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Anti-Doping Regulations (2018 Revision) [Effective]
反兴奋剂条例(2018修订) [现行有效]
【法宝引证码】
  • Issuing authority: State Council
  • Document Number: Order No.703 of the State Council of the People's Republic of China
  • Date issued: 09-18-2018
  • Effective date: 09-18-2018
  • Level of Authority: Administrative Regulations
  • Area of Law:Sports

Anti-Doping Regulations 

反兴奋剂条例

(Promulgated by the Order No. 398 of the State Council of the People's Republic of China on January 13, 2004; revised in accordance with the Decision of the State Council on Amending Some Administrative Regulations on January 8, 2011 for the first time; and revised in accordance with the Decision of the State Council on Amending Some Administrative Regulations on July 29, 2014 for the second time; and thirdly amended according to the Decision of the State Council to Amend Certain Administrative Regulations on September 18, 2018)

 (2004年1月13日中华人民共和国国务院令第398号公布 根据2011年1月8日《国务院关于废止和修改部分行政法规的决定》第一次修订 根据2014年7月29日《国务院关于修改部分行政法规的决定》第二次修订 根据2018年9月18日《国务院关于修改部分行政法规的决定》第三次修订)

Chapter I General Provisions 

第一章 总  则

Article 1 These Regulations are hereby formulated in accordance with the Sports Law of the People's Republic of China and other relevant laws for the purpose of preventing the use of dopes in sports, safeguarding the health of the participants of sports both in body and mind, and maintaining the fair competition of the sports events.   第一条 为了防止在体育运动中使用兴奋剂,保护体育运动参加者的身心健康,维护体育竞赛的公平竞争,根据《中华人民共和国体育法》和其他有关法律,制定本条例。
Article 2 The dopes as mentioned in these Regulations, refer to the banned substances in the List of Dopes, etc.. The List of Dopes shall be formulated, adjusted and publicized by the department in charge of sports under the State Council together with the drug supervision and administration department, the department in charge of public health and commerce of the State Council, and the Customs General Administration.   第二条 本条例所称兴奋剂,是指兴奋剂目录所列的禁用物质等。兴奋剂目录由国务院体育主管部门会同国务院药品监督管理部门、国务院卫生主管部门、国务院商务主管部门和海关总署制定、调整并公布。
Article 3 The state advocates the healthy and civilized sports, strengthens the anti-dope publicity, education and supervision, and sticks to the anti-dope policy of prohibiting and inspecting strictly, and seriously punishing the use of dopes. The use of dopes shall be strictly forbidden.   第三条 国家提倡健康、文明的体育运动,加强反兴奋剂的宣传、教育和监督管理,坚持严格禁止、严格检查、严肃处理的反兴奋剂工作方针,禁止使用兴奋剂。
No entity or individual may provide dopes to any sportsman directly or in any disguised forms. 任何单位和个人不得向体育运动参加者提供或者变相提供兴奋剂。
Article 4 The department in charge of sports under the State Council shall be responsible for organizing the national anti-dope work.   第四条 国务院体育主管部门负责并组织全国的反兴奋剂工作。
The departments in charge of drug supervision and administration, and health, education and other relevant departments of the people's governments at or above the county level shall be responsible for the anti-dope work within their respective jurisdictions in accordance with these Regulations and the provisions of relevant laws or administrative regulations. 县级以上人民政府负责药品监督管理的部门和卫生、教育等有关部门,在各自职责范围内依照本条例和有关法律、行政法规的规定负责反兴奋剂工作。
Article 5 The department in charge of sports of the people's governments above the county level shall strengthen the anti-dope publicity and education so as to improve the anti-dope awareness of sportsmen and the general public.   第五条 县级以上人民政府体育主管部门,应当加强反兴奋剂宣传、教育工作,提高体育运动参加者和公众的反兴奋剂意识。
The broadcasting stations, TV stations, the press and media, and the internet information service providers shall carry out anti-dope publicity. 广播电台、电视台、报刊媒体以及互联网信息服务提供者应当开展反兴奋剂的宣传。
Article 6 In case any entity or individual finds out any act in violation of these Regulations, it/he shall have the right to report to the department in charge of sports and other relevant departments.   第六条 任何单位和个人发现违反本条例规定行为的,有权向体育主管部门和其他有关部门举报。
Chapter II Dopes Control 

