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	MEASURES REGARDING THE ADMINISTRATION OF DRUG INFORMATION SERVICE OVER THE INTERNET

	(Order No. 9 of the State Food and Drug Administration, July 8, 2004: The Measures Regarding the Administration of Drug Information Service over the Internet, which have been deliberated and adopted at the executive meeting of the State Food and Drug Administration on May 28, 2004, are hereby promulgated and shall become effective as of the date of promulgation)


SUBJECT : INFORMATION SERVICE OVER THE INTERNET; DRUG
ISSUING DEPARTMENT : THE STATE FOOD AND DRUG ADMINISTRATION
ISSUE DATE : 07/08/2004
IMPLEMENT DATE : 07/08/2004
LENGTH : 2,854 words
TEXT :

Article 1. These Measures are formulated under the P.R.C Drug Administration Law and the Measures Regarding the Administration of Information Service over the Internet with a view to strengthening the supervision and administration of drugs, regulating the drug information service over the Internet and guaranteeing the authenticity and accuracy of the drug information over the Internet.

Article 2. These Measures shall apply to the provision of drug information services over the Internet within the territory of the P. R. C.

For the purposes of these Measures, the term "drug information service over the Internet" means the provision of drugs (including medical appliances) information over the Internet for the internet users.

Article 3. The drug information service over the Internet is divided into for-profit service and not-for-profit service.

The term "for-profit drug information service over the Internet" means the paid drug information service provided over the Internet for the Internet users.

The term "not-for-profit drug information service" means the public drug information service provide gratuitously for the Internet users to share.

Article 4. The State Food and Drug Administration shall implement the supervision and administration of such websites who provide drug information service over the Internet throughout China.

The food and drug administrations of all provinces, autonomous regions and municipalities directly under the Central Government shall implement the supervision and administration of the websites providing drug information services over the Internet within their respective administrative region.

Article 5. Any website which proposes to provide drug information services over the Internet shall apply for a business license to the department in charge of information industry under the State Council or the administration of telecommunication at the provincial level or, prior to going through the procedures for recording, file an application with the food and drug administration of the province, autonomous region and municipality directly under the Central Government where the entity sponsoring the website is located under the principle of territorial supervision and, subject to the examination and approval, obtain the qualification of providing drug information services over the Internet.

Article 6. The food and drug administrations of all provinces, autonomous regions and municipalities directly under the Central Government shall carry out the examination and approval of the Internet websites that apply for providing drug information services over the Internet within their respective jurisdiction and issue a Qualification Certificate for Drug Information Services over the Internet to such websites that comply with the conditions.

Article 7. The format of the Qualification Certificate for Drug Information Services over the Internet shall be made uniformly by the State Food and Drug Administration.

Article 8. Such websites that provide drug information services over the Internet shall indicate the serial number of the Qualification Certificate for Drug Information Services over the Internet on an eye-catching position of its website home page.

Article 9. The drug information uploaded by such websites that provide the drug information services must be scientific and accurate and comply with the State laws, regulations and other relevant provisions of the State relating to the administration of drug and medical appliances.

All websites that provide the drug information services over the Internet shall not publish any information about any narcotic drugs, mental medicines, toxic medicines, radioactive medicines, anti-drug medicines or the preparation products of medical institutions.

Article 10. Any advertisement for the drugs published by any website that provides drug information services over the Internet must be subject to the examination and approval of the administration for food and drug.

The advisement for drugs (including medical appliances) published by such a website that provides drug information services over the Internet shall indicate the approval document number of the advertisements.

Article 11. Any website that applies for providing drug information services over the Internet shall fulfill the following conditions in addition to complying with the requirements set forth in the Measures Regarding the Administration of Information Service over the Internet:

(1) The provider of drug information services over the Internet shall be an enterprise, institution or any other organization;

(2) It shall have professionals, facilities and relevant rules that suit the provision of drug information services over the Internet; and

(3) It shall have more than two technical personnel in pharmaceutics and medical appliance who are familiar with the laws and regulations relating to the administration of medical appliances and the professional knowledge therein or certified according to the law.

Article 12. The application for providing drug information service over the Internet shall take one website as a basic unit.

