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    Home > Medical News > Latest Medical News > Special rectification of drug online sales is coming!

    Special rectification of drug online sales is coming!

    • Last Update: 2021-04-18
    • Source: Internet
    • Author: User
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    Medical Network, April 8 News On April 6, the Office of the Shanxi Provincial Drug Administration issued the "Notice on Launching Special Rectification of Drug Online Sales Violations" (hereinafter referred to as the "Notice").
    It is reported that this special rectification in Shanxi is to implement the relevant requirements of the "Notice of the Comprehensive Department of the State Drug Administration on Continuing Special Remediation Actions for Drug Online Sales Violations" (Yao Jian Zong Yao Guan [2021] No.
    36).
    It lies in further regulating drug online sales activities, purifying the drug online sales market, severely cracking down on illegal drug online sales, and consolidating the results of the special rectification action for illegal drug online sales.
     
    According to the arrangements, Shanxi will focus on safety net sales of the drug quality and safety, according to the characteristics of Internet sales of drugs, for key areas, focusing on business , never obtaining the qualification to carry out the problem of drugs Internet sales, drug sales net sellers of illegal drugs through a network problem , Three dimensions, including the performance of third-party platforms for online transaction services, continued to carry out special rectifications in depth.
     
    The principle of "online and offline consistency" cannot be violated
     
    The Measures for the Supervision and Administration of Drug Online Sales (Draft for Solicitation of Comments) issued in November 2020 (hereinafter referred to as the "Draft for Comments") clarified that drug online sellers should be the drug marketing license holder (hereinafter referred to as the holder) or the drug Running a company.
    In the delineated online sales scope, it is emphasized that online sales of pharmaceuticals shall not exceed the business method of the enterprise and the scope of pharmaceutical business.
    If a drug network seller is the holder, he can only sell the drug with the approval number.
    Those who have not obtained the qualification for drug retailing shall not sell drugs to individuals.
     
    Based on this, the problem of not obtaining qualifications to carry out drug online sales has become one of the key contents of this Shanxi special rectification action.
    In accordance with the requirements of the "Notice", Shanxi will focus on inspecting whether companies have the following two types of behaviors: First, units that have not obtained the qualifications for the production and operation of drugs or illegally engaged in drug online pharmnet.
    com.
    cn/news/yyzb/" target="_blank">procurement and sales activities beyond the validity period ; Second, they have not obtained or exceeded the "Internet The validity period of the "Drug Information Service Qualification Certificate" is engaged in the activities of providing drug network information services and publishing false drug information.
     
    Although the new version of the "Drug Administration Law" establishes the principle of "consistent online and offline" for the emerging business of online drug sales, the virtual, concealed, and cross-regional characteristics of the Internet have led to illegal drug sales on the Internet.
    Problems often occur, bringing new exam questions to the supervision of online drug sales.
     
    In response to the problem of drug online sellers selling drugs illegally through the Internet, Shanxi will focus on seven types of behaviors during the rectification, four of which involve specific online drug categories: one is the illegal sale of counterfeit drugs and inferior drugs, which have been requested to be recalled or Regulatory authorities require the suspension of the sale of drugs used; second, illegal sales of vaccines, blood products, narcotic drugs, psychotropic drugs, medical toxic drugs, radiopharmaceuticals, pharmaceutical precursor chemicals, and other drugs subject to special management; According to regulations, it sells compound preparations containing ephedrines, codeine, tramadol and other special medicines; fourth, illegally sells traditional Chinese medicine granules and preparations for medical institutions.
     
    At the same time, drugs are sold beyond the scope and methods; the relevant regulations on the classification management of prescription drugs and non-prescription drugs are not strictly implemented, and prescription drugs are sold without a prescription or without the review of a licensed pharmacist; drug distribution does not comply with the relevant regulations of the "Pharmaceutical Management Standards", etc.
    The three types of violations that frequently occur in enterprises are also the focus of this special rectification in Shanxi.
     
    Strengthen case investigation, form an effective deterrent
     
    In the current ecosystem of online drug sales, third-party service platforms are an indispensable part and play a vital role in ensuring the safety of patients' medication.
    In accordance with the requirements of the "Draft Opinions", third-party platforms should implement the establishment and implementation of a system to ensure drug quality and safety, establish a drug quality management agency, undertake drug quality management, establish transaction record storage, complaint management and dispute resolution, and collection of information on adverse drug reactions The establishment and implementation of the delivery quality management system and other obligations.
     
    Obviously, the performance of third-party platforms for online trading services is also another major focus of this special rectification.
    Shanxi emphasizes that it will focus on checking whether third-party platform providers have the following three types of behavior: Whether to strictly perform the drug network on the platform The seller’s qualification review obligation; whether to effectively manage the drug business activities that occur on the platform; whether to promptly stop the online transaction services of drug online sellers suspected of illegal activities.
     
      According to the specific work arrangements in Shanxi, April will be the mobilization and deployment phase.
    All cities and comprehensive reform areas are required to formulate specific implementation plans based on actual work, and the special rectification work requirements are timely communicated to the drug network sales companies in their jurisdictions, and the drug network sales companies will be carried out.
    Through registration, all drug online sales companies and third-party platforms proactively carry out self-examination and in-depth rectification in accordance with special rectification requirements; May to October is the stage of centralized rectification, and comprehensively use orders for rectification and interviews for problems found in violations of laws and regulations.
    Measures such as warning, public exposure, and administrative punishment shall be dealt with in accordance with the law.
    November to December is the stage of supervision and random inspection, and the problems found in the inspection are dealt with seriously and thoroughly rectified.
     
