Online drug sales have restrictions on drug online sales supervision of new actions

According to the newly revised Drug Administration Law, the State Drug Administration has made amendments to the Measures for the Supervision and Administration of Drug Network Sales (Draft for Comments) and is now seeking public comments on the Measures again, please send the relevant comments back to ypjgs@nmpa.gov.cn by e-mail by November 30, 2020, with the title of the e-mail indicating "Feedback on the Regulatory Measures for drug Network Sales".
, according to Cypress Blue combing, this release of the draft for comments, the following provisions deserve attention.
Article 8 of the Administrative Measures for the Administration of The Sale of Vaccines, Blood Products, Narcotic Drugs, etc. shall not exceed the mode of operation of the enterprise and the scope of the operation of the drug.
who is the holder of a drug network seller, may only sell the drug whose approval number is held.
not obtain the retail qualification of drugs, the drug shall not be sold to individuals.
medicines under special administration in the countries of vaccines, blood products, narcotic drugs, psychotic drugs, toxic drugs for medical use, radioactive drugs, pharmaceutical-type easily-to-poison chemicals, etc., shall not be sold through the Internet.
drug retail enterprises that sell drugs through the Internet shall not give prescription drugs and Class A over-the-counter drugs to the public by buying medicines or goods to give medicines.
article 9 of the Measures for the Real and Reliable Administration of The Source of Electronic Prescriptions stipulates that if a pharmaceutical retail enterprise sells prescription drugs over the Internet, it shall ensure that the source of the electronic prescription is true and reliable, and conduct a prescription adjustment examination in accordance with the relevant requirements, and electronically mark the prescriptions used.
To sell drugs to individuals, it is necessary to be equipped with a practicing pharmacist Article 10 clearly stipulates the obligations of drug network sellers - drug network sellers shall comply with the relevant requirements of the state drug supervision and management and network transaction management laws, regulations and regulations, and fulfill the following obligations: (1) establish a drug network sales safety management system, to achieve the full process of drug sales traceability, verifiability; (2) Establish and implement a distribution management system to ensure the quality and safety of medicines; (3) establish and implement a complaint reporting system; (4) establish and implement a monitoring and reporting system for adverse reactions to the sale of drugs online; (5) assist holders in fulfilling their drug recall obligations, communicate and feedback drug recall information in a timely manner, and control and recover drugs with safety hazards.
selling drugs to individuals, an online pharmaceutical service system shall also be established, equipped with practicing pharmacists to guide rational drug use, the number of practicing pharmacists shall be appropriate to the scale of operation, and the sales record of the minimum sales unit of the drug shall be clearly retained and traceable.
addition, Article 13 of the Administrative Measures also stipulates that drug network sellers shall clearly display relevant qualification documents and contact information in a prominent position on the home page of the website or on the main page of their business activities.
the relevant information is changed, it shall be updated in a timely manner.
drug network seller is a pharmaceutical retail enterprise, it shall also display the registration certificate of the practicing pharmacist equipped with a practicing pharmacist.
Article 25 of the Administrative Measures for the Supervision and Reporting of Third-Party Platforms stipulates that if a third-party platform discovers any violations of laws or regulations by the drug network sellers in which they reside, it shall promptly stop them and immediately report them to the local county-level drug supervision and administration department.
If one of the following circumstances occurs, the third-party platform shall prohibit the display of information on the relevant drugs, make public the relevant drugs in accordance with the provisions, and immediately report to the local county-level drug supervision and administration department, and, if necessary, assist in the recall or recovery of the drugs sold: (1) the drug supervision and administration department shall issue decisions such as withdrawing the drug from the market and canceling the drug approval documents; (2) If the drug supervision and administration department or the holder announces that there is a quality safety problem or requests a recall of the drug; (3) the pharmaceutical business enterprise requires the recovery of the drug; (4) if it discovers that the drug has quality safety problems or safety hazards.
If there are any of the following circumstances, the third-party platform shall also immediately stop providing drug network trading services: (1) if it discovers that it sells illegal drugs and sells drugs beyond its scope of business; (2) if it finds that the drug network seller does not have the qualifications to sell drugs online; and (3) if it finds other serious violations of the law.
The drug regulatory department shall have the right to inspect drugs sold online Article 29 stipulates that when the drug regulatory department inspects drug network sales and drug network trading services, it shall have the right to take the following measures: (1) enter the business premises, office premises, logistics activities, server locations and other relevant places to carry out on-site inspections; (3) To inquire about the relevant personnel and investigate and understand the relevant information about the drug network sales activities or the logistics activities entrusted by them; (4) to consult and copy transaction data, contracts, bills, books of account and other relevant information; (5) to obtain technical monitoring and recording materials for online sales; (6) to take measures to seal up and seize drugs, data storage media and other articles and places and facilities engaged in illegal business activities and related logistics activities in accordance with the law; (7) other measures that may be taken by laws and regulations.
