State Market Supervision and Administration Order No. 58 The Measures for the Supervision and Administration of Online Sales of Pharmaceuticals have been adopted by the 9th Bureau Meeting of the General Administration of Market Supervision and Administration (GAMSA) on July 15, 2022, and are hereby promulgated and shall come into force on December 1, 2022, in consensus with the Health and Wellness Commission (HWC). Director Luo Wen August 3, 2022 Supervision and Management of Drug Network Sales Chapter I General Provisions Article 1 In order to regulate the sale of drugs on the Internet and the service activities of drug network trading platforms, to protect the safety of public medication, according to the "People's Republic of China *** and the State Drug Administration Law" (hereinafter referred to as the Drug Administration Law) and other laws, administrative regulations, to formulate the present measures. Article II in the Chinese People's *** and the State engaged in the sale of drugs on the Internet, providing pharmaceutical network trading platform services and its supervision and management, shall comply with these measures. Article III of the State Drug Administration in charge of the supervision and management of the national drug network sales. Provincial drug supervision and management departments are responsible for the supervision and management of drug network sales in the administrative region, is responsible for the supervision and management of drug network trading third-party platforms, as well as drug marketing license holders, pharmaceutical wholesale enterprises through the network sales of pharmaceutical activities. Municipal and county-level departments responsible for drug supervision and management (hereinafter referred to as drug supervision and management department) is responsible for the supervision and management of the sale of drugs network within the administrative region, is responsible for the supervision and management of drug retailers through the network sales of pharmaceutical activities. Article 4 engaged in the sale of drugs network, providing drug network trading platform services, should comply with drug laws, regulations, rules, standards and norms, in accordance with the law and integrity of the business, to protect the quality and safety of drugs. Article 5 engaged in the sale of drugs on the Internet, providing pharmaceutical network trading platform services, should take effective measures to ensure that the whole process of transaction information is true, accurate, complete and traceable, and to comply with the relevant provisions of the national personal information protection. Article VI drug supervision and management departments should strengthen collaboration with relevant departments, give full play to the role of industry organizations and other institutions to promote the construction of the credit system and promote social **** governance. Chapter II of the drug network sales management Article 7 engaged in the sale of drugs on the network, should have the ability to ensure that the network sales of drugs safety drug listing license holders or drug business enterprises. Chinese medicine tablet producers to sell their production of Chinese medicine tablets, should fulfill the relevant obligations of the drug listing license holder. Article 8 of the drug network sales enterprises should be in accordance with the approved mode of operation and business scope of operation. Pharmaceutical network sales enterprises for the drug listing license holder, can only sell their drugs to obtain the certificate of registration of drugs. Did not obtain the qualification of drug retailing, shall not sell drugs to individuals. Vaccines, blood products, narcotic drugs, psychotropic substances, toxic drugs for medical use, radioactive drugs, drugs and other chemicals such as drug-type drug-type chemicals shall not be sold on the network of special management of drugs, the specific directory by the State Drug Administration to develop the organization. Pharmaceutical network retail enterprises shall not violate the provisions of the purchase of drugs to gift drugs, buy goods to gift drugs to individuals in the form of prescription drugs, Class A non-prescription drugs. Article IX sales of prescription drugs to individuals through the network, should ensure that the source of the prescription is real and reliable, and the implementation of real-name system. Drug network retailers should sign an agreement with the electronic prescription provider unit, and strictly in accordance with the relevant provisions of the prescription audit and deployment, the electronic prescription has been used to mark, to avoid the repeated use of prescriptions. The third-party platform to undertake e-prescription, should verify the situation of the e-prescription provider unit, and sign an agreement. The prescription received by the pharmaceutical network retail enterprises for paper prescription photocopy version, effective measures should be taken to avoid the repeated use of prescriptions. Article 10 of the drug network sales enterprises should establish and implement drug quality and safety management, risk control, drug traceability, storage and distribution management, adverse reaction reports, complaints and reports processing system. Drug network retail enterprises should also establish online pharmacy service system, by the qualification of the pharmacist or other pharmacy technicians to carry out prescription review and allocation, guidance on the rational use of drugs and other work. The number of pharmacists or other pharmacy technicians qualified according to law