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| Regulation on the Control of Narcotic Drugs and Psychotropic Drugs | | 麻醉药品和精神药品管理条例 |
| (issued by the Order No. 442 of the State Council of the People's Republic of China on August 3, 2005, revised in accordance with the Decision of the State Council on Amending Some Administrative Regulations by the Order No. 645 of the State Council on December 7, 2013) | | （2005年8月3日中华人民共和国国务院令第442号公布 根据2013年12月7日国务院令第645号《国务院关于修改部分行政法规的决定》修订） |
| Chapter I General Provisions | | 第一章 总 则 |
| Article 1 With a view to strengthening control on narcotic drugs and psychotropic drugs, ensuring the lawful, safe and reasonable use of narcotic drugs and psychotropic drugs, and preventing them from flowing into illegal channels, the present Regulation is formulated in accordance with the provisions of the Pharmaceutical Administration Law and other relevant laws. | | 第一条 为加强麻醉药品和精神药品的管理，保证麻醉药品和精神药品的合法、安全、合理使用，防止流入非法渠道，根据药品管理法和其他有关法律的规定，制定本条例。 |
| Article 2 The present Regulation shall be applicable to the plant of anesthetic raw herbs and the experiment and research, production, management, use, storage, and transportation of narcotic drugs and psychotropic drugs, and other activities, and the supervision and administration thereof. | | 第二条 麻醉药品药用原植物的种植，麻醉药品和精神药品的实验研究、生产、经营、使用、储存、运输等活动以及监督管理，适用本条例。 |
| The import and export of narcotic drugs and psychotropic drugs shall be handled in accordance with the provisions of relevant laws. | | 麻醉药品和精神药品的进出口依照有关法律的规定办理。 |
| Article 3 The narcotic drugs and the psychotropic drugs as mentioned in the present Regulation shall refer to the drugs and other substances listed into the Catalog of Narcotic Drugs and the Catalog of Psychotropic Drugs (hereinafter called Catalogs). Psychotropic drugs shall be classified into psychotropic drugs of category I and psychotropic drugs of category II. | | 第三条 本条例所称麻醉药品和精神药品，是指列入麻醉药品目录、精神药品目录（以下称目录）的药品和其他物质。精神药品分为第一类精神药品和第二类精神药品。 |
| The Catalogs shall be formulated, adjusted and publicized by the department of drug supervision and administration of the State Council together with the public security department of the State Council and the competent department of health of the State Council. | | 目录由国务院药品监督管理部门会同国务院公安部门、国务院卫生主管部门制定、调整并公布。 |
| In case there occurs any misuse of any drug or any other substance that is listed for sale but has not been listed in the Catalogs or of the psychotropic drugs of category II, which has resulted in or may result in serious social harmfulness, the department of drug supervision and administration of the State Council shall, together with the public security department of the State Council and the competent department of health of the State Council, list the drug or the substance into the Catalogs or adjust the psychotropic drugs of category II into the psychotropic drugs of category I. | | 上市销售但尚未列入目录的药品和其他物质或者第二类精神药品发生滥用，已经造成或者可能造成严重社会危害的，国务院药品监督管理部门会同国务院公安部门、国务院卫生主管部门应当及时将该药品和该物质列入目录或者将该第二类精神药品调整为第一类精神药品。 |
| Article 4 The state shall make control on anesthetic raw herbs and narcotic drugs and psychotropic drugs. Unless otherwise specified by the present Regulation, no entity or individual may plant any anesthetic raw herbs, or carry out experiment and research, production, management, use, storage, or transportation of narcotic drugs and psychotropic drugs and other activities. | | 第四条 国家对麻醉药品药用原植物以及麻醉药品和精神药品实行管制。除本条例另有规定的外，任何单位、个人不得进行麻醉药品药用原植物的种植以及麻醉药品和精神药品的实验研究、生产、经营、使用、储存、运输等活动。 |
