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According to the website of the State Administration for Market Regulation, recently, the State Administration for Market Regulation issued the "Measures for the Supervision and Administration of Drug Online Sales" (Order No.
58 of the State Administration for Market Regulation), which will come into force on December 1, 2022
.
58 of the State Administration for Market Regulation), which will come into force on December 1, 2022
.
The responsibility of drug safety is heavy, and it is related to the lives and health ofthe people .
The Party Central Committee and the State Council attach great importance to it
.
In order to implement the "four strictest" requirements of the Party Central Committee and the State Council on drug supervision and a series of decision-making arrangements, refine and concretize the provisions of the Drug Administration Law on drug online sales, coordinate the convenience of the masses to purchase drugs and drug safety supervision, and effectively guarantee On the basis of drug safety and legitimate rights and interests of the public, the State Administration for Market Regulation and the Food and Drug Administration have formulated the "Measures for the Supervision and Administration of Drug Online Sales" on the basis of in-depth research and full demonstration
.
The "Measures" has 6 chapters and 42 articles, which stipulates the management of drug online sales, platform responsibility performance, supervision and inspection measures and legal responsibilities.
The main contents include:
The Party Central Committee and the State Council attach great importance to it
.
In order to implement the "four strictest" requirements of the Party Central Committee and the State Council on drug supervision and a series of decision-making arrangements, refine and concretize the provisions of the Drug Administration Law on drug online sales, coordinate the convenience of the masses to purchase drugs and drug safety supervision, and effectively guarantee On the basis of drug safety and legitimate rights and interests of the public, the State Administration for Market Regulation and the Food and Drug Administration have formulated the "Measures for the Supervision and Administration of Drug Online Sales" on the basis of in-depth research and full demonstration
.
The "Measures" has 6 chapters and 42 articles, which stipulates the management of drug online sales, platform responsibility performance, supervision and inspection measures and legal responsibilities.
The main contents include:
The first is to implement the main responsibility ofpharmaceutical business enterprises
.
Clarify the main qualifications and requirements of drug business enterprises engaged in drug online sales, and specify in accordance with the law vaccines, blood products, narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, pharmaceutical precursor chemicals and other drugs subject to special state management Not to be sold online
.
At the same time, strict management of the whole process of drug operation is required, and clear requirements are put forward for the whole process management of drug network sales enterprises such as quality and safety management system, pharmaceutical services, drug storage and distribution, drug traceability, risk control, and information disclosure
.
.
Clarify the main qualifications and requirements of drug business enterprises engaged in drug online sales, and specify in accordance with the law vaccines, blood products, narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, pharmaceutical precursor chemicals and other drugs subject to special state management Not to be sold online
.
At the same time, strict management of the whole process of drug operation is required, and clear requirements are put forward for the whole process management of drug network sales enterprises such as quality and safety management system, pharmaceutical services, drug storage and distribution, drug traceability, risk control, and information disclosure
.
The second is to consolidate the responsibility of the online drug sales platform
.
It is clarified that a third-party platform should set up a drug quality and safety management agency, staffed with pharmacy technicians, and establish and implement drug quality and safety, drug information display, prescription review, real-name purchase of prescription drugs, drug distribution, transaction record keeping, adverse reaction reporting, and handling of complaints and reports, etc.
management system, and filing in accordance with regulations
.
At the same time, the platform is required to sign an agreement with the drug online sales company, clarifying the responsibilities of both parties for drug quality and safety, stipulating that the platform should perform the obligations of auditing, inspection and monitoring, and suspending services and reporting if serious violations are found, and strengthen the platform’s responsibility for drug recalls and emergencies.
Responsibilities for emergency response and supervision and inspection
.
.
It is clarified that a third-party platform should set up a drug quality and safety management agency, staffed with pharmacy technicians, and establish and implement drug quality and safety, drug information display, prescription review, real-name purchase of prescription drugs, drug distribution, transaction record keeping, adverse reaction reporting, and handling of complaints and reports, etc.
management system, and filing in accordance with regulations
.
At the same time, the platform is required to sign an agreement with the drug online sales company, clarifying the responsibilities of both parties for drug quality and safety, stipulating that the platform should perform the obligations of auditing, inspection and monitoring, and suspending services and reporting if serious violations are found, and strengthen the platform’s responsibility for drug recalls and emergencies.
Responsibilities for emergency response and supervision and inspection
.
The third is to clarify the management of online sales of prescription drugs
.
Considering medication safety risks and online and offline consistency management requirements, it is clear that the real-name system will be implemented for online sales of prescription drugs, and prescriptions will be reviewed and dispensed in accordance with regulations; prescription drugs and non-prescription drugs should be displayed separately, and it should not be directly disclosed on the main page and home page of prescription drug sales Display packaging, labels and other information; before passing the prescription review, no information such as instructions shall be displayed, and services related to the purchase of prescription drugs shall not be provided, which is intended to emphasize the management requirements of "prescription before drug" and prescription review
.
