, inspect and test the quality of drugs in drug-producing enterprises, drug-handling enterprises and medical treatment units within the Controller's area of jurisdiction. If necessary, the Drug Controller may, in accordance with regulations, take samples and obtain relevant data which the relevant unit may not refuse to provide and may not conceal.
药品监督员对药品的生产企业和科研单位提供的技术资料，负责保密。
Drug Controllers are responsible for keeping the technical data provided by drug-manufacturing enterprises or scientific research units confidential.
第四十八条药品生产企业、药品经营企业和医疗单位，应当经常考察本单位所生产、经营、使用的药品的质量、疗效和不良反应。
[Article 48] Drug-producing enterprises, drug-handling enterprises and medical treatment units shall regularly inspect and study the quality, efficacy and side-effects of drugs produced, handled or used by them.
医疗单位发现药品中毒事故，必须及时向当地卫生行政部门报止。
If a medical treatment unit discovers a case of poisoning in relation to a drug, it must immediately report it to the department administering health in that area.
第四十九条药品生产企业和药品经营企业的药品检验机构或者人员，受当地药品检验机构的业务指导。
[Article 49] The drug-inspection body or personnel of a drug-producing enterprise or drug-handling enterprise will receive guidance in their professional work from the drug-inspection organ of that area.
第十章法律责任
CHAPTER X LEGAL RESPONSIBILITIES
第五十条生产、销售假药的，没收假药和违法所得，处以�？睿⒖梢栽鹆罡玫ノ煌２�、停业整顿或者吊销《药品生产企业许可证》、《药品经营企业许可证》、《制剂许可证》。
[Article 50] Where spurious drugs are produced or sold, the spurious drugs and the illegally obtained income will be confiscated and a fine will be imposed. In addition, the relevant unit may be ordered to stop production or stop operations for rectification or its "Drug-production Enterprise Licence", "Drug-handling Enterprise Licence" or "Dispensing Licence" may be revoked.
对生产、销售假药，危害人民健康的个人或者单位直接责任人员，依照刑法第一百六十四条规定追究刑事责任。
In pursuance of the regulations of Article 164 of the Penal Code, criminal liability will be investigated and determined in relation to individuals or units directly involved in the production or sale of spurious drugs endangering the people's health.
第五十一条生产、销售劣药的，没收劣药和违法所得，可以并处�？�；情节严重的，并责令该单位停产、停业整顿或者吊销《药品生产企业许可证》、《药品经营企业许可证》、《制剂许可证》。
[Article 51] Where inferior drugs are produced or sold, the inferior drugs and the illegally obtained income will be confiscated and a fine may also be imposed; if the circumstances are serious, the relevant unit may be ordered to stop production or stop its operations and rectify itself, or its "Drug-production Enterprise Licence", "Drug-handling Enterprise Licence" or "Dispensing Licence" may be revoked.
对生产销售劣药，危害人民健康，造成严重后果的个人或单位直接责任人员，比照刑法第一百六十四条的规定追究刑事责任。
In pursuance of Article 164 of the Penal Code, criminal liability will be investigated and determined in relation to individuals or units directly involved in the production or sale of inferior drugs endangering the people's health.
第五十二条未取得《药品生产企业许可证》、《药品经营企业许可证》、《制剂许可证》生产药品、经营药品或者配制制剂的，责令该单位停产、停业或者停止配制制剂，没收全部药品和违法所得，可以并处�？�。
[Article 52] Where drugs are manufactured, handled or made up without a "Drug-production Enterprise Licence", Drug-handling Enterprise Licence" or "Dispensing Licence", the relevant unit will be ordered to stop production, stop operations or stop preparing medications. All of the illegally-produced drugs and the illegally-obtained income shall be confiscated and a fine may also be imposed.
第五十三条违反本法关于药品生产、药品经营的管理的其他规定的，处以警告或者罚款。
[Article 53] A violation of any other provision of this law in relation to the administration of drug production or handling will be punished by a caution or by a fine.
