Measures for the Supervision and Administration of Drug Online Sales

(promulgated by Order No. 58 of the State Administration for Market Regulation on August 3, 2022 and effective as of December 1, 2022)

 

Chapter I General Provisions

 

Article 1These Measures are formulated in accordance with the the People's Republic of China Drug Administration Law (hereinafter referred to as the Drug Administration Law) and other laws and administrative regulations for the purpose of regulating drug online sales and drug online trading platform service activities and ensuring the safety of drug use by the public.

Article IIEngaged in drug network sales within the territory of the People's Republic of China, provide drug network trading platform services and supervision and management, shall abide by these measures.

Article IIIThe State Drug Administration shall be in charge of the supervision and administration of online drug sales throughout the country.

The provincial drug supervision and administration department is responsible for the supervision and management of drug online sales within its administrative area, and is responsible for the supervision and management of the third-party platform for drug online trading, as well as the activities of drug marketing license holders and drug wholesale enterprises selling drugs through the network.

The departments responsible for drug supervision and administration at the city and county levels divided into districts (hereinafter referred to as drug supervision and administration departments) shall be responsible for the supervision and administration of drug online sales within their respective administrative areas, and shall be responsible for the supervision and administration of drug retail enterprises' activities of selling drugs through the Internet.

Article 4Engaging in drug online sales and providing drug online trading platform services shall abide by drug laws, regulations, rules, standards and norms, operate in good faith in accordance with the law, and ensure drug quality and safety.

Article VTo engage in online drug sales and provide online drug trading platform services, effective measures shall be taken to ensure that the information in the entire transaction process is true, accurate, complete and traceable, and comply with the relevant national regulations on the protection of personal information.

ARTICLE VIDrug regulatory departments should 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 co-governance.

 

Chapter II Administration of Online Drug Sales

 

Article VIIThose who engage in online drug sales shall be the drug marketing license holders or drug trading enterprises that have the ability to ensure the safety of drugs sold online.

A traditional Chinese medicine decoction pieces production enterprise shall perform the relevant obligations of the drug marketing license holder when selling the traditional Chinese medicine decoction pieces it produces.

Article 8Pharmaceutical online sales enterprises shall operate in accordance with the approved mode of operation and business scope. If a drug online sales enterprise is a drug marketing license holder, it can only sell drugs for which it has obtained a drug registration certificate. A person who has not obtained the qualification for 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 under special management by the state shall not be sold on the Internet, and the specific catalogue shall be formulated by the State Drug Administration.

Pharmaceutical online retail enterprises shall not, in violation of regulations, give prescription drugs and Class A non-prescription drugs to individuals by buying drugs and giving drugs, buying commodities and giving drugs.

Article IXWhere prescription drugs are sold to individuals through the Internet, it shall be ensured that the source of the prescription is true and reliable, and a real-name system shall be implemented.

Drug online retail enterprises should sign an agreement with the electronic prescription provider, review and allocate prescriptions in strict accordance with relevant regulations, and mark the electronic prescriptions that have been used to avoid repeated use of prescriptions.

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

If the prescription received by a drug online retail enterprise is a photocopied version of a paper prescription, effective measures shall be taken to avoid the repeated use of the prescription.

Article XDrug online sales enterprises shall establish and implement drug quality and safety management, risk control, drug traceability, storage and distribution management, adverse reaction reporting, complaint reporting and handling systems.

Drug online retail enterprises should also establish an online pharmaceutical service system, and pharmacists or other pharmaceutical technicians who have been qualified in accordance with the law should carry out prescription review and deployment, and guide rational drug use. The number of pharmacists or other pharmaceutical technicians who have been certified according to law shall be commensurate with the scale of operation.

Article 11An online drug sales enterprise shall report to the drug regulatory department the enterprise name, website name, application name, IP address, domain name, drug production license or drug trading license and other information. If the information changes, it shall be reported within 10 working days.

If a drug online sales enterprise is a drug marketing license holder or a drug wholesale enterprise, it shall report to the local provincial drug regulatory department. If an enterprise selling drugs online is a drug retail enterprise, it shall report to the drug regulatory department at the city and county level where it is located.

Article 12An online drug sales enterprise shall continuously publicize its drug production or business license information in a prominent position on the main page of the Home or business activities. Pharmaceutical online retail enterprises shall also display information such as the qualification of pharmacists or other pharmaceutical technicians equipped in accordance with the law. If the above information changes, it shall be updated within 10 working days.

Article 13Drug-related information displayed by drug sales enterprises online shall be true, accurate and legal.

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

Pharmaceutical online retail enterprises should distinguish between prescription drugs and non-prescription drugs, and prominently 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 main page and front page of prescription drug sales. Before passing the prescription review, no information such as instructions shall be displayed, and no services related to prescription drug purchase shall be provided.

