Order the President of the People's Republic of China | | 中华人民共和国主席令 |
(No.18) | |
（第十八号） |
The Pharmaceutical Administration Law of the People's Republic of China, as adopted at the Seventh Meeting of the Standing Committee of the Sixth National People's Congress on September 20, 1984, is hereby promulgated, and effective as of July 1, 1985 | |
《中华人民共和国药品管理法》已由中华人民共和国第六届全国人民代表大会常务委员会第七次会议于一九八四年九月二十日通过，现予公布，自一九八五年七月一日起施行。 |
President of the People's Republic of China, Li Xiannian | |
中华人民共和国主席 李先念 |
September 20, 1984 | |
一九八四年九月二十日 |
PHARMACEUTICAL ADMINISTRATION LAW OF THE PEOPLE'S REPUBLIC OF CHINA | |
中华人民共和国药品管理法 |
(Adopted
at the Seventh Meeting of the Standing Committee of the Sixth National
People's Congress) | |
（一九八四年九日二十日第六届全国人民代表大会常务委员会第七会议通过） |
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| CHAPTER I GENERAL PROVISIONS | | 第一章 总 则 |
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| Article 1. This Law is formulated with a view to enhancing the supervision and control of pharmaceuticals, ensuring their quality, improving their curative effects, guaranteeing safety in medication and safeguarding the health of the people. | | 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。 |
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| Article 2. The administrative department of health under the State Council shall be responsible for the supervision and control of pharmaceuticals throughout the country. | | 第二条 国务院卫生行政部门主管全国药品监督管理工作。 |
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| Article 3. The state shall develop both modern and traditional medicines and give full play to their role in the prevention and treatment of diseases and in health care. | | 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。 |
The state shall protect the resources of wild medicinal materials and encourage the domestic cultivation of Chinese traditional medicinal crops. | |
国家保护野生药材资源，鼓励培育中药材。 |
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| CHAPTER II ADMINISTRATION OF PHARMACEUTICAL PRODUCING ENTERPRISES | | 第二章 药品生产企业的管理 |
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| Article 4. The establishment of a pharmaceutical producing enterprise must be sanctioned by the competent authorities for the production and trading of pharmaceuticals of the province, autonomous region, or municipality directly under the Central Government in which the enterprise is located, and approved by the administrative department of health of the same province, autonomous region or municipality, which will issue a Pharmaceuticals Producer Licence. The administrative authorities for industry and commerce shall not issue business licences to any enterprises producing pharmaceuticals without the Pharmaceutical Producer Licence. | | 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》。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》。 |
The Pharmaceutical Producer Licence shall have a period of validity, upon expiration of which a new licence shall be issued after an examination for its renewal. Detailed measures for the renewal of such licences shall be stipulated by the administrative department of health under the State Council. | |
《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部门规定。 |
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| Article 5. To establish a pharmaceutical producing enterprise, the following requirements must be met: | | 第五条 开办药品生产企业必须具备以下条件： |
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| (1) It shall be staffed with the necessary personnel required for producing the medicines concerned, that is, pharmacists or technical personnel with a qualification equivalent to or higher than assistant engineer as well as skilled workers. | | 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。 |
If an enterprise processing Chinese traditional medicines into ready-to-use mixture and powder forms does not have pharmacists or technical personnel with a qualification equivalent to or higher than assistant engineer, it shall be staffed instead with skilled pharmaceutical workers who are familiar with the properties of the medicines processed and are registered with the administrative department of health at or above the county level. | |
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的，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。 |
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| (2) It shall have factory premises, facilities and a sanitary environment suitable for the medicines produced. | | 二、具有与所生产药品相适应的厂房、设施和卫生环境。 |
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| (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. | | 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。 |
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| Article 6. Pharmaceuticals must be produced in accordance with the technological procedure, and the record of production must be complete and accurate. | | 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。 |
