Measures for the supervision and administration of drug online sales

Chapter I General provisions

 

　　Article one　These Measures are formulated in accordance with the Drug Administration Law of the People's Republic of China (hereinafter referred to as the Drug Administration Law) and other laws and administrative regulations in order to regulate the service activities of drug online sales and drug online trading platforms and ensure the safety of public drugs。

　　Article 2　Within the territory of the People's Republic of China, engaging in online drug sales, providing online drug trading platform services and their supervision and administration shall comply with these Measures。

　　Article 3　The State Drug Administration shall be responsible for the supervision and administration of online drug sales throughout the country。

　　The provincial drug supervision and administration department is responsible for the supervision and administration of online drug sales within its administrative region, and is responsible for the supervision and administration of third-party platforms for online drug trading and the activities of drug marketing authorization holders and drug wholesale enterprises to sell drugs through the Internet。

　　The department responsible for drug supervision and administration at the city or county level divided into districts (hereinafter referred to as the drug supervision and administration department) shall be responsible for the supervision and administration of drug online sales within its administrative region, and shall be responsible for the supervision and administration of drug retail enterprises' activities of selling drugs through the Internet。

　　Article 4　Engaging in online drug sales and providing online drug trading platform services shall comply with drug laws, regulations, rules, standards and norms, operate in good faith according to law, and ensure drug quality and safety。

　　Article 5　To engage in online drug sales and provide online drug trading platform services, effective measures shall be taken to ensure that the whole process of the transaction information is true, accurate, complete and traceable, and comply with the relevant provisions of the State on the protection of personal information。

　　Article 6　Drug regulatory departments should strengthen cooperation with relevant departments, give full play to the role of industry organizations and other institutions, promote the construction of the credit system, and promote social co-governance。

 

Chapter II Administration of drug network sales

 

　　Article 7　Those engaged in the online sale of drugs shall be drug marketing authorization holders or drug distributors with the ability to ensure the safety of drugs sold online。

　　Chinese medicine decoction pieces production enterprises selling its production of Chinese medicine decoction pieces, shall perform the relevant obligations of the drug marketing authorization holder。

　　Article VIII　An online drug marketing enterprise shall operate its business in accordance with the approved mode and scope of operation。If a drug online sales enterprise is a drug marketing authorization holder, it can only sell the drugs for which it has obtained a drug registration certificate。Those who have not obtained the qualification for drug retail may not sell drugs to individuals。

　　Vaccines, blood products, narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, precursor chemicals for pharmaceuticals and other drugs under special control of the State may not be sold on the Internet, and the specific list shall be formulated by the State Drug Administration。

　　Drug online retail enterprises shall not, in violation of regulations, give prescription drugs and class A non-prescription drugs to individuals in the form of giving drugs for purchase or giving drugs for purchase。

　　The ninth article　Those who sell prescription drugs to individuals through the Internet shall ensure that the prescription source is true and reliable, and implement the real-name system。

　　The drug online retail enterprise shall sign an agreement with the electronic prescription provider, and conduct prescription review and allocation in strict accordance with the relevant provisions, and mark the electronic prescription that has been used to avoid repeated use of the prescription。

　　Where the third-party platform undertakes electronic prescription, it shall verify the situation of the electronic prescription provider and sign an agreement。

　　If the prescription received by the drug online retail enterprise is the photocopy version of the paper prescription, effective measures shall be taken to avoid the reuse of the prescription。

　　Article ten　Drug online sales enterprises shall establish and implement drug quality and safety management, risk control, drug traceability, storage and distribution management, adverse reaction reporting, complaints and reports processing and other systems。

　　Drug online retail enterprises should also establish an online pharmaceutical service system, by qualified pharmacists or other pharmaceutical technical personnel to carry out prescription review and allocation, guidance for rational drug use and other work。The number of qualified pharmacists or other pharmaceutical technicians shall be commensurate with the scale of operation。

　　Article 11　An online drug marketing enterprise shall report its name, website name, application program name, IP address, domain name, drug production license or drug distribution license, etc., to the drug regulatory department。Any change in information shall be reported within 10 working days。