Article 14Online drug retail enterprises shall be responsible for the quality and safety of drug distribution. When distributing drugs, appropriate transportation tools and facilities and equipment shall be selected according to the quantity of drugs, transportation distance, transportation time, temperature and humidity requirements, etc. The drugs distributed shall be placed in an independent space and clearly marked to ensure that the requirements are met and the whole process can be traced.

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, operating procedures, etc., and supervise the entrusted party.

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

Article XVFor the sale of drugs to individuals, a sales certificate shall be issued in accordance with the provisions. Sales vouchers can be issued in electronic form, and the sales records of the smallest sales unit of the drug should be clearly retained to ensure traceability.

Pharmaceutical online sales enterprises shall keep complete records of supplier qualification documents, electronic transactions, etc. Online drug retail enterprises that sell prescription drugs shall also keep records of prescriptions, online pharmaceutical services, etc. Relevant records shall be kept for not less than 5 years and not less than 1 year after the expiration of the drug.

Article 16Drug online sales companies shall take corresponding risk control measures in accordance with the law for drugs with quality problems or potential safety hazards, and promptly disclose corresponding information on the main page of the Home or business activities.

 

Chapter III Platform Management

 

Article 17The third-party platform shall establish a drug quality and safety management agency, be equipped with pharmaceutical technical personnel to undertake drug quality and safety management, establish and implement drug quality and safety, drug information display, prescription review, prescription real-name purchase, drug distribution, transaction record preservation, adverse reaction reports, Management systems such as complaint handling.

Third-party platforms should strengthen inspections, manage the drug information display, prescription review, drug sales and distribution of drug sales companies that have settled on the platform, and urge them to strictly fulfill their legal obligations.

Article 18The third-party platform shall file the 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 19The third-party platform shall continuously publicize the business license, relevant administrative license and filing, contact information, complaint reporting method and other information or the link mark of the above information in a prominent position on the main page of its Home or drug trading activities.

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

Article 20The third-party platform shall review the qualifications and quality and safety assurance capabilities of the drug online sales companies that apply for entry, establish registration files for the drug online sales companies, and verify and update them at least every six months to ensure that the drug online sales companies that enter meet the statutory 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.

Article 21The third-party platform shall keep information such as drug display, transaction records and complaint reporting. The shelf life is not less than 5 years, and not less than 1 year after the expiration of the drug. The third-party platform shall ensure the authenticity and integrity of relevant materials, information and data, and provide convenience for the resident drug sales enterprises to save their own data.

Article 22Third-party platforms shall establish an inspection and monitoring system for online drug sales activities. If it is found that the settled drug online sales enterprises have illegal acts, they shall be stopped in time and immediately reported to the local drug supervision and administration department at the county level.

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

(I) does not have the qualification to sell drugs;

(II), in violation of the provisions of Article 8 of these Measures, sell drugs under special management by the State;

(III) selling drugs beyond the scope of the drug business license;

(IV) is ordered by the pharmaceutical supervisory and administrative department to stop the sale, revoke the pharmaceutical approval certificate or revoke the pharmaceutical business license due to illegal acts;

(V) other serious violations.

If the drug registration certificate is revoked or canceled according to law, the information of the relevant drugs shall not be displayed.

Article 24In the event of public health emergencies or other emergencies that seriously threaten public health, third-party platforms and drug online sales companies shall abide by the relevant national emergency response regulations and take corresponding control and disposal measures in accordance with the law.

If the drug marketing license holder recalls the drug in accordance with the law, the third-party platform and the drug network sales enterprise shall actively cooperate.

Article 25When the drug supervision and administration department carries out supervision and inspection, case investigation, incident handling and other work, the third-party platform shall cooperate. If the drug supervision and administration department discovers that the drug network sales enterprise has illegal behavior and requires the third-party platform to take measures to stop it according to law, the third-party platform shall perform the relevant obligations in a timely manner.

If the drug regulatory department provides information on sellers, sales records, pharmaceutical services and traceability in the platform in accordance with the requirements of 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 authorities.

 

Chapter IV Supervision and Inspection

 

Article 26The drug regulatory department shall, in accordance with the provisions of laws, regulations and rules, supervise and inspect the third-party platforms and drug online sales enterprises in accordance with the division of responsibilities.

Article 27The pharmaceutical supervisory and administrative department may take the following measures in accordance with the law when inspecting third-party platforms and pharmaceutical online sales enterprises:

(I) access to the drug network sales and network platform services related places to implement on-site inspection;

(II) sample testing of drugs sold online;

(III) ask the relevant personnel, understand the drug network sales activities related to the situation;

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

The (V) shall, in accordance with the law, take measures to seal up or detain the drugs and related materials that have evidence to prove that they may endanger human health;

Other measures that may be taken in (VI) with the provisions of laws and regulations.