The process for preparing traditional Chinese medicines in ready-to-use forms must conform to the Pharmacopoeia of the People's Republic of China or the Processing Norms stipulated by the administrative departments of health of the provinces, autonomous regions, or municipalities directly under the Central Government. | |
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。 |
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| Article 7. The raw and supplementary materials used for the production of pharmaceuticals and containers and packaging materials in direct contact with pharmaceuticals must conform to the requirements for medicinal use. | | 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。 |
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| Article 8. Pharmaceuticals must go through quality inspection before they leave the factory; products which do not meet the standards shall not leave the factory. | | 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。 |
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| Article 9. Pharmaceutical producing enterprises must draw up and carry out rules and regulations and sanitary requirements for ensuring the quality of pharmaceuticals in accordance with the Standards for Quality Control of Pharmaceutical Production stipulated by the administrative department of health under the State Council. | | 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。 |
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| CHAPTER III ADMINISTRATION OF PHARMACEUTICAL TRADING ENTERPRISES | | 第三章 药品经营企业的管理 |
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| Article 10. The establishment of a pharmaceutical trading enterprise must be sanctioned by the local competent authorities for the production and trading of pharmaceuticals and approved by the administrative department of health at or above the county level, which will issue a Pharmaceutical Trading Enterprise Licence. The administrative authorities for industry and commerce shall not issue business licences to any enterprises without the Pharmaceutical Trading Enterprise Licence. | | 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，工商行政管部门不得发给《营业执照》。 |
The Pharmaceutical Trading Enterprise Licence shall have a period of validity, upon expiration of which a new licence shall be issued after an examination for its renewal. Detailed measures for the renewal of such licences shall be stipulated by the administrative department of health under the State Council. | |
《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。 |
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| Article 11. To establish a pharmaceutical trading enterprise, the following requirements must be met: | | 第十一条 开办药品经营企业必须具备以下条件： |
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| (1) It shall be staffed with pharmaceutical technicians qualified for the handling of the pharmaceuticals. | | 一、具有与所经营药品相适应的药学技术人员。 |
If an enterprise trading in Chinese traditional medicines or an enterprise concurrently trading in medicines does not have pharmaceutical technicians, it shall be staffed instead with pharmaceutical workers who are familiar with the properties of the medicines it trades in and are registered with the administrative department of health at or above the county level. | |
经营中药的企业和兼营药品的企业没有药学技术人员的，配备熟悉所经营药品的药性并经县级以上卫生行政部门审查登记的药工人员。 |
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| (2) It shall have business premises, equipment, storage facilities and a sanitary environment suitable for the pharmaceuticals in which it trades. | | 二、具有与所经营药品相适应的营业场所、设备、仓储设施和卫生环境。 |
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| Article 12. The quality of pharmaceuticals must be inspected on purchasing. Pharmaceuticals that do not meet the required standards must not be purchased. | | 第十二条 收购药品，必须进行质量验收；不合格的，不得收购。 |
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| Article 13. It is imperative, 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. 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 out. | | 第十三条 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，经处方医生更正或者重新签字，方可调配。 |
When famous traditional Chinese medicinal materials are offered for sale, their origin must be indicated. | |
销售地道中药材，必须标明产地。 |
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| Article 14. Rules for storage of pharmaceuticals shall be formulated and implemented by pharmaceutical warehouses, which must adopt necessary measures to facilitate cold storage and protection against moisture, insects and rodents. | | 第十四条 药品仓库必须制定和执行药品保管制度， 采取必要的冷藏、 防潮、防虫、防鼠等措施。 |
An inspection system shall be carried out for pharmaceuticals entering or leaving warehouses. | |
药品入库和出库必须执行检查制度。 |
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| Article 15. Unless otherwise stipulated by the state, traditional Chinese medicinal materials may be marketed at urban or rural fairs. | | 第十五条 城乡集市贸易市场可以出售中药材，国家另有规定的除外。 |
