According to the general is to refer to the "Internet Drug Information Service Management Measures" (Bureau Decree No. 9) to operate more. The following will be attached to the full text:
Internet Drug Information Service Management Measures
Article 1 In order to strengthen the supervision and management of drugs, standardize the Internet drug information service activities, to ensure that the Internet drug information is true and accurate, according to the "Chinese People's Republic of China *** and the State Drug Administration Law", "Internet Information Service Management Measures", the formulation of the present measures.
Second, the provision of Internet drug information service activities within the Chinese People's **** and the State, the application of these measures.
The Internet drug information service referred to in these measures, refers to the Internet to provide Internet users with drugs (including medical devices) information service activities.
Article 3 of the Internet drug information service is divided into two categories of operational and non-operational.
Operational Internet drug information service refers to the Internet to the Internet users paid to provide drug information and other services.
Non-operational Internet drug information service refers to the Internet to the Internet users without compensation to provide public, **** enjoyment of drug information and other services.
Article 4 of the State Food and Drug Administration to provide Internet drug information service activities of the national website to implement supervision and management.
Provinces, autonomous regions, municipalities directly under the Central (Food) Drug Administration to provide Internet drug information service activities within the administrative region of the website to implement supervision and management.
Article V to provide Internet drug information services website, should be in the State Council department in charge of the information industry or provincial telecommunications regulatory agencies to apply for a business license or for the record before, in accordance with
the principle of supervision and management of the local area, to the site where the organizer of the provincial, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments to apply, after examination and verification Agree to obtain the qualification to provide Internet drug information services.
Sixth Provinces, autonomous regions, municipalities directly under the Central (Food) Drug Administration of the jurisdiction to apply for the provision of Internet drug information services for the review of Internet sites, meet the conditions for the issuance of the "Internet drug information service qualification certificate.
Seventh, "Internet drug information service qualification certificate" format developed by the State Food and Drug Administration.
Article VIII to provide Internet drug information services, the website should be marked on the home page of its website in a prominent position, "Internet drug information service qualification certificate" certificate number.
Article IX to provide Internet drug information services website published drug information must be scientific, accurate, and must be consistent with national laws and regulations and the state of the relevant provisions of the management of drugs, medical devices.
Websites providing Internet drug information services shall not publish product information on narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, drug rehabilitation drugs and preparations for medical institutions.
Article 10 The advertisements of drugs (including medical devices) published by websites providing Internet drug information services must be examined and approved by the (food) drug supervision and management departments.
The advertisements of medicines (including medical devices) published on websites providing Internet drug information services should indicate the advertisement examination and approval number.
Article 11 The application for the provision of Internet drug information services, in addition to the requirements set forth in the "Measures for the Administration of Internet Information Services", it shall also have the following conditions:
(a) the provider of Internet drug information services shall be established by law for the enterprises and public institutions or other organizations;
(b) with the development of Internet drug information service activities Compatible professionals, facilities and related systems;
(3) more than two familiar with the drugs, medical devices management laws, regulations and drugs, medical devices and professional knowledge, or by law, the qualification of pharmacy, medical device technicians.
Article XII of the application for the provision of Internet drug information services shall be a website as the basic unit.
Article XIII of the application for the provision of Internet drug information services, should fill out the State Food and Drug Administration issued a unified "Internet Drug Information Service Application Form" to the website organizer's location in the provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management department to apply, and also to submit the following materials:
(a) a copy of the business license (new business) Provide industrial and commercial administration issued by the name of the pre-approval notice and related materials);
(b) the website domain name registration certificate or document. Engaged in the Internet drug information service website's Chinese name, in addition to the name of the same with the organizer, shall not be "China", "China", "national"
etc. Title; in addition to obtaining the qualification certificate of drug bidding agency units run by the Internet site, other websites providing Internet drug information services shall not appear in the name of the "e-commerce", "drug investment", "drugs
Bidding" and other content;
(c) site columns set description (apply for operating Internet drug information services website is required to provide a fee columns and fees description);
(d) site on the history of the release of information on the backup and access to the relevant management system and implementation of the description;
(e) (Food) Drug Administration and Supervision Department to browse online all the columns on the website, the content of the method and operating instructions;
(vi) drugs and medical devices related professional and technical personnel academic certificates or a copy of their professional and technical qualification certificates, a copy of the identity card of the person in charge of the website and curriculum vitae;
(vii) a sound network and information security measures, including website security measures, Information security and confidentiality management system, user information security management system;
(viii) to ensure that the source of drug information is legitimate, true, safe management measures, information and proof.
Article XIV of the provinces, autonomous regions, municipalities directly under the Central (Food) Drug Administration in the receipt of the application materials within five days from the date of acceptance of the decision, acceptance, issued by the acceptance of the notification; not acceptance, the applicant shall be notified in writing and explain the reasons for the applicant and also inform the applicant of the right to apply for administrative reconsideration according to law, or to bring an administrative lawsuit.
Article XV of the application materials are not standardized, incomplete, provinces, autonomous regions, municipalities directly under the Central (Food) Drug Administration within five days from the date of application to inform the applicant of all the contents of the need to make corrections at once; notification of the late, since the date of receipt of the material is accepted.
Article 16 Provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments from the date of acceptance of the application for the provision of Internet drug information services within 20 days of the material for review, and to make a decision to agree or disagree
It is agreed. Agree, by the provinces, autonomous regions, municipalities directly under the Central (food) drug supervision and management department issued "Internet drug information service qualification certificate", while reporting to the State Food and Drug Administration for the record and issue a public notice; do not
agree, the applicant shall be notified in writing and explain the reasons, and inform the applicant enjoys the right to apply for administrative reconsideration or to bring an administrative lawsuit according to law.