The drug regulatory department shall have the right to interview the person in charge of drug online sales Article 34 stipulates that if a drug network seller or third-party platform has one of the following circumstances, the drug regulatory department may interview its legal representative or principal person in charge in accordance with its duties: (1) there are hidden dangers of drug quality and safety, which may lead to the risk of drug quality and safety;
the interview does not affect the drug supervision and administration department to deal with it administratively in accordance with the law.
the enterprise interviewed fails to rectify the situation in accordance with the requirements without valid reasons, the local drug supervision and administration department at or above the county level shall increase the frequency of supervision and inspection in accordance with its duties.
Drug online sales, constitute a crime according to law accountability Management Measures Chapter V provides for the corresponding legal responsibilities: Article 38 "Execution link" drug network sellers, third-party platforms in violation of e-commerce and drug management laws and regulations to engage in sales activities or trading services, laws and regulations have provisions, from its provisions.
constitutes a crime, criminal responsibility shall be investigated in accordance with the law.
Article 39 (Penalties for engaging in online activities) If one of the following circumstances occurs, he shall be ordered to make corrections within a specified period of time and shall be fined between 10,000 yuan and 30,000 yuan: (1) engaged in the online sale of drugs in violation of the provisions of Article 11 of these Measures; (2) engaged in drug network trading services in violation of the provisions of these Measures; (3) he shall not suspend (or terminate) online sales or online trading services in accordance with the decision of the drug regulatory authority.
Article 40 If, in violation of the provisions of Articles 12 and 20 of these Measures, it fails to report or file in accordance with the provisions, it shall be ordered to make corrections within a specified period of time;
Article 41 If, in violation of the provisions of Articles 14 and 17 of these Measures, the relevant information is not displayed or published as required, it shall be ordered to make corrections within a time limit;
Article 42 (Penalty for failure to issue sales vouchers) If, in violation of the provisions of Article 16, paragraph 1, of these Measures, a sales voucher is not issued, it shall be ordered to make corrections within a specified period of time;
violate the provisions of Article 16, paragraph 2, of these Measures and fail to keep electronic order ledger records in accordance with the provisions, he shall be ordered to make corrections within a specified period of time and shall be fined between 5,000 yuan and 20,000 yuan.
Article 43 (GSP-related penalties) that violate the provisions of Article 8, paragraph 3, Article 9, Article 10 and Article 15 of these Measures shall be punished in accordance with the provisions of Article 126 of the Drug Administration Law.
44 (Platform Penalties) for violating the provisions of Articles 22, 23 and 25 (3) of these Measures shall be punished in accordance with the provisions of Article 131 of the Drug Administration Law.
violate the provisions of Article 24, paragraph 1, of these Measures, and fail to keep relevant records, vouchers and information in accordance with the provisions, they shall be ordered to make corrections within a specified period of time and shall be fined between 10,000 yuan and 30,000 yuan.
Article 45 (Severe Punishment) If, in violation of the provisions of these Measures, the drug supervision and administration department refuses, obstructs or does not cooperate with the supervision and inspection carried out in accordance with the law, it shall be severely punished in accordance with the law.
Article 46 (Responsibility of Supervisors) If the drug supervision and administration department and its staff do not perform their duties or abuse their power, neglect their duties or commit fraud for personal gain, they shall be investigated for administrative responsibility in accordance with the law;
From article 48 of the draft for comments on the implementation date of the expression can be seen, if smooth, drug online sales management measures are expected to be implemented within the year, after the official liberalization of online sales of prescription drugs, the supervision of online drug sales will also be more legal.
Attached: Drug Network Sales Supervision and Administration Measures (Draft for Comments) Chapter I General Article 1 (Legislative Purposes) 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 the E-Commerce Law of the People's Republic of China (hereinafter referred to as the E-Commerce Law) and other laws and administrative regulations to regulate the sale of drugs and the trading services of drug networks.
Article 2 (Scope of Application) These Measures shall be observed when engaging in the sale of drug networks, providing drug network trading services and supervision and management within the territory of the People's Republic of China.
