{0>精神药品管理办法<}0{>MEASURES FOR THE CONTROL OF PSYCHOTROPIC DRUGS<0}

{0>英文本源自中华人民共和国务院法制局编译, 中国法制出版社出版的《中华人民共和国涉外法规汇编》(1991年7月版)<}0{>This English document is coming from the “LAWS  AND  REGULATIONS  OF THE PEOPLE'S REPUBLIC OF  CHINA  GOVERNING  FOREIGN-RELATED  MATTERS” (1991.7) which  is  compiled  by  the  Bureau  of  Legislative Affairs of the State Council of  the  People's Republic of China, and is published by the China Legal System Publishing House.<0}

{0>当发生歧意时, 应以法律法规颁布单位发布的中文原文为准<}0{>In case of discrepancy, the original version in Chinese shall prevail<0}

{0>第一章　总　则<}0{>Chapter I General Provisions<0}

{0>第一条　为了加强精神药品的管理，根据《中华人民共和国药品管理法》的规定，制定本办法。<}0{>Article 1 These Measures are formulated   in   accordance   with   the   Medicine Administration Law of the People's Republic of China in order to further control psychotropic drugs.<0}

{0>第二条　精神药品是指直接作用于中枢神经系统，使之兴奋或抑制，连续使用能产生依赖性的药品。<}0{>Article 2 Psychotropic drugs refer to those drugs that produce direct effect on the central nerve system so as to excite or sooth the sense and may result in drug dependence through constant use.<0}

{0>第三条　依据精神药品使人体产生的依赖性和危害人体健康的程度，分为第一类和第二类，各类精神药品的品种由卫生部确定。<}0{>Article 3 According to  the  extent  of  drug  dependence  and  hazards  to  health, psychotropic drugs are classified into category I  and  category  II.  The classification shall be done by the Ministry of Public Health.<0}

{0>第二章　精神药品的生产<}0{>Chapter II The Production of Psychotropic Drugs<0}

{0>第四条　精神药品由国家指定的生产单位按计划生产，其他任何单位和个人不得从事精神药品的生产活动。<}0{>Article 4 Psychotropic drugs shall be produced according to the plan by the production units appointed by the State. No other unit or individual shall be allowed to engage in the production of psychotropic drugs.<0}

{0>精神药品的原料和第一类精神药品制剂的生产单位，由卫生部会同国家医药管理局确定。<}0{>The units that  may  produce  raw  materials  of  psychotropic  drugs  and psychotropic drugs of  category  I  shall  be  appointed  jointly  by  the Ministry of Public Health and the State Administration for Medicine.<0}

{0>第二类精神药品制剂的生产单位，由省、自治区、直辖市卫生行政部门会同同级医药管理部门确定。<}0{>The units that may produce psychotropic drugs  of  category  II  shall  be appointed  jointly  by  the  health  administration  department   at   the provincial, autonomous regional or municipal (directly under  the  Central Government) level and the administrative department for  medicine  at  the corresponding level.<0}

{0>第五条　精神药品的原料和第一类精神药品制剂的年度生产计划，由卫生部会同国家医药管理局联合下达。<}0{>Article 5 The annual production plan for raw materials of psychotropic drugs and for the psychotropic drugs of category I shall be made jointly by the Ministry of Public Health and the State Administration for Medicine.  <0}

{0>第二类精神药品制剂的年度生产计划，由省、自治区、直辖市卫生行政部门会同同级医药管理部门联合下达。<}0{>The  annual production plan for the psychotropic drugs of category II  shall  be  made jointly  by  the  health  administration  department  at  the  provincial, autonomous regional or municipal (directly under the Central Government) level and the administrative department for medicine at the  corresponding level.<0}

{0>精神药品的生产单位未经批准，不得擅自改变生产计划。<}0{>Without authorization, no production unit shall be allowed to change the production plan of psychotropic drugs.<0}

{0>第六条　精神药品的原料和制剂，按国家计划调拨，生产单位不得自行销售。<}0{>Article 6 Raw materials of psychotropic drugs and psychotropic drugs shall be allotted by the State according to plan.No production unit shall be allowed to sell them without authorization.<0}

{0>第七条　精神药品的原料和制剂的生产单位必须建立严格的管理制度，<}0{>Article 7 The units that produce raw materials of psychotropic drugs and the units that produce psychotropic drugs must establish a strict control system.<0}

{0>设立原料和制剂的专用仓库，并指定专人管理；<}0{>The raw materials and the drugs must be kept in separate storage under the charge of person(s) specially appointed for the purpose.  <0}

{0>建立生产计划执行情况的报告制度，按季度报省、自治区、直辖市卫生行政部门和同级医药管理部门，并报卫生部和国家医药管理局备案。<}0{>They  must  make regular reports about the fulfillment of the seasonal production  plan  to the  health  administration  department  at  the  provincial,   autonomous regional or municipal (directly under the Central  Government)  level  and the administration department for medicine at the corresponding level  and send copies of the reports to the Ministry of Public Health and the  State Administration for Medicine for the record.<0}

{0>在生产精神药品的过程中产生的废弃物，必须妥善处理，不得污染环境。<}0{>Waste materials discharged during the production of psychotropic drugs must be treated properly so as not to pollute the environment.<0}

{0>第三章　精神药品的供应<}0{>Chapter III the Supply of Psychotropic Drugs<0}

{0>第八条　精神药品的原料和第一类精神药品制剂，由卫生部会同国家医药管理局指定的经营单位统一调拨或者收购；<}0{>Article 8 Raw materials of psychotropic drugs and psychotropic drugs of  category  I shall be allotted or purchased by the drug dealer units appointed  jointly by the  Ministry  of  Public  Health  and  the  State  Administration  for Medicine. <0}

{0>第二类精神药品制剂，由县以上卫生行政部门会同同级医药管理部门指定的经营单位经营，<}0{>Psychotropic drugs of category II shall be handled by the drug dealer units appointed jointly by the health administrative department at or above the county level and the administrative department for medicine at the corresponding level. <0}

{0>其他任何单位和个人均不得经营。<}0{>No other unit or individual shall be allowed to engage in the trading of psychotropic drugs.<0}

{0>第九条　精神药品的原料和第一类精神药品制剂的供应计划，由卫生部会同国家医药管理局，根据省、自治区、直辖市医药管理部门提出的计划，综合平衡后与生产计划一并下达。<}0{>Article 9 The plan for the supply of raw materials of psychotropic drugs

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