第二章 兴奋剂管理

Article 7 The state shall make strict control over the banned substances in the List of Dopes. No entity or individual may illegally produce, sell, or import and export them.   第七条 国家对兴奋剂目录所列禁用物质实行严格管理,任何单位和个人不得非法生产、销售、进出口。
Article 8 The Drugs Production License and the number of the document of approval for drugs shall be obtained in accordance with the provisions of the Pharmaceutical Administration Law of the People's Republic of China (hereinafter referred to as Pharmaceutical Administration Law) for the production of anabolic steriods and peptide hormone in the List of Dopes (hereinafter referred to as anabolic steriods and peptide hormone).   第八条 生产兴奋剂目录所列蛋白同化制剂、肽类激素(以下简称蛋白同化制剂、肽类激素),应当依照《中华人民共和国药品管理法》(以下简称药品管理法)的规定取得《药品生产许可证》、药品批准文号。
The production enterprises shall record the conditions for the production, sales and storage of anabolic steriods or peptide hormone, and shall keep the records for over 2 years of the period of validity of anabolic steriods or peptide hormone. 生产企业应当记录蛋白同化制剂、肽类激素的生产、销售和库存情况,并保存记录至超过蛋白同化制剂、肽类激素有效期2年。
Article 9 No drug wholesale enterprises may deal in anabolic steriods or peptide hormone until they have obtained the Drugs Business License in accordance with the provisions of the Pharmaceutical Administration Law, meet the following requirements, and are approved by the drug supervision and administration departments of the people's governments of the provinces, autonomous regions, and municipalities directly under the Central Government:   第九条 依照药品管理法的规定取得《药品经营许可证》的药品批发企业,具备下列条件,并经省、自治区、直辖市人民政府药品监督管理部门批准,方可经营蛋白同化制剂、肽类激素:
1. Having special managers; (一)有专门的管理人员;
2. Having special storage warehouses or special storage medicine chests; (二)有专储仓库或者专储药柜;
3. Having special systems of checking and acceptance, inspection, keeping, selling, and the registration for in-and-out of the warehouse; and (三)有专门的验收、检查、保管、销售和出入库登记制度;
4. Other conditions as prescribed by laws and administrative regulations. (四)法律、行政法规规定的其他条件。
The records on checking and acceptance, inspection, keeping, selling and the registration of the in-and-out of the warehouse shall be kept for over 2 years of the period of validity of anabolic steriods and peptide hormone. 蛋白同化制剂、肽类激素的验收、检查、保管、销售和出入库登记记录应当保存至超过蛋白同化制剂、肽类激素有效期2年。
Article 10 No drug retail enterprise shall undertake the management of anabolic steriods or peptide hormone except insulin.   第十条 除胰岛素外,药品零售企业不得经营蛋白同化制剂或者其他肽类激素。
Article 11 The import permit issued by the drug supervision and administration departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government is also required for the import of anabolic steroids and peptide hormone, in addition to obtaining the import drug registration certificate issued by the drug supervision and administration department of the State Council in accordance with the provisions of the Pharmaceutical Administration Law and its detailed implementation regulations.   第十一条 进口蛋白同化制剂、肽类激素,除依照药品管理法及其实施条例的规定取得国务院药品监督管理部门发给的进口药品注册证书外,还应当取得省、自治区、直辖市人民政府药品监督管理部门颁发的进口准许证。
The use of anabolic steriods and peptide hormone shall be stated when applying for their import. 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 decision on it within 15 days from the date of receiving the application. If the use is legal, it shall grant approval and issue the import permit. And the customs shall give release upon the strength of the import permit. 申请进口蛋白同化制剂、肽类激素,应当说明其用途。省、自治区、直辖市人民政府药品监督管理部门应当自收到申请之日起15个工作日内作出决定;对用途合法的,应当予以批准,发给进口准许证。海关凭进口准许证放行。
Article 12 Those who apply for export of anabolic steriods and peptide hormone shall explain the object to whom the goods are supplied and submit the relevant certificate documents issued by the competent departments of the governments of the import country, and other relevant documents. The drug supervision and administration departments of the people's governments of the provinces, autonomous regions, and municipalities directly under the Central Government shall make decisions within 15 working days from the date of receiving the application; and approve those who have submitted the relevant certificate documents of the competent department of the governments of the import country, and issue the export permit. The customs shall give release upon the strength of the export permit.   第十二条 申请出口蛋白同化制剂、肽类激素,应当说明供应对象并提交进口国政府主管部门的相关证明文件等资料。省、自治区、直辖市人民政府药品监督管理部门应当自收到申请之日起15个工作日内作出决定;提交进口国政府主管部门的相关证明文件等资料的,应当予以批准,发给出口准许证。海关凭出口准许证放行。
Article 13 A domestic enterprise shall conclude a written entrustment production contract with an overseas enterprise who entrusts it to produce anabolic steriods and peptide hormone, and submit the contract to and put it on records at the drug supervision and administration department of the people's governments of the provinces, autonomous regions, and municipalities directly under the Central Government. The production entrustment contract shall specify the nationality of the entrusting enterprise, the species, quantities and the production date of anabolic steriods and peptide hormone produced through entrustment, and other contents.   第十三条 境内企业接受境外企业委托生产蛋白同化制剂、肽类激素,应当签订书面委托生产合同,并将委托生产合同报省、自治区、直辖市人民政府药品监督管理部门备案。委托生产合同应当载明委托企业的国籍、委托生产的蛋白同化制剂或者肽类激素的品种、数量、生产日期等内容。
No anabolic steriods and peptide hormone, which are produced by domestic enterprises upon the entrustment of overseas enterprises may be sold within the territory of China. 境内企业接受境外企业委托生产的蛋白同化制剂、肽类激素不得在境内销售。
Article 14 The enterprises engaging in the production of anabolic steriods and peptide hormone may only provide anabolic steriods and peptide hormone to the medical treatment institutions, the drug wholesale enterprises as prescribed in Article 9 of these Regulations and other similar production enterprises.   第十四条 蛋白同化制剂、肽类激素的生产企业只能向医疗机构、符合本条例第九条规定的药品批发企业和其他同类生产企业供应蛋白同化制剂、肽类激素。
The enterprises engaging in the wholesale of anabolic steriods and peptide hormone may only provide anabolic steriods and peptide hormone to the medical treatment institutions, enterprises engaging in their production, and other similar wholesale enterprises. 蛋白同化制剂、肽类激素的批发企业只能向医疗机构、蛋白同化制剂、肽类激素的生产企业和其他同类批发企业供应蛋白同化制剂、肽类激素。
The entities importing anabolic steriods and peptide hormone may only provide anabolic steriods and peptide hormone to the enterprises undertaking the production of anabolic steriods and peptide hormone, the medical treatment institutions, and the drug wholesale enterprises as prescribed in Article 9 of these Regulations.
......
 蛋白同化制剂、肽类激素的进口单位只能向蛋白同化制剂、肽类激素的生产企业、医疗机构和符合本条例第九条规定的药品批发企业供应蛋白同化制剂、肽类激素。
......

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