When necessary, the pharmaceutical supervisory and administrative department may conduct extended inspections of units and individuals that provide products or services for the development, production, marketing, and use of pharmaceuticals.

Article 28The provincial drug supervision and administration department shall be responsible for the investigation and punishment of illegal acts of selling drugs through the network by third-party platforms, drug marketing license holders and drug wholesale enterprises. The investigation and punishment of illegal acts of drug retail enterprises shall be the responsibility of the drug supervision and administration departments at the city and county level.

Illegal acts of online drug sales shall be investigated and dealt with by the drug regulatory department in the place where the illegal acts occurred. If a drug safety incident is caused by drug online sales activities or there is evidence to prove that it may endanger human health, the drug supervision and administration department of the place where the illegal act results may also be responsible.

Article 29The pharmaceutical supervisory and administrative departments shall strengthen the monitoring of online drug 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.

The pharmaceutical supervisory and administrative department shall investigate and dispose of the illegal acts discovered by monitoring in accordance with its duties in accordance with the law.

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 administrative measures in accordance with the law.

Article 30If there is evidence to prove that there may be potential safety hazards, the drug supervision and administration department shall, based on the supervision and inspection, take measures such as warnings, interviews, rectification within a time limit, and suspension of production, sales, use, and import to drug online sales companies or third-party platforms. And publish the inspection and handling results in a timely manner.

Article 31The pharmaceutical supervisory and administrative department shall strictly keep confidential the personal information and trade 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 32Where laws and administrative regulations provide for the punishment of illegal acts of drug sales on the Internet, they shall be in accordance with their provisions. If the drug regulatory department discovers that the illegal act of drug sales on the Internet is suspected of committing a crime, it shall promptly transfer the case to the public security organ.

Article 33In violation of the provisions of the second paragraph of Article 8 of these measures, the sale of drugs under special management by the state through the Internet shall be punished in accordance with the provisions of laws and administrative regulations. If there is no provision in laws or administrative regulations, it shall be ordered to make corrections within a time limit and be fined not less than 50000 yuan but not more than 100000 yuan; if harmful consequences are caused, a fine of not less than 100000 yuan but not more than 200000 yuan shall be imposed.

Article 34Violation of 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 a fine of 30000 yuan up to 50000 yuan shall be imposed; if the circumstances are serious, a fine of 50000 yuan up to 100000 yuan shall be imposed.

Violation of the provisions of the third paragraph of Article 9 of these Measures shall be ordered to make corrections within a time limit, and a fine of 50000 yuan up to 100000 yuan shall be imposed; if harmful consequences are caused, a fine of 100000 yuan up to 200000 yuan shall be imposed.

Violation of the provisions of the fourth paragraph of Article 9 of these Measures shall be ordered to make corrections within a time limit, and a fine of 10000 yuan up to 30000 yuan shall be imposed; if the circumstances are serious, a fine of 30000 yuan up to 50000 yuan shall be imposed.

Article 35In violation of the provisions of Article 11 of these Measures, it shall be ordered to make corrections within a time limit; if it fails to make corrections within the time limit, it shall be fined between 10000 yuan and 30000 yuan; if the circumstances are serious, it shall be fined between 30000 yuan and 50000 yuan.

Article 36In violation of the provisions of Article 13 and the second paragraph of Article 19 of these Measures, it shall be ordered to make corrections within a time limit; if it fails to make corrections within the time limit, a fine of 50000 yuan to 100000 yuan shall be imposed.

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

Article 38Violation of the provisions of the first paragraph of Article 17 of these Measures shall be ordered to make corrections within a time limit, and a fine of 30000 yuan up to 100000 yuan shall be imposed; if harmful consequences are caused, a fine of 100000 yuan up to 200000 yuan shall be imposed.

Article 39In violation of the provisions of Article 18 of these Measures, it shall be ordered to make corrections within a time limit; if it fails to make corrections within the time limit, a fine of 50000 yuan up to 100000 yuan shall be imposed; if harmful consequences are caused, a fine of 100000 yuan up to 200000 yuan shall be imposed.

Article 40In violation of the provisions of Article 20, Article 22, and Article 23 of these Measures, third-party platforms that fail to perform their obligations such as qualification review, reporting, and stopping the provision of online trading platform services shall be in accordance with the provisions of Article 131 of the Drug Administration Law Penalty.

Article 41Pharmaceutical supervisory and administrative departments and their staff members who fail to perform their duties or abuse their powers, neglect their duties or engage in malpractices for personal gain 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 42These Measures shall come into force on December 1, 2022.