Administrative Measures On Internet Drug Information Service

Original Language Title: 互联网药品信息服务管理办法

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(July 8, 2004 the State food and drug administration released 9th come into force on the date of promulgation) first to strengthen pharmaceutical supervision and management, regulating the activities of drug information service, guarantee the authenticity, accuracy of drug information, in accordance with the People's Republic of China pharmaceutical administration law and the management of Internet information services, these measures are formulated.
    Article in the People's Republic of China provides drug information services activities in the territory, these measures shall apply.
    Drug information services mentioned in these measures refers to provide drugs to Internet users through the Internet (including medical) information services activities.
    Third drug information services are operating and non-operating categories.
    Profitable Internet information service is available to Internet users through the Internet drug information service activities.
    Non-profit drug information service is provided free to Internet users through the Internet public, sharing drug information services activities.
    Fourth State food and Drug Administration to the national Web site provides drug information services activities to implement supervision and administration.
    Provinces, autonomous regions and municipalities (food) Drug Administration provides drug information services activities within the administrative area of supervise and administer the site.
    Article fifth Web site provides drug information services, should be in charge of the information industry under the State Council departments or provincial Telecom administration agency to apply for a business license or prior to the filing procedure, in accordance with the regulatory principle of territoriality, Organizer to the website location of provinces, autonomous regions and municipalities (foods) apply to the pharmaceutical supervisory and administrative departments, and providing drug information had been obtained by the examination and approval of eligibility for services.
    Article sixth of all provinces, autonomous regions and municipalities (food) Drug Administration to apply within their respective jurisdictions to provide drug information service's website to review, in line with the conditions of issuance of the drug information service qualification certificate.
    Seventh of the drug information service qualification certificate format developed centrally by the State food and drug administration.
    Article eighth Web site provides drug information services, should be prominently marked on its Web site home page on the Internet Information Services certificate certificate number.
    Nineth provides drug information, published by the drug information service Web site must be scientific, accurate and must comply with the national laws and regulations and national regulations on management of pharmaceuticals, medical devices.
    Website that provides drug information services shall publish the narcotic drugs, psychotropic drugs, toxic drugs for medical use and radioactive pharmaceuticals, drug product information for pharmaceutical and medical preparations.
    Article tenth website that provides drug information services of Medicine (including medical devices) ads must go through (food) drug regulatory agency for review and approval.
    Website of medicine that provides drug information services (including medical devices) ad ad review approval number. 11th article application provides Internet drug information service, except should meet Internet information service management approach provides of requirements outside, also should has following conditions: (a) Internet drug information service of provides who should for law established of enterprises or other organization; (ii) has and carried out Internet drug information service activities phase adapted of professionals, and facilities and the related system; (three) has two name above familiar drug, and medical devices management legal, and regulations and drug, and medical devices expertise,
    Or through the qualification of pharmaceutical, medical equipment and technical personnel.
    12th provides drug information services should be based on a Web site as the basic unit. 13th article application provides Internet drug information service, should fill in national food drug supervision authority unified business sent of Internet drug information service application table, to website hosted units location province, and autonomous regions, and municipalities (food) drug supervision management sector proposed application, while submitted following material: (a) Enterprise license copies (new do Enterprise provides business administration sector issued of name pre approved notice and the related material); (ii) website domain name registered of related certificate or proved file.
    Engaged in Internet drug information service website of Chinese name, except and hosted units name same of yiwai, shall not to "China", and "Chinese", and "national", Crown name; except made drug tender agent institutions qualification certificate of units opened of Internet station outside, other provides Internet drug information service of website name in the shall not appeared "e-commerce", and "drug investment", and "drug tender", content; (Three) website column set description (application business sex Internet drug information service of website needed provides charges column and the charges way of description); (four) website on history released information for backup and check out of related management system and the implementation situation description; (five) (food) drug supervision management sector online browse website Shang all column, and content of method and the operation description; (six) drug and the medical devices related professional technicians degree proved or its professional technology qualification certificate copies, and
    Webmaster copy of ID card and a resume, (VII) measures to improve network and information security, including security measures, information security management, information security management system, (VIII) ensure drug information from legitimate sources, real, safe management measures, information notes and references.
    14th of provinces, autonomous regions and municipalities (food) the pharmaceutical supervisory and administrative departments in 5th from the date of receipt of the application materials in making admissibility decisions, accept, to accept the notice; not accepted, inform the applicant in writing and state the reasons, at the same time inform the applicant have the right to apply for administrative reconsideration or bring an administrative lawsuit in accordance with law.
    Article 15th application materials are standard, not complete, provinces, autonomous regions and municipalities (food) from the date of application for the drug regulatory agency in the 5th time inform all applicants need to supplement content; fails to inform the, starting from the day of receipt of the materials shall be accepted. 16th of provinces, autonomous regions and municipalities (food) pharmaceutical supervisory and administrative departments with effect from the date of acceptance in the 20th for material that provides drug information services to carry out audits, and agree or disagree with the decision.
    Agreed to by provinces, autonomous regions and municipalities directly under the (food) issued by the pharmaceutical supervisory and Administrative Department of the drug information service qualification certificate, also reported that the State food and Drug Administration for record and publish an announcement; do not agree, it shall notify the applicant in writing and state the reasons, at the same time inform the applicant have the right to apply for administrative reconsideration or bring an administrative lawsuit in accordance with law.
    The State food and drug administration of provinces, autonomous regions and municipalities directly under the (food) drug supervision and management departments to supervise the audit work. Article 17th of the drug information service qualification certificate is valid for 5 years. Has expired, the need to continue to provide drug information service, certified unit shall, within 6 months before the expiry of the validity period, the original issuing authority for the renewal of the drug information service qualification certificate.
    Original issuing authorities for approval, that qualified, recertification; think does not meet the criteria, to grant notice of recertification and explanations, original drug information service qualification certificate by the issuing authority to withdraw and declared a write-off. Provinces, autonomous regions and municipalities (food) the pharmaceutical supervisory and administrative department in accordance with the applicant's application, should the drug information service before the expiry date of the certificate of eligibility whether or not to grant the renewal decision.
    Fails to make a decision, as a grant renewal. 18th the drug information service qualification certificate according to drug information service provider's written application by the issuing authority to recover, the issuing authority shall report to the State food and Drug Administration for record and publish an announcement.
    Is withdrawing the drug information service qualification certificate of the website must not continue to engage in drug information service. 19th article Internet drug information service provides who change following matters one of of, should to original sent card organ application handle change procedures, fill in Internet drug information service project change application table, while provides following related proved file: (a) Internet drug information service qualification certificate in the audit approved of project (Internet drug information service provides who units name, and website name, and IP address,); (ii) Internet drug information service provides who of basic project (address, and statutory representative people, and
    Heads of enterprises, etc) and (iii) Web site gives basic information about drug information service (service, service projects, etc). 20th of provinces, autonomous regions and municipalities (food) drug regulatory Department accepting changes within 20 working days from the date of the application whether to agree to change the examination and decision.
    Agree to changes, will make an announcement and report on changes to the State food and Drug Administration for record; does not agree with the change, notify the applicant in writing and state the reasons. 21st of provinces, autonomous regions and municipalities (food) drug supervision and management departments to review the applicant's application should be public approval process and the results. The applicant and interested parties to submit written views on matters directly related to the vital interests of State and to defend themselves.
    The hearing according to law, in accordance with due process hearings. 22nd article without or beyond the validity of the use of the drug information service qualification certificate to engage in drug information service, by the State or the provinces, autonomous regions and municipalities directly under the food and Drug Administration (food) the pharmaceutical supervisory and administrative departments to give warning and ordered to stop the drug information service in serious cases, transferred to the relevant departments, and punished in accordance with relevant laws and regulations.

