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.

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。

属类：法学专业-中国法律-药品管理法

The processing standards stipulated by the supervisory and administrative departments of pharmaceuticals of the provinces, autonomous regions, or municipalities directly under the central governments

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

属类：法学专业-中国法律-药品管理法

shall be placed on record at the pharmaceutical supervisory and administrative department under the State Council.

应当报国务院药品监督管理部门备案。

属类：法学专业-中国法律-药品管理法

Article 11 The raw and supplementary materials used for the production of pharmaceuticals must conform to the requirements for medicinal use.

第十一条 生产药品所需的原料、辅料，必须符合药用要求。

属类：法学专业-中国法律-药品管理法

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。

属类：法学专业-中国法律-药品管理法

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。

属类：法学专业-中国法律-药品管理法

Chapter III Administration of Pharmaceutical Trading Enterprises

第三章 药品经营企业管理

属类：法学专业-中国法律-药品管理法

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.

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》;

属类：法学专业-中国法律-药品管理法

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.

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。

属类：法学专业-中国法律-药品管理法

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。

属类：法学专业-中国法律-药品管理法

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.

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。

属类：法学专业-中国法律-药品管理法

Article 15 To establish a pharmaceutical trading enterprise, the following requirements must be met

第十五条 开办药品经营企业必须具备以下条件:

属类：法学专业-中国法律-药品管理法

(1)1 It shall be staffed with legally certified pharmaceutical technical personnel.

(一)具有依法经过资格认定的药学技术人员;

属类：法学专业-中国法律-药品管理法

(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、卫生环境;

属类：法学专业-中国法律-药品管理法

(3)It shall have a quality control organ or personnel 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;

属类：法学专业-中国法律-药品管理法

(4)It shall have rules and regulations to ensure the quality of the pharmaceuticals in which it trades.

(四)具有保证所经营药品质量的规章制度。

属类：法学专业-中国法律-药品管理法

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.

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。

属类：法学专业-中国法律-药品管理法

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。

属类：法学专业-中国法律-药品管理法

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.

《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。

属类：法学专业-中国法律-药品管理法

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。

属类：法学专业-中国法律-药品管理法