There are new regulations for online sales prescription medicines!Practice from December 1st

Recently, the General Administration of Market Supervision issued the "Measures for the Supervision and Administration of Drug Network Sales" (Order No. 58 of the State Administration of Market Supervision and Administration), which will be implemented from December 1, 2022.

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Drug safety responsibility is greatly responsible for the lives and health of the people, and the Party Central Committee and the State Council attach great importance to it. In order to implement the "four most stringent" requirements of the Central Committee of the Communist Party of China and the State Council and a series of decision -making deployments, the regulations on the sales of drug networks are refined and the drug management law. The public drug safety and legitimate rights and interests, the General Administration of Market Supervision and the Drug Administration formulated the "Measures for the Supervision and Administration of Drug Network Sales Sales" on the basis of in -depth research and fully demonstration. "Measures" total 6 chapters and 42 articles, and stipulates the management of drug network sales, platform responsibilities, supervision and inspection measures and legal responsibilities. The main contents include:

The first is to implement the main responsibility of drug management enterprises. Clarify the qualifications and requirements of the pharmaceutical business enterprise engaged in drug network sales, and clarify the vaccine, blood products, anesthesia drugs, psychotropic drugs, medical drugs, radioactive drugs, pharmaceutical and chemicals and other countries in accordance with the law Do not sell on the Internet. At the same time, strict management of drug operations, 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 of drug network sales enterprises.

The second is the responsibility of compacting the drug network sales platform. Clarify that third -party platforms should set up drug quality and safety management institutions, equipped with pharmacy and technical personnel, and establish and implement drug quality and safety, pharmaceutical information display, prescription review, prescription drug real -name purchase, drug distribution, transaction record preservation, adverse reaction report, complaint report processing, etc. Management system and record in accordance with regulations. At the same time, the platform is required to sign an agreement with the drug network sales enterprise to clarify the responsibility of drug quality and safety between the two parties. It stipulates that the platform shall perform the obligations and reports of the stop service and report of the suspension of the audit, inspection and monitoring, and the discovery of serious violations. Emergency treatment and coordination obligations in supervision and inspection.

The third is to clarify the management of prescription drug network sales. Considering the safety risks of medication and online consistency management requirements, clearly implement a real -name system for the sales of prescription drug networks, and conduct prescription review and deployment in accordance with regulations. Display packaging, labels and other information; before the prescription review, no information such as instructions shall be displayed, and the relevant services of prescription medicine purchase shall not be provided. It is intended to emphasize the management requirements of "first medicine" and prescription review. At the same time, before the sales of prescription drugs, consumers should 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.

The fourth is to implement the "four strictests" requirements and strengthen supervision measures of regulatory departments at all levels. Clarify the duties of drug supervision and management departments at all levels in the division of responsibilities in drug network sales and the jurisdiction of illegal acts. It is required to strengthen the monitoring of drug network sales, and investigate and dispose of illegal acts found in accordance with the law in accordance with the law. 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. In addition, the "Measures" also clarified the corresponding legal liability for the illegal act of drug network sales.

Source/ CCTV News Client

Edit/Yuanyuan

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