Measures for the Supervision and Administration of Drug Network Sales

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 1 General Provisions Article 1 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 standardize the online sales of drugs and the service activities of the drug online trading platform and ensure the safety of public drug use.
Article 2: Those engaged in online drug sales, the provision of drug online trading platform services, and their supervision and management within the territory of the People's Republic of China shall comply with these Measures
.
Article 3 The State Drug Administration shall be in charge of the supervision and management of the sales of the national drug network
.
Provincial drug supervision and management departments are responsible for the supervision and management of drug network sales within their respective administrative regions, and are responsible for supervising and managing third-party platforms for drug network transactions, as well as the activities of
drug marketing authorization holders and drug wholesale enterprises selling drugs through the network.
The departments at the districted city and county levels that undertake drug supervision and management responsibilities (hereinafter referred to as the drug supervision and management departments) are responsible for the supervision and management of drug network sales within their respective administrative regions, and are responsible for supervising and managing the activities of
drug retail enterprises in selling drugs through the network.
Article 4 Those engaged in online drug sales and the provision of drug network trading platform services shall abide by drug laws, regulations, rules, standards and norms, operate in good faith in accordance with law, and ensure the quality and safety of
drugs.
Article 5: Engaging in online drug sales and providing drug online trading platform services shall employ effective measures to ensure that the information in the whole process of the transaction is true, accurate, complete, and traceable, and comply with the relevant provisions
of the State on the protection of personal information.
Article 6: Drug supervision and management departments shall strengthen coordination with relevant departments, giving full play to the role of industry organizations and other such bodies, advancing the establishment of a credit system, and promoting social co-governance
.
Chapter II: Management of Online Drug Sales Article 7 Those engaged in online drug sales shall be drug marketing license holders or drug trading enterprises
that have the ability to ensure the safety of online sales of drugs.
Chinese medicine tablet production enterprises selling Chinese medicine tablets they produce shall perform the relevant obligations
of the holder of the drug marketing authorization.
Article 8 Pharmaceutical network sales enterprises shall operate in accordance with the approved business methods and business scope
.
If the drug network sales enterprise is the holder of the drug marketing authorization, it can only sell the drugs that have obtained the drug
registration certificate.
Those who have not obtained the qualification for retailing drugs shall not sell drugs to individuals
.
Vaccines, blood products, narcotic drugs, psychotropic substances, toxic drugs for medical use, radioactive drugs, precursor chemicals such as pharmaceuticals under special management by the State must not be sold on the Internet, and the specific catalogue is to be organized and formulated
by the State Drug Administration.
Pharmaceutical network retail enterprises must not violate regulations by donating prescription drugs or Class A non-prescription drugs to individuals by purchasing drugs for gifts or buying goods for gifting drugs
.
Article 9: Where 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
.
Pharmaceutical network retail enterprises shall sign agreements with electronic prescription providers, and strictly follow the relevant provisions to review and allocate prescriptions, mark the electronic prescriptions that have been used, and avoid repeated use of prescriptions
.
Where a third-party platform undertakes an electronic prescription, it shall verify the circumstances provided by the electronic prescription and sign an agreement
.
Where a prescription received by a pharmaceutical network retail enterprise is a photocopy of a paper prescription, effective measures shall be taken to avoid the repeated use
of the prescription.
Article 10: Drug network sales enterprises shall establish and implement systems
for drug quality and safety management, risk control, drug traceability, storage and distribution management, adverse reaction reports, and complaint and report handling.
Pharmaceutical network retail enterprises shall also establish an online pharmacy service system, and pharmacists or other pharmaceutical technicians who have been qualified in accordance with law shall carry out work such as
reviewing and allocating prescriptions and guiding rational use of drugs.
The number of pharmacists or other pharmaceutical technicians who have passed the qualification certification in accordance with law shall be commensurate
with the scale of operation.
Article 11: Drug network sales enterprises shall report to the drug supervision and administration departments information
such as the enterprise name, website name, application name, IP address, domain name, drug production license or drug business license.
Where there is a change in information, it shall be reported
within 10 working days.
Where a drug network sales enterprise is a drug marketing authorization holder or a drug wholesale enterprise, it shall report
to the provincial drug supervision and management department where it is located.
