Measures for the Administration of Pharmaceutical Trade License | | 药品经营许可证管理办法 |
| （Promulgated by the Order No. 6 of the China Food and Drug Administration on February 4, 2004; and amended in accordance with the Decision to Amend Certain Rules adopted at the administrative meeting of the China Food and Drug Administration on November 7, 2017) | | （2004年2月4日国家食品药品监督管理局令第6号公布 根据2017年11月7日国家食品药品监督管理总局局务会议《关于修改部分规章的决定》修正） |
| Chapter I General Provisions | | 第一章 总 则 |
| Article 1 The present Measures are hereby formulated in accordance with the Pharmaceutical Administration Law of the People's Republic of China, the Regulations on the Implementation of the Pharmaceutical Administration Law of the People's Republic of China (hereinafter referred to as the Pharmaceutical Administration Law, and Regulations on the Implementation of the Pharmaceutical Administration Law), for the purpose of strengthening supervision and administration on the licensing of pharmaceutical trading. | | 第一条 为加强药品经营许可工作的监督管理，根据《中华人民共和国药品管理法》、《中华人民共和国药品管理法实施条例》（以下简称《药品管理法》、《药品管理法实施条例》）的有关规定，制定本办法。 |
| Article 2 The present Measures shall be applicable to the license issuance, change, alteration and supervision and administration on Pharmaceutical Trade License. | | 第二条 《药品经营许可证》发证、换证、变更及监督管理适用本办法。 |
| Article 3 The China Food and Drug Administration shall be in charge of the work of supervision and administration on the licensing of national pharmaceutical trading. | | 第三条 国家食品药品监督管理总局主管全国药品经营许可的监督管理工作。 |
| The food and drug administrative departments of the provinces, autonomous regions, and municipalities directly under the Central Government shall be responsible for the work of license issuance, change, alteration, and routine supervision and administration on Pharmaceutical Trade License of pharmaceutical wholesale enterprises within their own jurisdictions, and shall direct and supervise the lower level food and drug administrative departments for their carrying out of the work of supervision and administration on Pharmaceutical Trade License. | | 省、自治区、直辖市食品药品监督管理部门负责本辖区内药品批发企业《药品经营许可证》发证、换证、变更和日常监督管理工作，并指导和监督下级食品药品监督管理部门开展《药品经营许可证》的监督管理工作。 |
| The food and drug administrative departments at the level of cities divided into districts or those at the county level which are set up directly by the food and drug administrative departments at the provinces, autonomous regions, and municipalities directly under the Central Government, shall be responsible for the work of license issuance, change, alteration and routine supervision and administration on Pharmaceutical Trade License of drug retail enterprises within their own jurisdictions. | | 设区的市级食品药品监督管理部门或省、自治区、直辖市食品药品监督管理部门直接设置的县级食品药品监督管理部门负责本辖区内药品零售企业《药品经营许可证》发证、换证、变更和日常监督管理等工作。 |
| Chapter II Conditions for Applying for Obtaining Drug Business License | | 第二章 申领《药品经营许可证》的条件 |
| Article 4 According to the provisions of Article 14 of the Pharmaceutical Administration Law, a pharmaceutical wholesale enterprise shall meet the requirements for the reasonable overall arrangement for pharmaceutical wholesale enterprises of provinces, autonomous regions, and municipalities directly under the Central Government for its establishment, and shall measure up to the following standards for establishment: | | 第四条 按照《药品管理法》第14条规定，开办药品批发企业，应符合省、自治区、直辖市药品批发企业合理布局的要求，并符合以下设置标准： |
| 1. Having rules and regulations that can ensure the quality of drugs it manages. | | （一）具有保证所经营药品质量的规章制度； |
| 2. The enterprise, the legal representative, responsible person, or the person responsible for quality control of the enterprise has no circumstances as prescribed in Articles 75 and 82 of the Pharmaceutical Administration Law; | | （二）企业、企业法定代表人或企业负责人、质量管理负责人无《药品管理法》第75条、第82条规定的情形； |