Pharmaceuticals other than traditional Chinese medicinal materials may not be sold at urban or rural fairs, except by those who have Pharmaceuticals Trading Enterprise Licences. | |
城乡集市贸易市场不得出售中药材以外的药品， 持有《药品经营企业许可证》的除外。 |
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| CHAPTER IV ADMINISTRATION OF PHARMACEUTICALS AT MEDICAL UNITS | | 第四章 医疗单位的药剂管理 |
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| Article 16. Medical units must be staffed with pharmaceutical technical personnel commensurate with their medical functions. Non-pharmaceutical technical personnel may not engage directly in pharmaceutical technical work. | | 第十六条 医疗单位必须配备与其医疗任务相适应的药学技术人员 ， 非药学技术人员不得直接从事药剂技术工作。 |
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| Article 17. To make medicinal preparations, a medical unit must be examined, approved and issued a Dispensing Permit by the administrative department of health of the province, autonomous region, or municipality directly under the Central Government in which the unit is located. | | 第十七条 医疗单位制制剂必须经所在省 、 自治区、直辖市卫生行政部门审查批准，并发给《制剂许可证》。 |
The Dispensing Permit shall have a period of validity, upon expiration of which a new permit shall be issued after an examination for its renewal. Detailed measures for the renewal of such permits shall be stipulated by the administrative department of health under the State Council. | |
《制剂许可证》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。 |
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| Article 18. Medical units making medicinal preparations must be equipped with facilities, inspection instruments and sanitary conditions capable of ensuring the quality of the preparations. | | 第十八条 医疗单位配制制剂必须具有能够保证制剂质量的设施 、 检验仪器和卫生条件。 |
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| Article 19. The quality of the medicinal preparations made by medical units must be inspected in accordance with relevant regulations and clinical needs. Those up to standard can be used as the doctor prescribes. | | 第十九条 医疗单位配制的制剂 ， 必须根据临床需要并按照规定进行质量检验；合格的，凭医生处方使用。 |
Medicinal preparations made by medical units may not be sold on the market. | |
医疗单位配制的制剂，不得在市场销售。 |
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| Article 20. Medical units must implement a system of quality inspection when purchasing pharmaceuticals. | | 第二十条 医疗单位购进行药品，必须执行质量验收制度。 |
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| CHAPTER V PHARMACEUTICAL ADMINISTRATION | | 第五章 药品的管理 |
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| Article 21. The state encourages research on and development of new medicines. | | 第二十一条 国家鼓励研究、创制新药。 |
When working on a new medicine, it is necessary to submit, as required, the methods of production, quality indices, pharmacological and toxicological testing results, and other related materials and sales to the administrative department of health under the State Council or to the administrative department of health of the relevant province, autonomous region, or municipality directly under the Central Government. Clinical tests or clinical verifications can be carried out only after approval. | |
研制新药，必须按照规定向国务院卫生行政部门或者省、自治区、直辖市卫生行政部门报送研制方法、质量指标、药理及毒理试验结果等有关资料和样品，经批准后，方可进行临床试验或者临床验证。 |
A new medicine which has completed its clinical tests or clinical verification and been approved after appraisal shall be issued a certificate by the administrative department of health under the State Council. | |
完成临床试验或者临床验证并通过鉴定的新药，由国务院卫生行政部门批准，发给证书。 |
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| Article 22. A new medicine can be put into production only after the administrative department of health under the State Council has approved it and issued a registered document of approval. However, this does not apply to the production of traditional Chinese medicines prepared in ready-to-use forms. | | 第二十二条 生产新药，必须经国务院卫生行政部门批准， 并发给批准文号。但是，生产中药饮片除外。 |
A medicine standardized by the state or by a province, an autonomous region, or a municipality directly under the Central Government shall be put into production only after the administrative department of health of the relevant province, autonomous region, or municipality directly under the Central Government has made an examination of the medicine, given it approval and issued a registered document of approval, seeking beforehand the opinions of the authorities at the same level in charge of the production and trading of medicines. However, this does not apply to the production of traditional Chinese medicines prepared in ready-to-use forms. | |
生产已有国家标准或者省、自治区、直辖市标准的药品，必须经省、自治区、直辖市卫生行政部门征求同级药品生产经营主管部门意见后审核批准，并发给批准文号。但是，生产中药饮片除外。 |
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| Article 23. Pharmaceuticals must meet the pharmaceutical standards of the state or those of the relevant province, autonomous region, or municipality directly under the Central Government. | | 第二十三条 药品必须符合国家药品标准或者省、自治区、直辖市药品标准。 |
