According to the clear provisions of the state, the sale of COVID-19 antigen kits must have a Drug Business License or a Medical Device Business License (6840 includes in vitro diagnostic reagents), and retail and wholesale can only be prohibited after the second-class filing is obtained. Moreover, COVID-19 antigen is a three-class medical device, and it is illegal and criminal for unqualified enterprises and individuals to resell antigens.
Enterprises are the main body of the third kind of medical device business, and must obtain the medical device business license. Individuals can't engage in the third kind of medical devices (including the second kind) business activities, and it is illegal for individuals to sell COVID-19 antigen kits on online platforms such as friends circle. If the detection antigen reagents sold by individuals are fake and shoddy products, or fake and genuine products are passed off as qualified products with unqualified products, and the sales amount is large, then they will also be suspected of producing and selling fake and shoddy products.
The crime of producing and selling fake and inferior products refers to the behavior of producers and sellers doping and adulterating goods, making the fake genuine and shoddy, and the general sales amount is more than 50 thousand yuan. Criteria for filing the crime of producing and selling fake and inferior products: If a producer or seller adulterates a product, shoddy it, or passes off a substandard product as a qualified product, and it is suspected of any of the following circumstances, it shall file a case and investigate the relevant legal responsibilities:
1, the sales of fake and inferior products is more than 50,000 yuan;
2, the production of fake and shoddy products have not yet been sold, but the total value of goods reached 654.38+500 thousand yuan;
3. The sales amount of producing and selling fake and inferior products is less than 50,000 yuan, but after multiplying the sales amount by 3 times, the total value of unsold goods containing fake and inferior products is more than 6.5438+0.5 million yuan.
Individual reselling antigen reagents belongs to the production and sale of fake and inferior products, and the punishment is:
1, if the sales amount is more than 50,000 yuan but less than 200,000 yuan, he shall be sentenced to fixed-term imprisonment of not more than two years or criminal detention, and shall also be fined not less than 50% but not more than two times the sales amount;
2. Whoever sells more than 200,000 yuan but less than 500,000 yuan shall be sentenced to fixed-term imprisonment of not less than two years but not more than seven years, and shall also be fined not less than 50% but not more than two times the sales amount;
3. If the sales amount is more than 500,000 yuan but less than 2 million yuan, he shall be sentenced to fixed-term imprisonment of more than seven years and fined more than 50% but less than two times the sales amount;
4. If the sales amount is more than 2 million yuan, he shall be sentenced to fixed-term imprisonment of 15 years or life imprisonment, and shall also be fined more than 50% but less than 2 times the sales amount, or his property shall be confiscated.
It should be pointed out that:
1, "doping, adulteration" refers to the act of doping impurities or foreign bodies in a product, which leads to the product quality not meeting the quality requirements stipulated by national laws, regulations or express product quality standards, and reduces or loses its due performance;
2. "Confusing the fake with the real" refers to the act of passing off a product with certain performance as a product with that performance;
3. "shoddy" refers to the act of passing off low-grade and low-grade products as high-grade and high-grade products, or passing off defective products and old spare parts as genuine products or assembled new products;
4. "Unqualified products" refers to products that do not meet the quality requirements stipulated in the Product Quality Law of People's Republic of China (PRC).
If it is difficult to identify the above acts, it shall entrust a product quality inspection institution as stipulated by laws and administrative regulations for identification;
5. "Sales amount" refers to all illegal income obtained by producers and sellers after selling fake and inferior products and all illegal income due;
6 "value" is calculated by the marked price of fake and inferior products illegally produced and sold; If the price is not indicated, it shall be calculated according to the intermediate market price of similar qualified products. If it is difficult to determine the value of the goods, it shall entrust an evaluation institution to determine it in accordance with the provisions of the Measures for the Administration of the Evaluation of Seizure, Recovery and Confiscation of Goods.