第五十四条本法规定的行政处罚，由县级以上卫生行政部门决定。违反本法第十五条规定、第八章有关广告管理的规定的行政处罚，由工商行政管理部门决定。
[Article 54] Any decision relating to the imposition of an administrative penalty pursuant to this law shall be made by the department administering health at above the county level. Any decision relating to the imposition of a penalty for and offence against Article 15 of this law or the provisions of Chapter VIII of this law with respect to the advertising of drugs, shall be made by the department administering industry and commerce. In relation to the penalty of ordering a drug-producing enterprise or drug-handling enterprise which is directly under the management of the Central Government or the People's Government of a province, autonomous region or municipality directly under the control of the Central Government to stop production or stop its operations for more than seven days, or of revoking its "Drug-production Enterprise Licence", or "Drug-handling Enterprise Licence", the department of the province, autonomous region or municipality under the direct control of the Central Government administering health shall submit it to the People's Government at the same level for decision.
对中央或者省、自治区、直辖市人民政府直接管辖的药品生产企业、药品经营企业处以停产、停业整顿7天以上或者吊销《药品生产企业许可证》、 《药品经营企业许可证》处罚的，由省、自治区、直辖市卫生行政部门报同级人民政府决定。对市、县或者市、县以下人民政府管辖的药品生产企业、药品经营企业处以停产，停业整顿 7天以上或者吊销《药品生产企业许可证》、《药品经营企业许可证》处罚的，由市、县人民政府卫生行政部门报同级人民政府决定。
In relation to a penalty ordering a drug-producing enterprise or drug-handling enterprise under the direct management of the People's Government at or below the city or county level to stop production or stop operations for more than seven days or of revoking its "Drug-production Enterprise Licence" or its "Drug-handling Enterprise Licence", the department of the city or county People's Government administering health shall submit the matter to the People's Government of the same level for decision.
没收的药品由卫生行政部门监督处理。
Confiscated drugs shall be disposed of under the supervision of the department responsible for health administration.
第五十五条当事人对行政处罚决定不服的，可以在接到处罚通知之日起 15 天内向人民法院起诉。
[Article 55] If a party objects to the decision to impose a penalty on him, he may, within 15 days from the date of receipt of notification of the penalty, bring an action in the People's Court. H
但是，对卫生行政部门作出的药品控制的决定，当事人必须立即执行。对处罚决定不履行逾期又不起诉的，由作出行政处罚决定的机关申请人民法院强制执行。
owever, in the case of a decision relating to drug control taken by the department responsible for health administration, the party shall immediately comply. Where the decision has not been complied with within the time limit and no action has been brought, the People's Court shall compulsorily enforce compliance upon application by the organ which made the decision.
第五十六条违反本法，造成药品中毒事故的，致害单位或者个人应当负损害赔偿责任。受害人可以请求县级以上卫生行政部门处理；当事人不服的，可以向人民法院起诉。受害人也可以直接向人民法院起诉。
[Article 56] In case of drug poisoning caused by a breach of this law, the unit or person who caused it shall be liable to pay compensation. The person suffering harm may request a department administering health at above county level to handle the matter; if the party who caused the harm objects, he or it may bring an action in the People's Court. The person suffering harm may also sue directly in the People's Court.
损害赔偿要求，应当从受害人或者其代理人知道或者应当知道之日起 1年内提出；超过期限的，不予受理。
A demand to be compensated for damage shall be submitted within a period of one year from the date on which the victim or his representative became aware or ought to have become aware of it. When this period has expired, the claim will not be entertained.
第五十七条本法下列用语的含义是：
[Article 57] The expressions used in this law are defined as follows:
药品：指用于预防、治疗、诊断人的疾病，有目的地调节人的生理机能并规定有适应症、用法和用量的物质，
"Drug" refers to a substance used for the prevention, treatment and diagnosis of human diseases, and with the object of regulating human physiological functions, with stipulated indications, usage and dosage.
包括中药材、中药饮片、中成药、化学原料药及其制剂、抗生素、生化药品、放射性药品、血清疫苗、血液制品和诊断药品等。
It includes Chinese medicinal materials and Chinese medicines sliced and prepared for decoction, prepared Chinese medicines, chemical raw material drugs and their components, antibiotics, biochemical drugs, radioactive drugs, blood serums and vaccines, blood products, diagnostic drugs and so on.
