Measures for the Quality Supervision and Administration of the Distribution and Use of Medicinal Products,北大法宝V6

Measures for the Quality Supervision and Administration of the Distribution and Use of Medicinal Products Not Yet Effective

[CLI Code] CLI.4.5180029(EN) Statement

Document Number：Order No. 84 of the State Administration for Market Regulation
Area of Law： Pharmaceutical Administration
Level of Authority： Departmental Rules
Date Issued：09-27-2023
Effective Date：01-01-2024
Issuing Authority： State Administration for Market Regulation
Status： Not Yet Effective

Measures for the Quality Supervision and Administration of the Distribution and Use of Medicinal Products
药品经营和使用质量监督管理办法

(Issued by Order No. 84 of the State Administration for Market Regulation on September 27, 2023 and shall come into force on January 1, 2024)
（2023年9月27日国家市场监督管理总局令第84号公布自2024年1月1日起施行）

Article 1 These Measures are developed in accordance with the Pharmaceutical Administration Law of the People's Republic of China (hereinafter referred to as the “Pharmaceutical Administration Law”), the Vaccine 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, and other laws and administrative regulations, for the purposes of strengthening the quality supervision and administration of the Distribution and use of medicinal products, and regulating the administrative activities for the quality of distribution and use of medicinal products.
　　第一条　为了加强药品经营和药品使用质量监督管理，规范药品经营和药品使用质量管理活动，根据《中华人民共和国药品管理法》（以下简称《药品管理法》）《中华人民共和国疫苗管理法》《中华人民共和国药品管理法实施条例》等法律、行政法规，制定本办法。

Article 2 The administration of the quality of distribution and use of medicinal products and its supervision and administration activities within the territory of the People's Republic of China shall comply with these Measures.
　　第二条　在中华人民共和国境内的药品经营、使用质量管理及其监督管理活动，应当遵守本办法。

Article 3 Those who carry out wholesale or retail activities of medicinal products shall obtain approval of the medical products administrative department, obtain a medicinal products distribution license according to the law, and strictly comply with the laws, regulations, rules, standards and norms.
　　第三条　从事药品批发或者零售活动的，应当经药品监督管理部门批准，依法取得药品经营许可证，严格遵守法律、法规、规章、标准和规范。