| Article 5 The department of drug supervision and administration of the State Council shall be responsible for the supervision and administration of narcotic drugs and psychotropic drugs nationwide, and shall, together with the competent department of agriculture of the State Council, conduct supervision and administration on anesthetic raw herbs. The department of public security of the State Council shall be responsible for making investigation into acts which result in the flowing of anesthetic raw herbs and narcotic drugs and psychotropic drugs into illegal channels. Other competent departments of the State Council shall be responsible for the work in relation to the administration of narcotic drugs and psychotropic drugs within their own scope of functions. | | 第五条 国务院药品监督管理部门负责全国麻醉药品和精神药品的监督管理工作，并会同国务院农业主管部门对麻醉药品药用原植物实施监督管理。国务院公安部门负责对造成麻醉药品药用原植物、麻醉药品和精神药品流入非法渠道的行为进行查处。国务院其他有关主管部门在各自的职责范围内负责与麻醉药品和精神药品有关的管理工作。 |
| The departments of drug supervision and administration of the people's governments at provinces, autonomous regions, and municipalities directly under the Central Government shall be responsible for the supervision and administration of narcotic drugs and psychotropic drugs within their own administrative regions. The local public security organs at or above the county level shall be responsible for making investigation into acts which result in the flowing of narcotic drugs and psychotropic drugs into illegal channels within their own administrative regions. Other relevant competent departments of the local people's governments at or above the county level shall be responsible for the work relating to the administration of narcotic drugs and psychotropic drugs within their own scope of 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麻醉药品和精神药品的监督管理工作。县级以上地方公安机关负责对本行政区域内造成麻醉药品和精神药品流入非法渠道的行为进行查处。县级以上地方人民政府其他有关主管部门在各自的职责范围内负责与麻醉药品和精神药品有关的管理工作。 |
| Article 6 Any enterprise undertaking the production and management of narcotic drugs and psychotropic drugs and any entity using these drugs may take part in the industry association according to law. The industry association shall strengthen self-disciplinary management on the industry. | | 第六条 麻醉药品和精神药品生产、经营企业和使用单位可以依法参加行业协会。行业协会应当加强行业自律管理。 |
| Chapter II Planting, Experiment and Research and Production | | 第二章 种植、实验研究和生产 |
| Article 7 The state shall, according to the needs for medical treatment, national reserve and the materials needed for enterprise production, determine the demand of narcotic drugs and psychotropic drugs, and control the total amount of the planting of anesthetic raw herbs and the production of narcotic drugs and psychotropic drugs. | | 第七条 国家根据麻醉药品和精神药品的医疗、国家储备和企业生产所需原料的需要确定需求总量，对麻醉药品药用原植物的种植、麻醉药品和精神药品的生产实行总量控制。 |
| The department of drug supervision and administration of the State Council shall formulate annul production plan according to the demand of narcotic drugs and psychotropic drugs. | | 国务院药品监督管理部门根据麻醉药品和精神药品的需求总量制定年度生产计划。 |
| The department of drug supervision and administration of the State Council and the competent department of agriculture of the State Council shall, according to the annual production plan for narcotic drugs, make an annual plan for planting anesthetic raw herbs. | | 国务院药品监督管理部门和国务院农业主管部门根据麻醉药品年度生产计划，制定麻醉药品药用原植物年度种植计划。 |
| Article 8 Any enterprise undertaking the plant of anesthetic raw herbs shall, according to the annual planting plan, plant the anesthetic raw herbs. | | 第八条 麻醉药品药用原植物种植企业应当根据年度种植计划，种植麻醉药品药用原植物。 |
| The enterprises undertaking the plant of anesthetic raw herbs shall report the planting conditions periodically to the department of drug supervision and administration of the State Council and the competent department of agriculture of the State Council. | | 麻醉药品药用原植物种植企业应当向国务院药品监督管理部门和国务院农业主管部门定期报告种植情况。 |
| Article 9 The enterprises undertaking the plant of anesthetic raw herbs shall be determined by the department of drug supervision and administration of the State Council and the competent department of agriculture of the State Council together, no other entity or individual shall plant anesthetic raw herbs. | | 第九条 麻醉药品药用原植物种植企业由国务院药品监督管理部门和国务院农业主管部门共同确定，其他单位和个人不得种植麻醉药品药用原植物。 |