新药指我国未生产过的药品。
"New drugs" refers to those drugs which have never been produced in this country.
辅料指生产药品和调配处方时所用的赋形剂和附加剂。
"Supplementary materials" refers to excipients and additives used in the production and making up of drugs.
药品生产企业指生产药品的专营企业或者兼营企业。
"Drug-producing enterprise" refers to those enterprises exclusively or partially engaged in the production of drugs.
药品经营企业指经营药品的专营企业或者兼营企业。
"Drug-handling enterprise" refers to those enterprises exclusively or partially engaged in the handling of drugs.
第五十八条本法所说的药品生产，不包括中药材的种植、采集和饲养。
[Article 58] The production of drugs referred to in this law does not include the cultivation and collection of raw materials for Chinese medicines or the raising of animals in relation to Chinese medicines.
第五十九条国务院卫生行政部门根据本法制定实施办法报国务院批准施行。
[Article 59] Measures for the implementation of this law will be set down by the State Council department responsible for health administration and submitted to the State Council for approval and implementation.
中国人民解放军特需药品的管理办法由国家军事主管部门制定。
Special provisions for the management of drugs in the People's Liberation Army will be laid down by the department in charge of national military affairs.
第六十条本法自一九八五年七月一日起施行。
[Article 60] This law shall come into force on July 1, 1985.
中华人民共和国药品管理法
The Pharmaceutical Administration Law of the People's Republic of China
第一章 总 则
Chapter I General Provisions
第一条 为加强药品监督管理，保证药品质量，保障人体用药安全，维护人民身体健康和用药的合法权益，特制定本法。
Article 1 This law is formulated to enhance the supervision and control of pharmaceuticals, ensure their quality, guarantee safety in medication, and safeguard the health and legal rights and interests of the people.
第二条 在中华人民共和国境内从事药品的研制、生产、经营、使用和监督管理的单位或者个人，必须遵守本法。
Article 2 The law shall be applicable to any units or individuals engaged in research, production, trade, use, supervision and management of pharmaceuticals within the territory of the People's Republic of China.
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。
Article 3 The State shall develop both modern and traditional medicines encourage their role in the prevention and treatment of diseases and in health care.
国家�；ひ吧┎淖试�，鼓励培育中药材。
The State shall protect the resources of wild medicinal resources and encourage the domestic cultivation of Chinese traditional medicinal crops.
第四条 国家鼓励研究和创制新药，�；す瘛⒎ㄈ撕推渌橹芯�、开发新药的合法权益。
Article 4 The State shall encourage the research and production of new medicine and protect the legal rights and interests of its citizens, natural persons and other organizations in the research and development of new medicine.
第五条 国务院药品监督管理部门主管全国药品监督管理工作。国务院有关部门在各自的职责范围内负责与药品有关的监督管理工作。
Article 5 The pharmaceuticals supervisory and administrative departments under the State Council shall be responsible for the supervision and control of pharmaceuticals throughout the country. Other relevant departments under the State Council shall be responsible for the supervision and control of pharmaceuticals related to the scope of their functions.
省、自治区、直辖市人民政府药品监督管理部门负责本行政区域内的药品监督管理工作。省、自治区、直辖市人民政府有关部门在各自的职责范围内负责与药品有关的监督管理工作。
The pharmaceutical supervisory and administrative departments of the provinces, autonomous regions and municipalities directly under the central government shall be responsible for the supervision and control of pharmaceuticals within their administrative regions. Other relevant departments of the provinces, autonomous regions and municipalities directly under the central government shall be responsible for the supervision and control of pharmaceuticals related to the scope of their functions.
国务院药品监督管理部门应当配合国务院经济综合主管部门，执行国家制定的药品行业发展规划和产业政策。
The pharmaceutical supervisory and administrative departments under the State Council shall cooperate with the general administrative department of the economy under the State Council to carry out pharmaceutical development plans and industrial policies formulated by the State.
第六条 药品监督管理部门设置或者确定的药品检验机构，承担依法实施药品审批和药品质量监督检查所需的药品检验工作。
Article 6 The pharmaceutical inspection institutions established or approved by the pharmaceutical supervisory and administrative departments shall be charged with the work of pharmaceutical examination and approval, as well as quality inspection, in accordance with laws and regulations.
