Provisions for Supervision and Administration of Online Drug Sales

(Promulgated by Decree No. 58 of the State Administration for Market Regulation on August 3, 2022, these Provisions shall go into effect as of December 1, 2022.)

Chapter I General Provisions

Article 1　These Provisions 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 online drug sales and online drug transaction platform services, and safeguard the drug safety of the public.

Article 2　These Provisions shall apply to activities involving online drug sales, providing online drug transaction platform services and their supervision and administration within the territory of the People's Republic of China.

Article 3　The National Medical Products Administration (NMPA) shall be responsible for supervision and administration of online drug sales nationwide.

The provincial drug regulatory departments shall be responsible for supervision and administration of online drug sales in their administrative areas, and supervision and administration of online drug sales activities of third-party online drug transaction platforms (hereinafter referred to as third-party platform) as well as marketing authorization holders (MAHs) and wholesalers.

The departments in charge of drug supervision and administration (hereinafter referred to as drug regulatory departments) of the local people's government at the level of municipalities divided into districts or of counties shall be responsible for supervision and administration of online drug sales in their respective administrative areas, and for supervision and administration of online drug sales activities of drug retailers.

Article 4　Those engaged in online drug sales and providing online drug transaction platform services shall comply with drug laws, regulations, rules, standards and norms, run business honestly according to law, and guarantee drug quality and safety.

Article 5　Those engaged in online drug sales and providing online drug transaction platform services shall take effective measures to ensure the authenticity, accuracy, integrity and traceability of information throughout the transaction process, and shall observe relevant national provisions on the protection of personal information.

Article 6 The drug regulatory departments 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 co-governance.

 Chapter II Administration of Online Drug Sales

Article 7　Those engaged in online drug sales shall be the MAHs or drug distributors with the ability to ensure the safety of online drug sales.

The manufacturer of prepared slices of Chinese crude drugs shall perform relevant obligations as the MAH of the drug when selling the prepared slices of Chinese crude drugs.

Article 8　The online drug sales enterprises shall operate in accordance with the approved business mode and business scope. The online drug sales enterprises that are the drug MAHs can only sell the drugs for which they have obtained the drug approval licenses. Those who have not obtained the qualification for drug retail shall not sell drugs to individuals.

Vaccines, blood products, narcotic drugs, psychotropic substances, toxic drugs for medical use, radioactive drugs, pharmaceutical precursor chemicals and other drugs under special control of the country cannot be sold online. The specific catalog shall be formulated by the NMPA.

The online drug retailers shall not, in violation of regulations, give prescription drugs and Class A non-prescription drugs to individuals in the form of gifts for buying drugs or buying commodities.

Article 9　Those selling prescription drugs to individuals through the Internet shall ensure that the sources of prescriptions are authentic and reliable, and implement the real-name registration system.

Drug online retailers shall sign an agreement with the electronic prescription provider, examine and dispense the prescriptions in strict accordance with relevant provisions, mark the electronic prescriptions already used, and avoid reuse of prescriptions.

Any third-party platform that accepts electronic prescriptions shall verify the conditions of the electronic prescription provider and sign an agreement.

If the prescription received by drug online retailers is a photocopy of a paper prescription, effective measures shall be taken to avoid the reuse of the prescription.

Article 10　The online drug sales enterprises shall establish and implement systems for  drug quality and safety management, risk control, drug tracing, storage and delivery management, adverse reaction report, complaints and reports handling.

The online drug retailers shall also establish an online pharmaceutical service system, under which the legally qualified pharmacists or other pharmaceutical technicians shall examine and dispense the prescriptions, guide rational drug use, etc. The number of legally qualified pharmacists or other pharmaceutical technicians shall be commensurate with the business scale.

Article 11　The online drug sales enterprises shall report the enterprise name, website name, application name, IP address, domain name, drug manufacturing certificate or drug distribution certificate and other information to the drug regulatory departments. Any change in such information shall be reported within 10 working days.

