精神药品管理办法

MEASURES FOR THE CONTROL OF PSYCHOTROPIC DRUGS

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)

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.

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

In case of discrepancy, the original version in Chinese shall prevail

第一章　总　则

Chapter I General Provisions

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。

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.

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。

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.

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。

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.

第二章　精神药品的生产

Chapter II The Production of Psychotropic Drugs

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。

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.

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。

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.

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。

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.

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。

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.

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。

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.

精神药品的生产单位未经批准，不得擅自改变生产计划。

Without authorization, no production unit shall be allowed to change the production plan of psychotropic drugs.

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。

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.

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，

Article 7 The units that produce raw materials of psychotropic drugs and the units that produce psychotropic drugs must establish a strict control system.

设立原料和制剂的专用仓库，并指定专人管理；

The raw materials and the drugs must be kept in separate storage under the charge of person(s) specially appointed for the purpose.

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。

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.

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。

Waste materials discharged during the production of psychotropic drugs must be treated properly so as not to pollute the environment.

第三章　精神药品的供应

Chapter III the Supply of Psychotropic Drugs

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；

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.

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，

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.

其他任何单位和个人均不得经营。

No other unit or individual shall be allowed to engage in the trading of psychotropic drugs.

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。

Article 9 The plan for the supply of raw materials of psychotropic drugs and for the supply of psychotropic drugs of category I shall be made  jointly  by  the Ministry of Public Health and the State Administration for Medicine  after balancing the plans made by the administration department for medicine  of each province,  autonomous  region  or  municipality  directly  under  the Central Government and shall be assigned together with the production plan by the  Ministry  of  Public  Health  and  the  State  Administration  for Medicine.

第二类精神药品制剂的供应计划，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。

The plan for the supply of psychotropic drugs of category II shall be assigned jointly by the health administrative department of  each province, autonomous region or municipality  directly  under  the  Central Government  and  the  administration  department  for  medicine   at   the corresponding level.

第十条　第一类精神药品只限供应县以上卫生行政部门指定的医疗单位使用，不得在医药门市部零售。

Article 10 the psychotropic drugs of category I are available only to those medical treatment units appointed by the health administrative department at or above the county level. No retail sale of these drugs shall be allowed at any drug stores.

第二类精神药品可供各医疗单位使用，医药门市部应当凭盖有医疗单位公章的医生处方零售。处方应留存两年备查。

The psychotropic drugs of category II are available to all medical treatment units. Drug stores may sell such drugs by retail on the strength of a doctor's prescription with an official seal of a medical treatment unit stamped on.  The prescriptions must be kept for two years for reference.

医疗单位购买第一类精神药品，需持县以上卫生行政部门核发的《精神药品购用卡》在指定的经营单位购买。

Any medical unit in need of psychotropic drugs  of  category  I must purchase them at a designated drugstore with a  Purchasing  Card  for Psychotropic Drugs issued by the health administrative  department  at  or above the county level.

《精神药品购用卡》由卫生部统一制定。

The Purchasing Card for Psychotropic Drugs shall be made solely by the Ministry of Public Health.

第十一条　科研和教学机构因科研和教学需要的精神药品，需经县以上卫生行政部门批准后，由指定的医药经营单位供应。

Article 11 the psychotropic drugs needed in scientific research or teaching shall be provided by the appointed drug dealers with an approval by the health administrative department at or above the county level.

第四章　精神药品的运输

Chapter IV Transportation of Psychotropic Drugs

第十二条　生产单位和供应单位托运精神药品（包括邮寄），应当在货物的运单上，写明该精神药品的具体名称，并在发货人记事栏内加盖“精神药品专用章”，凭此办理运输手续。

Article 12 When consigning psycho pharmaceuticals, the production unit or  the  supply unit must fill out the full name of the  drug  on  the  parcel  form,  and stamp, in the space for the consigner, a  special  Seal  for  Psychotropic drugs.

第十三条　运输单位承运精神药品，必须加强管理，及时运输，缩短在车站、码头、机场存放时间。

Article 13 the transportation units must strengthen administration work to ensure prompt shipment of psychotropic drugs by shortening its storage time at the station, on the dock or at the airport.

