□ Our reporter Wan Jing
On December 1, the "Measures for the Supervision and Administration of Drug Online Sales" (hereinafter referred to as the "Measures") formulated by the State Administration for Market Regulation and the State Drug Administration was officially implemented.
Not long ago, the State Food and Drug Administration issued the "Drug Network Sales Prohibition List (First Edition)" (hereinafter referred to as the "Prohibition List"), which clearly included vaccines, narcotic drugs, traditional Chinese medicine formula granules and other drugs within the scope of network sales prohibition. .
The "Prohibition List" and the above-mentioned "Measures" came into effect on the same day.
In order to further implement the various systems of the "Measures" and comprehensively do a good job in the supervision and management of drug online sales, the State Food and Drug Administration also issued the "Notice on Doing a Good Job in the Implementation of the "Measures for the Supervision and Administration of Drug Online Sales" (hereinafter referred to as The "Notice") requires drug regulatory authorities at all levels to establish a sound mechanism, strictly investigate illegal activities, and maintain the order of drug online sales. They must closely focus on outstanding problems in drug online sales, insist on treating both symptoms and root causes, and emphasize containment, strong pressure, and long-term deterrence.
At the same time, various places have also successively launched special campaigns to rectify drug online sales.
With the promulgation of a series of regulatory policies and regulations and the development of law enforcement activities, a new era of standardization, compliance and strict supervision of online drug sales has begun.
Prohibited list of drugs sold online
In recent years, drug online sales activities have become increasingly active, but the rapid development process is accompanied by various chaos, such as illegal sales of drugs by unqualified entities, illegal sales of prescription drugs, passing off non-drugs as drugs, inadequate medical supporting services, and distribution links. There are hidden dangers, etc., which greatly limit the healthy development of my country's drug network sales.
Song Hualin, Dean of the School of Law of Nankai University and Director of the Medical and Health Law Research Center, believes that among the chaos of many drug online sales, illegal sales of prescription drugs have always been the "hardest hit area" and have been criticized.
According to the relevant laws and regulations of our country, prescription drugs can only be prepared, purchased and used with the prescription of a licensed physician or a licensed assistant physician.
As a special item for maintaining human health, drugs are strictly controlled by relevant laws and regulations in all aspects of research, production, sales, and use. Organizations or individuals participating in these links must be granted corresponding authority by the competent government department.
According to statistics from the China Adverse Drug Reaction Monitoring Center, the adverse reactions of prescription drugs are much higher than those of non-prescription drugs.
For this reason, the "Measures" clearly stipulate that those engaged in drug online sales should be drug marketing authorization holders or drug dealers with the ability to ensure the safety of online sales of drugs.
That is to say, the drug marketing authorization holder or the business enterprise that has obtained the drug business license can carry out the drug online sales business.
In addition, the "Measures" also clearly implement the real-name system for online sales of prescription drugs, and conduct prescription review and deployment according to regulations; stipulate that prescription drugs and over-the-counter drugs should be displayed separately, and clarify that packaging, labels and other information should not be directly displayed on the main page and home page of prescription drug sales; Before passing the prescription review, information such as instruction sheets shall not be displayed, and services related to the purchase of prescription drugs shall not be provided, which is intended to emphasize the management requirements of "prescription before drug" and prescription review.
In order to ensure that the "Measures" can "take root" smoothly after the implementation, the State Food and Drug Administration has started to deploy a lot of supporting work, the most important of which is to issue the "Prohibited List" to draw a "red line area" for drug online sales.
The "Prohibited List" includes drugs that are clearly prohibited from sale by policies and regulations, such as vaccines, blood products, narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, pharmaceutical precursor chemicals; medical institution preparations, traditional Chinese medicine formula granules ; It also includes other drugs that are prohibited from being retailed through the Internet, such as injections (except hypoglycemic drugs), itraconazole, etc.
Song Hualin pointed out that the above-mentioned regulations have fully considered the virtuality and concealment of the drug online sales model, and used detailed standardized operations to avoid them.
At the same time, the promulgation of the "Prohibited List" is to establish another "firewall" for the online sales of drugs.
These are all to strengthen the quality and safety of medicines and the protection of consumers' rights and interests.
On-site inspection of third-party platforms
In fact, my country's regulatory authorities are still cautious about whether drug online sales are "opened and released".