If the online drug sales enterprise is the MAH or wholesaler of the drug, it shall report to the provincial drug regulatory department. If the online drug sales enterprise is the drug retailer, it shall report to the county-level drug regulatory department of the city where it is located.

Article 12　The online drug sales enterprise shall continuously publicize its drug manufacturing certificate or drug distribution certificate information in a prominent position on the home page of its website or on the main page of its distribution activities. The online drug retailer shall also display the qualifications of pharmacists or other pharmaceutical technicians employed according to law. Any change of the above information shall be updated within 10 working days.

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

The online drug retailers engaged in the sales of prescription drugs shall highlight the risk warning information under each drug display page, such as "the prescription drugs must be purchased with prescription and used under the guidance of pharmacists". Before selling prescription drugs, the enterprises shall fully inform the consumers of the relevant risk warning information, and ask the consumers to confirm that they know such information.

The online drug retailers shall display prescription drugs and non-prescription drugs separately, and prominently mark prescription drugs and non-prescription drugs on relevant web pages.

The online drug retailers shall not directly display the package and label of prescription drugs on the main page and the home page of prescription drug sales. Before the prescription examination is passed, the enterprises shall not display the package inserts and other relevant information, or provide services related to the purchase of prescription drugs.

Article 14　The online drug retail enterprises shall be responsible for the quality and safety of drug delivery. When delivering drugs, appropriate transportation means, facilities and equipment shall be selected according to the quantity of drugs, transportation distance, transportation time, and requirements of temperature and humidity, etc. The drugs delivered shall be placed in an independent space and clearly marked to ensure that they meet the requirements and can be traced throughout the whole process.

If the online drug retailer entrusts the drug delivery service, it shall review audit the quality management system of the entrusted enterprise, sign a quality agreement with the entrusted enterprise to stipulate the drug quality responsibility, operating procedures and other contents, and supervise the entrusted enterprise.

The specific delivery requirements for online drug retail shall be separately formulated by the NMPA.

Article 15　Where drugs are sold to individuals, the proof of sales shall be issued in accordance with regulations. The proof of sales can be issued in electronic form, and the sales record of the minimum sales unit of the drug shall be clearly retained to ensure traceability.

The online drug sales enterprises shall keep complete records of qualification documents and electronic transactions of the suppliers. The online drug retailers selling prescription drugs shall also keep records of prescriptions, online pharmaceutical services, etc. The relevant records shall be kept for not less than 5 years, and not less than 1 year after the expiration of the drug.

Article 16　For drugs with quality problems or potential safety hazards, the online drug sales enterprises shall take corresponding risk control measures according to law, and promptly disclose the corresponding information on the home page of the website or the main page of distribution activities.

 Chapter III  Platform Management

Article 17　The third-party platform shall establish a drug quality and safety management organization, assign pharmaceutical technicians to undertake drug quality and safety management work, establish and implement the management systems for drug quality and safety, drug information display, prescription examination, real-name purchase of prescription drugs, drug delivery, preservation of transaction records, adverse reaction reports, complaints and reports handling, etc.

The third-party platform shall strengthen the examination, manage the drug information display, prescription examination, drug sales and delivery, and other behaviors of the online drug sales enterprises settled on the platform, and urge them to strictly perform their legal obligations.

Article 18　The third-party platform shall submit the enterprise name, legal representative, unified social credit identifier, website name, domain name and other information to the provincial drug regulatory department where the platform is located for filing. The provincial drug regulatory department shall publicize the filing information of the platform.

Article 19　The third-party platform shall continuously publicize the business license, relevant administrative license and filing, contact information, complaint and reporting ways and other information or the mark that links to the above information on the home page of its website or the main page of its drug distribution activities.

The display of drug information on third-party platforms shall meet the requirements in Article 13 of these Provisions.

Article 20　The third-party platform shall audit the qualifications, and the quality and safety assurance capabilities of the online drug sales enterprises that apply for settlement, establish registration record for online drug sales enterprises, and check and update such information at least every six months to ensure that the settled online drug sales enterprises meet the legal requirements.