      It is worth noting that, in order to strengthen the investigation and handling of the case and form an effective deterrent, Shanxi will also seriously investigate and deal with the transferred monitoring clues and problems found in the inspection according to law, and provide timely feedback on the progress and results of the disposal through the national drug network transaction monitoring system within 60 days .
    For key cases, Shanxi also proposed to organize specialized forces, concentrate superior forces, resolutely investigate to the end, and punish severely in accordance with the law.
    However, “online” false information cannot be “deleted” or “off the shelf”.
    A batch of typical cases must be investigated and a batch of companies exposed to form an effective deterrent and effectively maintain the order of drug online sales.
     
      From the perspective of the industry, as a new round of special rectification of illegal drug online sales is carried out across the country, the market environment for drug online sales will be further purified.
    Under the continuous compliance operation of relevant companies, the "fourth terminal" It is expected to welcome new market growth.
      Medical Network, April 8 News On April 6, the Office of the Shanxi Provincial Drug Administration issued the "Notice on Launching Special Rectification of Drug Online Sales Violations" (hereinafter referred to as the "Notice").
    It is reported that this special rectification in Shanxi is to implement the relevant requirements of the "Notice of the Comprehensive Department of the State Drug Administration on Continuing Special Remediation Actions for Drug Online Sales Violations" (Yao Jian Zong Yao Guan [2021] No.
    36).
    It lies in further regulating drug online sales activities, purifying the drug online sales market, severely cracking down on illegal drug online sales, and consolidating the results of the special rectification action for illegal drug online sales.
     
      According to the arrangements, Shanxi will focus on safety net sales of the drug quality and safety, according to the characteristics of Internet sales of drugs, for key areas, focusing on business , never obtaining the qualification to carry out the problem of drugs Internet sales, drug sales net sellers of illegal drugs through a network problem , Three dimensions, including the performance of third-party platforms for online transaction services, continued to carry out special rectifications in depth.
     
       The principle of "online and offline consistency" cannot be violated
     
      The Measures for the Supervision and Administration of Drug Online Sales (Draft for Solicitation of Comments) issued in November 2020 (hereinafter referred to as the "Draft for Comments") clarified that drug online sellers should be the drug marketing license holder (hereinafter referred to as the holder) or the drug Running a company.
    In the delineated online sales scope, it is emphasized that online sales of pharmaceuticals shall not exceed the business method of the enterprise and the scope of pharmaceutical business.
    If a drug network seller is the holder, he can only sell the drug with the approval number.
    Those who have not obtained the qualification for drug retailing shall not sell drugs to individuals.
     
      Based on this, the problem of not obtaining qualifications to carry out drug online sales has become one of the key contents of this Shanxi special rectification action.
    In accordance with the requirements of the "Notice", Shanxi will focus on inspecting whether companies have the following two types of behaviors: First, units that have not obtained the qualifications for the production and operation of drugs or illegally engaged in drug online pharmnet.
    com.
    cn/news/yyzb/" target="_blank">procurement and sales activities beyond the validity period ; Second, they have not obtained or exceeded the "Internet The validity period of the "Drug Information Service Qualification Certificate" is engaged in the activities of providing drug network information services and publishing false drug information.
     
      Although the new version of the "Drug Administration Law" establishes the principle of "consistent online and offline" for the emerging business of online drug sales, the virtual, concealed, and cross-regional characteristics of the Internet have led to illegal drug sales on the Internet.
    Problems often occur, bringing new exam questions to the supervision of online drug sales.
     
      In response to the problem of drug online sellers selling drugs illegally through the Internet, Shanxi will focus on seven types of behaviors during the rectification, four of which involve specific online drug categories: one is the illegal sale of counterfeit drugs and inferior drugs, which have been requested to be recalled or Regulatory authorities require the suspension of the sale of drugs used; second, illegal sales of vaccines, blood products, narcotic drugs, psychotropic drugs, medical toxic drugs, radiopharmaceuticals, pharmaceutical precursor chemicals, and other drugs subject to special management; According to regulations, it sells compound preparations containing ephedrines, codeine, tramadol and other special medicines; fourth, illegally sells traditional Chinese medicine granules and preparations for medical institutions.
     
      At the same time, drugs are sold beyond the scope and methods; the relevant regulations on the classification management of prescription drugs and non-prescription drugs are not strictly implemented, and prescription drugs are sold without a prescription or without the review of a licensed pharmacist; drug distribution does not comply with the relevant regulations of the "Pharmaceutical Management Standards", etc.
    The three types of violations that frequently occur in enterprises are also the focus of this special rectification in Shanxi.
     
      Strengthen case investigation, form an effective deterrent
     
      In the current ecosystem of online drug sales, third-party service platforms are an indispensable part and play a vital role in ensuring the safety of patients' medication.
    In accordance with the requirements of the "Draft Opinions", third-party platforms should implement the establishment and implementation of a system to ensure drug quality and safety, establish a drug quality management agency, undertake drug quality management, establish transaction record storage, complaint management and dispute resolution, and collection of information on adverse drug reactions The establishment and implementation of the delivery quality management system and other obligations.
     
      Obviously, the performance of third-party platforms for online trading services is also another major focus of this special rectification.
    Shanxi emphasizes that it will focus on checking whether third-party platform providers have the following three types of behavior: Whether to strictly perform the drug network on the platform The seller’s qualification review obligation; whether to effectively manage the drug business activities that occur on the platform; whether to promptly stop the online transaction services of drug online sellers suspected of illegal activities.
     
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