| Article 10 The following conditions shall be met for carrying out the experiment and research on narcotic drugs and psychotropic drugs, with the approval of the department of drug supervision and administration of the State Council: | | 第十条 开展麻醉药品和精神药品实验研究活动应当具备下列条件，并经国务院药品监督管理部门批准： |
| 1. The purpose is for medical treatment, scientific research or teaching; | | （一）以医疗、科学研究或者教学为目的； |
| 2. The entity has measures and management system for ensuring the safety of narcotic drugs and psychotropic drugs needed for the experiment; and | | （二）有保证实验所需麻醉药品和精神药品安全的措施和管理制度； |
| 3. The entities or its personnel have no acts in violation of the provisions of any anti-drug law or administrative regulation within 2 years. | | （三）单位及其工作人员2年内没有违反有关禁毒的法律、行政法规规定的行为。 |
| Article 11 The entities undertaking the experiments and research of narcotic drugs and psychotropic drugs shall, when applying for the certificate documents of approval for the relevant drugs, handle it according to the provisions of the Pharmaceutical Administration Law; if there is necessity to transfer the research results, they shall be subject to the approval of the department of drug supervision and administration of the State Council. | | 第十一条 麻醉药品和精神药品的实验研究单位申请相关药品批准证明文件，应当依照药品管理法的规定办理；需要转让研究成果的，应当经国务院药品监督管理部门批准。 |
| Article 12 In case any drug research entity produces any controlled drugs as prescribed in the present Regulation during the process of making experiment and research on ordinary drugs, it shall stop the activity of experiment and research immediately, and report to the department of drug supervision and administration of the State Council. The department of drug supervision and administration of the State Council shall, according to the reality, make decision on whether to approve it to continue the experiment and research in a timely manner. | | 第十二条 药品研究单位在普通药品的实验研究过程中，产生本条例规定的管制品种的，应当立即停止实验研究活动，并向国务院药品监督管理部门报告。国务院药品监督管理部门应当根据情况，及时作出是否同意其继续实验研究的决定。 |
| Article 13 The clinical trials on narcotic drugs and the psychotropic drugs of category I shall not target on healthy people. | | 第十三条 麻醉药品和第一类精神药品的临床试验，不得以健康人为受试对象。 |
| Article 14 The state shall implement the system of designated production on narcotic drugs and psychotropic drugs. | | 第十四条 国家对麻醉药品和精神药品实行定点生产制度。 |
| The department of drug supervision and administration of the State Council shall, according to the demand of narcotic drugs and psychotropic drugs, determine the quantity and overall arrangement of the designated production enterprises of narcotic drugs and psychotropic drugs, and make adjustment and publicity on the quantity and layout according to annual demand. | | 国务院药品监督管理部门应当根据麻醉药品和精神药品的需求总量，确定麻醉药品和精神药品定点生产企业的数量和布局，并根据年度需求总量对数量和布局进行调整、公布。 |
| Article 15 The designated production enterprises of narcotic drugs and psychotropic drugs shall have the following conditions: | | 第十五条 麻醉药品和精神药品的定点生产企业应当具备下列条件： |
| 1. Having drug production license; | | （一）有药品生产许可证； |
| 2. Having documents of approval for the experiment and research of narcotic drugs and psychotropic drugs; | | （二）有麻醉药品和精神药品实验研究批准文件； |
| 3. Having production facilities, storage conditions and the corresponding safeguard management establishments for narcotic drugs and psychotropic drugs complying with the requirements; | | （三）有符合规定的麻醉药品和精神药品生产设施、储存条件和相应的安全管理设施； |
| 4. Having the ability to conduct work safety management on enterprises through network and to report production information to the department of drug supervision and administration; | | （四）有通过网络实施企业安全生产管理和向药品监督管理部门报告生产信息的能力； |
| 5. Having the management system for ensuring the safety production of narcotic drugs and psychotropic drugs; | | （五）有保证麻醉药品和精神药品安全生产的管理制度； |
| 6. Having the management level and business scale meeting the requirement for safety production of narcotic drugs and psychotropic drugs; | | （六）有与麻醉药品和精神药品安全生产要求相适应的管理水平和经营规模； |