铁路运输不得使用敞车，水路运输不得配装仓面，公路运输应当苫盖严密，捆扎牢固。

They must not be transported in open wagons on railways and, if by ship, no top loading is allowed; if by truck, they must be securely fastened up and safely protected.

第十四条　精神药品在运输途中如有丢失，承运单位必须认真查找，并立即报告当地公安机关和卫生行政部门查处。

Article 14 In the event that any of the psychotropic drugs is found  missing  in  the course of transportation, the freighter-unit must report the case promptly to  the  local  public  security  organ  and  the  health   administrative department for investigation.

第五章　精神药品的使用

Chapter V the Use of Psychotropic Drugs

第十五条　医生应当根据医疗需要合理使用精神药品，严禁滥用。

Article 15 Doctors must prescribe psychotropic drugs on the basis of the actual need in treatment.  Abuse of such drugs is strictly forbidden.

除特殊需要外，第一类精神药品的处方，每次不超过三日常用量，第二类精神药品的处方，每次不超过七日常用量。处方应当留存两年备查。

Normally, a prescription for the psychotropic drugs of category I shall not exceed the therapeutically dosage for three days. A prescription for the psychotropic drugs of category II shall not exceed the therapeutically dosage for seven days. The prescriptions must be kept for two years for reference.

第十六条　精神药品的处方必须载明患者的姓名、年龄、性别、药品名称、剂量、用法等。

Article 16 On a prescription of psychotropic drugs, the name, age, sex of  the  user, the name of the drug, dosage  and  administration  must  be  written  down clearly.

精神药品的经营单位和医疗单位对精神药品的购买证明、处方不得涂改。

The drug dealer unit and  the  medical  treatment  unit  are  not allowed to alter the purchasing certificates  and  the  prescriptions  for psychotropic drugs.

第十七条　精神药品的经营单位和医疗单位应当建立精神药品收支帐目，按季度盘点，做到帐物相符，发现问题应当立即报告当地卫生行政部门，卫生行政部门应当及时查处。

Article 17 the drug dealer unit and the medical treatment unit are required to keep a balance account book of psychotropic drugs. An inventory of the drugs must be made every three months to ensure the stock conforms to the account book. Should anything suspicious is found, a report must be made promptly to the local health administrative department and the latter must make immediate investigation in the matter.

医疗单位购买的精神药品只准在本单位使用，不得转售。

Psychotropic drugs purchased by the medical treatment unit can only be used in their unit. No resale of the drugs shall be allowed.

第六章　精神药品的进出口

Chapter VI the Import and Export of Psychotropic Drugs

第十八条　精神药品的进出口业务由对外经济贸易部指定的单位按照国家有关对外贸易的规定办理。

Article 18 the import and export of psychotropic drugs shall be handled by the units appointed by the Ministry of Foreign Economic Relations and Trade in accordance with the State provisions governing foreign trade.

精神药品进出口的年度计划应当报卫生部审批。

The annual plan for the import or export of psychotropic drugs must be submitted to the Ministry of Public Health for examination and approval.

第十九条　因医疗、教学和科研工作需要进口精神药品的，应报卫生部审查批准，发给《精神药品进口准许证》后，方可申请办理进口手续。

Article 19 Medical treatment units, medical  colleges  or  medical  science  research institutions that are in need of imported psychotropic drugs  must  submit an application to the  Ministry  of  Public  Health  for  examination  and approval. Only after a License for the Import of Psychotropic Drugs is issued to them can they go through import formalities.

第二十条　出口精神药品、应当向卫生部提出申请，并交验进口国政府主管部门签发的进口许可证，经卫生部审查批准，

Article 20 The units that  export  psychotropic  drugs  are  required  to  submit  an application to the Ministry of Public  Health,  together  with  an  import license issued by the competent government  department  of  the  importing country, for examination and approval.

发给《精神药品出口准许证》后，方可办理出口手续。

Only after a License for the Export of Psychotropic Drugs is issued to them can they go through export formalities.