should be commensurate with the scale of operation. Article 11 of the drug network sales enterprises should be reported to the drug supervision and management department of the enterprise name, website name, application name, IP address, domain name, drug production license or drug license and other information. Changes in information should be reported within 10 working days. Drug network sales enterprises for drug marketing license holders or drug wholesalers, should be reported to the provincial drug supervision and management departments. Drug network sales enterprises for drug retailers, should be reported to the municipal and county drug supervision and management departments. Article 12 of the drug network sales enterprises should be in the website home page or the main page of the business activities of the prominent position, and continue to publicize its drug production or business license information. Pharmaceutical network retail enterprises should also show the pharmacist or other pharmacy technician qualified according to law and other information. Changes in the above information should be updated within 10 working days. Article 13 of the drug network sales enterprises to display drug-related information should be true, accurate and legal. Engaged in the sale of prescription drugs in the pharmaceutical network retail enterprises, should be displayed in each drug display page highlights the "prescription drugs must be purchased and used under the guidance of a pharmacist with a prescription" and other risk warning information. Before the sale of prescription drugs, consumers should be fully informed of the relevant risk warning information, and the consumer to confirm informed. Pharmaceutical network retail enterprises should distinguish between prescription drugs and non-prescription drugs show, and in the relevant web page prominently marked prescription drugs, non-prescription drugs. Pharmaceutical network retail enterprises in the main page of the sale of prescription drugs, the home page shall not directly and publicly display prescription drug packaging, labeling and other information. Before passing the prescription audit, shall not display instructions and other information, and shall not provide services related to the purchase of prescription drugs. Article 14 of the drug network retail enterprises should be responsible for the quality and safety of drug distribution. The distribution of drugs, should be based on the number of drugs, transport distance, transport time, temperature and humidity requirements, choose the appropriate means of transportation and facilities and equipment, distribution of drugs should be placed in an independent space and clearly marked to ensure compliance with the requirements, the whole process can be traced. The pharmaceutical network retail enterprises entrusted distribution, should be entrusted to the quality management system of the enterprise audit, and signed a quality agreement with the entrusted enterprise, agreed to the quality of the drug responsibility, operating procedures, and other content, and the entrusted party to carry out supervision. The specific distribution requirements of the pharmaceutical network retail by the State Drug Administration to develop separately. Article 15 of the sale of drugs to individuals, should be issued in accordance with the provisions of the sales voucher. Sales vouchers can be issued in electronic form, the smallest sales unit of drugs sales records should be clearly retained to ensure traceability. Drug network sales enterprises should be completely preserved supply business qualification documents, electronic transactions and other records. The sale of prescription drugs, pharmaceutical network retail enterprises should also save the prescription, online pharmacy services and other records. The relevant record retention period of not less than five years, and not less than one year after the expiration of the validity of the drug. Article 16 of the pharmaceutical network sales enterprises on the existence of quality problems or safety risks of drugs, should be taken in accordance with the corresponding risk control measures, and in a timely manner in the home page of the website or the main page of business activities to disclose the appropriate information. Chapter III platform management Article 17 The third-party platform should establish a drug quality and safety management organization, equipped with pharmacy technicians to undertake the management of drug quality and safety, the establishment and implementation of the quality and safety of drugs, drug information display, prescription audit, real-name purchases of prescription drugs, drug distribution, transaction record-keeping, adverse reaction reports, complaints and reports of the handling of the management system. The third-party platform should strengthen the inspection and management of drug information display, prescription audit, drug sales and distribution of pharmaceutical network sales enterprises stationed on the platform, and urge them to strictly fulfill their legal obligations. Article 18 The third-party platform should be the enterprise name, legal representative, unified social credit code, website name and domain name information to the platform where the provincial drug supervision and management department for the record. Provincial drug supervision and management departments should be the platform for the record information publicized. Article 19 of the third party platform should be in its website home page or engaged in pharmaceutical business activities in the main page of the prominent position, and continue to publicize