The Pharmacopoeia of the People's Republic of China and the pharmaceutical standards promulgated by the administrative department of health under the State Council shall be the State pharmaceutical standards. | |
国务院卫生行政部门颁布的《中华人民共和国药典》和药品标准为国家药品标准。 |
The Pharmacopoeia Committee of the administrative department of health under the State Council shall be responsible for organizing the formulation and revision of the state pharmaceutical standards. | |
国务院卫生行政部门的药典委员会，负责组织国家药品标准的制定和修订。 |
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| Article 24. The administrative department of health under the State Council and administrative departments of health of provinces, autonomous regions, and municipalities directly under the Central Government may establish pharmaceuticals examination and evaluation committees to carry out examination and evaluation of new medicines and re-evaluate medicines already put into production. | | 第二十四条 国务院卫生行政部门和省、 自治区、 直辖市卫生行政部门可以成立药品审评委员会，对新药进行审评，对已经生产的药品进行再评价。 |
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| Article 25. The administrative department of health under the State Council shall organize investigations on medicines which have been approved for production. It shall revoke the registered documents of approval if it discovers that the medicines' curative effects are uncertain or poor, or that they produce serious adverse reactions or for other reasons are harmful to people's health. | | 第二十五条 国务院卫生行政部门对已经批准生产的药品 ， 应当组织调查；对疗效不确、不良反应大或者其他原因危害人民健康的药品，应当撤销其批准文号。 |
Production and sale of the medicines whose registered documents of approval have been revoked shall not be allowed to continue; those which have already been produced shall be destroyed or disposed of under the supervision of the local administrative department of health. | |
已被撤销批准文号的药品，不得继续生产、销售；已经生产的，由当地卫生行政部门监督销毁或者处理。 |
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| Article 26. Import of medicines whose curative effects are uncertain or poor, or which produce adverse reactions or have other harmful effects on people's health shall be prohibited. | | 第二十六条 禁止进口疗效不确、不良反应大或者其他原因危害人民健康的药品。 |
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| Article 27. For any medicine which is to be imported for the first time, the importer must submit the manuals, quality standards, methods of inspection and other related information and samples, as well as the exporting country's (region's) certification documents approving its production, to the administrative department of health under the State Council, and import contracts may be signed only with the prior approval of the said department. | | 第二十七条 首次进口的药品， 进口单位必须提供该药品的说明书、 质量标准、检验方法等有关资料和样品以及出口国（地区）批准生产的证明文件，经国务院卫生行政部门批准，方可签订进口合同。 |
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| Article 28. Imported medicines must be inspected by the pharmaceutical inspection institutions authorized by the administrative department of public health under the State Council; those having passed the inspection shall be allowed to be imported. | | 第二十八条 进口的药品， 必须经国务院卫生行政部门授权的药品检验机构检验； 检验合格的，方准进口。 |
Medicines to be imported in small quantities for urgent clinical needs by medical units or for personal use shall be handled according to customs regulations. | |
医疗单位临床急需或者个人自用进口的少量药品，按照海关的规定办理进口手续。 |
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| Article 29. The administrative department of health under the State Council shall have the power to restrict or prohibit the export of traditional Chinese medicinal materials and prepared Chinese medicines which are in short supply in the domestic market. | | 第二十九条 对国内供应不足的中药材、 中成药， 国务院卫生行政部门有权限制或者禁止出口。 |
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| Article 30. Import Licences or Export Licences issued by the administrative department of health under the State Council are required for the import or export of narcotics and psychotropic substances falling within the restricted scope prescribed by the administrative department of health under the State Council. | | 第三十条 进口 、 出口麻醉药品和国务院卫生行政部门规定范围内的精神药品，必须持有国务院卫生行政部门发给的《进口准许证》、《出口准许证》。 |
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| Article 31. Newly discovered domestic medicinal plants or medicinal plants introduced from abroad may be sold only after they have been examined and approved by the administrative department of health of the relevant province, autonomous region, or municipality directly under the Central Government. | | 第三十一条 新发现和从国外引种的药材， 经省、 自治区、直辖市卫生行政部门审核批准后，方可销售。 |
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| Article 32. Measures for controlling medicinal materials traditionally used by local people in certain regions shall be formulated by the administrative department of health under the State Council. | | 第三十二条 地区性民间习用药材的具体管理办法，由国务院卫生行政部门制定。 |