第二章 药品生产企业管理
Chapter II Administration of Pharmaceutical Producing Enterprises
第七条 开办药品生产企业，须经企业所在地省、自治区、直辖市人民政府药品监督管理部门批准并发给《药品生产许可证》，
Article 7 The establishment of a pharmaceutical producing enterprise must be approved by and issued a Pharmaceutical Production License by the pharmaceutical supervisory and administrative department of the province, autonomous region, or municipality directly under the Central government in which the enterprise is located.
凭《药品生产许可证》到工商行政管理部门办理登记注册。无《药品生产许可证》的，不得生产药品。
The establishment shall be registered at the industry and commerce administrative department based on the Pharmaceutical Production License, without which no pharmaceuticals shall be produced.
《药品生产许可证》应当标明有效期和生产范围，到期重新审查发证。
The Pharmaceutical Production License shall bear the scope of production and a period of validity, and upon expiration a new license shall be issued after examination for its renewal.
药品监督管理部门批准开办药品生产企业，除依据本法第八条规定的条件外，还应当符合国家制定的药品行业发展规划和产业政策，防止重复建设。
The approval of the establishment of pharmaceutical producing enterprises by the pharmaceutical supervisory and administrative departments shall be in conformity with Article 8 of this law, as well as the pharmaceutical development plan and the industrial policies formulated by the State to avoid the instance of a repeat establishment.
第八条 开办药品生产企业，必须具备以下条件：
Article 8 To establish a pharmaceutical producing enterprise, the following requirements must be met:
（一）具有依法经过资格认定的药学技术人员、工程技术人员及相应的技术工人；
(1) It shall be staffed with legally certified pharmaceutical technical personnel, engineering technical personnel, as well as corresponding skilled workers.
（二）具有与其药品生产相适应的厂房、设施和卫生环境；
(2) It shall have factory premises, facilities and a sanitary environment suitable for the medicines produced.
（三）具有能对所生产药品进行质量管理和质量检验的机构、人员以及必要的仪器设备；
(3) It shall have a unit or competent personnel capable of inspecting the quality of the medicines produced, as well as necessary instruments and equipment.
（四）具有保证药品质量的规章制度。
(4) It shall have rules and regulations to ensure the quality of medicines.
第九条 药品生产企业必须按照国务院药品监督管理部门依据本法制定的《药品生产质量管理规范》组织生产。药品监督管理部门按照规定对药品生产企业是否符合《药品生产质量管理规范》的要求进行认证；对认证合格的，发给认证证书。
Article 9 Pharmaceutical producing enterprises must organize production in accordance with the "Standards for Quality Control of Pharmaceutical Production" formulated by the pharmaceutical supervisory and administrative departments under the State Council on the basis of this Law. Pharmaceutical supervisory and administrative departments shall confirm whether the pharmaceutical producing enterprises have met the requirements of the "Standards," and shall issue certificates to those qualified ones.
《药品生产质量管理规范》的具体实施办法、实施步骤由国务院药品监督管理部门规定。
The detailed implementation measures and implementation process of the "Standards for Quality Control of Pharmaceutical Production" shall be formulated by the pharmaceutical supervisory and administrative department under the State Council.
第十条 除中药饮片的炮制外，药品必须按照国家药品标准和国务院药品监督管理部门批准的生产工艺进行生产，生产记录必须完整准确。药品生产企业改变影响药品质量的生产工艺的，必须报原批准部门审核批准。
Article 10 Except in the preparation of traditional Chinese medicines into ready-to-use forms, pharmaceuticals must be produced in accordance with the national pharmaceutical standard and the technological procedures approved by the supervisory and administrative departments of pharmaceuticals under the State Council, and the record of production must be complete and accurate. The changes of technological procedure made by the pharmaceutical producing enterprises which affect the quality of the pharmaceuticals shall be examined and approved by the original approval authorities.
