No.58
The Measures for the Supervision and Administration of Drug Online Sales were adopted at the 9th executive meeting of the General Administration of Market Supervision on July 1 2022, and are hereby promulgated and shall come into force on February 1 2022.
Director tan
August 3(rd), 2022
Measures for the supervision and administration of online drug sales
Chapter I General Provisions
Article 1 These Measures are formulated in accordance with the Drug Administration Law of People's Republic of China (PRC) (hereinafter referred to as "Drug Administration Law") and other laws and administrative regulations in order to standardize the online sales of drugs and the service activities of drug online trading platforms, and ensure the safety of public drug use.
Article 2 These Measures shall be observed when engaging in online drug sales, providing online drug trading platform services and their supervision and management within the territory of People's Republic of China (PRC).
Article 3 The State Administration of Pharmaceutical Products shall be in charge of the supervision and administration of online sales of drugs throughout the country.
The provincial drug supervision and administration department is responsible for the supervision and management of online drug sales within its administrative area, and is responsible for the supervision and management of online drug trading third-party platforms, drug marketing license holders and drug wholesale enterprises selling drugs through the Internet.
The drug supervision and administration departments at the city and county level divided into districts (hereinafter referred to as the drug supervision and administration departments) shall be responsible for the supervision and administration of the online sales of drugs within their respective administrative areas, and for the supervision and administration of the online sales activities of drug retail enterprises.
Article 4 Those who engage in online drug sales and provide online drug trading platform services shall abide by drug laws, regulations, rules, standards and norms, operate in good faith according to law, and ensure the quality and safety of drugs.
Article 5 When engaging in online drug sales and providing online drug trading platform services, effective measures shall be taken to ensure the truthfulness, accuracy, completeness and traceability of the information in the whole transaction process, and the relevant national regulations on the protection of personal information shall be observed.
Article 6 The pharmaceutical supervisory and administrative department shall strengthen cooperation with relevant departments, give full play to the role of industry organizations and other institutions, promote the construction of credit system and promote social governance.
Chapter II Administration of Drug Online Sales
Article 7 Anyone who engages in online sales of drugs shall be the holder of drug marketing license or a drug trading enterprise with the ability to ensure the safety of online sales of drugs.
Enterprises producing Chinese herbal pieces shall fulfill the relevant obligations of drug marketing license holders when selling the Chinese herbal pieces they produce.
Article 8 An enterprise selling drugs online shall operate in accordance with the approved mode and scope of operation. If the online drug sales enterprise is the holder of the drug listing license, it can only sell the drugs for which it has obtained the drug registration certificate. Those who have not obtained the qualification of drug retail shall not sell drugs to individuals.
Vaccines, blood products, narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, pharmaceutical precursor chemicals and other drugs subject to special management by the state shall not be sold on the Internet. The specific catalogue shall be formulated by the State Administration of Pharmaceutical Products.
Drug online retail enterprises are not allowed to give prescription drugs and Class A over-the-counter drugs to individuals in violation of regulations by buying drugs as gifts or goods as gifts.
Article 9 Whoever sells prescription drugs to individuals through the Internet shall ensure the authenticity and reliability of prescription sources and implement the real-name registration system.
Drug online retail enterprises shall sign agreements with electronic prescription providers, review and allocate prescriptions in strict accordance with relevant regulations, and identify used electronic prescriptions to avoid repeated use of prescriptions.
If a third-party platform accepts electronic prescriptions, it shall verify the situation of the providers of electronic prescriptions and sign an agreement.
If the prescription received by a pharmaceutical online retail enterprise is a photocopy of a paper prescription, it shall take effective measures to avoid the repeated use of the prescription.
Article 10 An online drug sales enterprise shall establish and implement systems for drug quality and safety management, risk control, drug traceability, storage and distribution management, adverse reaction reporting, complaint reporting and handling.
Online pharmaceutical retail enterprises should also establish an online pharmaceutical service system, and pharmacists or other pharmaceutical technicians who have obtained qualifications according to law will conduct prescription review and deployment to guide rational drug use. The number of pharmacists or other pharmaceutical technicians qualified according to law shall be commensurate with the scale of operation.