Article 13. To apply to provide drug information services over the Internet, any website shall fill in the Application Form for Drug Information Service over the Internet uniformly made and issued by the State Food and Drug Administration, file an application with the food and drug administration of the province, autonomous region or municipality directly under the Central Government where the entity sponsoring the website is located and submit the following materials:

(1) The copy of the enterprise business license (a newly established enterprise may submit the notice of advance approval of enterprise and other relevant materials issued by the administration for industry and commerce);

(2) The certificate or certification document relating to the website domain registration. The Chinese name of such a website engaging in the provision of drug information service over the Internet shall not contain words such as "China", "Chinese" or "national" unless it is the same as that of the entity sponsoring the website; unless a website is set up by an entity that has obtained the agency qualification certificate for the invitation to tender for drugs, the names of other websites providing the drug information service over the Internet shall not contain words such as "E-commerce", "drugs for commerce" or "the invitation to tender for drugs";

(3) The explanations of setting up the columns of the website (such a website that applies to provide for-profit drug information services over the Internet must provide an instruction of the fee-charging columns and ways);

(4) The rules and by-laws relating to the administration of backup and consultation by the website of historically published information and an instruction of its compliance therewith;

(5) An instruction of how the (food and) drug regulatory departments can browse all the columns and contents online of the website;

(6) The education background certificates or copies of professional qualification certificates of the relevant professionals in drugs and medical appliances and the copy of the ID card of the principal of the website and the resume thereof;

(7) Sound measures for the network and information security, including the measures for safeguarding the security of the website, the system for the administration of the security and confidentiality of the information and the system for the administration of the security of users' information; and

(8) The measures for the administration of guaranteeing the legality, reality and security of the source of the drug information, the explanations of circumstances and the certification materials in relation thereto.

Article 14. The food and drug administration of a province, autonomous region or municipality directly under the Central Government shall, within 5 days from the date of receiving the application materials, make a decision on whether to accept it. If it is accepted, a notice of acceptance shall be given. If it is not accepted, the applicant shall be notified in writing accompanied by an explanation, and the applicant shall be informed that he/it has the right to apply for administrative review or institute administrative proceedings according to the law.

Article 15. If the application materials submitted are not standard or incomplete, the food and drug administration of a province, autonomous region or municipality directly under the Central Government shall, within 5 days from the date of receiving the application, make an one-off notification to the applicant of all contents that need to be supplemented and corrected. If the said notification fails to be made within the said time limit, the date of receiving the application materials shall be the date of acceptance.

Article 16. The food and drug administration of a province, autonomous region or municipality directly under the Central Government shall, within 20 days from the date of acceptance, examine the materials for applying for providing drug information services over the Internet, and make a decision on whether to grant an approval. If an approval is granted, the food and drug administration of the province, autonomous region or municipality directly under the Central Government shall issue a Qualification Certificate for Providing Drug Information Services over the Internet, report it to the State Food and Drug Administration and make an announcement thereof. If an approval is not granted, the applicant shall be notified in writing, the reasons therefor shall be explained, and the applicant shall be also informed that he/it has the right to apply for administrative review or institute administrative proceedings according to law.

The State Food and Drug Administration shall supervise the examination and approval of the food and drug administrations of all provinces, autonomous regions and municipalities directly under the Central Government.

Article 17. The effective term of the Qualification Certificate for Providing Drug Information Services over the Internet shall be 5 years. If the effective term expires, and the entity holding the Qualification Certificate for Providing Drug Information Services over the Internet need continue to provide drug information services over the Internet, it shall, within 6 months before the expiration of the effective term, apply to the original issuing authority for exchanging a new one. If the original issuing authority believes that the conditions are fulfilled upon examination, it shall reissue a new Qualification Certificate for Providing Drug Information Services over the Internet; if it believes the conditions fail to be complied with, the notice of not exchanging the certificate shall be given, the reasons shall be explained and the original issuing authority shall call it in, and make an announcement of its cancellation.

The food and drug administration of a province, autonomous region or municipality directly under the Central Government shall, based on the application of the applicant, make a decision on whether to approve the exchange of the Qualification Certificate for Providing Drug Information Services over the Internet before the expiration of the effective term of original certificate. If a decision thereon fails to be made within the said time limit, it shall be deemed that approval has been granted to exchange the certificate.

Article 18. The original issuing authority may, based on the written application of the provider of the drug information service over the Internet, call in the Qualification Certificate for Providing Drug Information Services over the Internet, report thereon to the State Food and Drug Administration for recording and make an announcement thereof. Such a website whose Qualification Certificate for Providing Drug Information Services over the Internet is called in shall not continue to engage in the drug information service over the Internet.