中药饮片必须按照国家药品标准炮制；国家药品标准没有规定的，必须按照省、自治区、直辖市人民政府药品监督管理部门制定的炮制规范炮制。省、自治区、直辖市人民政府药品监督管理部门制定的炮制规范应当报国务院药品监督管理部门备案。
The process for preparing traditional Chinese medicines into ready-to-use forms must conform to the national pharmaceutical standards, and in the absence of such standards, the process must conform to the processing standards stipulated by the supervisory and administrative departments of pharmaceuticals of the provinces, autonomous regions, or municipalities directly under the central government. The processing standards stipulated by the supervisory and administrative departments of pharmaceuticals of the provinces, autonomous regions, or municipalities directly under the central governments shall be placed on record at the pharmaceutical supervisory and administrative department under the State Council.
第十一条 生产药品所需的原料、辅料，必须符合药用要求。
Article 11 The raw and supplementary materials used for the production of pharmaceuticals must conform to the requirements for medicinal use.
第十二条 药品生产企业必须对其生产的药品进行质量检验；不符合国家药品标准或者不按照省、自治区、直辖市人民政府药品监督管理部门制定的中药饮片炮制规范炮制的，不得出厂。
Article 12 The pharmaceutical producing enterprises must conduct quality inspections on the pharmaceuticals they produce; products which do not meet national pharmaceutical standards or are not prepared in conformity with the processing standards stipulated by the pharmaceutical supervisory and administrative departments of the provinces, autonomous regions, or municipalities directly under the central government shall not leave the factory.
第十三条 经国务院药品监督管理部门或者国务院药品监督管理部门授权的省、自治区、直辖市人民政府药品监督管理部门批准，药品生产企业可以接受委托生产药品。
Article 13 Pharmaceutical producing enterprises can accept the authorization to produce pharmaceuticals after they obtain approval from the pharmaceutical supervisory and administrative department under the State Council or the pharmaceutical supervisory and administrative departments of the provinces, autonomous regions, or municipalities directly under the central government authorized by the supervisory and administrative department of pharmaceuticals under the State Council.
第三章 药品经营企业管理
Chapter III Administration of Pharmaceutical Trading Enterprises
第十四条 开办药品批发企业，须经企业所在地省、自治区、直辖市人民政府药品监督管理部门批准并发给《药品经营许可证》；
Article 14 The establishment of pharmaceutical wholesale enterprises must be sanctioned by the competent local authorities of the production and trade of pharmaceuticals of the provinces, autonomous regions or municipalities directly under the central government, which will issue a Pharmaceutical Trade License.
开办药品零售企业，须经企业所在地县级以上地方药品监督管理部门批准并发给《药品经营许可证》，凭《药品经营许可证》到工商行政管理部门办理登记注册。无《药品经营许可证》的，不得经营药品。
The establishment of pharmaceutical retail enterprises must be sanctioned by local authorities for the supervision and control of pharmaceuticals at or above the county level, which will issue a Pharmaceutical Trade License, on the basis of which registration at the industry and commerce administrative departments shall be conducted. Without the Pharmaceutical Trade License, any enterprises shall not engage in the trade of pharmaceuticals.
《药品经营许可证》应当标明有效期和经营范围，到期重新审查发证。
A Pharmaceutical Trade License shall bear a scope of trade and a period of validity, and upon expiration a new license shall be issued after examination for its renewal.
药品监督管理部门批准开办药品经营企业，除依据本法第十五条规定的条件外，还应当遵循合理布局和方便群众购药的原则。
The approval of the establishment of pharmaceutical trading enterprises by the pharmaceutical supervisory and administrative departments shall adhere to the principle of reasonable positioning and convenience for buying of pharmaceuticals, and in addition must conform to Article 15 of this Law.
第十五条 开办药品经营企业必须具备以下条件：
Article 15 To establish a pharmaceutical trading enterprise, the following requirements must be met
（一）具有依法经过资格认定的药学技术人员；
(1) 1 It shall be staffed with legally certified pharmaceutical technical personnel.
（二）具有与所经营药品相适应的营业场所、设备、仓储设施、卫生环境；
(2) It shall have business premises, equipment, storage facilities and a sanitary environment suitable for the pharmaceuticals in which it trades.