Article 3 "Regulatory Responsibilities" The State Drug Administration is responsible for guiding the supervision and management of drug network sales and drug network trading services throughout the country.
provincial drug supervision and administration department is responsible for the supervision and management of third-party platforms for drug network transactions.
departments responsible for drug supervision and management at or above the county level shall be responsible for the supervision and management of drug network sales within their administrative areas in accordance with the division of responsibilities. article
Article 4 (Article 4) When engaging in the sale of drugs online and providing third-party platform services for drug network transactions, they shall have the corresponding qualifications or conditions, abide by the laws, regulations and norms of drugs, operate in good faith in accordance with the law, and ensure the quality and safety of medicines.
Third-party platform providers for drug network transactions (hereinafter referred to as third-party platforms) refer to legal entities or illegal organizations that provide network business premises, transaction matching, information release and other services in drug network transactions for both parties or parties to carry out transaction activities.
Article 5 "Retrospective Obligations" When engaging in the sale of drugs online and providing drug network trading services, effective measures shall be taken to ensure that the information and data are true, complete and the transaction information is traceable.
6 (Social Co-Management) The departments responsible for drug supervision and management shall strengthen cooperation between departments, give full play to the role of industry organizations and other institutions, promote the construction of an integrity system and promote social co-management.
II Drug Network Sales Management Article 7 Drug Network Sellers shall be drug market license holders (hereinafter referred to as holders) or pharmaceutical business enterprises.
chinese medicine tablets produced by the chinese medicine beverage tablets manufacturing enterprises shall fulfill the relevant obligations of the holders stipulated in these Measures.
Article 8 "Network Sales Scope" Drug network sales shall not exceed the mode of operation of enterprises and the scope of drug business.
who is the holder of a drug network seller, may only sell the drug whose approval number is held.
not obtain the retail qualification of drugs, the drug shall not be sold to individuals.
medicines under special administration in the countries of vaccines, blood products, narcotic drugs, psychotic drugs, toxic drugs for medical use, radioactive drugs, pharmaceutical-type easily-to-poison chemicals, etc., shall not be sold through the Internet.
drug retail enterprises that sell drugs through the Internet shall not give prescription drugs and Class A over-the-counter drugs to the public by buying medicines or goods to give medicines.
Article 9 (Prescription Drug Conditions for Online Sales) If a pharmaceutical retail enterprise sells prescription drugs over the Internet, it shall ensure that the source of the electronic prescription is true and reliable, and conduct a prescription adjustment examination in accordance with the relevant requirements, and electronically mark the prescriptions used. article
Article 10 (Obligations of Network Sellers) Drug network sellers shall comply with the relevant requirements of the laws, regulations and regulations of the State drug supervision and management and the management of online transactions, and shall fulfill the following obligations: (1) establish a safety management system for the sale of drug networks, and realize the traceability and verifiability of the entire process of drug sales; (2) Establish and implement a distribution management system to ensure the quality and safety of medicines; (3) establish and implement a complaint reporting system; (4) establish and implement a monitoring and reporting system for adverse reactions to the sale of drugs online; (5) assist holders in fulfilling their drug recall obligations, communicate and feedback drug recall information in a timely manner, and control and recover drugs with safety hazards.
selling drugs to individuals, an online pharmaceutical service system shall also be established, equipped with practicing pharmacists to guide rational drug use, the number of practicing pharmacists shall be appropriate to the scale of operation, and the sales record of the minimum sales unit of the drug shall be clearly retained and traceable.
11 (Technical Requirements) Drug network sellers may conduct drug network sales through self-built websites, web client applications, third-party platforms or other forms of relying on relevant network service providers to build their own online stores.
to carry out drug network sales through the above means, it shall have application software, network security measures and relevant databases to meet the requirements for business development.
Article 12 Reporting Requirements: Drug network sellers shall report to the drug regulatory department information such as the name of the enterprise or the name of the holder, the legal representative, the principal person in charge, the unified social credit code, the name of the website or the name of the application of the network client, the domain name of the website, the license for the production of drugs or the number of the license for the operation of the drug.
the drug network seller is the holder, it shall also submit information on the drug approval number, and if the drug retail enterprise sells prescription drugs over the network, it shall also submit supporting materials to ensure the true and reliable source of the electronic prescription.
drug network seller is the holder or the wholesale pharmaceutical enterprise, it shall report to the provincial drug supervision and administration department.
drug network seller is a drug retail enterprise, it shall report to the municipal department responsible for drug supervision and management in the district.
provincial drug supervision and administration departments and the municipal drug supervision and administration departments shall make the report information public in a timely manner.
Article 13 (Certificate Information Display) Drug network sellers shall clearly display the relevant qualification documents and contact information in a prominent position on the home page of the website or on the main page of the business activity.
the relevant information is changed, it shall be updated in a timely manner.
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