Illegal sale of antigen how to punish

The State Council joint prevention and control mechanism "new ten" to further optimize the implementation of measures to prevent and control the epidemic after the promulgation of a portion of the individual driven by the interests of the use of microblogging circle of friends and other channels to illegally sell the new crown antigen test kits.

Shandong Provincial Bureau of Pharmaceutical Supervision, individuals selling new crown antigen test reagents are illegal, up to 30 times the amount of the value of the new crown antigen test reagents sold fines! The first step in the process is to make sure that you have a good understanding of the situation, and that you have a good understanding of the situation.

2020 March 30, 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 of medical device management. Article 42 of the "Regulations for the Supervision and Administration of Medical Devices" provides that, engaged in the operation of Class III medical devices, the business enterprise should be located in the municipal people's government responsible for the supervision and management of drugs to apply for a license to operate.

According to the "State Drug Administration Comprehensive Department on the new coronavirus antigen test reagents to do a good job in the quality and safety supervision of the work of the notice" requirements, in the epidemic prevention and control period, 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 be sold in the new coronavirus antigen test reagents.

"Supervision and Administration of Medical Devices Regulations" Article 81 provides that unauthorized third class medical equipment business activities, by the drug supervision and management departments responsible for the confiscation of the illegal income, illegal operation of medical equipment and tools used for the illegal operation of equipment, raw materials and other items;

illegal operation of medical devices less than 10,000 yuan of the value of the goods and impose 50,000 yuan more than 150,000 yuan or less. Fines; value of more than 10,000 yuan, and impose a value of more than 15 times the amount of 30 times the following fine.

If the individual sales of new crown antigen test reagents belong to the fake for real, substandard products as qualified products and other circumstances, and sales amounted to more than 50,000 yuan; or sales of new crown antigen test reagents that do not meet the national standards for the protection of human health, enough to seriously endanger human health, the drug regulatory authorities will be referred to the judicial authorities to pursue criminal responsibility.

Shandong Provincial Bureau of Pharmaceutical Supervision reminds consumers to buy the new crown antigen test reagents must be purchased from the regular channels. If you find illegal clues,

please call 12315 or 12345 hotline to report complaints.