Guangxi Food and Drug Administration: Three months! The special rectification of online drug sales is coming

Recently, the Guangxi Food and Drug Administration issued a notice to carry out a three-month special action for the supervision of the drug network market in the whole region, focusing on rectifying the prominent problems in the drug network market, standardizing the competition order, optimizing the consumption environment, preventing and resolving major risks and hidden dangers, and promoting the healthy and sustainable development of
the drug network market 。 01 Focus on cracking down on four illegal acts In this special action, the Guangxi Food and Drug Administration focused on hot issues with high social concern, wide coverage and strong reflection in the drug circulation link, paid attention to the supervision of the whole chain before and after the event, adhered to the equal emphasis on regulatory norms and promoted development, further maintained the order of the drug market of fair competition, effectively protected the legitimate rights and interests of operators and consumers, and focused on cracking down on illegal acts
in the online sales of "two products and one device".
There are four main tasks: First, to crack down on illegal acts of
online drug sales.
Severely crack down on engaging in online drug sales without the conditions for online sales, and selling drugs beyond the scope and licensing methods; Comprehensively regulate the sale of prescription drugs, and severely crack down on illegal acts such as selling prescription drugs without prescriptions; Lawfully investigate and punish third-party platform providers for failing to perform the qualification review of settled merchants and failing to perform their responsibility for managing business conduct within the platform; Strictly investigate and deal with illegal and criminal acts such as online sales of counterfeit and inferior drugs; Strictly investigate and deal with illegal acts of selling vaccines, blood products, narcotic drugs, and other drugs
under special management by the state on the Internet.
The second is to crack down on illegal acts of online sales of medical devices
.
Severely crack down on illegal acts
such as selling Class II and III medical devices through the Internet without permission or filing, selling medical devices beyond the scope or mode of operation of the licensed or filed business, and selling medical devices that have not been registered or filed.
The third is to crack down on illegal acts
of online sales of cosmetics.
Severely crack down on illegal acts
such as online sales of unregistered or unregistered cosmetics, illegal addition of cosmetics that may endanger human health, and cosmetics produced using prohibited raw materials.
The fourth is to strictly investigate false and illegal advertisements
involving drugs, medical devices, cosmetics, myopia prevention and control products for children and adolescents, and so on.
The circular requires drug regulatory departments at all levels in the region to strengthen monitoring and supervision, increase law enforcement, and accurately crack down on serious violations
of laws and regulations in response to new problems in new formats and models in the drug network market.
It is necessary to strengthen online and offline integrated supervision, strengthen cross-departmental, cross-level and cross-regional coordinated supervision, and form a regulatory synergy
.
It is necessary to make overall plans for the use of wisdom supervision and credit supervision, further strengthen interdepartmental coordinated supervision and joint disciplinary action, and promote interdepartmental information sharing and mutual assistance
in law enforcement on lists of the seriously illegal and untrustworthy.
It is necessary to strengthen the connection between administrative law enforcement and criminal justice, and severely punish illegal and criminal acts
.
It is necessary to urge drug e-commerce operators, especially platform operators, to perform their statutory responsibilities and obligations, and provide strong support
for promoting the healthy and sustainable development of drug network economic norms.
It is necessary to timely issue consumer warnings, tips, and exposure of typical cases of violations, interpret the law by case, popularize the law by case, and effectively improve the overall effectiveness
of drug network market supervision and law enforcement.
02 Online sales of drugs to meet the new regulations on supervision In recent years, online drug sales have shown a rapid development momentum
.
Especially since the outbreak of the new crown pneumonia epidemic, under the condition of restricting social distancing and isolating people at home, the online drug sales model delivered by online order stores has become one
of the ways for many pharmacies to increase customer flow.
Combing through the past several rounds of special rectification actions, it is not difficult to find that the rectification of illegal acts of online drug sales mainly focuses on three aspects: First, the third-party platform of online transaction services performs
its responsibilities.
Including the third-party platform that provides drug network sales services, it has not reviewed the qualifications of drug marketing authorization holders and drug trading enterprises that apply to enter the platform in accordance with the law, has not guaranteed that it meets the statutory requirements, and has not managed the drug business behavior that occurs on the platform in place; Failure to promptly stop and immediately report violations of drug marketing license holders and drug trading enterprises that have entered the platform for business, and not immediately report to the drug regulatory department of the local county-level people's government, and not immediately stop providing online trading platform services
for serious illegal acts discovered.
The second is the problem
of not obtaining qualifications to carry out drug network sales.
Including those who have not obtained the qualification for the production, operation and use of drugs, or whose qualifications have exceeded the validity period, illegally engaged in drug network procurement and sales activities; Have not obtained or exceeded the validity period of the "Internet Drug Information Service Qualification Certificate" to engage in the provision of drug network information services and the publication of false drug information activities
.
The third is to focus on the problem
of drug network sellers selling drugs illegally and illegally through the Network.
Including the illegal sale of vaccines, blood products, narcotic drugs, psychotropic substances, toxic drugs for medical use, radioactive drugs, precursor chemicals such as pharmaceuticals and other drugs under special management by the State; Beyond the scope and mode of operation of drugs; Failure to strictly enforce the relevant regulations on the classification and management of prescription drugs and over-the-counter drugs, and sell prescription drugs without a prescription or without the review of a licensed pharmacist; Drug distribution does not comply with the relevant provisions of the "Good Management Practice for Drug Business" and other relevant provisions
.
The Measures for the Supervision and Administration of Drug Network Sales, which will be implemented on December 1, put forward new regulatory requirements, and the State Administration for Market Regulation considers the drug safety risks and online and offline consistency management requirements, clarifies the implementation of a real-name system for online sales of prescription drugs, and conducts prescription review and allocation in accordance with regulations; Stipulate that prescription drugs and over-the-counter drugs shall be displayed separately, and make it clear that packaging, labels and other information must not be directly displayed on the main page and home page of prescription drug sales; Before passing the prescription review, it is not allowed to display information such as instructions, and it is not allowed to provide relevant services for the purchase of prescription drugs, which is intended to emphasize the management requirements
of "prescription after drug" and prescription review.
At the same time, it is required that the relevant risk warning information should be fully informed to consumers before the sale of prescription drugs and confirmed by consumers to know, and effectively prevent drug safety risks
.
01 Focus on cracking down on four illegal acts cosmetics drugs and medical devices 02 Online sales of drugs to welcome the new regulations on the supervision of pharmacy enterprises