Market supervision in Nanjing is in action to solve the problem of household entry of COVID-19 antigen testing reagents

2022-05-31 0 By

China Quality News Network – Have you found?Recently, more and more pharmacies in Nanjing are selling novel Coronavirus antigen testing reagents!In fact, this is behind the Nanjing market supervision in force.Nanjing Municipal Administration for Market Supervision has taken the initiative to provide both services and supervision to ensure the public’s demand for novel Coronavirus antigen self-testing.On 11 March 2022, the Comprehensive Group of the Joint Prevention and Control Mechanism of The State Council issued a plan to add antigen testing as a supplementary means of screening the Novel Coronavirus, which can be tested by residents themselves.As novel Coronavirus antigen test reagents belong to class III in vitro diagnostic reagents, operators need to apply for class III business license of medical devices with corresponding business scope. Before March 2022, only a few pharmacies in Nanjing meet the sales qualification requirements.So can other pharmacies sell novel Coronavirus antigen tests?Pharmacies are inquiring about specific regulatory requirements.At the national and provincial drug administration rules under the condition of having not enacted, to fully guarantee the epidemic prevention and control in the whole city general situation, meet the demand of residents, nanjing market regulatory authority without, proactive planning, came on the second day of the New Deal immediately to carry out special study, take the lead in the province to form “will be coronavirus antigen detection reagent management link quality and safety supervision work plan”,Novel Coronavirus antigen test reagents are allowed to be sold offline in pharmacies with storage conditions corresponding to the products.On the same day, pharmacies began actively placing orders for novel Coronavirus antigen tests from manufacturers.Standardize management use according to the nanjing will be coronavirus antigen detection reagent management link quality and safety supervision work plan, the city market regulatory authority to act quickly, notify the pharmacy sales self-test use will be approved by state food and drug administration coronavirus antigen detection reagent, and in nanjing containing ephedrine compound preparations of the regulatory system “four types of drug registration” sales module registration related information in time,Easy to trace.At the same time, pharmacies are required to carry out online sales of novel Coronavirus antigen testing reagents for self-testing in accordance with the approved business mode and business scope, and to display the business license of medical devices in a prominent position on the main page of the website, and the registration certificate of medical devices and other information on the product page.Keeping the bottom line of quality and safety The municipal and district market supervision bureaux will continue to carry out supervision and inspection of drugstores operating Novel Coronavirus antigen testing reagents, focusing on checking product qualification, supplier qualification, storage environment, purchase inspection record and sales record, etc., to urge enterprises to fulfill their main responsibilities and further keep the bottom line of quality and safety.Up to now, there are 247 pharmacies in The city selling Novel Coronavirus antigen testing reagents, and 852 pieces of purchase information have been registered. All the products involved have been approved by the SFDA.Convenient service measures nanjing market regulator design the unified format of the self-test with will remind “coronavirus antigen detection reagent purchased and used, contain due to need to purchase, compliance, standardization of storage self-test, results disposal, waste treatment, pharmacy area related to epidemic prevention and control institutions on duty phone, and asked the pharmacy with the antigen detection reagent were given to the purchaser,Buy citizen to close prompt in succession give high praise.(Liu Shuyuan, Shen Zhou)