Article 1 These Measures are formulated in accordance with the Drug Administration Law of People's Republic of China (PRC) and the Measures for the Administration of Internet Information Services in order to strengthen drug supervision and administration, standardize drug information service activities on the Internet and ensure the truthfulness and accuracy of drug information on the Internet.
Article 2 These Measures shall apply to Internet drug information service activities within the territory of People's Republic of China (PRC).
The term "Internet drug information service" as mentioned in these Measures refers to the service activities of providing drugs (including medical devices) information to Internet users through the Internet.
Article 3 Internet drug information services are divided into two categories: operational and non-operational.
Operating Internet drug information service refers to the activities of providing drug information and other services to Internet users free of charge through the Internet.
Non-operating Internet drug information service refers to the activities of providing free public and exclusive drug information services to Internet users through the Internet.
Article 4 China Food and Drug Administration shall supervise and manage the websites providing Internet drug information service activities throughout the country.
The food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall supervise and manage the websites providing Internet drug information services within their respective administrative areas.
Article 5 Before applying for business license or filing procedures to the competent information industry department of the State Council or the provincial telecommunications regulatory agency, a website that intends to provide Internet drug information services shall apply to the food and drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government where the website organizer is located in accordance with the principle of territorial supervision and management, and obtain the qualification to provide Internet drug information services after examination and approval.
Article 6 The food and drug supervision and administration departments of all provinces, autonomous regions and municipalities directly under the Central Government shall examine the Internet websites that apply for providing Internet drug information services within their respective jurisdictions, and issue the Qualification Certificate for Internet drug information services if they meet the requirements.
Article 7 The format of the Qualification Certificate for Internet Drug Information Service shall be uniformly formulated by the State Food and Drug Administration.
Article 8 A website providing Internet drug information service shall mark the certificate number of the Qualification Certificate for Internet drug information service in a prominent position on its homepage.
Article 9 The drug information published by websites providing Internet drug information services must be scientific and accurate, and must comply with the laws and regulations of the state and the provisions of the state on the administration of drugs and medical devices.
Websites providing Internet drug information services shall not publish product information of narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, drug rehabilitation drugs and preparations of medical institutions.
Article 10 Advertisements for drugs (including medical devices) published by websites providing Internet drug information services must be examined and approved by the food and drug supervision and administration department.
Advertisements of drugs (including medical devices) published by websites providing Internet drug information services shall be marked with the approval number of advertisement examination.
Article 11 An application for providing Internet drug information services shall meet the following conditions in addition to those stipulated in the Measures for the Administration of Internet Information Services:
(1) Internet drug information service providers shall be legally established enterprises, institutions or other organizations;
(2) Having professionals, facilities and related systems suitable for developing drug information service activities on the Internet;
(three) there are two or more technicians who are familiar with the laws, regulations and professional knowledge of drugs and medical devices or who have passed the examination according to law.
Article 12 An application for providing drug information services on the Internet shall take the website as the basic unit.
Article 13 To apply for providing Internet drug information service, an application form for Internet drug information service issued by China Food and Drug Administration shall be filled in, and an application shall be submitted to the food and drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government where the website organizer is located, and the following materials shall be submitted at the same time:
(1) Copy of the business license of the enterprise.
(2) Relevant certificates or documents for the domain name registration of the website. The Chinese name of the website engaged in Internet drug information service shall not be preceded by the words "China", "China" and "National" unless it is the same as the name of the organizer; In addition to the Internet websites run by units that have obtained the qualification certificate of drug tendering agency, the names of other websites that provide Internet drug information services shall not contain the words "e-commerce", "drug investment invitation" and "drug bidding".
(3) Description of website column setting (the website applying for commercial Internet drug information service should provide a description of charging column and charging method).
(four) the relevant management system and implementation of the backup and access of historical website information.
(5) The methods and operating instructions for the food and drug supervision and administration department to browse all the columns and contents of the website online.
(6) Copies of academic certificates or professional and technical qualification certificates of professional and technical personnel related to drugs and medical devices, and copies of ID cards and resumes of the person in charge of the website.
(seven) sound network and information security measures, including website security measures, information security management system, user information security management system.
(eight) management measures, explanations and relevant certificates to ensure the legality, truthfulness and safety of drug information sources.
Article 14 The food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall, within 5 days from the date of receiving the application materials, make a decision on whether or not to accept them, and issue a notice of acceptance if they accept them; If it is not accepted, it shall notify the applicant in writing and explain the reasons, and inform the applicant of the right to apply for administrative reconsideration or bring an administrative lawsuit according to law.
Article 15 If the application materials are not standardized or complete, the food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall inform the applicant of all the contents that need to be supplemented within 5 days from the date of application; Fails to inform, since the date of receipt of the materials is accepted.
Article 16 The food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall, within 20 days from the date of acceptance, examine the materials applied for providing Internet drug information services and make a decision on approval or disapproval. If approved, the food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall issue the Qualification Certificate for Internet Drug Information Service, and report it to China Food and Drug Administration for filing and announcement; If it disagrees, it shall notify the applicant in writing and explain the reasons, and inform the applicant of the right to apply for administrative reconsideration or bring an administrative lawsuit according to law.
China Food and Drug Administration shall supervise the audit work of food and drug supervision and administration departments of all provinces, autonomous regions and municipalities directly under the Central Government.
