"Turn" heavy!New regulations for drug network sales release

Source: Sai Bailan/Mu Zhi

01

New changes in drug network sales

On September 1, the State Administration of Market Supervision and Administration 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.

"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:

1. Implement the responsibility of the main body of drug business 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.

2. Pressing pharmaceutical network sales platform responsibility

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.

3. Clarify prescription drug network sales management

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.

4. Implement the "four strictest" requirements

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. According to its regulations. If the drug supervision and management department finds that the drug network sales are suspected of crime, the case shall be transferred to the public security organs in a timely manner. If the laws and administrative regulations are not stipulated, they shall be ordered to make corrections within a time limit, and shall be fined 300,000 to 200,000.

02

The new policy was released, pharmaceutical e -commerce was relieved

In June of this year, a "national plan to ban third -party platforms from participating in the drug network sales directly" appeared on the top of the Weibo hot search list. Under the commentary area of ​​related news, some people interpreted it as "prohibiting Internet platforms for selling medicines", causing triggering extensive attention.

After analyzing by insiders, the so -called "prohibiting Internet platforms from selling medicines" is more a misunderstanding under the spread of social media fission.

However, in the secondary market, with the spread of the news, Ali's health and JD health stock prices with related business layout have plummeted, and the decline in the market has exceeded 9%. At the same time, pharmaceutical commercial stocks have burst into collective outbreaks. As of the closing, the number of medicines, Shusu civilians, Dashenlin, and Yifeng Pharmacy have increased by more than 5%.

To sum up, although it has a huge volume, pharmaceutical e -commerce has not yet established enough "confidence" to face possible official supervision.

The person in charge of a pharmaceutical e -commerce platform that is inconvenient to disclose names told Siberlan: "In recent years, the development of Internet medical care is like a huge balloon, watching the bluff, but a needle can poke it. I want to speculate in this industry. There are many people who make money, and there are very few people who do things. Because of this, the wind and grass movement in any policy can scare them. "

With the changes in consumer purchasing habits, the supervision of the third -party platform of pharmaceutical e -commerce has become the general trend.

The current Internet drug sales platforms include Kyushu, Yifeng, etc., which are purely self -operated drug sales business. There are also pure third -party platforms, such as Hungry and Meituan. Some people in the industry pointed out that the new rules "third -party platform providers must not directly participate in pharmaceutical network sales activities" or directly point out the self -employed business of pharmaceutical e -commerce platforms.

In order to avoid risks, to maintain their own interests to the greatest extent, and the e -commerce giants who have experienced many policy baptisms have long -term layout for possible supervision.

Taking Jingdong Health as an example, JD.com acquired Qingdao Anji Hall of Pharmacy at a price of hundreds of thousands of yuan a few years ago, that is, the predecessor of JD.com's self -operated (Jingdong Pharmacy).

In order to make business compliance, JD.com selected a chain store in each region for his collaboration. These pharmacies set up flagship stores on the Jingdong platform. After ordering online, it is still distributed by offline pharmacies, that is, the on -site delivery of chain stores and regional development. In this way, you can maximize the safety and compliance distribution of drugs. In November 2015, Jingdong Pharmacy obtained the Internet trading service C certificate, which has the qualifications for B2C drug sales. At this point, JD.com has completed its qualification reserves. In May of the following year, Jingdong Pharmacy was launched, and the pharmaceutical retail business was officially launched.

In other words, even if the new policy is landed and strictly implemented, due to the complete offline chain pharmacy qualifications, enterprises can ensure business compliance by stripping business. However, in the situation where supervision is stricter, pharmaceutical e -commerce still lives "trembling". It wasn't until the new policy was promulgated that it was really ate "reassurance".

The "Measures for the Supervision and Administration of Drug Network Sales and Supervision" released on September 1st has not changed significantly compared with previous policies in terms of the qualifications and requirements of the drug operating enterprise. The implementation of special management drugs for online sales is not the profit of pharmaceutical e -commerce companies. core. At the same time, after the release of the New Deal is released, the prescription drug network sales have become more important, which is important for pharmaceutical e -commerce.

In general, the "Measures for the Supervision and Administration of Drug Networks" mainly focuses on business specifications, platform responsibilities, and legal supervision. In the long run, this is the signal of the Internet's drug sales to the regularization.

When the policy is unknown and the supervision is not strict, a emerging format often has a explosive barbarous growth period, as is the online sales of drugs. But as the industry gradually matures, the contest of pharmaceutical e -commerce has really begun.

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