Sell antigen test paper illegal

Recently, the new coronavirus antigen test reagent (referred to as antigen reagent) has become a "net red" material. Many netizens reflect,

in the drugstore can not buy antigen test reagents, but in the social platform there are many people touting and even promotions.

The reporter contacted the sellers on the social platform, they all claimed "manufacturers resources, to protect the regular source". They asked customers to buy at least a minimum of one box, and some people even said "100,000 to start, less not shipped", publicly released information that "today do not buy tomorrow, but also to increase the price.

There are also netizens released information that the purchase of reagents suspected of problems, testing and uploaded by the system shows:

The two-dimensional code on the reagent has been uploaded, can not be repeated to submit

.

The lawyer said,

individuals

private sale of antigenic reagents is illegal,

if the reagents appear to be fake, to fail to pass,

the circumstances are serious can be sentenced to life imprisonment.

On March 30, 2020, the State Drug Administration issued "China's new coronary virus test reagents and protective equipment regulatory requirements and standards", the new coronary virus test reagents as a third class medical device management.

In March this year, the State Drug Administration issued

"on the new coronavirus antigen test reagent quality and safety supervision of the work of the notice"

,

required to obtain a drug license or medical device license, and have the appropriate storage conditions of the retail drugstores and medical equipment business enterprises, can sell the new coronavirus antigen test reagents

.

The eye of the sky information shows that

recently there have been a number of companies for illegal sales of new crown antigen test reagents were fined

. Among them, a logistics company in Shanghai without authorization to buy antigen kits at a price of $ / person, and then sold at a price of $ 10 / person, sold 46 copies of *** counted 460 yuan, was fined 50,000 yuan and confiscated the illegal income.

December 7, Chaoyang District Market Supervision Bureau received a report on the Beijing Rehabilitation Home Medical Supplies Company Limited Chaoyang first branch of high-priced sales of antigen kits to investigate.

Fu Jian, director of Henan Zegen Law Firm, said that the new crown pneumonia virus test reagent belongs to the third class of medical devices,

unqualified individuals private sales is illegal.

The drug supervision and management departments at or above the county level ordered to stop operating, confiscate the illegal operation of the product and illegal income, illegal income of more than five thousand yuan, and impose a fine of more than two times the illegal income of more than five times the fine; in addition to administrative penalties, if it involves disrupting the market order, the circumstances are serious, may be suspected of illegal business crime,

illegal business amount of more than 50,000 yuan, or more than 10,000 yuan illegal income, it is

the illegal operation of the amount of more than 50,000 yuan, or more than 10,000 yuan, it is

the illegal operation of the amount of more than 50,000 yuan.

The illegal business amount of more than 50,000 yuan, or illegal income of more than 10,000 yuan, it

has reached the criminal prosecution standard, should be investigated by the public security organs.

Fu Jian said, if the private sale of antigenic reagents are fake and shoddy products, or fake for real, unqualified products as qualified products, and sales of large amounts, but also suspected of production and sale of fake and shoddy products crime. According to the provisions of the Criminal Law,

the sales amount of more than two million,

up to life imprisonment,

and impose a fine of more than 50% of the sales amount of more than two times the amount of confiscation, or confiscation of property.

It is noted that a number of places have carried out corresponding measures against people selling epidemic-related medical products privately. Among them, Baoding Municipal Market Supervision Bureau of Hebei Province, the Municipal Public Security Bureau, but also issued

"on the fight against epidemic prevention and control during the drugs and medical equipment related to illegal and criminal behavior of the letter", which provides that individuals are strictly prohibited in any form of business drugs and medical equipment.

It is noted that a number of places have already carried out corresponding measures in response to the above situation. Among them,

Baoding City, Hebei Province Market Supervision Bureau, the City Public Security Bureau,

but also for the epidemic prevention and control of drugs and medical equipment during the illegal and criminal behavior issued a letter of information:

Baoding City Market Supervision Bureau

Baoding City Public Security Bureau

on the fight against epidemic prevention and control of drugs and medical equipment during the period of illegal and criminal behavior of the letter of information

in order to strengthen the epidemic comprehensively, the management of pharmaceutical and medical equipment during the period of prevention and control of drugs and medical devices

a. Individuals are strictly prohibited from operating in any form of drugs and medical devices.

Drugs, medical devices are special commodities, according to the "People's Republic of China *** and the State Drug Administration Law" relevant provisions of the business of drugs need to obtain a "drug license". The state of medical devices in accordance with the degree of risk to implement classification management. According to the relevant provisions of the Regulations on the Supervision and Administration of Medical Devices, the operation of Class III medical devices requires a Medical Device License. New coronavirus antigen test reagent belongs to the third class of medical devices. Where to obtain a drug license or medical device license, and have the appropriate storage conditions of retail pharmacies and medical device companies can sell new coronavirus antigen test reagents; but the mode of operation is only retail, not wholesale business.

Not obtaining a drug license to sell drugs, ordered to close, confiscate the illegal sale of drugs and illegal income, and impose illegal sale of drugs more than thirty times the value of fifteen times the amount of fines; the amount of less than 100,000 yuan, calculated in accordance with 100,000 yuan. Sales of fake and shoddy drugs constitute a crime, be held criminally responsible.

Second, effectively safeguard the legitimate rights and interests of consumers.

Through the WeChat circle of friends, WeChat group and other informal channels to buy drugs and medical equipment, the quality and safety of drugs and equipment is not only unable to ensure that, due to the limitations of personal privacy, but also to the traceability and maintenance of the right to bring greater difficulties. Here we suggest that consumers purchase medicines and medical devices through legal channels and formal pharmaceutical business units, and retain sales certificates as the basis for rights protection.

Third, increase the supervision and enforcement.

The market supervision departments at all levels and public security organs continue to increase the whole chain of drugs and medical devices, the whole chain of supervision and law enforcement, for the epidemic prevention and control of drugs and medical equipment during the illegal and criminal behavior, and always maintain a high-pressure situation. The daily inspection, supervision and sampling, complaints and reports, network monitoring and other channels found in the problem clues should be traced back to the root, and investigated to the end; found that there are violations of the law, to be investigated; suspected of a criminal offense, transferred to the public security organs to pursue their criminal responsibility.

The public is welcome to participate actively in the illegal sale of drugs and medical equipment, suspected of selling fake and shoddy drugs and medical equipment and other illegal situations, call 12315 complaint hotline to report complaints, *** with the maintenance of the city's drug safety and market order.

Baoding Municipal Market Supervision Administration

Baoding Municipal Public Security Bureau

December 9, 2022