This can be seen from the long-term solicitation and revision process behind the release of the Measures.
In addition, in addition to the above-mentioned "Prohibition List", before the implementation of the "Measures", the State Food and Drug Administration also specially issued the "Announcement on Regulating the Filing and Reporting of Drug Online Sales" (hereinafter referred to as the "Announcement") and the "Notice".
The "Announcement" stipulates that the third-party platform for drug online trading should file with the provincial drug supervision and management department where the platform is located.
The provincial drug supervision and management department shall disclose the filing information to the public within 7 working days after the filing.
The public filing information should include: enterprise name, legal representative, website name, network client application name, website domain name, website IP address, telecommunications business license and non-commercial Internet information service filing number, drug network transaction number The filing number of the third-party platform, etc.
The provincial drug supervision and management department shall organize on-site inspections of the third-party online drug transaction platform within 3 months after the third-party online drug transaction platform is filed, and ensure that at least one inspection is carried out every year to guide enterprises to operate legally and orderly.
The "Notice" proposes that drug regulatory departments at all levels should supervise and guide drug online sales companies to effectively fulfill their main responsibilities, establish and implement systems such as drug quality and safety management, risk control, traceability, storage and distribution, and online pharmaceutical services.
Provincial drug regulatory departments should supervise and guide third-party platforms to establish and improve drug network sales management systems, establish drug quality and safety management institutions, establish and implement systems such as drug quality and safety, drug information display, prescription review, real-name purchase of prescription drugs, and drug distribution; supervise and urge Guide third-party platforms to carry out dynamic monitoring of drug sales behavior; urge third-party platforms to carefully review and check the qualifications of drug online sales companies, establish registration files, and ensure continuous quality and safety assurance capabilities; the main page and home page of prescription drug sales are not directly publicly displayed Prescription drug packaging, labeling and other information.
Strict investigation of illegal activities to form a strong deterrent
At the same time, in order to implement the central decision-making and maintain the normal market order of online drug sales, local market supervision, drug supervision and other departments are responsible for combating and rectifying various illegal and illegal drug online sales.
The State Food and Drug Administration emphasized that drug regulatory departments at all levels should closely focus on outstanding problems in drug online sales, and focus on investigating and dealing with illegal and regulatory issues such as the sale of counterfeit and inferior drugs, drugs that are subject to special management by the state, and operations beyond the scope and mode.
It is necessary to discover a batch, investigate a batch, severely punish a batch, and expose a batch of typical cases to form a strong deterrent and effectively maintain the order of drug online sales.
Drug regulatory departments at all levels should sort out the situation of drug online sales companies and third-party platforms in their jurisdictions, establish and improve regulatory accounts, and fully grasp the number of regulatory objects in their jurisdictions; they should strengthen supervision by means of routine inspections, unannounced inspections, and cross-inspections, and ensure that distribution Enterprises, etc. carry out necessary extended inspections; it is necessary to strengthen the coordination and cooperation of cross-regional drug regulatory departments, strengthen communication and cooperation with public security, health, network information and other departments, and establish a cross-regional drug online sales case investigation mechanism and cross-departmental liaison mechanism.
As early as February this year, Shaanxi Province held a video conference on in-depth special drug safety rectification actions. Key products such as intrusive medical devices and children's cosmetics, as well as online sales of drugs, are subject to key supervision.
In order to carry out special rectification actions on drug safety in depth, the Market Supervision Bureau of Linyi City, Shandong Province has continuously increased the supervision of drug online sales, and included clues of drug online sales suspected of violating laws and regulations into the key content of the city's rectification. Drugs that have not been registered and approved, products that are suspected of counterfeit drugs, and the use of false addresses to register Linyi City business licenses, illegal online sales of drugs in other cities and other violations of laws and regulations, will be severely punished and publicly exposed.
In June of this year, the Linyi Municipal Market Supervision Bureau exposed 38 market entities that illegally sold drugs online.
The Guangxi Food and Drug Administration issued a notice in September this year, clarifying that it will carry out a three-month special drug network market supervision campaign in the whole region, focusing on rectifying prominent problems in the drug network market, standardizing the competition order, optimizing the consumption environment, preventing and resolving major Risks and hidden dangers, and promote the healthy and sustainable development of the drug network market.
(Source: Rule of Law Daily)