Where a drug network sales enterprise is a drug retail enterprise, it shall report
to the drug supervision and management department at the city or county level where it is located.
Article 12: Drug network sales enterprises shall continuously publicize their drug production or business license information
in a conspicuous position on the home page of the website or the main page of their business activities.
Pharmaceutical online retail enterprises shall also display information
such as the qualification of pharmacists or other pharmaceutical technicians equipped in accordance with law.
Where the above information changes, it shall be updated
within 10 working days.
Article 13: Drug-related information displayed by drug network sales enterprises shall be true, accurate, and lawful
.
Online drug 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 with prescriptions" under each drug display page.
Before the prescription drug is sold, the relevant risk warning information shall be fully informed to the consumer, and the consumer shall confirm that he is aware
.
Pharmaceutical online retail enterprises shall display prescription drugs and over-the-counter drugs separately, and conspicuously mark prescription drugs and over-the-counter drugs on relevant web pages
.
Pharmaceutical online retail enterprises must not directly and publicly display information
such as prescription drug packaging and labels on the main page or home page of prescription drug sales.
Before passing the prescription review, information such as instructions shall not be displayed, and services related to the purchase of prescription drugs shall not be provided
.
Article 14 Pharmaceutical online retail enterprises shall be responsible for
the quality and safety of drug distribution.
The distribution of drugs shall be based on the number of drugs, transportation distance, transportation time, temperature and humidity requirements, etc.
, select appropriate means of transport and facilities and equipment, and the distributed drugs shall be placed in an independent space and clearly marked to ensure that they meet the requirements and can be traced
throughout the process.
Where a pharmaceutical 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 trustee.
The specific distribution requirements for online retail of drugs shall be formulated
separately by the State Drug Administration.
Article 15 Where drugs are sold to individuals, sales vouchers shall be issued in accordance with regulations
.
Sales vouchers can be issued in electronic form, and sales records of the minimum sales unit of drugs should be clearly retained to ensure traceability
.
Pharmaceutical network sales enterprises shall completely keep the qualification documents of the supplier enterprises, electronic transactions and other records
.
Online drug retail enterprises that sell prescription drugs shall also keep records of prescriptions, online pharmacy services, and so forth
.
The relevant record keeping period is not less than 5 years, and not less than 1 year
after the expiration of the validity period of the drug.
Article 16: Drug network sales enterprises shall adopt corresponding risk control measures for drugs with quality problems or potential safety hazards in accordance with law, and promptly disclose corresponding information
on the home page of the website or the main page of business activities.
Chapter III Platform Management Article 17 The third-party platform shall establish a drug quality and safety management institution, allocate pharmacy technicians to undertake drug quality and safety management work, and establish and implement management systems
such as drug quality and safety, drug information display, prescription review, prescription drug real-name purchase, drug distribution, transaction record preservation, adverse reaction reporting, and complaint and report handling.
Third-party platforms shall strengthen inspections, manage drug information display, prescription review, drug sales and distribution, and other such conduct of drug network sales enterprises stationed on the platform, and urge them to strictly perform their statutory obligations
.
Article 18: Third-party platforms shall file information such as the enterprise name, legal representative, uniform social credit code, website name, and domain name with the provincial drug regulatory department where the platform is located
.
The provincial drug supervision and administration department shall publicize
the platform filing information.
Article 19: Third-party platforms shall continuously publish information such as business licenses, relevant administrative licenses and filings, contact information, complaint and reporting methods, or link logos
of the above-mentioned information in a conspicuous position on the home page of their websites or on the main page of their drug business 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 and quality and safety assurance capabilities of the drug network sales enterprises applying for settlement, establish registration files for the drug network sales enterprises, and verify and update them at least once every six months, to ensure that the drug network sales enterprises settled in meet the statutory requirements
.
The third-party platform shall sign an agreement with the drug network sales enterprise to clarify the responsibilities of both parties for drug quality and safety
.
Article 21: Third-party platforms shall preserve information such as drug display, transaction records, complaints and reports
。 The storage period is not less than 5 years, and not less than 1 year
after the expiration of the validity of the drug.