| 7. The personnel in the departments of production management and quality control over narcotic drugs and psychotropic drugs shall be familiar with the laws and administrative regulations on the control of narcotic drugs and psychotropic drugs and the relevant anti-drug laws and administrative regulations; | | （七）麻醉药品和精神药品生产管理、质量管理部门的人员应当熟悉麻醉药品和精神药品管理以及有关禁毒的法律、行政法规； |
| 8. Having no acts of production and sale of bogus drugs, low quality drugs or in violation of the relevant anti-drug laws and administrative regulations; and | | （八）没有生产、销售假药、劣药或者违反有关禁毒的法律、行政法规规定的行为； |
| 9. Complying with the requirements for the quantity and overall arrangement of the designated production enterprises of narcotic drugs and psychotropic drugs as publicized by the department of drug supervision and administration of the State Council. | | （九）符合国务院药品监督管理部门公布的麻醉药品和精神药品定点生产企业数量和布局的要求。 |
| Article 16 Any enterprise that undertakes the production of narcotic drugs, the psychotropic drugs of category I and the raw material medicines of psychotropic drugs of category II shall be subject to the preliminary examination of the department of drug supervision and administration of the province, autonomous region, and municipality directly under the Central Government at its locality, and be subject to the approval of the department of drug supervision and administration of the State Council; any enterprise that undertakes the production of the preparations of psychotropic drugs of category II shall be subject to the approval of the department of drug supervision and administration of the people's government at the province, autonomous region and municipality directly under the Central Government at its locality. | | 第十六条 从事麻醉药品、第一类精神药品生产以及第二类精神药品原料药生产的企业，应当经所在地省、自治区、直辖市人民政府药品监督管理部门初步审查，由国务院药品监督管理部门批准；从事第二类精神药品制剂生产的企业，应当经所在地省、自治区、直辖市人民政府药品监督管理部门批准。 |
| Article 17 Any designated production enterprise shall, when producing narcotic drugs and psychotropic drugs, obtain the number of documents of approval for drugs according to the provisions of the Pharmaceutical Administration Law. | | 第十七条 定点生产企业生产麻醉药品和精神药品，应当依照药品管理法的规定取得药品批准文号。 |
| The department of drug supervision and administration of the State Council shall organize experts in the aspects of medical science, pharmacy, social science and ethics, as well as anti-drugs, and etc. to form an expert team, which shall make appraisal on the social harmfulness of narcotic drugs and psychotropic drugs coming into the market for the first time and the possibility for their being misused, and propose suggestions on whether to approve it or not. | | 国务院药品监督管理部门应当组织医学、药学、社会学、伦理学和禁毒等方面的专家成立专家组，由专家组对申请首次上市的麻醉药品和精神药品的社会危害性和被滥用的可能性进行评价，并提出是否批准的建议。 |
| No enterprise that has not obtained the number of documents of approval for drugs may produce narcotic drugs and psychotropic drugs. | | 未取得药品批准文号的，不得生产麻醉药品和精神药品。 |
| Article 18 In case of occurrence of any serious critical incident, which results in the incapability of any designated production enterprise to carry out ordinary production or the failure to ensure the supply of narcotic drugs and psychotropic drugs, the department of drug supervision and administration of the State Council shall determine another pharmaceutical production enterprise to produce narcotic drugs and psychotropic drugs. | | 第十八条 发生重大突发事件，定点生产企业无法正常生产或者不能保证供应麻醉药品和精神药品时，国务院药品监督管理部门可以决定其他药品生产企业生产麻醉药品和精神药品。 |
| After the end of the serious critical incident, the department of drug supervision and administration of the State Council shall determine in time that the enterprises as prescribed in the preceding paragraph shall stop production of narcotic drugs and psychotropic drugs. | | 重大突发事件结束后，国务院药品监督管理部门应当及时决定前款规定的企业停止麻醉药品和精神药品的生产。 |