    23rd article provides Internet drug information service of website is not its website home page of significantly location mark Internet drug information service qualification certificate of certificate number of, national food drug supervision authority or province, and autonomous regions, and municipalities (food) drug supervision management sector give warning, ordered deadline corrected; in qualified term within refused to corrected of, on provides non-business sex Internet drug information service of website sentenced 500 Yuan following fine,
    To provide profitable Internet information service website fined 5000 Yuan and 10,000 yuan fine. 24th article Internet drug information service provides who violation this approach, has following case one of of, by national food drug supervision authority or province, and autonomous regions, and municipalities (food) drug supervision management sector give warning, ordered deadline corrected; plot serious of, on provides non-business sex Internet drug information service of website sentenced 1000 Yuan following fine, on provides business sex Internet drug information service of website sentenced 10,000 yuan above 30,000 yuan following fine; constitute crime of,
    Transferred judicial sector held criminal: (a) has get Internet drug information service qualification certificate, but provides of drug information directly set drug online trading of; (ii) has get Internet drug information service qualification certificate, but beyond audit agreed of range provides Internet drug information service of; (three) provides not real Internet drug information service and caused bad social effect of; (four) unauthorized change Internet drug information service project of.
    25th drug information service provider in its operational activities, illegal use of the drug information service qualification certificate by the State food and drug administration or the provinces, autonomous regions and municipalities directly under the (food) drug supervision and management departments in accordance with the provisions of the relevant laws and regulations.
    26th article province, and autonomous regions, and municipalities (food) drug supervision management sector illegal on Internet drug information service application made audit approved of, original sent card organ should revoked original approved of Internet drug information service qualification certificate, which to applicants of lawful rights and interests of caused damage of, by original sent card organ in accordance with national compensation method of provides give compensation; on directly is responsible for of competent personnel and other directly responsibility personnel, by its where units or superior organ law give administrative sanctions.
    27th of provinces, autonomous regions and municipalities (food) the pharmaceutical supervisory and administrative departments shall supervise and inspect the site provides drug information services, and check to society announcements.
    28th article of the approach by the State food and Drug Administration is responsible for the interpretation. 29th these measures come into force on the date of promulgation.
                                                                                                                State drug administration order 26th, of the interim provisions on the administration of Internet information services repealed simultaneously.

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