The third-party platform shall ensure the authenticity and completeness of relevant materials, information and data, and facilitate the retention of data by the settled drug network sales enterprises
.
Article 22: Third-party platforms shall establish inspection and monitoring systems
for drug network sales activities.
Where it is discovered that the settled drug network sales enterprise has violated the law, it shall be promptly stopped and immediately reported
to the drug supervision and management department at the county level where it is located.
Article 23: Where third-party platforms discover the following serious violations of law, they shall immediately stop providing online trading platform services and stop displaying drug-related information: (1) Those who do not have the qualifications to sell drugs; (2) Violating article 8 of these Measures by selling drugs under special management by the State; (3) Selling drugs beyond the scope of the drug business license; (4) Being ordered by the drug supervision and management department to stop selling or revoke the drug approval documents or revoke the drug business license due to illegal conduct; (5) Other serious illegal conduct
.
Where the drug registration certificate is revoked or cancelled in accordance with law, the information
on the relevant drug must not be displayed.
Article 24: When public health emergencies or other emergencies that seriously threaten public health occur, third-party platforms and drug network sales enterprises shall comply with the relevant national emergency response provisions, and lawfully employ corresponding control and disposition measures
.
Where drug marketing authorization holders recall drugs in accordance with law, third-party platforms and drug network sales enterprises shall actively cooperate
.
Article 25: When drug supervision and management departments carry out supervision and inspection, case investigation and handling, incident handling, and other such work, the third-party platform shall cooperate
.
Where the drug supervision and administration department discovers that a drug network sales enterprise has illegal conduct and requires the third-party platform to take measures to stop it in accordance with law, the third-party platform shall promptly perform the relevant obligations
.
Where the drug supervision and administration departments provide information such as sellers, sales records, pharmaceutical services, and traceability within the platform in accordance with laws and administrative regulations, the third-party platform shall provide
it in a timely manner.
Encourage third-party platforms and drug supervision and management departments to establish automated information reporting mechanisms
in the form of open data interfaces.
Chapter IV Supervision and Inspection Article 26 The drug supervision and management departments shall, in accordance with laws, regulations, rules, and other provisions, supervise and inspect
third-party platforms and drug network sales enterprises in accordance with the division of duties 。 Article 27 When the drug supervision and administration department conducts inspections of third-party platforms and drug network sales enterprises, it may employ the following measures in accordance with law: (1) Entering the relevant places for drug network sales and network platform services to carry out on-site inspections; (2) Conduct sampling inspections of drugs sold online; (3) Ask relevant personnel to understand the relevant situation of drug network sales activities; (4) Lawfully consulting and copying transaction data, contracts, bills, account books, and other relevant materials; (5) Employ measures to seal or seize drugs and related materials that have evidence to prove that they may endanger human health; (6) Other measures that laws and regulations provide may be employed
.
When necessary, the drug supervision and management department may conduct extended inspections
of individuals who provide products or services for the development, production, operation, and use of drugs.
Article 28 The provincial drug supervision and management departments shall be responsible
for the investigation and handling of illegal acts of third-party platforms, drug marketing authorization holders, and drug wholesale enterprises selling drugs through the Internet.
The drug supervision and management departments at the municipal and county levels shall be responsible for
the investigation and handling of illegal acts of pharmaceutical online retail enterprises.
Illegal acts of online drug sales shall be investigated and handled by the drug supervision and management department of the place where the illegal acts occurred
.
Where drug safety incidents are triggered by drug network sales activities or there is evidence that it may endanger human health, the drug supervision and management department at the place where the illegal act results may also be responsible
.
Article 29: Drug supervision and administration departments shall strengthen the monitoring of
online drug sales.
The drug network sales monitoring platform established by the provincial drug supervision and management department shall achieve data docking
with the national drug network sales monitoring platform.
The drug supervision and management department shall investigate and deal
with the illegal acts discovered by monitoring in accordance with its duties in accordance with law.
The technical monitoring records of illegal acts of online sales by drug supervision and management departments may be used as electronic data evidence
for the implementation of administrative punishments or the adoption of administrative measures in accordance with law.