| 3. Having a certain number of practicing apothecaries fitting in with its business scale. The person responsible for quality control shall have a bachelor's degree or above, and shall be a practicing apothecary as well; | | （三）具有与经营规模相适应的一定数量的执业药师。质量管理负责人具有大学以上学历，且必须是执业药师； |
| 4.Having normal temperature warehouses, cool warehouses or refrigeratories, which can ensure the quality requirements for pharmaceutical storage and can fit in with its variety and scale of business, and in which there are special goods shelves fit for pharmaceutical storage, and installations and equipment of modern logistic system for the pharmaceuticals' entering a warehouse, transmission, separate checking, putting on shelves, or leaving a warehouse. | | （四）具有能够保证药品储存质量要求的、与其经营品种和规模相适应的常温库、阴凉库、冷库。仓库中具有适合药品储存的专用货架和实现药品入库、传送、分检、上架、出库现代物流系统的装置和设备； |
| 5. Having independent computer management information system, which can cover the whole process of the pharmaceutical purchase, storage, sale, and management and quality control within the enterprise, and can record all the information on the management and implementation of the Standards for Quality Control of Pharmaceutical Trading of the enterprise; meeting the requirements of the Standards for Quality Control of Pharmaceutical Trading for each process of pharmaceutical management, and having conditions for accepting supervision of the local food and drug administrative departments; and | | （五）具有独立的计算机管理信息系统，能覆盖企业内药品的购进、储存、销售以及经营和质量控制的全过程；能全面记录企业经营管理及实施《药品经营质量管理规范》方面的信息；符合《药品经营质量管理规范》对药品经营各环节的要求，并具有可以实现接受当地食品药品监督管理部门监管的条件； |
| 6.Having conditions meeting the requirements of the Standards for Quality Control of Pharmaceutical Trading for pharmaceutical business office, auxiliary and office buildings, and warehouse management, quality safeguards for pharmaceuticals in the warehouse, and the entry-exit of warehouse, in-warehouse storage and maintenance. | | （六）具有符合《药品经营质量管理规范》对药品营业场所及辅助、办公用房以及仓库管理、仓库内药品质量安全保障和进出库、在库储存与养护方面的条件。 |
| Unless there are otherwise state provisions on management of stupefacient, psychotropic drugs，toxic drugs for medical treatment, and preventive biological produce, those provisions shall be followed. | | 国家对经营麻醉药品、精神药品、医疗用毒性药品、预防性生物制品另有规定的，从其规定。 |
| Article 5 The establishment of a pharmaceutical retail enterprise shall meet the requirements of the number of local permanent residents, regions, traffic status and actual needs, and follow the principle of convenience for the mass people to purchase pharmaceuticals, and accord with the following provisions on establishment: | | 第五条 开办药品零售企业，应符合当地常住人口数量、地域、交通状况和实际需要的要求，符合方便群众购药的原则，并符合以下设置规定： |
| 1. Having rules and regulations that can ensure the quality of pharmaceuticals it manages; and | | （一）具有保证所经营药品质量的规章制度； |
| 2. Having pharmaceutical technical personnel whose qualifications have been certified according to law. | | （二）具有依法经过资格认定的药学技术人员； |
| A pharmaceutical retail enterprise, which undertakes the trading of prescriptive pharmaceuticals, or Class A non-prescriptive pharmaceuticals (OTC), shall have practicing apothecaries or other pharmaceutical technical personnel whose qualifications have been certified according to law. The person responsible for quality control shall have work experiences of quality control for pharmaceutical trading for one year or more. | | 经营处方药、甲类非处方药的药品零售企业，必须配有执业药师或者其他依法经过资格认定的药学技术人员。质量负责人应有一年以上（含一年）药品经营质量管理工作经验。 |
| A pharmaceutical retail enterprise, which undertakes the trading of Class B non-prescriptive pharmaceuticals (OTC), and the pharmaceutical retail enterprises established at districts below the rural villages and towns, shall recruit business personnel in accordance with Article 15 of the Regulations on the Implementation of the Pharmaceutical Administration Law, and the practicing apothecaries shall also be recruited in case conditions permit. The foregoing personnel shall be on the job during the business hours of the enterprise. | | 经营乙类非处方药的药品零售企业，以及农村乡镇以下地区设立药品零售企业的，应当按照《药品管理法实施条例》第15条的规定配备业务人员，有条件的应当配备执业药师。企业营业时间，以上人员应当在岗。 |