Article 19. If the provider of drug information services over the Internet makes any change in any of the following matters, it shall apply to the original issuing authority for completing the procedures for the change, fill in the Application Form for the Change of Drug Information Service Items over the Internet and submit the following relevant certification documents:

(1) The approved items of the provider of drug information services over the Internet in the Qualification Certificate for Providing Drug Information Services over the Internet such as the name, website name, IP address thereof;

(2) The basic information of the provider of the drug information service over the Internet such as the name, legal representative, the principal thereof; and

(3) The basic information, such as the drug information service provided by the website such as the service means and items.

Article 20. The food and drug administration of a province, autonomous region or municipality directly under the Central Government shall, within 20 days from the date of accepting the application for the said change, make a decision on whether to approve the said change. If the said change is approved, it shall make announcement of the change and report it to the State Food and Drug Administration for recording; if the said change is not approved, the applicant shall be notified in writing and the reasons shall be explained.

Article 21. The food and drug administration of a province, autonomous region or municipality shall, in reviewing the application of an applicant, publicize the reviewing process and decision. The applicant or any interested party may submit the written opinions on the matters that have a direct major interest in it to make a statement and defend itself. If a hearing shall be held according to law, the hearing shall be held according to the statutory procedures.

Article 22. If an entity fails to obtain a Qualification Certificate for Providing Drug Information Services over the Internet or uses it beyond its effective term, the State Food and Drug Administration or the food and drug administration of the province, autonomous region or municipality directly under the Central Government shall give a warning against it and order it to stop its drug information services; if the circumstances are serious, the case shall be removed to the relevant department and it shall be imposed penalties according to the relevant laws and regulations.

Article 23. If any website that provides drug information services over the Internet fails to indicate the serial number of its Qualification Certificate for Providing Drug Information Services over the Internet on the conspicuous place of its home page, the State Administration of Food and Drug or the food and drug administration of the province, autonomous region or municipality directly under the Central Government shall give it a warning and order it to make corrections within the specified time limit. Any website that refuses to make corrections within the specified time limit shall be imposed a fine of less than RMB 500 yuan if it provides not-for-profit drug information service over the Internet or a fine of between RMB 5,000 yuan and 10,000 yuan if it provides the for-profit drug information service over the Internet.

Article 24. If the provider of drug information services over the Internet violates any of these Measures and is involved in any of the following circumstances, the State Food and Drug Administration or the food and drug administration of the province, autonomous region or municipality directly under the Central Government shall give it a warning and order it to make corrections within the specified time limit; if the circumstances are serious, such a website that provides not-for-profit drug information service over the Internet shall be imposed a fine of less than RMB 1,000 yuan, and such a website that provides the for-profit drug information service over the Internet shall be imposed a fine of between 10,000 yuan and 30,000 yuan. If a crime is constituted, the case shall be removed to the judiciary departments for criminal responsibilities:

(1) It has obtained the Qualification Certificate for Providing Drug Information Services over the Internet but the drug information it provides results in the trading of drug over the Internet;

(2) It has obtained the Qualification Certificate for Providing Drug Information Services over the Internet but provides drug information services over the Internet beyond the approved scope;

(3) It provides untrue drug information services over the Internet and causes a bad effect upon the society; or

(4) It changes any of its drug information service items over the Internet.

Article 25. If the provider of drug information services over the Internet uses, in violation of law, the Qualification Certificate for Providing Drug Information Services in its business operations, the State Food and Drug Administration of or the food and drug administration of the province, autonomous region or municipality directly under the Central Government shall impose penalties upon it according to the provisions of laws and regulations.

Article 26. If the food and drug administration of a province, autonomous region or municipality directly under the Central Government grants, in violation of law, an approval of the application for drug information services over the Internet, the original issuing authority shall cancel the original approved Qualification Certificate for Providing Drug Information Services over the Internet, and the damage to the lawful interest of the applicant shall be compensated by the original issuing authority according to the provisions of the state compensation law; the direct responsible managers and other direct responsible persons shall be imposed penalties by the authority with which they are working or the authority at next higher level according to law.

Article 27. The food and drug administrations of the provinces, autonomous regions and municipalities directly under the Central Government shall carry out supervision and inspection of such websites that provide drug information services over the Internet, and publish the result of inspection to the general public.

Article 28. The power to interpret these Measures shall remain with the State Food and Drug Administration.

Article 29. These Measures shall enter into force as of the date of promulgation. The Interim Provisions Regarding the Administration of the Drug Information Service over the Internet issued by Order No. 26 of the State Administration of Food and Drug shall be repealed simultaneously.