药品经营许可证申请：Legal basis、企业条件与申报材料要求

药品经营许可证的申请涉及法律依据、企业设置标准、申报材料规范等多个环节。以下从法律依据、申请数量及方式、企业应具备的条件、申请材料要求、批发与零售企业设置标准、验收实施标准及经营范围核定等方面进行系统说明。

one、药品经营许可证申请的法律依据

1. 《中华人民共和国药品管理法》
2. 《中华人民共和国药品管理法实施条例》
3. 《药品经营许可证管理办法》

two、申请的数量及方式

按照《药品管理法》第14条规定，开办药品批发企业，应符合省、autonomous region、直辖市药品批发企业合理布局的要求。

three、申请企业应具备的条件

1. Have rules and regulations to ensure the quality of the drugs they handle。
2. enterprise、Legal representative of the enterprise or person in charge of the enterprise、There is no person in charge of quality management. Article 76 of the Drug Administration Act、Circumstances provided for in Article 83。
3. Have a certain number of licensed pharmacists commensurate with the business scale。The person in charge of quality management must have a college degree or above，and must be a licensed pharmacist。
4. 具有能够保证药品储存质量要求的、A room temperature warehouse suitable for its business variety and scale、cool library、cold storage。The warehouse has special shelves suitable for drug storage and realizes drug storage、transmit、Sorting、On the shelves、Devices and equipment for outbound modern logistics systems。
5. Have an independent computer management information system，Can cover the purchase of drugs within the enterprise、store、The whole process of sales, operation and quality control；Able to comprehensively record information on business management and implementation of "Good Manufacturing Practices for Pharmaceutical Products"；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）药品监管部门（机构）监管的条件。
6. Have pharmaceutical business premises and auxiliary facilities that comply with the "Pharmaceutical Goods Management Practice"、Office space and warehouse management、Drug quality and safety assurance in the warehouse and entry and exit of the warehouse、Conditions for storage and maintenance in the warehouse。

The state regulates the sale of narcotic drugs、psychotropic drugs、Toxic drugs for medical use、Preventive biological products are otherwise specified，According to its provisions。

Four、申请材料要求

（一）申报资料的一般要求

申报材料应真实、whole，统一用A4纸打印或复印，Binned in order。

（二）申报资料的具体要求

1. 企业法人提出申请的，申请人一栏填写企业法人单位名称，所有申报材料加盖公章。
2. 自然人提出申请的，申请人一栏填写被委托授权人名字，所有申报材料需被委托授权人签字。
3. drug、医疗器械经营许可证管理系统企业端“企业验收申请”填报完整、correct，符合导入系统条件。
4. business place、仓库地理位置图应清楚标示周围街道及标志性建筑物情况，以便查找。如非整层，还需提供所在楼层中所处位置的平面图。
5. 仓库平面布局图需注明详细地址（楼层）和各库区、验收养护室、仓库办公室面积。

five、药品批发企业设置标准

按照《药品管理法》第14条规定，开办药品批发企业，应符合省、autonomous region、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. Have rules and regulations to ensure the quality of the drugs they handle。
2. enterprise、Legal representative of the enterprise or person in charge of the enterprise、There is no person in charge of quality management. Article 76 of the Drug Administration Act、Circumstances provided for in Article 83。
3. Have a certain number of licensed pharmacists commensurate with the business scale。The person in charge of quality management must have a college degree or above，and must be a licensed pharmacist。
4. 具有能够保证药品储存质量要求的、A room temperature warehouse suitable for its business variety and scale、cool library、cold storage。The warehouse has special shelves suitable for drug storage and realizes drug storage、transmit、Sorting、On the shelves、Devices and equipment for outbound modern logistics systems。
5. Have an independent computer management information system，Can cover the purchase of drugs within the enterprise、store、The whole process of sales, operation and quality control；Able to comprehensively record information on business management and implementation of "Good Manufacturing Practices for Pharmaceutical Products"；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）药品监管部门（机构）监管的条件。
6. Have pharmaceutical business premises and auxiliary facilities that comply with the "Pharmaceutical Goods Management Practice"、Office space and warehouse management、Drug quality and safety assurance in the warehouse and entry and exit of the warehouse、Conditions for storage and maintenance in the warehouse。

The state regulates the sale of narcotic drugs、psychotropic drugs、Toxic drugs for medical use、Preventive biological products are otherwise specified，According to its provisions。

six、药品零售企业设置标准

开办药品零售企业，应符合当地常住人口数量、region、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. Have rules and regulations to ensure the quality of the drugs they handle。
2. 具有依法经过资格认定的药学技术人员；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。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. enterprise、Legal representative of the enterprise、Business person in charge、质量负责人无《药品管理法》第76条、第83条规定情形的。
4. 具有与所经营药品相适应的营业场所、equipment、Warehousing facilities and sanitary environment。Establishing retail pharmacies in supermarkets and other commercial enterprises，Must have separate area。
5. Have the ability to prepare medicines that meet the needs of local consumers，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、autonomous region、直辖市（食品）药品监督管理部门结合当地具体情况确定。The state regulates the sale of narcotic drugs、psychotropic drugs、Toxic drugs for medical use、Preventive biological products are otherwise specified，According to its provisions。

seven、验收实施标准

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局制定。开办药品零售企业验收实施标准，by provinces、autonomous region、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局备案。

eight、药品经营企业经营范围的核定

药品经营企业经营范围包括：麻醉药品、psychotropic drugs、Toxic drugs for medical use；biological products；Chinese medicinal materials、Chinese medicine pieces、Chinese patent medicine、化学原料药及其制剂、抗生素原料药及其制剂、Biochemical drugs。

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。

Toxic drugs for medical use、麻醉药品、psychotropic drugs、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。