Article 11 A pharmaceutical online sales enterprise shall report the enterprise name, website name, application name, IP address, domain name, pharmaceutical production license or pharmaceutical business license and other information to the pharmaceutical supervisory and administrative department. If the information changes, it should be reported within 10 working days.
If a drug online sales enterprise is a drug listing license holder or a drug wholesale enterprise, it shall report to the local provincial drug supervision and administration department. If the drug online sales enterprise is a drug retail enterprise, it shall report to the drug supervision and administration department of the local city and county.
Article 12 A pharmaceutical online sales enterprise shall continuously publicize its pharmaceutical production or business license information in a prominent position on the homepage of the website or the main page of business activities. Drug online retail enterprises should also display information such as the qualification identification of pharmacists or other pharmaceutical technicians equipped according to law. If the above information is changed, it should be updated within 10 working days.
Thirteenth drug-related information displayed by online drug sales enterprises should be true, accurate and legal.
Drug online retail enterprises engaged in the sale of prescription drugs should highlight the 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 relevant risk warning information and confirmed by consumers.
Drug online retail enterprises should display prescription drugs and non-prescription drugs separately, and clearly mark prescription drugs and non-prescription drugs on relevant websites.
Drug online retail enterprises are not allowed to directly display prescription drug packaging, labels and other information on the home page and home page of prescription drug sales. Before passing the prescription review, information such as instructions shall not be displayed, and services related to prescription drug purchase shall not be provided.
Article 14 Drug online retail enterprises shall be responsible for the quality and safety of drug distribution. When distributing drugs, appropriate means of transportation and facilities should be selected according to the quantity, transportation distance, transportation time, temperature and humidity requirements, etc. Drugs distributed should be placed in an independent space and clearly marked to ensure that they meet the requirements and can be traced back to the whole process.
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, stipulate the drug quality responsibility, operation process and other contents, and supervise the entrusted party.
The specific distribution requirements for online retail of drugs shall be formulated separately by the State Administration of Pharmaceutical Products.
Fifteenth sales of drugs to individuals, should be issued in accordance with the provisions of the sales certificate. Sales vouchers can be issued in electronic form, and the sales records of the smallest drug sales unit should be clearly kept to ensure traceability.
An online drug sales enterprise shall keep the supplier's qualification documents and electronic transactions intact. Online retail enterprises selling prescription drugs should also keep records of prescriptions and online pharmaceutical services. The retention period of relevant records shall not be less than 5 years, and shall not be less than 1 year after the expiration of the drug.
Article 16 An online drug sales enterprise shall take corresponding risk control measures for drugs with quality problems or potential safety hazards according to law, and disclose corresponding information on the homepage of the website or the main page of business activities in time.
Chapter III Platform Management
Article 17 Third-party platforms shall establish drug quality and safety management institutions, equip pharmaceutical technicians to undertake drug quality and safety management, and establish and implement management systems such as drug quality and safety, drug information display, prescription review, real-name purchase of prescription drugs, drug distribution, transaction record keeping, adverse reaction reporting and complaint handling.
Third-party platforms should strengthen inspection, manage the drug information display, prescription review, drug sales and distribution of drug online sales enterprises stationed on the platform, and urge them to strictly fulfill their legal obligations.
Article 18 A third-party platform shall file information such as enterprise name, legal representative, unified social credit code, website name and domain name with the provincial drug supervision and administration department where the platform is located. The provincial drug supervision and administration department shall publicize the platform filing information.
Article 19 A third-party platform shall continuously publicize the business license, relevant administrative license and filing, contact information, complaint reporting methods and other information or the link identification of the above information in a prominent position on the homepage of its website or the main page engaged in drug business activities.
The display of drug information on third-party platforms shall comply with the provisions of Article 13 of these Measures.
Article 20 The third-party platform shall review the qualification, quality and safety guarantee ability of the drug online sales enterprises that apply to settle in, establish the registration files of drug online sales enterprises, and verify and update them at least once every six months to ensure that the drug online sales enterprises that settle in meet the legal requirements.
The third-party platform shall sign an agreement with the drug online sales enterprise to clarify the drug quality and safety responsibilities of both parties.
