This new rules have been implemented since December!

The State Administration of Market Supervision announced the "Measures for the Supervision and Administration of Drug Network Sales" on September 1 to further implement the responsibility of the main body of pharmaceutical business enterprises and the responsibility of compacting the drug network sales platform. It will be implemented from December 1, 2022.

The management method clarifies the qualifications and requirements of the drug operating enterprise engaged in drug network sales, and clarifies vaccines, blood products, anesthesia drugs, psychotropic drugs, medical drugs, radioactive drugs, pharmaceuticals and chemicals and other countries in accordance with the law. Managed medicines must not be sold on the Internet. Strict management of the entire process of drug management, and put forward clear requirements for the management system of drug network sales enterprises, pharmaceutical services, pharmaceutical storage and distribution, pharmaceutical traceability, risk control, and information disclosure.

The management measures also clearly make clear that the third -party platform should set up a drug quality and safety management institution, equipped with pharmacy and technical personnel, and establish and implement drug quality safety, drug information display, prescription review, prescription drug real -name purchase, drug distribution, transaction record preservation, adverse reaction reports, complaints, complaints, complaints Report the management system and other management systems, and record in accordance with regulations. The platform is required to sign an agreement with the pharmaceutical network sales enterprise to clarify the responsibility for the quality and safety of the pharmaceutical quality of both parties. It stipulates that the platform shall perform the obligations and reports of the stop service and report of the discovery of serious violations of the law, and strengthen the platform And the coordination obligation in supervision and inspection.

At the same time, the real -name system is implemented on the sales of prescription drug networks, and prescription review and deployment shall be conducted in accordance with regulations; prescribed prescription drugs and over -the -counter drugs shall be distinguished, and information on the homepage of prescription drugs shall not directly display packaging, labels and other information on the homepage; There must be no information such as the instructions, and the relevant services of the purchase of prescription medicines are not allowed. It is intended to emphasize the management requirements of "first medicine" and prescription review. Before the sales of prescription drugs, consumers shall fully inform consumers to fully inform the relevant risk warning information and confirm their knowledge by consumers, and effectively prevent the safety risk of medication.

In addition, the management measures also clarify the corresponding legal responsibility for the illegal act of drug network sales. To strengthen the control of drug safety risks, if there is a hidden safety hazard in the evidence, it is clear that the drug regulatory authorities can adopt advice, interviews, rectification within a time limit, and suspending production, sales, use, and imports. (Reporter Zhao Wenjun Dai Xiaohe)

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