State Food and Drug Administration: Strict investigation!

State Food and Drug Administration: Strict investigation! Pharmacies must pay attention to these when purchasing and selling COVID-19 self-testing agents
.
The sales of new crown self-testing reagents in pharmacies need to be recorded in order to effectively ensure the quality and safety of new coronavirus antigen detection reagent products, and to further strengthen the quality and safety supervision of new crown virus antigen detection reagent products.
Notice on Quality and Safety Supervision of Antigen Detection Reagents (hereinafter referred to as the “Notice”)
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The "Notice" requires that all relevant departments should strengthen the supervision and inspection of business links, supervise and guide enterprises to purchase new coronavirus antigen detection reagents from legally qualified medical device registrants and production and operation enterprises, make records of purchase inspection and sales, and prepare relevant equipment.
Adapted facilities and equipment to ensure that product transportation and storage conditions meet the labeling requirements of labels and instructions
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Regarding the key points of the inspection, the "Notice" clarifies that it pays attention to whether the new coronavirus antigen detection reagents operated by enterprises have been approved for registration and have qualification certificates, and whether the product manual contains instructions for consumers' personal use,
etc.
For medical device business enterprises engaged in online sales, it is also necessary to urge them to display the medical device business license in a prominent position on the main page of the website, and display the medical device registration certificate and other information on the product page
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At the request of the State Food and Drug Administration, many notices were issued to strictly control the sales of new crown antigen detection reagents in pharmacies
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Taking Heilongjiang as an example, it issued a document stating that it will carry out supervision and inspection of retail pharmacies and medical device business enterprises that sell new coronavirus antigen detection reagents
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The Heilongjiang document makes it clear that in order to ensure quality and safety, retail pharmacies that sell new coronavirus antigen detection reagents must do "five checks": 1.
Whether it has been approved by registration and has qualification certificates
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2.
Whether the product manual contains instructions for consumers' personal use
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3.
Check whether it is purchased from a legally qualified medical device registrant or production and operation enterprise
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4.
Whether the transportation and storage conditions of the product meet the labeling requirements of the label and instruction manual
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5.
Whether the company engaged in online sales displays information such as the medical device business license and the medical device registration certificate on the product page in a prominent position on the main page of the website
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The Heilongjiang document emphasized that the inspection found that illegal production and operation of unauthorized production and operation, production and operation of unregistered new coronavirus antigen detection reagents and other illegal activities should be strictly investigated and punished according to law
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Those suspected of committing a crime shall be promptly transferred to the public security organ
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Large domestic chains and online pharmacies have followed up.
According to the "New Coronavirus Antigen Detection Application Plan (Trial)" announced by the National Health and Health Commission, community residents who have self-test needs can purchase antigens by themselves through retail pharmacies, online sales platforms and other channels.
The detection reagent is self-tested
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The State Food and Drug Administration also mentioned that during the epidemic prevention and control period, retail pharmacies and medical device business enterprises that have obtained a drug business license or a medical device business license and have corresponding storage conditions can sell novel coronavirus antigen detection reagents
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In this context, major chain pharmacies and Internet platforms are "eager to try"
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Yifeng: On March 13, Yifeng Pharmacy issued a document stating that the online booking channel has been opened.
After scanning the code to book, the public can purchase new crown antigen self-test products through some offline stores
.
Common People: Common People Pharmacy, a domestic chain pharmacy, has reached a cooperation with Guangzhou Wanfu Biological.
The first batch of rapid test products for the new crown antigen have been distributed and are expected to be sold on the shelves soon
.
The first batch of products will be launched in 12 provincial and municipal stores of People's Pharmacy, including Shanghai, Hunan and Jiangsu
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Dashenlin: A staff member of Dashenlin Guangzhou store told the media that the purchase of antigen test kits currently needs to be pre-ordered
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After the subsequent antigen kits are rolled out, customers do not need registration information and can purchase directly in the store
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Gaoji Medical: On March 12, Gaoji Health announced that Gaoji Medical is working closely with Wanfu Bio, Novizan, Huada Yinyuan, Beijing Jinwofu and other companies to produce the first batch of new crown antigens.
Quick test products will soon be sold in Henan, Jiangxi, and Liaoning markets first, and online ordering services will be provided to customers across the country through the Gaoji Health Pro WeChat applet
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Yikang Pharmaceutical: On the evening of March 12, Yikang Pharmaceutical also announced that it has reached a cooperation with Guangzhou Wanfu Bio, and the first batch of new crown antigen rapid test products have been in the process of logistics and transportation, and Yikang Pharmaceutical will be launched soon
.
Tmall Health: The pre-sale page of the first batch of COVID-19 self-testing products has been launched, and online sales are expected to be officially opened in the near future
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JD.
com: On March 13, JD Health reached sales cooperation with a number of domestic companies that were among the first batch of companies approved by the State Food and Drug Administration for their "New Crown Antigen Self-Test" products
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The first batch of COVID-19 antigen self-test products will open online appointments on JD Health in the near future
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Meituan: Starting from March 13, users can make an appointment to purchase related products through pharmacies that ship nationwide in the Meituan Buying Drug Channel
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At the same time, the platform has cooperated with many chain pharmacies such as People's Pharmacy, Guoda Pharmacy, Gaoji Medical, Neptune, Dashenlin Pharmacy, and Quanyuantang Pharmacy.
Together, we provide users with a 30-minute door-to-door service
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Dingdang Kuaiyao: The "antigen detection" 28-minute home delivery service will be launched soon
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