| 3. The enterprise, legal representative, responsible person or person responsible for quality control of the enterprise has no circumstances as prescribed in Articles 75 and 82 of the Pharmaceutical Administration Law; | | （三）企业、企业法定代表人、企业负责人、质量负责人无《药品管理法》第75条、第82条规定情形的； |
| 4. Having the places of business, equipment, warehouse facilities and sanitary conditions fitting in with the pharmaceuticals it manages. If a retail pharmaceutical store is established in the supermarkets or within other commercial enterprises, it must have an independent area; and | | （四）具有与所经营药品相适应的营业场所、设备、仓储设施以及卫生环境。在超市等其他商业企业内设立零售药店的，必须具有独立的区域； |
| 5. Having abilities capable of supplying drugs that can satisfy the demand of local consumers, and ensuring the 24-hour supply. The food and drug administrative departments of all provinces, autonomous regions, and municipalities directly under the Central Government shall, in light of the specific circumstances of the local regions, determine the variety and quantity of state basic pharmaceuticals that shall be stocked by the pharmaceutical retail enterprises. | | （五）具有能够配备满足当地消费者所需药品的能力，并能保证24小时供应。药品零售企业应备有的国家基本药物品种数量由各省、自治区、直辖市食品药品监督管理部门结合当地具体情况确定。 |
| Unless there are otherwise state provisions on management of stupefacient, psychotropic drugs，toxic drugs for medical treatment, and preventive biological produce, those provisions shall be followed. | | 国家对经营麻醉药品、精神药品、医疗用毒性药品、预防性生物制品另有规定的，从其规定。 |
| Article 6 The formulation of implementation standards for checking and accepting the establishment of pharmaceutical wholesale enterprises shall remain with the China Food and Drug Administration. The implementation standards for checking and accepting the establishment of drug retail enterprises shall be formulated by the food and drug administrative departments of all provinces, autonomous regions and municipalities directly under the Central Government in accordance with the relevant contents of the present Measures and the Standards for Quality Control of Pharmaceutical Trading, and shall be reported to and put on records at the China Food and Drug Administration. | | 第六条 开办药品批发企业验收实施标准由国家食品药品监督管理总局制定。开办药品零售企业验收实施标准，由各省、自治区、直辖市食品药品监督管理部门依据本办法和《药品经营质量管理规范》的有关内容组织制定，并报国家食品药品监督管理总局备案。 |
| Article 7 The checking and ratifying of the business scope of the pharmaceutical trading enterprises: | | 第七条 药品经营企业经营范围的核定。 |
| The business scope of pharmaceutical trading enterprises shall cover: | | 药品经营企业经营范围： |
| stupefacient, psychotropic drugs，and toxic drugs for medical treatment; | | 麻醉药品、精神药品、医疗用毒性药品； |
| Biological produce; | | 生物制品； |
| Chinese traditional medicinal materials; Chinese traditional medicine drink pills; Chinese patent medicines, chemical material medicines and their preparations; antibiotic material medicines and their preparations, biological and chemical medicines. | | 中药材、中药饮片、中成药、化学原料药及其制剂、抗生素原料药及其制剂、生化药品。 |
| Where the enterprises are to undertake pharmaceutical retail, their class of business shall be checked and ratified, the applicants' qualifications of managing the prescriptive pharmaceuticals or non-prescriptive pharmaceuticals or Class B non-prescriptive pharmaceuticals shall be determined first, and after the above-mentioned has been clarified in their business scope, the specific scope of business shall be checked and ratified. | | 从事药品零售的，应先核定经营类别，确定申办人经营处方药或非处方药、乙类非处方药的资格，并在经营范围中予以明确，再核定具体经营范围。 |
The checking and ratifying of toxic drugs for medical treatment, stupefacient, psychotropic drugs, radioactive drugs and preventive biological produce shall be made in accordance with the relevant state provisions on the administration of special pharmaceuticals and preventive biological produce.
．．．．．． | | 医疗用毒性药品、麻醉药品、精神药品、放射性药品和预防性生物制品的核定按照国家特殊药品管理和预防性生物制品管理的有关规定执行。
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