　　If a drug online sales enterprise is a drug marketing authorization holder or a drug wholesale enterprise, it shall report to the local drug regulatory department at the provincial level。If a drug online sales enterprise is a drug retail enterprise, it shall report to the local drug regulatory department at the city and county level。

　　Article 12　Drug online sales enterprises shall continue to publicize their drug production or business license information in a prominent position on the home page of the website or the main page of business activities。Drug online retail enterprises shall also display information such as the qualification of pharmacists or other pharmaceutical technical personnel lawfully equipped。If the above information changes, it shall be updated within 10 working days。

　　Article 13　The drug related information displayed by drug online sales enterprises shall be true, accurate and legal。

　　Drug online retail enterprises engaged in the sale of prescription drugs shall highlight risk warning information such as "Prescription drugs must be purchased and used under the guidance of pharmacists" under each drug display page。Before the sale of prescription drugs, consumers should be fully informed of the relevant risk warning information and confirmed by consumers。

　　Drug online retail enterprises shall distinguish between prescription drugs and non-prescription drugs, and significantly mark prescription drugs and non-prescription drugs on relevant web pages。

　　Drug online retail enterprises shall not directly publicly display prescription drug packaging, labels and other information on the home page and home page of prescription drug sales。Before passing the prescription review, you are not allowed to display information such as instructions, and you are not allowed to provide services related to prescription drug purchase。

　　Article 14　Drug online retail enterprises shall be responsible for the quality and safety of drug distribution。Distribution of drugs, should be based on the number of drugs, transport distance, transport time, temperature and humidity requirements, appropriate transport tools and facilities and equipment should be selected, the distribution of drugs should be placed in an independent space and clearly marked to ensure compliance with the requirements, traceability throughout。

　　If a drug online retail enterprise entrusts distribution, it shall review the quality management system of the entrusted enterprise, sign a quality agreement with the entrusted enterprise, agree on drug quality responsibilities, operating procedures and other contents, and supervise the entrusted party。

　　The specific distribution requirements of drug online retail shall be separately formulated by the State Drug Administration。

　　Article 15　Where drugs are sold to individuals, sales certificates shall be issued in accordance with relevant provisions。The sales certificate can be issued in electronic form, and the sales record of the smallest sales unit of the drug should be clearly retained to ensure traceability。

　　Drug online sales enterprises shall keep complete records of supplier qualification documents and electronic transactions。Drug online retail enterprises that sell prescription drugs shall also keep records of prescriptions and online pharmaceutical care。The relevant records shall be kept for a period of not less than 5 years and not less than 1 year after the expiry of the drug validity。

　　Article 16　For drugs with quality problems or hidden safety risks, drug online sales enterprises shall take corresponding risk control measures according to law, and disclose the corresponding information on the homepage of the website or the main page of business activities in a timely manner。

 

Chapter 3 Platform management

 

　　Article 17　The third-party platform shall establish a drug quality and safety management organization，It is equipped with pharmaceutical technicians to undertake the management of drug quality and safety，Establish and implement management systems for drug quality and safety, drug information display, prescription review, real-name purchase of prescription drugs, drug distribution, transaction record keeping, adverse reaction reporting, complaint and report handling, etc。

　　The third-party platform shall strengthen inspection, manage the drug information display, prescription review, drug sales and distribution behaviors of the drug online sales enterprises that have entered the platform, and urge them to strictly fulfill their legal obligations。

　　Article 18　The third-party platform shall record the company name, legal representative, unified social credit code, website name, domain name and other information to the provincial drug regulatory department where the platform is located。The provincial drug supervision and administration department shall publicize the platform record information。

　　Article 19　The third-party platform shall continue to publicize the business license, relevant administrative license and record, contact information, complaints and reporting methods, or the link identification of the above information in a prominent position on the home page of its website or the main page engaged in drug trading activities。

　　The display of drug information by third-party platforms shall comply with the provisions of Article 13 of these Measures。

　　Article 20　The third-party platform shall review the qualifications, quality and safety assurance capabilities of the drug online sales enterprises applying for admission, establish registration files for the drug online sales enterprises, and check and update them at least every six months to ensure that the drug online sales enterprises entering meet the legal requirements。

　　The third-party platform shall sign an agreement with the drug online sales enterprise to clarify the responsibility for drug quality and safety of both parties。