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

Article 21　The third-party platform shall keep the information on drug display, transaction records, complaints and reports, and other relevant information. The storage period shall not be 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 settled online drug sales enterprises to save their own data.

Article 22　The third-party platform shall establish an examination and monitoring system for online drug sales activities. If it is found that the settled online drug sales enterprise has any illegal act, the platform shall stop it promptly and immediately report to the local drug regulatory department at the county level.

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

(1) having no qualification for selling drugs;

(2) selling drugs under special control of the country in violation of Article 8 of these Provisions;

(3) selling drugs beyond the scope of the drug distribution certificate;

(4) being ordered to stop selling, being revoked the drug approval documents or being revoked the drug distribution certificate by the drug regulatory department due to illegal acts;

(5) any other serious illegal acts.

If the drug approval license is revoked or canceled according to law, the information about the relevant drugs shall not be displayed.

Article 24　In case of public health emergencies or other emergencies that seriously threaten public health, the third-party platforms and the online drug sales enterprises shall abide by relevant national regulations on handling emergencies and take corresponding control and handling measures according to law.

If the drug MAH recalls the drug according to law, the third-party platform and online drug sales enterprises shall cooperate actively.

Article 25　When the drug regulatory department carries out supervision and inspection, case investigation, and event handling, the third-party platform shall cooperate. If the drug regulatory department finds that the online drug sales enterprise has any illegal acts and requires the third-party platform to take measures to stop them according to law, the third-party platform shall perform relevant obligations promptly.

If the drug regulatory department requires information about the sellers, sales records, pharmaceutical services, traceability and other information on the platform according to laws and administrative regulations, the third-party platform shall provide such information promptly.

The third-party platform is encouraged to establish automatic information submission mechanisms with the drug regulatory departments, such as open data interface.

 Chapter IV Supervision and Inspection

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

Article 27　When conducting inspections on third-party platforms and online drug sales enterprises, the drug regulatory departments can take the following measures according to law:

(1) enter the sites related to online drug sales and network platform services to conduct on-site inspections;

(2) conduct sample testing on drugs sold online;

(3) inquire relevant personnel to obtain information about the conditions of online drug sales activities;

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

(5) seal up and detain the drugs and related materials as proved by evidence that may cause potential harm to human health according to law;

(6) other measures that can be taken according to laws and regulations.

When necessary, the drug regulatory department may conduct extended inspection over the units or individuals that provide products or services for the research and development, manufacturing, distribution, and use of drugs.

Article 28　The provincial drug regulatory departments shall be responsible for investigating and handling the illegal acts of drug sales through the Internet by third-party platforms, MAHs, and drug wholesalers. The municipal and county-level drug regulatory departments shall be responsible for investigating and handling the illegal acts of online drug retailers.

The illegal acts of online drug sales shall be investigated and punished by the drug regulatory department in the place where the illegal acts occur. If the online drug sales activities cause drug safety incidents or there is any evidence proving that it may cause potential harm to human health, the drug regulatory department in the place where the illegal acts cause consequences may also be responsible for such acts.

Article 29　The drug regulatory departments shall strengthen the monitoring of online drug sales. The online drug sales monitoring platform established by the provincial drug regulatory department shall realize data connection to the national online drug sales monitoring platform.

The drug regulatory departments shall investigate and handle the illegal acts found through monitoring according to their duties.

The technical monitoring records on the illegal acts of online sales from the drug regulatory department can be used as electronic data evidence for implementing administrative penalties or adopting administrative measures according to law.

Article 30　Where there is evidence to prove that potential safety hazards may exist, the drug regulatory department shall, based on supervision and inspection findings, adopt measures such as issuing a warning, scheduling a warning meeting, ordering a rectification within a stipulated period, or suspending manufacture, distribution, use, and importation, and shall promptly announce the inspection outcome.