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| Article 33. The production and sale of fake medicines are prohibited. A fake medicine has either of the following characteristics: | | 第三十三条 禁止生产、销售假药。有下列情形之一的为假药： |
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| (1) The names of its components are different from those prescribed for it by state pharmaceutical standards or pharmaceutical standards of the relevant province, autonomous region, or municipality directly under the Central Government; | | 一、药品所含成份的外称与国家药品标准或者省、自治区、直辖市药品标准规定不符合的。 |
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| (2) A non-medical substance is passed off as a medicine, or one medicine is passed off as another. | | 二、以非药品冒充药品或者以他种药品冒充此种药品的。 |
A medicine shall be handled as fake medicine in any of the following cases: | |
有下列情形之一的药品按假药处理： |
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| (1) Where the use of the medicine has been prohibited by the administrative department of health under the State Council; | | 一、国务院卫生行政部门规定禁止使用的。 |
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| (2) Where the medicine produced without being assigned a registration number; | | 二、未取得批准文号生产的。 |
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| (3) Where the medicine has deteriorated and cannot be used as such; or | | 三、变质不能药用的。 |
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| (4) Where the medicine has been contaminated and cannot be used as such. | | 四、被污染不能药用的。 |
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| Article 34. The production and sale of medicines of inferior quality shall be prohibited. A medicine of inferior quality has any of the following characteristics: | | 第三十四条 禁止生产、销售劣药。有下列情形之一的药品为劣药： |
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| (1) The components of the medicine does not conform in quantity to that required by state pharmaceutical standards or pharmaceutical standards of the relevant province, autonomous region, or municipality directly under the Central Government; | | 一、药品成份的含量与国家药品标准或者省、自治区、 直辖市药品标准规定不符合的。 |
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| (2) The medicine has passed its expire date; or | | 二、超过有效期的。 |
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| (3) The medicine fails to meet the prescribed standards in other respects. | | 三、其他不符合药品标准规定的。 |
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| Article 35. Personnel in pharmaceutical producing or trading enterprises and in medical units, who have direct contact with medicines, must undergo an annual medical examination. Persons who have contracted contagious diseases or any other disease which may contaminate the medicines shall not be allowed to engage in any work which has direct contact with pharmaceuticals. | | 第三十五条 药品生产企业 、 药品经营企业和医疗单位直接接触药品的工作人员，必须每年进行健康检查。患有传染病或者他可能污染药品的疾病的患者，不得从事直接接触药品的工作。 |
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| CHAPTER VI ADMINISTRATION OF PHARMACEUTICALS AT MEDICAL UNITS | | 第六章 药品的包装和分装 |
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| Article 36. Packaging must meet the specific quality requirements of the pharmaceuticals and facilitate their storage, transportation and medical use. If a medicine has a period of validity, it must be clearly indicated on the package. | | 第三十六条 药品包装必须适合药品质量的要求， 方便储存、 运输和医疗使用。规定有效期的药品，必须在包装上注明有效期。 |
Traditional Chinese medicinal materials must be packaged before transportation. There must appear on the package the name of the medicine, place of production, date, name of the consignor, and an indication showing that the quality of the medicine is up to standard. | |
发运中药材必须有包装。在每件包装上，必须注明品名、产地、日期、调出单位，并附有质量合格的标志。 |
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| Article 37. Packages of pharmaceuticals must, in accordance with the regulations, be labeled and include directions for use. | | 第三十七条 药品包装必须按照规定贴有标签并附有说明书。 |
The label or directions must indicate the name of the medicine, specifications, the producer, registration number, batch number of the product, principal components, indications, directions for use dosage, contraindications, adverse reactions and precautions. | |
标签或者说明书上必须注明药品的品名、规格、生产企业、批准文号、产品批号、主要成份、适应症、用法、用量、禁忌、不良反应和注意事项。 |
Special indications must be printed as required on the labels of narcotics, psychotropic substances, toxic drugs, radioactive drugs and medicines for external use. | |
麻醉药品、精神药品、毒性药品、放射性药品和外用药品的标签，必须印有规定的标志。 |
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| Article 38. A pharmaceuticals trading enterprise engaged in the repackaging of medicines must possess the necessary facilities and sanitary conditions suitable for the purpose, and pharmaceutical technicians must be placed in charge of this work. The repackaging records must be complete and accurate. | | 第三十八条 药品经营企业分装药品 ， 必须具有与所分装药品相适应的设施和卫生条件，由药学技术人员负责，分装记录必须完整准确。 |
The repackaged medicine must enclose directions for use, and on the package must be indicated the name of the medicine, specifications, the producter, the batch number of the product, the repackaging unit and the lot number of the repackaged product. If the medicine has a period of validity, it must also be indicated on the new package. | |
