How to evaluate this behavior? Can I buy this antigen? 12 16, the reporter interviewed Zhang Zhengquan, a lawyer of Beijing Deheheng (Wuhan) Law Firm. He said that the antigens sold by friends circle can't be real people, and it is illegal for individuals to sell antigens, which seriously constitutes a crime.
Ms. Wang, who lives in Houhu, booked a box of 10 antigen reagents online. As a result, she booked it for 2 weeks, and the merchant has not delivered it yet. In the community WeChat group, Ms. Wang saw someone selling antigen reagents, so she spent 20 yuan to buy three. She said that someone at home had a fever and was anxious to buy it at a high price. But Ms. Wang is not sure whether the antigen she bought is true or not.
On March 30th, 2020, the State Administration of Medical Supplies issued "Regulatory Requirements and Standards for Detection Reagents and Protective Articles in novel coronavirus", which classified medical devices including in vitro diagnostic reagents into Class I, Class II and Class III management according to the degree of risk. Among them, the first category has the lowest risk, and the third category has the highest risk. novel coronavirus detection reagents are managed as the third category of medical devices.
On March 12, 2022, the State Administration of Medical Devices issued the Notice of the General Department of the State Administration of Medical Devices on Doing a Good Job in the Quality and Safety Supervision of Antigen Detection Reagents in COVID-19. It is mentioned that illegal activities such as unauthorized production and operation and unregistered COVID-19 antigen detection reagents should be severely punished according to law. Anyone suspected of committing a crime shall be promptly transferred to the public security organ.
The Regulations on the Supervision and Administration of Medical Devices clearly stipulates that those who engage in the operation of Class III medical devices shall apply to the pharmaceutical supervisory and administrative department of the local municipal people's government for a business license, and have business premises and storage conditions, quality management system and quality management institutions or personnel suitable for the scale and scope of operation. So individuals can't sell antigen reagents.
Lawyer Zhang Zhengquan said that if an individual illegally sells antigen reagents without permission, the drug supervision and administration department will confiscate the illegal income and antigen reagents, and may impose fines to varying degrees according to the value of the illegally sold goods.
COVID-19 virus detection reagents belong to the third category of medical devices, and it is illegal for unqualified individuals to sell them privately. The drug supervision and administration department shall confiscate the illegal income, medical devices illegally produced and operated, tools, equipment, raw materials and other items used for illegal production and operation; If the value of illegally sold antigen reagents is less than 6.5438+0 million yuan, a fine of 50,000 yuan to 6.5438+0.5 million yuan shall be imposed; If the value of the goods is more than 10000 yuan, a fine of more than 15 times and less than 30 times shall be imposed; If the circumstances are serious, it shall be ordered to stop production and business, and the application for medical device license put forward by relevant responsible persons and units shall not be accepted within 10 years.
In addition to administrative punishment, if it involves disrupting market order and the circumstances are serious, it may be suspected of illegal business operations. If the amount of illegal business operation exceeds 50,000 yuan, or the illegal income exceeds 1 10,000 yuan, which reaches the standard of criminal prosecution, the public security organ shall file a case for investigation.
In addition, the antigen reagents sold by individuals are fake and inferior products, and if the sales amount reaches more than 50,000 yuan, it will also be suspected of constituting the crime of producing and selling fake and inferior products. If the sales amount is more than 2 million yuan, it can be sentenced to 15 years imprisonment or life imprisonment.
Lawyer Zhang Zhengquan reminded consumers that if they find someone illegally selling antigens, they can call the hotline 123 15 to complain and report in time. Please be sure to buy from regular channels to avoid being cheated.