Article 31　The drug regulatory department shall strictly keep confidential the personal information and trade secrets provided by online drug 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 penalties for illegal acts of online drug sales, such provisions shall prevail. Upon discovery of illegal behaviors related to online drug sales which allegedly constitutes a criminal offense, the drug regulatory departments shall promptly forward the case to the public security authorities.

Article 33　For those who, in violation of the provisions in Paragraph 2, Article 8 of these Provisions, sell the drugs under special control of the country through the Internet, where laws and administrative regulations already provide for such acts, the punishments under such laws and administrative regulations shall apply. If there are no provisions under laws and administrative regulations, it shall be ordered to make correction within the time limit, and subject to a fine of not less than RMB 50,000 and not more than RMB 100,000; for hazardous consequences, a fine of not less than RMB 100,000 and not more than RMB 200,000 shall be imposed.

Article 34　In case of violation of the provisions in Paragraph 1 and Paragraph 2, Article 9 of these Provisions, it shall be ordered to make correction within the time limit, and subject to a fine of not less than RMB 30,000 and not more than RMB 50,000; for severe circumstances, a fine of not less than RMB 50,000 and not more than RMB 100,000 shall be imposed.

In case of violation of the provisions in Paragraph 3, Article 9 of these Provisions, it shall be ordered to make correction within the time limit, and subject to a fine of not less than RMB 50,000 and not more than RMB 100,000; for hazardous consequences, a fine of not less than RMB 100,000 and not more than RMB 200,000 shall be imposed.

In case of violation of the provisions of Paragraph 4, Article 9 of these Provisions, it shall be ordered to make correction within the time limit, and subject to a fine of not less than RMB 10,000 and not more than RMB 30,000; for severe circumstances, a fine of not less than RMB 30,000 and not more than RMB 50,000 shall be imposed.

Article 35　In case of violation of the provisions in Article 11 of these Provisions, it shall be ordered to make correction within the time limit; where correction is not made within the prescribed period, a fine of not less than RMB 10,000 and not more than RMB 30,000 shall be imposed; for severe circumstances, a fine of not less than RMB 30,000 and not more than RMB 50,000 shall be imposed.

Article 36　In case of violation of the provisions in Article 13, Paragraph 2 of Article 19 of these Provisions, it shall be ordered to make correction within the time limit; where correction is not made within the prescribed period, a fine of not less than RMB 50,000 and not more than RMB 100,000 shall be imposed.

Article 37　If the online drug sales enterprise violates the provisions of Articles 14 and 15 of these Provisions and fails to comply with the Good Supply Practice, the punishments stipulated in Article 126 of the Drug Administration Law shall apply.

Article 38　In case of violation of the provisions in Paragraph 1, Article 17 of these Provisions, it shall be ordered to make correction within the time limit, and subject to a fine of not less than RMB 30,000 and not more than RMB 100,000; for hazardous consequences, a fine of not less than RMB 100,000 and not more than RMB 200,000 shall be imposed.

Article 39　In case of violation of the provisions of Article 18 of these Provisions, it shall be ordered to make correction within the time limit; where correction is not made within the prescribed period, a fine of not less than RMB 50,000 and not more than RMB 100,000 shall be imposed; for hazardous consequences, a fine of not less than RMB 100,000 and not more than RMB 200,000 shall be imposed.

Article 40　If the third-party platform violates the provisions of Article 20, Article 22 and Article 23 of these Provisions and fails to perform the obligations of qualification audit, reporting, suspension on providing online transaction platform services and other obligations, the punishments stipulated in Article 131 of the Drug Administration Law shall apply.

Article 41　If the drug regulatory department and its personnel fail to perform their duties or abuse their powers, neglect their duties, commit malpractices for personal gains, they shall be investigated for legal responsibility according to law; if such act constitutes a crime, corresponding criminal liabilities shall be pursued according to law.

 Chapter VI Supplementary Provisions

Article 42 These Provisions shall go into effect as of December 1, 2022.

Note: In case of any difference in interpretation between the English version and the Chinese version, the Chinese version shall prevail.