分装药品必须附有说明书，在包装上注明品名、规格、生产企业和产品批号、分装单位和分装批号。规定有效期的药品，分装后必须注明有效期。 |
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| CHAPTER VII PHARMACEUTICALS UNDER SPECIAL CONTROL | | 第七章 特殊管理的药品 |
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| Article 39. The state adopts special measures for the control of narcotics, psychotropic substances, toxic drugs and radioactive drugs. Regulations for the control of these drugs shall be formulated by the State Council. | | 第三十九条 国家对麻醉药品、 精神药品、 毒性药品、放射性药品，实行特殊的管理办法。管理办法由国务院制定。 |
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| Article 40. Narcotics, including their mother plants, must only be produced by units jointly designated by the administrative department of health under the State Council and other departments concerned, and must be supplied by units jointly designated by the administrative department of health of provinces, autonomous regions, and municipalities directly under the Central Government and other departments concerned. | | 第四十条 麻醉药品， 包括原植物， 只准由国务院卫生行政部门会同有关部门指定的单位生产，并由省、自治区、直辖市卫生行政部门会有关部门指定的单位按照规定供应。 |
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| CHAPTER VIII ADMINISTRATION OF TRADEMARKS AND ADVERTISEMENTS OF PHARMACEUTICALS | | 第八章 药品商标和广告的管理 |
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| Article 41. Registered trademarks must be used for all pharmaceuticals with the exception of traditional Chinese medicinal materials and their preparations in ready-to-use forms. The sale of pharmaceuticals without completing trademark registration shall be prohibited. | | 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。 |
The registered trademark must appear on the package and the label of the medicine. | |
注册商标必须在药品包装和标签上注明。 |
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| Article 42. Advertisements of pharmaceuticals must be examined and approved by the administrative department of health of the relevant province, autonomous region, or municipality directly under the Central Government. In the absence of such approval, advertisement of any medicine may not be published, broadcasted, handed out or posted on walls. | | 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。 |
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| Article 43. Foreign enterprises which apply to advertise pharmaceuticals in China must submit relevant documents of approval by the country (region) in which the pharmaceuticals are produced, directions for use and other relevant materials. | | 第四十三条 外国企业在我国申请理药品广告 ， 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。 |
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| Article 44. Advertisements of pharmaceuticals must be based on the directions for use approved by the administrative department of health under the State Council or the administrative departments of health of provinces, autonomous regions, or municipalities directly under the Central Government. | | 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。 |
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| CHAPTER IX SUPERVISION OVER PHARMACEUTICALS | | 第九章 药品监督 |
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| Article 45. The administrative departments of health at and above the county level shall exercise supervisory power over pharmaceuticals. | | 第四十五条 县级以上卫生行政门行使药品监督职权。 |
The administrative departments of health at and above the county level may set up organs for the administration of pharmaceuticals and organs for the inspection of pharmaceuticals. | |
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。 |
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| Article 46. There shall be pharmaceutical inspectors in the administrative departments of health at and above the county level. Pharmaceutical inspectors shall be appointed from among pharmacological technical personnel and issued certificates by the people's governments at the same level. | | 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。 |
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| Article 47. Pharmaceutical inspectors are authorized to exercise, in accordance with the regulations, supervision, inspection and sampling as regards the quality of pharmaceuticals in the producing enterprises, trading enterprises and medical units within their jurisdiction, and when necessary may pick samples at random and ask for relevant data in accordance with regulations. The enterprises and units concerned may not refuse such requests or withhold relevant data. Pharmaceutical inspectors are duty bound to keep confidential the technical information provided by pharmaceutical producing enterprises and scientific research institutions. | | 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。药品监督员对药品生产企业和科研单位提供的技术资料，负责保密。 |