| Article 19 A designated enterprise shall arrange the production strictly in accordance with the annual production plan for narcotic drugs and psychotropic drugs, and report the production conditions to the department of drug supervision and administration of the people's government at the province, autonomous region, and municipality directly under the Central Government at its locality as prescribed. | | 第十九条 定点生产企业应当严格按照麻醉药品和精神药品年度生产计划安排生产，并依照规定向所在地省、自治区、直辖市人民政府药品监督管理部门报告生产情况。 |
| Article 20 A designated production enterprise shall, according to the provisions of the present Regulation, sell narcotic drugs and psychotropic drugs to the enterprises that have the business qualification of narcotic drugs and psychotropic drugs or to other entities approved by the present Regulation. | | 第二十条 定点生产企业应当依照本条例的规定，将麻醉药品和精神药品销售给具有麻醉药品和精神药品经营资格的企业或者依照本条例规定批准的其他单位。 |
| Article 21 The labels of narcotic drugs and psychotropic drugs shall be printed with the marks as prescribed by the department of drug supervision and administration of the State Council. | | 第二十一条 麻醉药品和精神药品的标签应当印有国务院药品监督管理部门规定的标志。 |
| Chapter III Management | | 第三章 经 营 |
| Article 22 The state shall apply designated management system to narcotic drugs and psychotropic drugs. | | 第二十二条 国家对麻醉药品和精神药品实行定点经营制度。 |
| The department of drug supervision and administration of the State Council shall, according to the demand of narcotic drugs and the psychotropic drugs of category I, determine the overall arrangement of the designated wholesales enterprises of narcotic drugs and the psychotropic drugs in category I, and make adjustment and publicity on the overall arrangement according to the annual demand. | | 国务院药品监督管理部门应当根据麻醉药品和第一类精神药品的需求总量，确定麻醉药品和第一类精神药品的定点批发企业布局，并应当根据年度需求总量对布局进行调整、公布。 |
| No pharmaceutical management enterprise may deal in anesthetic raw herbs and raw material medicine of psychotropic drugs of category I. But the small package of the said drugs for the use of medical treatment, scientific research and teaching may be dealt in by wholesales pharmaceutical enterprises as prescribed by the department of drug supervision and administration of the State Council. | | 药品经营企业不得经营麻醉药品原料药和第一类精神药品原料药。但是，供医疗、科学研究、教学使用的小包装的上述药品可以由国务院药品监督管理部门规定的药品批发企业经营。 |
| Article 23 The designated wholesales enterprise of narcotic drugs and psychotropic drugs shall not only have the conditions for establishing pharmaceutical management enterprises as prescribed in Article 15 of the Pharmaceutical Administration Law, but also shall have the following conditions: | | 第二十三条 麻醉药品和精神药品定点批发企业除应当具备药品管理法第十五条规定的药品经营企业的开办条件外，还应当具备下列条件： |
| 1. Having the conditions for storage of narcotic drugs and pharmaceutical drugs as prescribed in the present Regulation; | | （一）有符合本条例规定的麻醉药品和精神药品储存条件； |
| 2. Having the ability to implement safety management on enterprises and to report management information to the department of drug supervision and administration through networks; | | （二）有通过网络实施企业安全管理和向药品监督管理部门报告经营信息的能力； |
| 3. The entity and its staff members have no acts in violation of the relevant anti-drug laws and administrative regulations within 2 years; and | | （三）单位及其工作人员2年内没有违反有关禁毒的法律、行政法规规定的行为； |
| 4. Complying with the overall arrangement of the designated wholesales enterprises as promulgated by the department of drug supervision and administration of the State Council. | | （四）符合国务院药品监督管理部门公布的定点批发企业布局。 |
| The designated wholesales enterprises of narcotic drugs and the psychotropic drugs of category I shall also have the ability to ensure the supply of narcotic drugs and the psychotropic drugs of category I as needed for the medical institutions within their own responsibility areas, and shall have the management system for ensuring the safety operation of narcotic drugs and the psychotropic drugs of category I. | | 麻醉药品和第一类精神药品的定点批发企业，还应当具有保证供应责任区域内医疗机构所需麻醉药品和第一类精神药品的能力，并具有保证麻醉药品和第一类精神药品安全经营的管理制度。 |