Twenty-first third-party platforms shall keep information such as drug display, transaction records, complaints and reports. The storage period shall not be less than 5 years, and the drug shall not be less than 1 year after its expiration. Third-party platforms should ensure the truthfulness and completeness of relevant materials, information and data, and provide convenience for drug online sales enterprises to save their own data.
Article 22 A third-party platform shall establish an inspection and monitoring system for drug online sales activities. If it is found that the drug online sales enterprises that have settled in have violated the law, they should stop it in time and immediately report to the local county-level drug supervision and administration department.
Article 23 If a third-party platform finds any of the following serious illegal acts, it shall immediately stop providing online trading platform services and displaying drug-related information:
(a) do not have the qualification to sell drugs;
(two) in violation of the provisions of article eighth of these measures, the sale of drugs under special state administration;
(3) Selling drugs beyond the scope of the Drug Business License;
(4) Being ordered by the pharmaceutical supervisory and administrative department to stop selling, revoke the pharmaceutical approval certificate or revoke the Pharmaceutical Business License due to illegal acts;
(5) Other serious illegal acts.
If the Drug Registration Certificate is revoked or cancelled according to law, the information of related drugs shall not 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 abide by the relevant state regulations on emergency handling and take corresponding control and disposal measures according to law.
If the drug marketing license holder recalls the drug according to law, the third-party platform and the drug online sales enterprise shall actively cooperate.
Twenty-fifth drug supervision and management departments to carry out supervision and inspection, case investigation, incident handling and other work, the third party platform should cooperate. If the drug supervision and administration department finds that the drug online sales enterprise has violated the law and requires the third-party platform to take measures to stop it according to law, the third-party platform shall fulfill the relevant obligations in a timely manner.
If the pharmaceutical supervisory and administrative department provides information such as sellers, sales records, pharmaceutical services and traceability in the platform according to the requirements of laws and administrative regulations, the third-party platform shall provide it in time.
Encourage third-party platforms and drug supervision and management departments to establish an automatic information reporting mechanism in the form of open data interfaces.
Chapter IV Supervision and Inspection
Twenty-sixth pharmaceutical supervisory and administrative departments shall, in accordance with laws, regulations, rules and other provisions, supervise and inspect third-party platforms and pharmaceutical online sales enterprises in accordance with the division of responsibilities.
Twenty-seventh pharmaceutical supervisory and administrative departments can take the following measures in accordance with the law when inspecting third-party platforms and pharmaceutical online sales enterprises:
(a) to enter the drug network sales and network platform services related places for on-site inspection;
(two) sampling inspection of drugs sold online;
(three) ask the relevant personnel to understand the relevant situation of drug online sales activities;
(4) Consulting and copying transaction data, contracts, bills, account books and other relevant materials according to law;
(5) Take measures of sealing up and detaining drugs and related articles that are proved to be harmful to human health according to law;
(six) other measures that can be taken as stipulated by laws and regulations.
When necessary, the pharmaceutical supervisory and administrative department may conduct extended inspections on units and individuals that provide products or services for drug research, production, marketing and use.
Twenty-eighth of the third party platform, drug marketing license holders, drug wholesale enterprises to investigate and deal with illegal acts of selling drugs through the Internet, by the provincial drug supervision and management departments. To investigate and deal with the illegal acts of drug online retail enterprises, the municipal and county drug supervision and administration departments shall be responsible.
Illegal acts of online drug sales shall be investigated and dealt with by the drug supervision and administration department in the place where the illegal acts occur. If a drug safety incident is caused by drug online sales activities or there is evidence that it may endanger human health, the drug supervision and administration department in the place where the illegal act results may also be responsible.
Twenty-ninth drug supervision and management departments should strengthen the monitoring of online sales of drugs. The online drug sales monitoring platform established by the provincial drug supervision and administration department shall realize data docking with the national online drug sales monitoring platform.
The pharmaceutical supervisory and administrative department shall investigate and deal with the illegal acts found in the monitoring according to law.
The technical monitoring records of drug supervision and administration departments on illegal online sales can be used as electronic data evidence for implementing administrative punishment or taking administrative measures according to law.
