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Laws & Regulations - Drugs - Regulations on Anti-doping
Regulations on Anti-doping
 
2011/8/9 14:59:34 Source:  Hits:

(Adopted at the 33rd Executive Meeting of the State Council on December 31, 2003, promulgated by Decree No. 398 of the State Council of the People¨s Republic of China on January 13, 2004, and effective as of March 1, 2004)

Chapter I  General Provisions

  Article 1  These Regulations are formulated in accordance with the Law of the People¨s Republic of China on Physical Culture and Sports as well as other relevant laws for the purposes of preventing doping in sport, protecting the physical and mental health of sport participants and upholding fair play in sports competitions.

  Article 2  Doping agents in these Regulations mean prohibited substances and methods identified on the Prohibited List. The Prohibited List is set down, adjusted and published by the competent physical culture and sports department of the State Council jointly with the food and drug administrative department, the competent health department and the competent commerce department of the State Council, as well as the General Administration of Customs.

  Article 3  The State calls on healthy and civilized sports involvements, reinforces publicity, education, supervision and administration of anti-doping, adheres to the policy of strict prohibition, rigorous control, and severe punishment in anti-doping practice, and practices doping free in sport.

  Any unit or individual may not provide or provide in disguised form doping agents to sport participants.

  Article 4  The competent physical culture and sports department of the State Council administers and organizes the nationwide anti-doping work.

  The departments of food and drug administration, health, education and other relevant departments of the people¨s governments at or above the county level, within their respective functions and duties, are responsible for conducting anti-doping work in accordance with the provisions of these Regulations and other relevant laws and administrative regulations.

  Article 5  The competent physical culture and sports departments of the people¨s governments at or above the county level shall reinforce anti-doping publicity and education, so as to heighten anti-doping awareness among the sport participants and the public.

  Radio stations, television stations, newspapers, periodicals and other forms of the media, as well as Internet service providers shall carry out anti-doping publicity.

   Article 6  Any unit or individual finding violations of these Regulations has the right to report to the competent physical culture and sports departments or other relevant departments.

Chapter II  Control of Doping Agents

  Article 7  The State carries out rigorous control of the prohibited substances identified on the Prohibited List, and any unit or individual may not illegally engage in manufacture, sale, import and export thereof.

  Article 8  To manufacture anabolic agents and peptide hormones on the Prohibited List (hereinafter referred to as anabolic agents and peptide hormones), the manufacturer shall, in accordance with the provisions of the Drug Administration Law of the People¨s Republic of China (hereinafter referred to as the Drug Administration Law), obtain the Drug Manufacturing Certificate and the drug approval number.

  Manufacturers shall make records of the production, sale and stock of anabolic agents and peptide hormones, and keep such records for two years in excess of the expiry date of anabolic agents and peptide hormones.

  Article 9  Drug wholesalers that have obtained the Drug Distribution Certificate in accordance with the provisions of the Drug Administration Law may not distribute anabolic agents and peptide hormones before they meet the following requirements and obtain approval from the food and drug administrative departments of the people¨s governments of the provinces, autonomous regions or municipalities directly under the Central Government:

  (1) assign special administrative staff;

  (2) provide special storehouses or special medicine-chests;

  (3) establish a special system for checking and acceptance, inspection, storage, sales and registration of in-storage and out-storage; and

  (4) other requirements as prescribed by laws and administrative regulations.

  Records of checking and acceptance, inspection, storage, sales and registration of in-storage and out-storage for anabolic agents and peptide hormones shall be kept for two years in excess of the expiry date of anabolic agents and peptide hormones.

  Article 10  Except insulin, drug retailers may not distribute anabolic agents or other peptide hormones.

  Article 11  To import anabolic agents and peptide hormones, the importer shall obtain the import permit in addition to the import drug license issued by the food and drug administrative department of the State Council in accordance with the provisions of the Drug Administration Law and its implementing regulations.

  To apply for the import of anabolic agents and peptide hormones, the applicant shall explain the intended use. The food and drug administrative department of the State Council shall make a decision within 15 working days from the date of receiving such application, and shall grant approval and issue an import permit if the use is legal. The Customs shall release the same on the basis of the import permit.

  Article 12  To apply for the export of anabolic agents and peptide hormones, the applicant shall describe the receiver and submit the relevant certifying documents and other materials from the competent government department of the importing country. The food and drug administrative department of the people¨s government of the province, autonomous region or municipality directly under the Central Government shall make a decision within 15 working days from the date of receiving such application, and shall grant approval and issue an export permit if the relevant certifying documents and other materials from the competent government department of the importing country have been submitted. The Customs shall release the same on the basis of the export permit.

  Article 13  An enterprise within the territory that accepts contract production of anabolic agents and peptide hormones from an enterprise outside the territory shall conclude a contract of production in written form, and submit the contract for the record to the food and drug administrative department of the people¨s government of the province, autonomous region or municipality directly under the Central Government. A contract of production shall state the nationality of the enterprise contracting out the production, the variety, quantity and date of production, etc., of anabolic agents and peptide hormones contracted for production.

  Anabolic agents and peptide hormones produced by an enterprise within the territory under a contract entrusted by an enterprise outside the territory may not be sold within the territory.

  Article 14  Manufacturers of anabolic agents and peptide hormones shall only provide anabolic agents and peptide hormones to medical institutions, drug wholesalers that meet the requirements in Article 9 of these Regulations and other manufacturers of their kind.

  Wholesalers of anabolic agents and peptide hormones shall only provide anabolic agents and peptide hormones to medical institutions, manufacturers of anabolic agents and peptide hormones and other wholesalers of their kind.

  Importers of anabolic agents and peptide hormones shall only provide anabolic agents and peptide hormones to manufactures of anabolic agents and peptide hormones, medical institutions and drug wholesalers that meet the requirements in Article 9 of these Regulations.

  Apart from being supplied in accordance with the first, second and third paragraphs of this Article, insulin of hormone of peptide type may be supplied to drug retailers.

  Article 15  Medical institutions shall only supply anabolic agents and peptide hormones to patients on the basis of prescriptions from licensed doctors who are qualified to prescribe in accordance with the law. Such prescriptions shall be kept for two years.

  Article 16  Where any prohibited substance identified on the Prohibited List is categorized in narcotic drugs, psychotropic substances, medicinal toxic drugs or chemicals liable to be misused for producing narcotic drugs, special control over its manufacture, sale, import, transportation and use shall be exercised in accordance with the provisions of the Drug Administration Law and relevant administrative regulations.

     Anabolic agents, peptide hormones and other prohibited substances on the Prohibited List than those prescribed by the preceding paragraph shall be controlled as prescription drugs.

     Article 17  Where a food or drug contains any prohibited substance on the Prohibited List, the manufacturer shall give clear indication of ^cautious use for athletes ̄ in Chinese in the label of the package or the product description.

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