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| Article 48. Pharmaceutical producing enterprises, pharmaceutical trading enterprises and medical institutions shall conduct regular surveys on the quality, curative effects and adverse reactions of the pharmaceuticals they have produced, traded in or used. | | 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、使用的药品的量、疗效和不良反应。 |
When drug poisoning is discovered, the medical institution concerned must promptly report the matter to the local administrative department of health. | |
医疗单位发现药品毒事故，必须及时向地卫生行政部门报告。 |
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| Article 49. The organs or personnel in charge of pharmaceutical inspection in pharmaceutical producing enterprises and pharmaceutical trading enterprises shall receive operational guidance from the local pharmaceutical inspection organs. | | 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。 |
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| CHAPTER X LEGAL RESPONSIBILITY | | 第十章 法律责任 |
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| Article 50. Whoever produces or sells fake medicines shall have his fake medicines and unlawful income confiscated and may concurrently be fined; in addition, he may be ordered to suspend production or business operations pending rectification, or have his Pharmaceutical Producer Licence, Pharmaceutical Trading Enterprise Licence or Dispensing Permit revoked. | | 第五十条 生产、 销售假药的， 没收假药和违法所得，处以罚款，并可以责令该单位停产、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》。 |
An individual who produces or sells fake medicines, or the person directly responsible for a unit which commits this offence, and thereby endangers people's health, shall be investigated for criminal liability under Article 164 of the Criminal Law | |
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的规定追究刑事责任。 |
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| Article 51. Whoever produces or sells medicines of inferior quality shall have his medicines of inferior quality and unlawful income confiscated and may be fined as well. If the circumstances are serious, the unit concerned shall be ordered to suspend production or business operations pending rectification, or have its Pharmaceutical Producer Licence, Pharmaceutical Trading Enterprise Licence or Dispensing Permit revoked. | | 第五十一条 生产、销售劣药的， 没收劣药和违法所得， 可以并处罚款； 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》。 |
An individual who produces or sells medicines of inferior quality or the person directly responsible for a unit which commits this offence, and thereby endangers people's health and causes serious consequences, shall be investigated for criminal liability in reference to the provisions of Article 164 of the Criminal Law. | |
对生产、销售劣药，危害人民健康，造成严重后果的个人或者单位直接责任人员，比照刑法第一百六十四条的规定追究刑事责任。 |
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| Article 52. Any unit engaged in the production, trading or preparation of medicines without obtaining the Pharmaceutical Producer Licence, Pharmaceutical Trading Enterprise Licence or Dispensing Permit shall be ordered to suspend production, business operations or preparation of such medicines. The medicines and unlawful income shall all be confiscated and a fine may also be imposed. | | 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，可以并处罚款。 |
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| Article 53. Whoever violates any other provision of this Law on the administration of pharmaceutical production and pharmaceutical trading shall be served a warning or be fined. | | 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。 |
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| Article 54. The decision to mete out administrative sanctions stipulated in this Law shall be made by the administrative departments of health at or above the county level. The decision to mete out administrative sanctions for violations of the provisions of Article 15 or of CHAPTER Eight on administration of advertisements of this Law shall be made by the administrative departments for industry and commerce. | | 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。 |
Punishment by suspension of production or business operations pending rectification for seven days or more, or revocation of the Pharmaceutical Producer Licence or Pharmaceutical Trading Enterprise Licence to be meted out to pharmaceutical producing enterprises or pharmaceutical trading enterprises directly under the jurisdiction of the Central Government or of the people's governments of provinces, autonomous regions, or municipalities directly under the Central Government, shall be submitted by the administrative department of health of the relevant province, autonomous region, or municipality directly under the Central Government to the people's government at the same level for final decision. Punishment by suspension of production or business operations for seven days or more, or revocation of the Pharmaceutical Producer Licence or Pharmaceutical Trading Enterprise Licence, to be meted out to pharmaceutical producing enterprises or pharmaceutical trading enterprises under the jurisdiction of people's governments at or below the city or county level, shall be submitted by the administrative department of health of the people's governments at or below the city or county level to the people's governments at the same level for final 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、停业整顿七天以上或者吊销《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、停业整顿七天以上或者吊销《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。 |