Article 30 If there is evidence that there may be potential safety hazards, the pharmaceutical supervisory and administrative department shall take measures such as warning, interview, rectification within a time limit, suspension of production, sale, use and import according to the supervision and inspection. For drug online sales enterprises or third-party platforms, the inspection results will be announced in a timely manner.
Article 31 The pharmaceutical supervisory and administrative department shall strictly keep confidential the personal information and business secrets provided by pharmaceutical 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 there are provisions in laws and administrative regulations on penalties for illegal drug sales on the Internet, such provisions shall prevail. If the drug supervision and administration department finds that the illegal act of drug online sales is suspected of a crime, it 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 specially managed by the state as stipulated by laws and administrative regulations through the Internet shall be punished in accordance with the provisions of laws and administrative regulations. If there are no provisions in laws and administrative regulations, it shall be ordered to make corrections within a time limit and be fined not less than 50,000 yuan but not more than 65,438+10,000 yuan; Causing harmful consequences, a fine of 654.38+10,000 yuan but not more than 200,000 yuan shall be imposed.
Thirty-fourth in violation of the provisions of the first and second paragraphs of Article 9 of these measures, it shall be ordered to make corrections within a time limit and impose a fine of not less than 30 thousand yuan but not more than 50 thousand yuan; If the circumstances are serious, a fine of not less than 50,000 yuan but not more than 654.38+10,000 yuan shall be imposed.
In violation of the provisions of the third paragraph of Article 9 of these measures, it shall be ordered to make corrections within a time limit and impose a fine of 50,000 yuan or more and 65,438+10,000 yuan or less; Causing harmful consequences, a fine of 654.38+10,000 yuan but not more than 200,000 yuan shall be imposed.
In violation of the provisions of the fourth paragraph of Article 9 of these measures, it shall be ordered to make corrections within a time limit, and a fine of 10000 yuan or more and 30000 yuan or less shall be imposed; If the circumstances are serious, a fine of not less than 30 thousand yuan but not more than 50 thousand yuan shall be imposed.
Thirty-fifth in violation of the provisions of article eleventh of these measures, shall be ordered to make corrections within a time limit; If it fails to make corrections within the time limit, it will be fined 6,543,800 yuan and 30,000 yuan; If the circumstances are serious, a fine of not less than 30 thousand yuan but not more than 50 thousand yuan shall be imposed.
Thirty-sixth in violation of the provisions of the thirteenth and nineteenth paragraphs of these measures, it shall be ordered to make corrections within a time limit; If no correction is made within the time limit, a fine of 50,000 yuan to 654.38+10,000 yuan shall be imposed.
Thirty-seventh in violation of the provisions of Article 14 and Article 15 of these measures, pharmaceutical online sales enterprises do not meet the quality management standards of pharmaceutical business, and shall be punished in accordance with the provisions of Article 126 of the Drug Administration Law.
Thirty-eighth in violation of the provisions of the first paragraph of article seventeenth of these measures, shall be ordered to make corrections within a time limit, and impose a fine of more than 30 thousand yuan and 6.5438+10 thousand yuan; Causing harmful consequences, a fine of 654.38+10,000 yuan but not more than 200,000 yuan shall be imposed.
Thirty-ninth in violation of the provisions of article eighteenth, shall be ordered to make corrections; If no correction is made within the time limit, a fine of 50,000 yuan to 654.38+10,000 yuan shall be imposed; Causing harmful consequences, a fine of 654.38+10,000 yuan but not more than 200,000 yuan shall be imposed.
Article 40 In violation of the provisions of Articles 20, 22 and 23 of these Measures, if a third-party platform fails to fulfill its obligations such as qualification examination, reporting and stopping providing online trading platform services, it shall be punished in accordance with the provisions of Article 131 of the Drug Administration Law.
Article 41 If the pharmaceutical supervisory and administrative department and its staff fail to perform their duties or abuse their powers, neglect their duties or engage in malpractices for selfish ends, they shall be investigated for legal responsibility according to law; If a crime is constituted, criminal responsibility shall be investigated according to law.
Chapter VI Supplementary Provisions
Article 42 These Measures shall come into force as of June 65438+February 65438+ 10, 2022.