　　Article 21　The third-party platform shall keep information such as drug display, transaction records and complaints and reports。The retention period shall not be less than 5 years, and not less than 1 year after the expiration of the drug validity。The third-party platform shall ensure the authenticity and integrity of the relevant materials, information and data, and provide convenience for the drug online sales enterprises to store their own data。

　　Article 22　Third-party platforms shall establish inspection and monitoring systems for drug online sales activities。If a drug online sales enterprise is found to have illegal acts, it shall promptly stop and immediately report to the local drug regulatory department at the county level。

　　Article 23　If the third-party platform finds the following serious violations, it shall immediately stop providing online trading platform services and stop displaying drug-related information:

　　(1) not qualified to sell drugs;

　　(2) Selling drugs under special administration by the State in violation of Article 8 of these Measures;

　　(3) Selling drugs beyond the scope of the drug trade license;

　　(4) Being ordered by the drug regulatory department to stop selling, revoke the drug approval certificate or revoke the drug distribution license because of an illegal act;

　　(5) Other serious illegal acts。

　　Where the drug registration certificate is revoked or cancelled according to law, no information about the drug may be displayed。

　　Article 24　In the event of public health emergencies or other emergencies that seriously threaten public health, third-party platforms and drug online sales enterprises shall comply with the relevant provisions of the State on emergency handling and take appropriate control and disposal measures according to law。

　　If the holder of the drug marketing authorization recalls the drug according to law, the third-party platform and the drug online sales enterprise shall actively cooperate。

　　Article 25　When the drug regulatory department carries out supervision and inspection, case investigation and handling, and incident handling, the third-party platform shall cooperate。Where the drug regulatory department finds that there are illegal acts of drug online sales enterprises and requires the third-party platform to take measures to stop them according to law, the third-party platform shall promptly fulfill the relevant obligations。

　　If the drug regulatory department provides information about sellers, sales records, pharmaceutical care and traceability in the platform in accordance with laws and administrative regulations, the third-party platform shall provide it in a timely manner。

　　Third-party platforms are encouraged to establish automated information reporting mechanisms in the form of open data interfaces with drug regulatory departments。

 

Chapter IV Supervision and inspection

 

　　Article 26　Drug regulatory departments shall, in accordance with laws, regulations, rules and other provisions, carry out supervision and inspection of third-party platforms and drug online sales enterprises according to the division of responsibilities。

　　Article 27　When inspecting third-party platforms and online drug sales enterprises, drug regulatory departments may take the following measures according to law:

　　(A) enter the drug network sales and network platform service related places to carry out on-site inspection;

　　(2) Conducting sampling inspection of drugs sold online;

　　(3) Ask relevant personnel to understand the relevant situation of drug online sales activities;

　　(4) to consult and copy transaction data, contracts, bills, account books and other relevant materials according to law;

　　(5) To seal up and detain drugs and related materials that can be proved to be harmful to human health;

　　(6) Other measures that may be taken as provided for by laws and regulations。

　　When necessary, the drug regulatory department may conduct extended inspection on units and individuals that provide products or services for the research, production, distribution and use of drugs。

　　Article 28　The provincial drug supervision and administration department shall be responsible for the investigation and punishment of illegal acts of third-party platforms, drug marketing authorization holders, and drug wholesale enterprises selling drugs through the Internet。The investigation and punishment of illegal acts of drug online retail enterprises shall be carried out by the drug supervisory and administrative departments at the city and county level。

　　Illegal drug online sales shall be investigated and punished by the drug regulatory department in the place where the illegal acts occur。Where a drug safety incident is caused by a drug's online sales activity or there is evidence that it may harm human health, the drug regulatory department in the place where the illegal act results may also be responsible。

　　Article 29　Drug regulatory departments shall strengthen the monitoring of drug online sales。The drug network sales monitoring platform established by the provincial drug supervision and administration department shall realize data docking with the national drug network sales monitoring platform。

　　Drug supervisory and administrative departments shall investigate and dispose of illegal acts discovered by monitoring according to law and in accordance with their duties。

　　The technical monitoring records of illegal online sales by drug regulatory departments may be used as electronic data evidence for the implementation of administrative penalties or the adoption of administrative measures in accordance with law。