（三）具有与所经营药品相适应的质量管理机构或者人员；
(3) It shall have a quality control organ or personnel suitable for the pharmaceuticals in which it trades.
（四）具有保证所经营药品质量的规章制度。
(4) It shall have rules and regulations to ensure the quality of the pharmaceuticals in which it trades.
第十六条 药品经营企业必须按照国务院药品监督管理部门依据本法制定的《药品经营质量管理规范》经营药品。
Article 16 Pharmaceutical producing enterprises must trade in pharmaceuticals in accordance with the "Standards for Quality Control of Pharmaceutical Trading" stipulated by the pharmaceutical supervisory and administrative departments under the State Council on the basis of this Law.
药品监督管理部门按照规定对药品经营企业是否符合《药品经营质量管理规范》的要求进行认证；对认证合格的，发给认证证书。
Pharmaceutical supervisory and administrative departments shall certify whether pharmaceutical trading enterprises meet the requirements of the "Standards for Quality Control of Pharmaceutical Trading" in accordance with relevant regulations, and issue certifications to qualified enterprises.
《药品经营质量管理规范》的具体实施办法、实施步骤由国务院药品监督管理部门规定。
Detailed implementation measures and procedures for the "Standards for Quality Control of Pharmaceutical Trading" shall be stipulated by the pharmaceutical supervisory and administrative departments under the State Council.
第十七条 药品经营企业购进药品，必须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；不符合规定要求的，不得购进。
Article 17 Pharmaceutical trading enterprises must formulate and implement check and approval rules for the purchase of pharmaceuticals, and check pharmaceutical certifications and other marks while purchasing pharmaceuticals. Pharmaceuticals that do not meet the required standards must not be purchased.
第十八条 药品经营企业购销药品，必须有真实完整的购销记录。购销记录必须注明药品的通用名称、剂型、规格、批号、有效期、生产厂商、购（销）货单位、购（销）货数量、购销价格、购（销）货日期及国务院药品监督管理部门规定的其他内容。
Article 18 Pharmaceutical trading enterprises shall keep accurate and complete records of purchased pharmaceuticals. Purchasing records must bear information on the pharmaceutical product's generic names, types, specifications, batches, valid periods, producing enterprises, purchasing (selling) units, purchasing (selling) quantity, purchasing and selling price, purchasing (selling) date and other contents required by the pharmaceutical supervisory and administrative department under the State Council.
第十九条 药品经营企业销售药品必须准确无误，并正确说明用法、用量和注意事项；调配处方必须经过核对，对处方所列药品不得擅自更改或者代用。对有配伍禁忌或者超剂量的处方，应当拒绝调配；必要时，经处方医师更正或者重新签字，方可调配。
Article 19 It is imperative for pharmaceutical trading enterprises, in the sale of pharmaceuticals, to be accurate and free of mistakes, and to provide correct directions for use, dosage and precautions. Prescriptions being dispensed must be checked. Pharmaceutical products listed in the prescription must not be presumptuously changed or substituted. Prescriptions containing incompatible substances or excessive dosages shall be rejected by the dispensary. If necessary, such prescriptions can be dispensed after they have been corrected or re-signed by the doctors who wrote them.
药品经营企业销售中药材，必须标明产地。
When traditional Chinese medicinal materials are offered for sale by pharmaceutical trading enterprises, their origin must be indicated.
第二十条 药品经营企业必须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。
Article 20 Rules for storage of pharmaceuticals shall be formulated and implemented by pharmaceutical trading enterprises, which must adopt necessary measures to facilitate cold storage and protection against freezing, moisture, insects and rodents to ensure pharmaceutical quality.
药品入库和出库必须执行检查制度。
An inspection system shall be carried out for pharmaceuticals entering or leaving a warehouse
第二十一条 城乡集市贸易市场可以出售中药材，国务院另有规定的除外。
Article 21 Unless otherwise stipulated by the State, traditional Chinese medicinal materials may be marketed at urban or rural fairs.
