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All provinces, autonomous regions, municipalities directly under the Central Government, and the Drug Administration of the Xinjiang Production and Construction Corps:
The Measures for the Supervision and Administration of Online Sales of Drugs (hereinafter referred to as the Measures) were promulgated on September 1, 2022 and came into force
on December 1, 2022.
In order to do a good job in the implementation of the Measures, the following notice is hereby issued on relevant matters:
1.
Effectively raise awareness and do a good job in publicizing and training the Measures
The Measures fully implement the "four strictest" requirements and series of decision-making arrangements of the Party Central Committee and the State Council on drug supervision, and further refine the provisions of the Drug Administration Law of the People's Republic of China on online sales of drugs, which is of great significance
to ensuring the safety of public drug use and safeguarding public health rights and interests.
Drug regulatory departments at all levels should fully understand the importance and urgency of the implementation of the Measures, and seriously grasp the implementation
in light of the actual work in their respective regions.
Drug regulatory departments at all levels should aim to improve drug supervision capabilities, maintain the order of drug online sales, and ensure the safety of public drug use, take regulatory practice as the guide, formulate training programs, and organize and carry out publicity and training through grading, classification, and multiple channels, so as to fully prepare
for the implementation of the Measures.
2.
Accurately grasp the key points and implement the various systems of the Measures
Drug regulatory departments at all levels should supervise and guide drug online sales enterprises to earnestly perform their main responsibilities, and establish and implement systems such as drug quality and safety management, risk control, traceability, storage and distribution, and online pharmaceutical services; Where the electronic division is used to sell prescription drugs to individuals, an agreement shall be signed with the medical institution or the electronic prescription circulation platform to ensure that the source of the prescription is authentic and reliable, and that the drug can be traced back to consumers or patients; Pharmacists or other pharmacy technicians who have been certified in accordance with the law to carry out prescription review and deployment, and must not provide services
related to the purchase of prescription drugs before passing the prescription review 。
Provincial-level drug regulatory departments should supervise and guide third-party platforms to establish and improve drug online sales management systems, establish drug quality and safety management institutions, and establish and implement systems such as drug quality and safety, drug information display, prescription review, real-name purchase of prescription drugs, and drug distribution; Supervise and guide third-party platforms to carry out dynamic monitoring of drug sales behavior; Supervise third-party platforms to carefully review and check the qualifications of pharmaceutical online sales enterprises, establish registration files, and ensure continuous quality and safety assurance capabilities; The main and home pages of prescription drug sales do not directly display information such as prescription drug packaging and labels
.
3.
Establish and complete mechanisms to comprehensively do a good job in the supervision and management of online drug sales
Drug regulatory departments at all levels should sort out the situation of drug online sales enterprises and third-party platforms within their jurisdiction, establish and improve regulatory ledgers, and fully grasp the number of supervision targets in their jurisdiction; It is necessary to strengthen supervision by means of routine inspections, flight inspections, cross-inspections, etc.
, and carry out necessary extended inspections of distribution enterprises; It is necessary to strengthen the coordination and cooperation of cross-regional drug regulatory departments, strengthen communication and coordination with public security, health, internet information and other departments, and establish cross-regional drug online sales case investigation mechanisms and cross-departmental liaison mechanisms
.
Drug regulatory departments at all levels should further strengthen the monitoring of drug online sales, and do a good job in the disposal of
monitoring information.
The drug network sales monitoring platform established by the provincial drug regulatory department should be connected
with the national drug network sales monitoring platform as soon as possible.
Provincial-level drug regulatory departments should strengthen efforts to implement relevant work
such as information reception, investigation and handling, and result feedback and upload on the national drug network transaction monitoring platform.
Encourage provincial-level drug regulatory departments where platforms are located to connect with third-party platform data docking to dynamically supervise
drug online sales enterprises.
Drug regulatory departments at all levels should formulate necessary supporting documents in accordance with the Measures and in light of actual work, further refine relevant systems around third-party platform filings or drug online sales enterprise reports, implement enterprise entity responsibilities, establish and improve supervision and inspection mechanisms, improve work processes and standards, and improve the institutionalization, standardization and scientific level
of drug online sales supervision 。
4.
Strictly investigate illegal acts and maintain the order of online drug sales
Drug regulatory departments at all levels should closely focus on the prominent problems of drug online sales, persist in treating both the symptoms and the root causes, and emphasize containment, strong pressure, and long-term deterrence
.
It is necessary to grasp the concentrated special rectification with one hand, and grasp the source and basic work with the other hand, innovate the risk prevention and control system of drug online sales, optimize the social environment for online drug sales, and strive to solve deep-seated problems
affecting drug safety.
For third-party platforms, it is necessary to focus on investigating and dealing with violations of laws and regulations in areas such as platform responsibility performance and business behavior management; For pharmaceutical online sales enterprises, it is necessary to focus on investigating and dealing with violations of laws and regulations, such as the sale of counterfeit and inferior drugs, drugs under special management by the state, and operation beyond the scope and method
.
It is necessary to discover, investigate, severely punish, and expose a number of typical cases, form a strong deterrent, and earnestly maintain the order
of online drug sales.
General Department of the State Food and Drug Administration
November 24, 2022
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