Shulou(Shulou.com)11/24 Report--

On September 1, CTOnews.com, the General Administration of Market Supervision and Administration issued the measures for the Supervision and Administration of Drug Network sales, which will enter into force on December 1, 2022.

CTOnews.com has learned that there are 6 chapters and 42 articles in the measures, which provide for the management of drug network sales, the implementation of platform responsibilities, supervision and inspection measures and legal liability, and the main contents include:

The first is to implement the main responsibility of drug trading enterprises. Clarify the subject qualifications and requirements of drug trading enterprises engaged in drug network sales, and make it clear in accordance with the law that vaccines, blood products, narcotic drugs, psychotropic substances, toxic drugs for medical use, radioactive drugs, pharmaceutical precursor chemicals and other drugs under special control shall not be sold on the Internet. At the same time, we should strictly manage the whole process of drug management, and put forward clear requirements for the whole process management of drug network sales enterprises, such as quality and safety management system, pharmaceutical care, drug storage and distribution, drug traceability, risk control, information disclosure and so on.

The second is to compact the responsibility of the drug network sales platform. It is clear that third-party platforms shall set up drug quality and safety management agencies, equipped with pharmaceutical technical personnel, establish and implement management systems such as drug quality and safety, drug information display, prescription examination, real-name purchase of prescription drugs, drug distribution, transaction records preservation, adverse reaction reports, complaint and report handling, and put on record in accordance with the relevant provisions. At the same time, the platform is required to sign an agreement with drug network sales enterprises to clarify the drug quality and safety responsibilities of both sides, and stipulate that the platform should perform the obligations of examination, inspection and monitoring, as well as stopping service and reporting when serious violations are found. and strengthen the platform's obligations to cooperate in drug recall, emergency handling, supervision and inspection.

The third is to clarify the network sales management of prescription drugs. Considering the safety risk of drug use and the requirements of online and offline consistency management, it is clear that the real-name system should be implemented for the network sales of prescription drugs, and the prescription should be examined and allocated in accordance with the regulations; it is stipulated that prescription drugs and over-the-counter drugs should be displayed separately, and it is clear that packaging, labels and other information shall not be publicly displayed directly on the main page and home page of prescription drug sales. Before passing the prescription review, instructions and other information shall not be displayed, and services related to the purchase of prescription drugs shall not be provided, which is intended to emphasize the management requirements of "prescription before medicine" and prescription review. At the same time, it is required that before the sale of prescription drugs, consumers should be fully informed of the relevant risk warning information and confirmed by consumers to effectively guard against drug safety risks.

Fourth, implement the "four most stringent" requirements and strengthen the supervision measures of regulatory departments at all levels. To clarify the division of responsibilities of drug supervision and administration departments at all levels in the supervision of drug network sales and the jurisdiction to investigate and deal with illegal acts, it is required to strengthen the monitoring of drug network sales and investigate and deal with illegal acts found by monitoring in accordance with their duties in accordance with the law. Strengthen drug safety risk control, and if there is evidence to prove that there may be hidden safety risks, it shall be clear in accordance with the law that the drug regulatory department may take measures such as warning, interview, rectification within a time limit and suspending production, sale, use and import. In addition, the "measures" also clearly defined the corresponding legal responsibilities for the illegal acts of online drug sales in accordance with the law.

Welcome to subscribe "Shulou Technology Information " to get latest news, interesting things and hot topics in the IT industry, and controls the hottest and latest Internet news, technology news and IT industry trends.