The State Food and Drug Administration of the provinces, autonomous regions and municipalities directly under the Central (food) Drug Administration to supervise the examination and approval work.
Article XVII of the "Internet drug information service qualification certificate" is valid for five years. The expiration of the validity period, the need to continue to provide Internet drug information services, the licensee shall, within six months before the expiration of the validity period
to the original licensing authority to apply for replacement of the "Internet drug information service qualification certificate". The original licensing authority for review, that meets the conditions, to be issued a new certificate; that does not meet the conditions, issued a new certificate is not issued
Notice and explain the reasons for the original "Internet drug information service qualification certificate" by the original licensing authority to withdraw and announce the cancellation.
Provinces, autonomous regions, municipalities directly under the Central (food) drug supervision and management departments, according to the applicant's application, should be in the "Internet drug information service qualification certificate" before the expiration of the validity of the decision on whether to grant its license renewal. If the decision is not made after the expiration date, the renewal shall be deemed to be granted.
Article XVIII of the "Internet drug information service qualification certificate" can be based on the written application of the Internet drug information service providers, the original licensing authority to withdraw, the original licensing authority shall report to the State Food and Drug Administration for the record and publish a notice. Recovered "Internet drug information service qualification certificate" of the website shall not continue to engage in Internet drug information services.
Article 19 of the Internet drug information service provider to change one of the following matters, shall apply to the original licensing authority for change procedures, fill out the "Internet drug information service project change application form", while providing the following relevant documents:
(a) "Internet drug information service qualification certificate" of the review and approval of the project (Internet drug information service providers) unit name, website name, IP address, etc.);
(ii) the basic items of the Internet drug information service provider (address, legal representative, corporate officer, etc.);
(iii) the basic information of the website to provide Internet drug information service (service mode, service items, etc.).
Article 20 Provinces, autonomous regions, municipalities directly under the Central Government (food) Drug Administration from the date of acceptance of the application for change within 20 working days to make a decision on whether to agree to change the review. Agree to change, the results will be announced and reported to the State Food and Drug Administration for the record; do not agree to change, notify the applicant in writing and explain the reasons.
Article 21 Provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management department of the applicant's application for review, shall publicize the approval process and approval results. Applicants and interested parties may submit written comments on matters directly related to their vital interests for statements and defenses. Where a hearing should be held in accordance with law, the hearing shall be held in accordance with legal procedures.
Article 22 does not obtain or exceed the validity of the use of "Internet Drug Information Service Certificate" engaged in Internet drug information services, by the State Food and Drug Administration or provinces, autonomous regions, municipalities (food) drug supervision and management departments to give a warning and ordered to stop engaging in the Internet drug information services; the circumstances are serious, transferred to the relevant departments, to be punished in accordance with relevant laws and regulations. In accordance with relevant laws and regulations to be punished.
Article 23 of the Internet drug information service website does not provide Internet drug information services in the home page of the website is prominently marked "Internet drug information service qualification certificate" certificate number, the State Food and Drug Administration
or provinces, autonomous regions, municipalities directly under the Central (food) drug supervision and management departments to give a warning and ordered to make corrections; in the limited period of time and refused to make corrections, the provision of non-operational Internet drug information services. Non-operational Internet drug information service website imposed a fine of 500 yuan
the following, to provide operational Internet drug information service website imposed a fine of 5,000 yuan or more than 10,000 yuan.
Article 24 Internet drug information service providers in violation of these measures, one of the following circumstances, by the State Food and Drug Administration or provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management
Departments to give a warning, and ordered to make corrections within a specified period of time; the circumstances are serious, the provision of non-operational Internet drug information services on the Web site to impose a fine of less than 1,000 yuan. A fine of 10,000
yuan or more than 30,000 yuan or less shall be imposed on a website providing operational Internet drug information services; if a crime is constituted, the website shall be transferred to the judicial department for the pursuit of criminal responsibility:
(a) the website has obtained the "Certificate of Qualification for Internet Drug Information Service", but the information provided on drugs is directly aggregated to facilitate the online transactions of drugs;
(b) the website has obtained the "Certificate of Qualification for Internet Drug Information Service", but the information provided on drugs exceeds the limit of the "Certificate of Qualification for Internet Drug Information Service". Information Service Qualification Certificate", but beyond the scope of the audit agreed to provide Internet drug information services;
(C) to provide untrue Internet drug information services and cause adverse social impact;
(D) unauthorized changes in the Internet drug information services.
Article 25 of the Internet drug information service providers in their business activities, illegal use of the "Internet drug information service qualification certificate", by the State Food and Drug Administration or provinces, autonomous regions and municipalities directly under the Central Government (food) drug supervision and management departments in accordance with relevant laws and regulations.
Article 26 Provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments illegal to the Internet drug information service applications for examination and approval, the original licensing authority shall revoke the original approval of the "Internet drug
Pharmaceutical information service qualification certificate", which caused damage to the legitimate rights and interests of the applicant, by the original licensing authority in accordance with the provisions of the State Compensation Law to give compensation; the directly responsible for the competent personnel and other directly responsible personnel and other directly responsible personnel and other directly responsible personnel, shall be punished in accordance with the relevant laws and regulations. The directly responsible person in charge and other directly responsible persons shall be given administrative sanctions by their
units or superior organs in accordance with the law.
Article 27 Provinces, autonomous regions and municipalities directly under the Central (food) Drug Administration shall supervise and inspect websites providing Internet drug information services, and shall make public announcements of the inspections.
Article 28 These Measures shall be interpreted by the State Food and Drug Administration.
Article 29 These measures shall come into force on the date of publication. State Drug Administration Decree No. 26 "Interim Provisions on the Management of Internet Drug Information Services" shall be repealed simultaneously.