　　Article 30　Where there is evidence to prove that there may be safety hazards, the drug regulatory department shall, according to the supervision and inspection situation, take warning, interview, rectification within a time limit, suspension of production, sales, use, import and other measures against drug online sales enterprises or third-party platforms, and publish the inspection results in a timely manner。

　　Article 31　Drug regulatory departments shall keep strictly confidential the personal information and trade secrets provided by drug online sales enterprises or third-party platforms, and shall not disclose, sell or illegally provide them to others。

 

Chapter V Legal liability

 

　　Article 32　Where laws and administrative regulations provide for the punishment of illegal acts of online drug sales, such provisions shall apply。Drug regulatory departments find drug online sales of illegal acts suspected of crime, shall promptly transfer the case to the public security organ。

　　Article 33　Whoever, in violation of the provisions of the second paragraph of Article 8 of these Measures, sells drugs under special administration by the State through the Internet, as already provided for by laws and administrative regulations, shall be punished in accordance with the provisions of laws and administrative regulations。If no provisions are made in laws or administrative regulations, it shall be ordered to make corrections within a time limit and be imposed a fine of not less than 50,000 yuan but not more than 100,000 yuan;If harm is caused, a fine of not less than 100,000 yuan but not more than 200,000 yuan shall be imposed。

　　Article 34　Those who violate the provisions of the first and second paragraphs of Article 9 of these Measures shall be ordered to make corrections within a time limit and be fined between 30,000 yuan and 50,000 yuan;If the circumstances are serious, a fine of not less than 50,000 yuan but not more than 100,000 yuan shall be imposed。

　　Violators of the provisions of the third paragraph of Article 9 of these measures shall be ordered to make corrections within a time limit and be fined between 50,000 yuan and 100,000 yuan;If harm is caused, a fine of not less than 100,000 yuan but not more than 200,000 yuan shall be imposed。

　　Violators of the provisions of the fourth paragraph of Article 9 of these measures shall be ordered to make corrections within a time limit and be fined between 10,000 yuan and 30,000 yuan;If the circumstances are serious, a fine of not less than 30,000 yuan but not more than 50,000 yuan shall be imposed。

　　Article 35　Violators of the provisions of Article 11 of these measures shall be ordered to make corrections within a time limit;Those who fail to make corrections within the time limit shall be fined not less than 10,000 yuan but not more than 30,000 yuan;If the circumstances are serious, a fine of not less than 30,000 yuan but not more than 50,000 yuan shall be imposed。

　　Article 36　Violation of the provisions of Article 13, Article 19, paragraph 2 of these measures, ordered to correct within a time limit;Those who fail to make corrections within the time limit shall be fined not less than 50,000 yuan but not more than 100,000 yuan。

　　Article 37　In violation of the provisions of Article 14 and 15 of these Measures, drug online sales enterprises that fail to comply with the quality management norms of drug distribution shall be punished in accordance with the provisions of Article 126 of the Drug Administration Law。

　　Article 38　Violators of the provisions of the first paragraph of Article 17 of these measures shall be ordered to make corrections within a time limit and be fined between 30,000 yuan and 100,000 yuan;If harm is caused, a fine of not less than 100,000 yuan but not more than 200,000 yuan shall be imposed。

　　Article 39　Violators of the provisions of article 18 of these measures shall be ordered to make corrections within a time limit;Those who fail to make corrections within the time limit shall be fined not less than 50,000 yuan but not more than 100,000 yuan;If harm is caused, a fine of not less than 100,000 yuan but not more than 200,000 yuan shall be imposed。

　　Article 40　In violation of the provisions of Article 20, 22 and 23 of these measures, the third-party platform fails to perform the qualification review, report, stop providing online trading platform services and other obligations, in accordance with the provisions of Article 131 of the Drug Administration Law。

　　Article 41　Drug regulatory departments and their staff who fail to perform their duties or abuse their power, neglect their duties or engage in malpractices for personal gains shall be investigated for legal responsibility according to law;If the case constitutes a crime, criminal responsibility shall be investigated according to law。

 

Chapter VI Supplementary Provisions

 

　　Article 42　These Measures shall come into force on December 1, 2022。