Seventeenth "Internet drug information service qualification certificate" is valid for 5 years. If it is necessary to continue to provide Internet drug information service upon the expiration of the validity period, the holder shall apply to the original issuing authority for renewal of the Qualification Certificate for Internet Drug Information Service within 6 months before the expiration of the validity period. Upon examination, if the original issuing authority considers that it meets the requirements, a new certificate shall be issued; If it does not meet the requirements, it will issue a notice not to renew the new card and explain the reasons. The original "Internet Drug Information Service Qualification Certificate" was withdrawn by the original issuing authority and announced for cancellation.
The food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall, according to the application of the applicant, make a decision on whether to approve the renewal of the Qualification Certificate for Internet Drug Information Service before the expiration of the validity period. If no decision is made within the time limit, it shall be deemed that the certificate has been renewed.
Eighteenth "Internet drug information service qualification certificate" can be revoked by the original issuing authority according to the written application of the Internet drug information service provider, and the original issuing authority shall report it to China Food and Drug Administration for the record and announcement. The website whose "Internet Drug Information Service Qualification Certificate" has been withdrawn shall not continue to engage in Internet drug information services.
Article 19 Where an Internet drug information service provider changes one of the following items, it shall apply to the original license issuing authority for the change procedures, fill in the Application Form for Change of Internet Drug Information Service Items, and provide the following relevant supporting documents:
(a) the examination and approval items in the "Internet Drug Information Service Qualification Certificate" (name of Internet drug information service provider, website name, IP address, etc.). );
(two) the basic items of the Internet drug information service provider (address, legal representative, person in charge of the enterprise, etc.). );
(three) the basic situation of the Internet drug information service provided by the website (service mode, service items, etc.). ).
Article 20 The food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall, within 20 working days from the date of accepting the application for change, make a decision on whether to approve the change. Agree to change, the change results will be announced and reported to the China Food and Drug Administration for the record; If it disagrees with the change, it shall notify the applicant in writing and explain the reasons.
Article 21 The food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall publish the examination and approval process and results when examining the applicant's application. Applicants and interested parties may submit written opinions, make statements and defend matters directly related to their major interests. If a hearing should be held according to law, it should be held in accordance with legal procedures.
Article 22 Anyone who engages in Internet drug information service without obtaining or exceeding the validity period shall be given a warning by China Food and Drug Administration or the food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government and ordered to stop engaging in Internet drug information service; If the circumstances are serious, it shall be transferred to relevant departments and punished in accordance with relevant laws and regulations.
Article 23 If a website providing Internet drug information service fails to mark the certificate number of the Qualification Certificate for Internet drug information service in a prominent position on its homepage, it shall be given a warning by China Food and Drug Administration or the food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government and ordered to make corrections within a time limit; Refuses to make corrections within a time limit, and impose a fine of less than 500 yuan on websites providing non-operating Internet drug information services, and impose a fine of more than 5000 yuan 10000 yuan on websites providing operating Internet drug information services.
Twenty-fourth Internet drug information service providers in violation of these measures, under any of the following circumstances, the China Food and Drug Administration or the food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the central government shall give a warning and order them to make corrections within a time limit; If the circumstances are serious, a fine of 1000 yuan shall be imposed on the website providing non-operating Internet drug information service, and a fine of 1000 yuan to 30,000 yuan shall be imposed on the website providing operating Internet drug information service; If the case constitutes a crime, it shall be transferred to the judicial department for criminal responsibility:
(1) Having obtained the Qualification Certificate for Internet Drug Information Service, but the drug information provided directly matches the online drug transaction;
(2) Having obtained the Qualification Certificate for Internet Drug Information Service, but providing Internet drug information service beyond the scope of examination and approval;
(3) Providing untrue drug information services on the Internet, causing adverse social impact;
(4) changing the drug information service items on the Internet without authorization.
Article 25 If an Internet drug information service provider illegally uses the Internet Drug Information Service Qualification Certificate in its business activities, it shall be handled by China Food and Drug Administration or the food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government in accordance with the provisions of relevant laws and regulations.
Article 26 If the food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government illegally examine and approve the application for Internet drug information service, the original license-issuing organ shall revoke the original approved Qualification Certificate for Internet drug information service, and if the legitimate rights and interests of the applicant are damaged, the original license-issuing organ shall compensate in accordance with the provisions of the State Compensation Law; The directly responsible person in charge and other directly responsible personnel shall be given administrative sanctions by their units or higher authorities according to law.
Article 27 The food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall supervise and inspect the websites that provide drug information services on the Internet, and make the inspection known to the public.
Twenty-eighth approach by the China Food and Drug Administration is responsible for the interpretation of.
Article 29 These Measures shall come into force as of the date of promulgation. The Interim Provisions on the Administration of Internet Drug Information Services (Order No.26 of the State Pharmaceutical Product Supervision and Administration) shall be abolished at the same time.
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Measures for the Administration of Internet Drug Information Services
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In order to strengthen drug supervision and management, standardize drug information service activities on the Internet, and ensure the truthfulness and accuracy of drug information on the Internet, these Measures are formulated in accordance with the Drug Administration Law of People's Republic of China (PRC) and the Measures for the Administration of Internet Information Services.