城乡集市贸易市场不得出售中药材以外的药品，但持有《药品经营许可证》的药品零售企业在规定的范围内可以在城乡集市贸易市场设点出售中药材以外的药品。具体办法由国务院规定。
Pharmaceuticals other than traditional Chinese medicinal materials may not be sold at urban or rural fairs, but those retail enterprises which have the Pharmaceutical Trade License may set up stalls at urban or rural fairs to sell pharmaceuticals other than traditional Chinese medicinal materials within prescribed areas. Detailed measures shall be stipulated by the State Council.
第四章 医疗机构的药剂管理
Chapter IV Administration of Pharmaceuticals at Medical Organizations
第二十二条 医疗机构必须配备依法经过资格认定的药学技术人员。非药学技术人员不得直接从事药剂技术工作。
Article 22 Medical organizations must be staffed with legally certified pharmaceutical technical personnel. Non-pharmaceutical technical personnel may not be directly engaged in the technical work of the pharmacy.
第二十三条 医疗机构配制制剂，须经所在地省、自治区、直辖市人民政府卫生行政部门审核同意，由省、自治区、直辖市人民政府药品监督管理部门批准，发给《医疗机构制剂许可证》。无《医疗机构制剂许可证》的，不得配制制剂。
Article 23 To make medicinal preparations, a medical organization must be examined and approved by the administrative departments of health of the provinces, autonomous regions, or municipalities directly under the central government where the organization is located , and approved and issued a Dispensing Permit for Medical Organizations by the pharmaceutical supervisory and administrative departments of the provinces, autonomous regions or municipalities directly under the central government. No medicinal preparations shall be made without a Dispensing Permit for Medical Organizations.
《医疗机构制剂许可证》应当标明有效期，到期重新, 审查发证。
The Dispensing Permit for Medical Organizations shall bear a period of validity, and upon expiration a new license shall be issued after examination for its renewal.
第二十四条 医疗机构配制制剂，必须具有能够保证制剂质量的设施、管理制度、检验仪器和卫生条件。
Article 24 Medical organizations that make medicinal preparations must have facilities, a m
第二十五条 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的品种，并须经所在地省、自治区、直辖市人民政府药品监督管理部门批准后方可配制。
Article 25 The medicinal preparations made by medical organizations shall be of the kinds that supply the clinical needs of the units themselves but have not been supplied on the market, and must not be made until the approval of the pharmaceutical supervisory and administrative departments of the provinces, autonomous regions and municipalities directly under the central government where the units are located.
配制的制剂必须按照规定进行质量检验；合格的，凭医师处方在本医疗机构使用。特殊情况下，经国务院或者省、自治区、直辖市人民政府的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医疗机构之间调剂使用。
The quality of the medicinal preparations made by medical organizations must be inspected in accordance with relevant regulations. Those preparations conforming to standard can be used as the doctor prescribes. Under special circumstances, with approval from the pharmaceutical supervisory and administrative departments of the central government or of the provinces, autonomous regions and municipalities directly under the central government, the medicinal preparations made by medical organizations can be shared among appointed medical organizations.
医疗机构配制的制剂，不得在市场销售。
Medicinal preparations made by medical organizations may not be sold on the market.
第二十六条 医疗机构购进药品，必须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；不符合规定要求的，不得购进和使用。
Article 26 When purchasing pharmaceuticals, medical organizations must formulate and implement a system of quality inspection and check the certificates and other marks of pharmaceuticals. Those pharmaceuticals that do not meet the requirements of relevant regulations shall not be purchased and used.
第二十七条 医疗机构的药剂人员调配处方，必须经过核对，对处方所列药品不得擅自更改或者代用。对有配伍禁忌或者超剂量的处方，应当拒绝调配；必要时，经处方医师更正或者重新签字，方可调配。
Article 27 Prescriptions being dispensed by the dispensers of medical organizations must be checked. Pharmaceuticals listed in prescriptions must not be presumptuously changed or substituted. Prescriptions containing incompatible substances or excessive dosages shall be rejected by the dispensary. If necessary, such prescriptions can be dispensed after they have been corrected or re-signed by the doctors who wrote them.
第二十八条 医疗机构必须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。
Article 28 Rules for storage of pharmaceuticals shall be formulated and implemented by medical organizations, which must adopt necessary measures to facilitate cold storage and protection against cold, moisture, insects and rodents to ensure the quality of pharmaceuticals.