第二十一条　精神药品的进口、出口准许证由卫生部统一印制。

Article 21 The License for the Import of Psychotropic Drugs and the License for the Export of Psychotropic Drugs shall be exclusively printed by the Ministry of Public health.

第七章　罚　则

Chapter VII Penalty Provisions

第二十二条　凡违反本办法的规定，有下列行为之一的，由当地卫生行政部门没收全部精神药品和非法收入，并视情节轻重，给予非法所得金额五至十倍的罚款，停业整顿，吊销《药品生产企业许可证》、《药品经营企业许可证》、《制剂许可证》的处罚：

Article 22 any violator of these Measures for any one of the following acts shall be punished by the local health administrative department. The penalty shall cover confiscation of all the psychotropic drugs and the illegal gains, a fine 5 to 10 times the illegal gains according to the seriousness of the case, suspension of business operations for rectification or revocation of the License for Pharmaceutical Production Enterprise,   License   for Pharmaceutical Business Enterprise or License for Medicaments:

（一）擅自生产精神药品或者改变生产计划，增加精神药品品种的；

(1) Those that produce psychotropic drugs or change the production plan or produce additional kinds of psychotropic drugs without authorization;

（二）擅自经营精神药品的；

(2) Those who are engaged in the trading of psychotropic drugs without authorization;

（三）擅自配制和出售精神药品制剂的；

(3) Those that prepare and sell any form of psychotropic drugs without authorization;

（四）将兽用精神药品供人使用的；

(4) Those that use veterinary psychotropic drugs on the human beings;

（五）未经批准擅自进口、出口精神药品的。

(5) Those who import or export psychotropic drugs without authorization.

第二十三条　对利用职务上的便利，为他人开具不符合规定的处方，或者为自己开具处方，骗取、滥用精神药品的直接责任人员，由其所在单位给予行政处分。

Article 23 Those who  take  advantage  of  their  professional  work  by  prescribing psychotropic drugs to other persons without complying with the rules or by prescribing the psychotropic drugs  for  themselves,  and  those  who  are directly responsible for cheating to gain or abusing the  drugs  shall  be given disciplinary sanctions by the authorities of the unit they are in.

第二十四条　凡违反本办法的规定，制造、运输、贩卖精神药品，构成犯罪的，由司法机关依法追究其刑事责任。

Article 24 Those  who  violate  these  rules  by  producing,  shipping   or   trading psychotropic drugs illegally, if the circumstances are serious  enough  to constitute a crime, shall be prosecuted for criminal responsibility to  be investigated by the judicial organs according to law.

第二十五条　当事人对行政处罚不服的，可在接到处罚通知之日起十五日内，向作出处理的机关的上一级机关申请复议。上一级机关应在接到申请之日起十五日内作出答复。

Article 25 A party who  is  dissatisfied  with  the  decision  on  an  administrative sanction may,  within  15  days  of  receiving  the  notification  on  the sanction, make a request for reconsideration to  the  authorities  at  the next higher level who shall make a reply within 15 days after it  receives the appeal.

对答复不服的，可在接到答复之日起十五日内，向人民法院起诉。

If he is dissatisfied with the decision of reconsideration, he may, within 15 days of receiving reconsideration decision, bring a suit before a people's court.

对处罚决定不服而逾期又不起诉的，原处理机关可向人民法院申请强制执行。

if, upon the expiration of  this  period,  the  party  has neither complied with the  sanction  nor  has  brought  a  suit  before  a people's court, the authorities that impose the sanction shall request the people's court to issue an injunction for compulsory enforcement.

第八章　附　则

Chapter VIII Supplementary Provisions

第二十六条　对兽用精神药品的管理，由农业部会同卫生部根据本办法制定具体办法。

Article 26 Specific measures for the control of veterinary psychotropic drugs shall be formulated jointly by the Ministry of Agriculture and the Ministry of Public Health in accordance with these Measures.

第二十七条　本办法由卫生部解释。

Article 27 the right to interpret these Measures resides in the Ministry of Public Health.

第二十八条　本办法自发布之日起施行。

Article 28 These Measures shall go into effect as of the date of promulgation.