the business license, the relevant administrative licensing and filing, contact information, complaints and reports, and other information or the link to the above information logo. The third-party platform to display drug information should comply with the provisions of Article 13 of these measures. Article 20 of the third party platform should apply for entry into the pharmaceutical network sales of enterprise qualifications, quality and safety assurance ability to audit the pharmaceutical network sales of enterprises to establish a registration file, at least once every six months to verify the update to ensure that entry into the pharmaceutical network sales of enterprises in line with the statutory requirements. The third-party platform should sign an agreement with the pharmaceutical network sales enterprises to clarify the quality and safety responsibilities of the two sides of the drug. Article 21 of the third-party platform should be saved drugs show, transaction records and complaints and other information. Preservation period of not less than 5 years, and not less than 1 year after the expiration of the validity of the drug. The third-party platform should ensure that the relevant information, information and data is true and complete, and for the stationed pharmaceutical network sales enterprises to save their own data to provide convenience. Article 22 The third-party platform shall establish an inspection and monitoring system for pharmaceutical network sales activities. Found in the pharmaceutical network sales enterprises have illegal behavior, should be stopped in a timely manner and immediately report to the county-level drug supervision and management department. Article 23 The third-party platform found the following serious violations, should immediately stop providing network trading platform services, stop displaying drug-related information: (a) does not have the qualification to sell drugs; (b) violation of the provisions of Article 8 of the sales of national implementation of the special management of pharmaceutical products; (c) more than the scope of the drug license to sell drugs; (D) due to violations of the drug supervision and management department ordered to stop selling, revocation of drug approval documents or revocation of drug business license; (E) other serious violations. If the certificate of registration of a drug is revoked or canceled according to law, the information about the drug shall not be displayed. Article 24 of the emergence of sudden public **** health incidents or other serious threat to public health emergencies, third-party platforms, pharmaceutical network sales enterprises should comply with the relevant national emergency disposal provisions, according to the law to take appropriate control and disposal measures. The holder of the listed drug license to recall the drug according to law, the third-party platform, drug network sales enterprises should actively cooperate. Article 25 of the drug supervision and management department to carry out supervision and inspection, case investigation, incident disposal and other work, the third party platform should be coordinated. The drug supervision and management department found that the drug network sales enterprises have illegal behavior, according to law requires the third-party platform to take measures to stop, the third-party platform should be timely fulfillment of the relevant obligations. The third-party platform should provide timely information on the seller, sales records, pharmacy services, and traceability of the platform as required by the drug regulatory authorities in accordance with laws and administrative regulations. Encourage third-party platforms and drug supervision and management departments to establish open data interfaces and other forms of automated information reporting mechanisms. Chapter IV Supervision and Inspection Article 26 The drug supervision and management departments shall, in accordance with the laws, rules and regulations, in accordance with the division of responsibilities of the third-party platform and drug network sales enterprises to implement supervision and inspection. Article 27 of the drug supervision and management departments of the third-party platform and pharmaceutical network sales enterprises to carry out inspections, you can take the following measures according to law: (a) access to the pharmaceutical network sales and network platform services related to the implementation of on-site inspections; (b) on the network sales of pharmaceutical samples for testing; (c) questioning of relevant personnel, to understand the pharmaceutical network sales activities related to the situation; (d) the network sales of pharmaceuticals, the network sales of pharmaceuticals, the network sales of pharmaceuticals, the network sales of pharmaceuticals, the network sales of pharmaceuticals and pharmaceutical products. (D) according to law, access, copy transaction data, contracts, bills, books and other related information; (E) evidence that may endanger human health of drugs and related materials, according to the law to take seizure, detention measures; (F) laws and regulations can be taken by other measures. When necessary, the drug supervision and management department can provide products or services for the development, production, operation, use of pharmaceutical units and individuals to extend the inspection. Article 28 of the third-party platforms, drug marketing license holders, pharmaceutical wholesale enterprises through the network sales of drugs illegal investigation and handling, by the provincial drug supervision and management departments. The investigation and handling of drug network retail enterprises in violation of the law, by the municipal and county-level drug supervision and management departments.
