Source: [Dahe Health News] After the three editions of the "Regulations on Supervision and Administration of Drug Online Sales (Draft for Comments)" published in 2017, 2018 and 2020, and the draft for review circulating online in 2021, the "Regulations on Supervision and Administ

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compact drug online sales platform responsibility

clearly states that third-party platforms should establish drug quality and safety management institutions, equip pharmaceutical technicians, establish and implement management systems such as drug quality and safety, drug information display, prescription review, real-name purchase of prescription drugs, drug distribution, transaction record prescription record prescription reports, complaint and reporting handling, and record them in accordance with regulations. At the same time, the platform is required to sign an agreement with the drug online sales company to clarify the drug quality and safety responsibilities of both parties, and stipulate that the platform should fulfill its obligations such as review, inspection and monitoring, and stop services and reporting when serious violations are found, and strengthen the platform's obligations to cooperate in drug recall , emergency response to emergencies, and supervision and inspection.

has added a new penalty and a higher penalty amount.

Compared with the fines of 1,000 yuan or 30,000 yuan in the draft of opinion or the draft for review, the fines of 1,000 yuan in the draft of are as low as 10,000 yuan, up to 200,000 yuan.

Among them, the newly added penalty includes violating the provisions of the scope of online sales and selling drugs that are subject to special management through the Internet, and fines of not less than RMB 50,000 and not more than RMB 100,000; if harmful consequences are caused, fines of not less than RMB 100,000 and not more than RMB 200,000 will be imposed. In addition, the fine amount is higher. For example, if a third-party platform undertakes electronic prescription and fails to verify the situation of the electronic prescription provider and signs an agreement, it will be fined not less than RMB 50,000 and not more than RMB 100,000; if it causes harmful consequences, it will be fined not less than RMB 100,000 and not more than RMB 200,000.

The scope of online banned drugs is consistent with the draft opinion

Previously, the draft for review expanded the list of banned drugs such as vaccines, blood products, and toxic and narcissum release. "Protein assimilation preparations, termination of pregnancy drugs, compound preparations containing special drugs, injections, infusion agents and other drugs with higher risk of drug use shall not be sold online." The official draft of

deleted this expanded catalog, which is consistent with the draft opinion.

Except for the eight types of drugs such as vaccines, blood products, and narcotic drugs stipulated in the National Drug Administration Law that cannot be sold online, the "Management Measures" do not limit the online sales of other types of drugs, including drugs in short supply in the country.

This actually affirms the ability of the Internet platform to adjust surplus and shortages and ensure supply .

Implement the "four strictest" requirements to strengthen the regulatory measures of regulatory departments at all levels

Clarify the division of responsibilities of drug supervision and administration departments at all levels in drug online sales supervision and jurisdiction for investigation and punishment of illegal acts, and require strengthening drug online sales monitoring work, and investigating and handling illegal acts found in monitoring in accordance with the law and in accordance with the responsibilities.

strengthens drug safety risk control. For those who have evidence that there may be safety hazards, it is clear in accordance with the law that the drug regulatory authorities can take measures such as warnings, interviews, rectification within a time limit, and suspension of production, sales, use, and imports. In addition, the Measures also clarifies corresponding legal responsibilities for illegal drug online sales in accordance with the law. Overall, for this official draft, the first has raised the entry threshold for . The conditions and obligations for selling prescription drugs online have been greatly improved, and supervision has been more comprehensive and refined. For example, the requirements for drug traceability , electronic prescription verification requirements, data confidentiality requirements, drug delivery requirements, etc. Without a certain scale and strength, it is difficult for Internet companies or physical pharmacies to participate in the game. Second, supervision is more strict . The core of strict supervision still depends on the penalty clause. The penalty for this formal draft has been increased compared with the previous one. Compared with the current offline supervision, it highlights the principle of consistency between online and offline.

is generally good for leading companies involved in the pharmaceutical retail market, whether they are Internet companies or physical pharmacies companies; for weaker companies, they are generally bad for them. The painstaking efforts of policy makers are completely understandable. For example, a single store sells prescription drugs online to make the business nationwide, which is obviously high regulatory costs and greater social risks than social benefits, which is something that no one wants to see. The implementation of the new

regulations is also inseparable from the continuous exploration and promotion of the industry.

As early as 2017, this "Management Measures" began to solicit opinions, witnessing the heyday of the Internet industry and experiencing the valuable value of online medical services under the test of the epidemic.

It can be said that without the exploration of a large number of enterprises, it will be difficult to legalize existing operations through legal forms as soon as possible.

Now, in the face of external doubts, the introduction of drug online sales regulations has given the industry a reassurance.

In fact, through standardized operations, the online sales model of drugs has gradually been recognized and accepted by the public and can generate huge social value.

For example, it has played an important social security value in helping to normalize epidemic prevention and control, providing the supply of drugs and epidemic prevention materials.