| Article 24 Any enterprise that undertakes the wholesales business of narcotic drugs and the psychotropic drugs of category I across any province, autonomous region, or municipality directly under the Central Government (hereinafter referred to as the national wholesales enterprise) shall be subject to the approval of the department of drug supervision and administration of the State Council; any enterprise undertaking the wholesales business of narcotic drugs and the psychotropic drugs of category I within its own province, autonomous region or municipality directly under the Central Government (hereinafter referred to as the regional wholesales enterprise) shall be subject to the approval of the department of drug supervision and administration department of the people's government at the province, autonomous region, and municipality directly under the Central Government at its locality. Any enterprise specially undertaking the wholesales business of the psychotropic drugs of category II shall be subject to the approval of the department of drug supervision and administration department of the people's government at the province, autonomous region, and municipality directly under the Central Government at its locality. | | 第二十四条 跨省、自治区、直辖市从事麻醉药品和第一类精神药品批发业务的企业（以下称全国性批发企业），应当经国务院药品监督管理部门批准；在本省、自治区、直辖市行政区域内从事麻醉药品和第一类精神药品批发业务的企业（以下称区域性批发企业），应当经所在地省、自治区、直辖市人民政府药品监督管理部门批准。 |
| National wholesales enterprises and regional wholesales enterprises may undertake the wholesales business of psychotropic drugs of category II. | | 专门从事第二类精神药品批发业务的企业，应当经所在地省、自治区、直辖市人民政府药品监督管理部门批准。 |
| | 全国性批发企业和区域性批发企业可以从事第二类精神药品批发业务。 |
| Article 25 A national wholesales enterprise may sell narcotic drugs and the psychotropic drugs of category I to regional wholesales enterprises or to the medical institutions that have obtained the qualification for using narcotic drugs and the psychotropic drugs of category I or other entities approved according to the provisions of the present Regulation. | | 第二十五条 全国性批发企业可以向区域性批发企业，或者经批准可以向取得麻醉药品和第一类精神药品使用资格的医疗机构以及依照本条例规定批准的其他单位销售麻醉药品和第一类精神药品。 |
| A national wholesales enterprise shall, when selling narcotic drugs and the psychotropic drugs of category I to any medical institution that has obtained the qualification on using narcotic drugs and the psychotropic drugs of category I, be subject to the approval of the department of drug supervision and administration of the people's government at the province, autonomous region, and municipality directly under the Central Government at the place where the medical institution is located. | | 全国性批发企业向取得麻醉药品和第一类精神药品使用资格的医疗机构销售麻醉药品和第一类精神药品，应当经医疗机构所在地省、自治区、直辖市人民政府药品监督管理部门批准。 |
| The department of drug supervision and administration of the State Council shall, when approving national wholesales enterprises, clarify the areas in which they shall undertake liabilities for drug supply. | | 国务院药品监督管理部门在批准全国性批发企业时，应当明确其所承担供药责任的区域。 |
| Article 26 A regional wholesales enterprise may sell narcotic drugs and the psychotropic drugs of category I to the medical institutions that have obtained the qualification on using narcotic drugs and the psychotropic drugs of category I within the administrative region of its own province, autonomous region, and municipality directly under the Central Government; where there is necessity to sell the said drugs to the medical institutions that have obtained the qualification on using narcotic drugs and the psychotropic drugs of category I within the administrative region of any neighboring province, autonomous region, and municipality directly under the Central Government due to the reason of special geographical locations, it shall be subject to the approval of the department of drug supervision and administration of the people's government of the province, autonomous region and municipality directly under the Central Government of the place where the enterprise is located. The drug supervision and administration department in charge of approval shall, within five days upon approval, notify the approval conditions to the drug supervision and administration of the people's government of the province, autonomous region, and municipality directly under the Central Government of the place where the medical institution is located. | | 第二十六条 区域性批发企业可以向本省、自治区、直辖市行政区域内取得麻醉药品和第一类精神药品使用资格的医疗机构销售麻醉药品和第一类精神药品；由于特殊地理位置的原因，需要就近向其他省、自治区、直辖市行政区域内取得麻醉药品和第一类精神药品使用资格的医疗机构销售的，应当经企业所在地省、自治区、直辖市人民政府药品监督管理部门批准。审批情况由负责审批的药品监督管理部门在批准后5日内通报医疗机构所在地省、自治区、直辖市人民政府药品监督管理部门。 |