At the same time, it is required that consumers should be fully informed of relevant risk warning information before the sale of prescription drugs and confirmed by consumers, so as to effectively prevent drug safety risks
.
.
Considering medication safety risks and online and offline consistency management requirements, it is clear that the real-name system will be implemented for online sales of prescription drugs, and prescriptions will be reviewed and dispensed in accordance with regulations; prescription drugs and non-prescription drugs should be displayed separately, and it should not be directly disclosed on the main page and home page of prescription drug sales Display packaging, labels and other information; before passing the prescription review, no information such as instructions shall be displayed, and services related to the purchase of prescription drugs shall not be provided, which is intended to emphasize the management requirements of "prescription before drug" and prescription review
.
At the same time, it is required that consumers should be fully informed of relevant risk warning information before the sale of prescription drugs and confirmed by consumers, so as to effectively prevent drug safety risks
.
The fourth is to implement the "four strictest" requirements and strengthen the supervision measures of the supervision departments at all levels
.
Clarify the division of responsibilities of drug supervision and administration departments at all levels in the supervision of online drug sales and the jurisdiction to investigate and deal with illegal acts, require strengthening the monitoring of drug online sales, and investigate and deal with illegal acts found in monitoring according to their duties in accordance with the law
.
Strengthen the control of drug safety risks, and if there is evidence to prove that there may be potential safety hazards, it is clarified that the drug regulatory authorities can take measures such as warnings, interviews, rectification within a time limit, and suspension of production, sales, use, and import
.
In addition, the "Measures" also clarified the corresponding legal responsibilities for illegal online sales of drugs in accordance with the law
.
.
Clarify the division of responsibilities of drug supervision and administration departments at all levels in the supervision of online drug sales and the jurisdiction to investigate and deal with illegal acts, require strengthening the monitoring of drug online sales, and investigate and deal with illegal acts found in monitoring according to their duties in accordance with the law
.
Strengthen the control of drug safety risks, and if there is evidence to prove that there may be potential safety hazards, it is clarified that the drug regulatory authorities can take measures such as warnings, interviews, rectification within a time limit, and suspension of production, sales, use, and import
.
In addition, the "Measures" also clarified the corresponding legal responsibilities for illegal online sales of drugs in accordance with the law
.
According to the website of the State Administration for Market Regulation, recently, the State Administration for Market Regulation issued the "Measures for the Supervision and Administration of Drug Online Sales" (Order No.
58 of the State Administration for Market Regulation), which will come into force on December 1, 2022
.
58 of the State Administration for Market Regulation), which will come into force on December 1, 2022
.
The responsibility of drug safety is heavy, and it is related to the lives and health of the people .
The Party Central Committee and the State Council attach great importance to it
.
In order to implement the "four strictest" requirements of the Party Central Committee and the State Council on drug supervision and a series of decision-making arrangements, refine and concretize the provisions of the Drug Administration Law on drug online sales, coordinate the convenience of the masses to purchase drugs and drug safety supervision, and effectively guarantee On the basis of drug safety and legitimate rights and interests of the public, the State Administration for Market Regulation and the Food and Drug Administration have formulated the "Measures for the Supervision and Administration of Drug Online Sales" on the basis of in-depth research and full demonstration
.
The "Measures" has 6 chapters and 42 articles, which stipulates the management of drug online sales, platform responsibility performance, supervision and inspection measures and legal responsibilities.
The main contents include:
healthy and healthyThe Party Central Committee and the State Council attach great importance to it
.
In order to implement the "four strictest" requirements of the Party Central Committee and the State Council on drug supervision and a series of decision-making arrangements, refine and concretize the provisions of the Drug Administration Law on drug online sales, coordinate the convenience of the masses to purchase drugs and drug safety supervision, and effectively guarantee On the basis of drug safety and legitimate rights and interests of the public, the State Administration for Market Regulation and the Food and Drug Administration have formulated the "Measures for the Supervision and Administration of Drug Online Sales" on the basis of in-depth research and full demonstration
.
The "Measures" has 6 chapters and 42 articles, which stipulates the management of drug online sales, platform responsibility performance, supervision and inspection measures and legal responsibilities.
The main contents include:
The first is to implement the main responsibility of pharmaceutical business enterprises
.
Clarify the main qualifications and requirements of drug business enterprises engaged in drug online sales, and specify in accordance with the law vaccines, blood products, narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, pharmaceutical precursor chemicals and other drugs subject to special state management Not to be sold online
.
At the same time, strict management of the whole process of drug operation is required, and clear requirements are put forward for the whole process management of drug network sales enterprises such as quality and safety management system, pharmaceutical services, drug storage and distribution, drug traceability, risk control, and information disclosure
.
enterprise enterprise.