Article 30: Where there is evidence to prove that there may be potential safety hazards, the drug supervision and management departments shall, on the basis of supervision and inspection, employ measures such as warnings, interviews, time-limited rectification, and suspension of production, sales, use, and import of drug network sales enterprises or third-party platforms, and promptly announce the results of
inspections and handling.
Article 31: Drug supervision and administration departments shall keep the personal information and trade secrets provided by drug network sales enterprises or third-party platforms strictly confidential, and must not leak, sell, or illegally provide
them to others.
Chapter V Legal Liability Article 32 Where laws or administrative regulations have provisions on the punishment of illegal acts of online drug sales, follow those provisions
.
Where the drug supervision and administration department discovers that the illegal conduct of drug network sales is suspected of being a crime, it shall promptly transfer the case to the public security organs
.
Article 33: Where the provisions of the second paragraph of Article 8 of these Measures are violated by selling drugs under special management by the State through the Internet, where laws or administrative regulations have already provided for them, punishment shall be given
in accordance with the provisions of laws and administrative regulations.
Where laws or administrative regulations do not provide for it, order corrections within a time limit and impose a fine of between 50,000 and 100,000 yuan; Where harmful consequences are caused, a fine of between 100,000 and 200,000 yuan shall be imposed
.
Article 34: Violating the provisions of the first and second paragraphs of Article 9 of these Measures, order corrections within a time limit, and impose a fine of between 30,000 and 50,000 yuan; Where the circumstances are serious, a fine of between 50,000 and 100,000 yuan shall be imposed
.
Violating the provisions of the third paragraph of Article 9 of these Measures, ordering corrections within a time limit and imposing a fine of between 50,000 and 100,000 yuan; Where harmful consequences are caused, a fine of between 100,000 and 200,000 yuan shall be imposed
.
Violating the provisions of paragraph 4 of Article 9 of these Measures, ordering corrections within a time limit and imposing a fine of between 10,000 and 30,000 yuan; Where the circumstances are serious, a fine of between 30,000 and 50,000 yuan shall be imposed
.
Article 35: Violations of the provisions of Article 11 of these Measures are ordered to make corrections within a time limit; Those who fail to make corrections within the time limit shall be fined between 10,000 and 30,000 yuan; Where the circumstances are serious, a fine of between 30,000 and 50,000 yuan shall be imposed
.
Article 36: Violations of the provisions of Article 13 and Paragraph 2 of Article 19 of these Measures are ordered to make corrections within a time limit; Those who fail to make corrections within the time limit shall be fined
between 50,000 and 100,000 yuan.
Article 37 Where, in violation of the provisions of Articles 14 and 15 of these Measures, a drug network sales enterprise fails to comply with the quality management norms for drug business, it shall be punished
in accordance with the provisions of Article 126 of the Drug Administration Law.
Article 38: Violating the provisions of the first paragraph of Article 17 of these Measures, ordering corrections within a time limit and imposing a fine of between 30,000 and 100,000 yuan; Where harmful consequences are caused, a fine of between 100,000 and 200,000 yuan shall be imposed
.
Article 39: Violating the provisions of Article 18 of these Measures, order corrections within a time limit; Those who fail to make corrections within the time limit shall be fined between 50,000 and 100,000 yuan; Where harmful consequences are caused, a fine of between 100,000 and 200,000 yuan shall be imposed
.
Article 40 Where the provisions of Articles 20, 22 and 23 of these Measures are violated, and a third-party platform fails to perform obligations such as qualification review, reporting, or stopping the provision of online trading platform services, it shall be punished
in accordance with the provisions of Article 131 of the Drug Administration Law.
Article 41 The drug supervision and management departments and their staff shall be investigated for legal responsibility if they do not perform their duties or abuse their powers, neglect their duties, or engage in favoritism; Where a crime is constituted, criminal responsibility
is to be pursued in accordance with law.
Chapter VI Supplementary Provisions Article 42 These Measures shall take effect as of
December 1, 2022.
Measures for the Supervision and Administration of Drug Network SalesChapter 1 General ProvisionsChapter 2 Adverse Reactions to Drug Network Sales ManagementChief EnterprisesChapter III Platform Management Health RegulationsChapter IV Supervision and InspectionChapter V Legal LiabilityChapter VI Supplementary Provisions