| The department of drug supervision and administration of the people's government of any province, autonomous region, and municipality directly under the Central Government shall, when approving any regional wholesales enterprise, clarify the region where it shall undertake liabilities for drug supply. | | 省、自治区、直辖市人民政府药品监督管理部门在批准区域性批发企业时，应当明确其所承担供药责任的区域。 |
| Where there is necessity to adjust narcotic drugs and the psychotropic drugs of category I between regional wholesales enterprises due to emergency medical treatment and difficulties in transportation and other special circumstances, the adjustment information shall be reported to the department of drug supervision and administration of the people's government at the province, autonomous region and municipality directly under the Central Government at the place where the enterprises are located for archival filing within 2 days after the adjustment. | | 区域性批发企业之间因医疗急需、运输困难等特殊情况需要调剂麻醉药品和第一类精神药品的，应当在调剂后2日内将调剂情况分别报所在地省、自治区、直辖市人民政府药品监督管理部门备案。 |
| Article 27 A national wholesales enterprise shall purchase narcotic drugs and the psychotropic drugs of category I from designated production enterprises. | | 第二十七条 全国性批发企业应当从定点生产企业购进麻醉药品和第一类精神药品。 |
| A regional wholesales enterprise may purchase narcotic drugs and the psychotropic drugs of category I from national wholesales enterprises or may purchase narcotic drugs and the psychotropic drugs of category I from designated production enterprises upon the approval of the department of drug supervision and administration of the people's government of the province, autonomous region, and municipality directly under the Central Government at its locality. | | 区域性批发企业可以从全国性批发企业购进麻醉药品和第一类精神药品；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，也可以从定点生产企业购进麻醉药品和第一类精神药品。 |
| Article 28 Any national wholesales enterprises or regional wholesales enterprise shall, when selling narcotic drugs and the psychotropic drugs of category I to any medical institution, send the drug to the medical institution. No medical institution shall pick up the goods by itself. | | 第二十八条 全国性批发企业和区域性批发企业向医疗机构销售麻醉药品和第一类精神药品，应当将药品送至医疗机构。医疗机构不得自行提货。 |
| Article 29 The designated wholesales enterprises of psychotropic drugs of category II may sell psychotropic drugs of category II to medical institutions, designated wholesales enterprises and the retailing pharmaceutical enterprises as prescribed in Article 31 of the present Regulation and other entities as approved by the provisions of the present Regulation. | | 第二十九条 第二类精神药品定点批发企业可以向医疗机构、定点批发企业和符合本条例第三十一条规定的药品零售企业以及依照本条例规定批准的其他单位销售第二类精神药品。 |
| Article 30 No narcotic drugs and the psychotropic drugs of category I may be retailed. | | 第三十条 麻醉药品和第一类精神药品不得零售。 |
| Trading of narcotic drugs and psychotropic drugs in cash shall be prohibited, but excluding the narcotic drugs and the psychotropic drugs lawfully purchased by individuals. | | 禁止使用现金进行麻醉药品和精神药品交易，但是个人合法购买麻醉药品和精神药品的除外。 |
| Article 31 Any pharmaceutical retail chain enterprise that applies unified purchase of goods, unified distribution and unified management may, upon the approval of the department of drug supervision and administration at the level of the city divided into districts at its locality, undertake the retail business of psychotropic drugs of category II. | | 第三十一条 经所在地设区的市级药品监督管理部门批准，实行统一进货、统一配送、统一管理的药品零售连锁企业可以从事第二类精神药品零售业务。 |
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