Clarify the main qualifications and requirements of drug business enterprises engaged in drug online sales, and specify in accordance with the law vaccines, blood products, narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, pharmaceutical precursor chemicals and other drugs subject to special state management Not to be sold online
.
At the same time, strict management of the whole process of drug operation is required, and clear requirements are put forward for the whole process management of drug network sales enterprises such as quality and safety management system, pharmaceutical services, drug storage and distribution, drug traceability, risk control, and information disclosure
.
The second is to consolidate the responsibility of the online drug sales platform
.
It is clarified that a third-party platform should set up a drug quality and safety management agency, staffed with pharmacy technicians, and establish and implement drug quality and safety, drug information display, prescription review, real-name purchase of prescription drugs, drug distribution, transaction record keeping, adverse reaction reporting, and handling of complaints and reports, etc.
management system, and filing in accordance with regulations
.
At the same time, the platform is required to sign an agreement with the drug online sales company, clarifying the responsibilities of both parties for drug quality and safety, stipulating that the platform should perform the obligations of auditing, inspection and monitoring, and suspending services and reporting if serious violations are found, and strengthen the platform’s responsibility for drug recalls and emergencies.
Responsibilities for emergency response and supervision and inspection
.
adverse reaction adverse reaction.
It is clarified that a third-party platform should set up a drug quality and safety management agency, staffed with pharmacy technicians, and establish and implement drug quality and safety, drug information display, prescription review, real-name purchase of prescription drugs, drug distribution, transaction record keeping, adverse reaction reporting, and handling of complaints and reports, etc.
management system, and filing in accordance with regulations
.
At the same time, the platform is required to sign an agreement with the drug online sales company, clarifying the responsibilities of both parties for drug quality and safety, stipulating that the platform should perform the obligations of auditing, inspection and monitoring, and suspending services and reporting if serious violations are found, and strengthen the platform’s responsibility for drug recalls and emergencies.
Responsibilities for emergency response and supervision and inspection
.
The third is to clarify the management of online sales of prescription drugs
.
Considering medication safety risks and online and offline consistency management requirements, it is clear that the real-name system will be implemented for online sales of prescription drugs, and prescriptions will be reviewed and dispensed in accordance with regulations; prescription drugs and non-prescription drugs should be displayed separately, and it should not be directly disclosed on the main page and home page of prescription drug sales Display packaging, labels and other information; before passing the prescription review, no information such as instructions shall be displayed, and services related to the purchase of prescription drugs shall not be provided, which is intended to emphasize the management requirements of "prescription before drug" and prescription review
.
At the same time, it is required that consumers should be fully informed of relevant risk warning information before the sale of prescription drugs and confirmed by consumers, so as to effectively prevent drug safety risks
.
over-the-counter medicines over -the -counter medicines.
Considering medication safety risks and online and offline consistency management requirements, it is clear that the real-name system will be implemented for online sales of prescription drugs, and prescriptions will be reviewed and dispensed in accordance with regulations; prescription drugs and non-prescription drugs should be displayed separately, and it should not be directly disclosed on the main page and home page of prescription drug sales Display packaging, labels and other information; before passing the prescription review, no information such as instructions shall be displayed, and services related to the purchase of prescription drugs shall not be provided, which is intended to emphasize the management requirements of "prescription before drug" and prescription review
.
At the same time, it is required that consumers should be fully informed of relevant risk warning information before the sale of prescription drugs and confirmed by consumers, so as to effectively prevent drug safety risks
.
The fourth is to implement the "four strictest" requirements and strengthen the supervision measures of the supervision departments at all levels
.
Clarify the division of responsibilities of drug supervision and administration departments at all levels in the supervision of online drug sales and the jurisdiction to investigate and deal with illegal acts, require strengthening the monitoring of drug online sales, and investigate and deal with illegal acts found in monitoring according to their duties in accordance with the law
.
Strengthen the control of drug safety risks, and if there is evidence to prove that there may be potential safety hazards, it is clarified that the drug regulatory authorities can take measures such as warnings, interviews, rectification within a time limit, and suspension of production, sales, use, and import
.
In addition, the "Measures" also clarified the corresponding legal responsibilities for illegal online sales of drugs in accordance with the law
.
medicines _ .
Clarify the division of responsibilities of drug supervision and administration departments at all levels in the supervision of online drug sales and the jurisdiction to investigate and deal with illegal acts, require strengthening the monitoring of drug online sales, and investigate and deal with illegal acts found in monitoring according to their duties in accordance with the law
.
Strengthen the control of drug safety risks, and if there is evidence to prove that there may be potential safety hazards, it is clarified that the drug regulatory authorities can take measures such as warnings, interviews, rectification within a time limit, and suspension of production, sales, use, and import
.
In addition, the "Measures" also clarified the corresponding legal responsibilities for illegal online sales of drugs in accordance with the law
.