The network sale of drugs by the drug supervision and management departments of the place where the illegal behavior is responsible for the investigation and handling. Drug network sales activities due to drug safety incidents or evidence that may endanger human health, can also be the result of illegal behavior by the drug supervision and management departments responsible for.
Article 29 The drug supervision and management departments shall strengthen the monitoring of drug network sales. Provincial drug supervision and management departments to establish a drug network sales monitoring platform, should be realized with the national drug network sales monitoring platform data docking. Drug supervision and management departments of the monitoring of illegal behavior found, should be in accordance with the duties of investigation and disposal. The drug supervision and management departments of the network sales of illegal behavior of the technical monitoring record information, can be used as the implementation of administrative penalties or administrative measures taken in accordance with the law of electronic data evidence. Article 30 of the evidence that there may be safety risks, drug supervision and management departments shall, according to the supervision and inspection, the drug network sales enterprises or third-party platforms, etc. to take admonition, interviews, rectification and suspension of the production, sale, use, import and other measures, and timely publication of the results of the inspection and processing. Article 31 The drug supervision and management department shall provide the drug network sales enterprises or third-party platform for personal information and trade secrets strictly confidential, shall not be leaked, sold or illegally provided to others. Chapter V Legal Liability Article 32 of the laws and administrative regulations on the sale of drugs on the network of illegal penalties are provided in accordance with its provisions. Drug supervision and management department found that the drug network sales of illegal behavior suspected of committing a crime, the case should be promptly transferred to the public security organs. Article 33 violation of the provisions of Article 8, paragraph 2, the sale of drugs through the network of the state to implement special management, laws and administrative regulations have been stipulated, in accordance with the provisions of laws and administrative regulations shall be punished. Laws and administrative regulations have not provided, and shall order rectification, impose a fine of 50,000 yuan or more than 100,000 yuan; resulting in harmful consequences, impose a fine of 100,000 yuan or more than 200,000 yuan. Article 34 violation of the provisions of Article 9, paragraph 1, paragraph 2, ordered to make corrections within a period of time, and impose a fine of 30,000 yuan or more than 50,000 yuan; the circumstances are serious, impose a fine of 50,000 yuan or more than 100,000 yuan. Violation of the provisions of Article 9, paragraph 3, ordered to make corrections within a period of time, a fine of 50,000 yuan or more than 100,000 yuan; resulting in harmful consequences, a fine of 100,000 yuan or more than 200,000 yuan. Violation of the provisions of Article 9, paragraph 4, ordered to make corrections within a period of time, a fine of 10,000 yuan or more than 30,000 yuan; the circumstances are serious, a fine of 30,000 yuan or more than 50,000 yuan. Article 35 violation of the provisions of Article 11 of these measures, shall order a period of time to make corrections; failure to make corrections, a fine of 10,000 yuan or more than 30,000 yuan; the circumstances are serious, a fine of 30,000 yuan or more than 50,000 yuan. Article 36 violates the provisions of Article 13, Article 19, paragraph 2, shall order a period of time to make corrections; failing to do so, a fine of 50,000 yuan or more than 100,000 yuan. Article 37 violation of the provisions of Article 14, Article 15, the drug network sales enterprises do not comply with the quality management standard for drug business, in accordance with the provisions of Article 126 of the Drug Administration Law shall be punished. Article 38 violation of the provisions of the first paragraph of Article 17 of these Measures, ordered to make corrections within a specified period of time, and impose a fine of 30,000 yuan or more than 100,000 yuan; resulting in harmful consequences, impose a fine of 100,000 yuan or more than 200,000 yuan. Article 39 violation of the provisions of Article 18 of these Measures, shall order a period of time to make corrections; failure to make corrections, a fine of 50,000 yuan or more than 100,000 yuan; resulting in harmful consequences, a fine of 100,000 yuan or more than 200,000 yuan. Article 40 violation of the provisions of Article 20, Article 22, Article 23, the third-party platform does not fulfill the qualification audit, report, stop providing network trading platform services and other obligations, in accordance with the provisions of Article 131 of the Drug Administration Law penalty. Article 41 The drug supervision and management departments and their staff do not perform their duties or abuse of power, dereliction of duty, favoritism and malpractice, shall be investigated for legal responsibility; constitutes a crime, shall be investigated for criminal responsibility. Chapter VI Supplementary Provisions Article 42 These measures shall come into force on December 1, 2022 .