The confiscated pharmaceuticals shall be disposed of under the supervision of the administrative departments of health. | |
没收的药品，由卫生行政部门监督处理。 |
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| Article 55. If the party concerned does not accept the administrative sanction decided on, it may file a suit in the people's court within 15 days after receiving notification of the sanction. However, the said party must immediately carry out the decision on the control of pharmaceuticals made by administrative department of health. If the party neither complies with sanction nor files a suit within the time limit, the organ which made the decision on the administrative sanction shall apply to the people's court for compulsory execution. | | 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十五天内向人民法院起诉。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。 |
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| Article 56. If any individual or unit, in violation of this Law, causes drug poisoning, he or it shall be liable for the damage. The victims may request the administrative department of health at or above the county level to handle the matter; the party which does not accept the decision may file a suit in the people's court. The victims, too, may directly bring the case to the people's court. | | 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。 |
The claim for compensation must be made within a year from the day on which the victim or his representative is aware or should have been aware of the damage done. No claim for compensation shall be entertained beyond the time limit. | |
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一年内提出；超过期限的，不予受理。 |
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| CHAPTER XI SUPPLEMENTARY PROVISIONS | | 第十一章 附 则 |
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| Article 57. For the purpose of this Law, the definitions of the following terms are: | | 第五十七条 本法下列用语的含义是： |
" Pharmaceuticals " means articles intended for use in the prevention, treatment or diagnosis of human diseases, or intended to effect the purposive regulation of human physiological functions, for which indications, usage and dosage are prescribed, including raw traditional Chinese medicinal materials, traditional medicines prepared in ready-to-use forms and other prepared Chinese medicines, medicinal chemicals and their preparations, antibiotics, biochemical medicines, radioactive drugs, serums, vaccines, blood products, diagnostic aids, etc. | |
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，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。 |
" New medicines " means medicines which have not been produced in this country before. | |
新药：指我国未生产过的药品。 |
" Supplementary materials " means the excipients and additives used for the production and dispensing of pharmaceuticals. | |
辅料：指生产药品和调配处方时所用的赋形剂和附加剂。 |
" Pharmaceutical producing enterprise " means an enterprise exclusively or partly engaged in the production of pharmaceuticals. | |
药品生产企业：指生产药品的专营企业或者兼营企业。 |
" Pharmaceutical trading enterprise " means an enterprise exclusively or partly engaged in the trading of pharmaceuticals. | |
药品经营企业：指经营药品的专营企业或者兼营企业。 |
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| Article 58. The production of pharmaceuticals referred to in this Law does not include the cultivation, collection and breeding of all categories of medicinal materials used in traditional Chinese medicine. | | 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。 |
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| Article 59. The administrative department of health under the State Council shall, pursuant to this Law, draw up measures for its implementation, which shall enter into force after being submitted to and approved by the State Council. | | 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。 |
Measures for the control of pharmaceuticals specially needed by the Chinese People's Army shall be formulated by the competent military department of the state. | |
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。 |
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| Article 60. This Law shall enter into force as of July 1, 1985. | | 第六十条 本法自一九八五年七月一日起施行。 |
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