精神药品管理办法 MEASURES FOR THE CONTROL OF PSYCHOTROPIC DR
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(Approved by the 25th Executive Meeting of the State Council on November 15, 1988 and promulgated1 by Decree No. 24 of the State Council of the People's Republic of China on December 27, 1988 and effective as of the date of promulgation)
颁布日期:19881227  实施日期:19881227  颁布单位:国务院

  Chapter I General Provisions

  Article 1 These Measures are formulated2 in accordance with the Medicine Administration Law of the People's Republic of China in order to further control psychotropic drugs.

  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 dependence3 through constant use.

  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 Ministry4 of Public Health.

  Chapter II The Production of Psychotropic Drugs

  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.

  The units that may produce raw materials of psychotropic drugs and psychotropic drugs of category I shall be appointed jointly5 by the Ministry of Public Health and the State Administration for Medicine.

  The units that may produce psychotropic drugs of category II shall be appointed jointly by the health administration department at the provincial6autonomous7 regional or municipal (directly under the Central Government) level and the administrative8 department for medicine at the corresponding level.

  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. 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.

  Without authorization9, no production unit shall be allowed to change the production plan of psychotropic drugs.

  Article 6 Raw materials of psychotropic drugs and psychotropic drugs shall be allotted10 by the State according to plan. No production unit shall be allowed to sell them without authorization.

  Article 7 The units that produce raw materials of psychotropic drugs and the units that produce psychotropic drugs must establish a strict control system. The raw materials and the drugs must be kept in separate storage under the charge of person(s) specially11 appointed for the purpose. They must make regular reports about the fulfillment of the seasonal12 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.

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

  Chapter III The Supply of Psychotropic Drugs

  Article 8 Raw materials of psychotropic drugs and psychotropic drugs of category I shall be allotted or purchased by the drug dealer13 units appointed jointly by the Ministry of Public Health and the State Administration for Medicine. 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. No other unit or individual shall be allowed to engage in the trading of psychotropic drugs.

  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. 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.

  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 retail14 sale of these drugs shall be allowed at any drug stores.

  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 prescription15 with an official seal of a medical treatment unit stamped on. The prescriptions16 must be kept for two years for reference. 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. The Purchasing Card for Psychotropic Drugs shall be made solely17 by the Ministry of Public Health.

  Article 11 The psychotropic drugs needed in scientific research or teaching shall be provided by the appointed drug dealers18 with an approval by the health administrative department at or above the county level.

  Chapter IV Transportation of Psychotropic Drugs

  Article 12 When consigning19 psychopharmaceuticals, 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.

  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. They must not be transported in open wagons21 on railways and, if by ship, no top loading is allowed; if by truck, they must be securely fastened up and safely protected.

  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 promptly22 to the local public security organ and the health administrative department for investigation23.

  Chapter V The Use of Psychotropic Drugs

  Article 15 Doctors must prescribe psychotropic drugs on the basis of the actual need in treatment. Abuse of such drugs is strictly24 forbidden. Normally, a prescription for the psychotropic drugs of category I shall not exceed the therapeutical25 dosage for three days. A prescription for the psychotropic drugs of category II shall not exceed the therapeutical dosage for seven days. The prescriptions must be kept for two years for reference.

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

  Article 17 The drug dealer unit and the medical treatment unit are required to keep a balance account book of psychotropic drugs. An inventory26 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 immediate27 investigation in the matter.

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

  Chapter VI The Import and Export of Psychotropic Drugs

  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.

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

  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 License28 for the Import of Psychotropic Drugs is issued to them can they go through import formalities.

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

  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.

  Chapter VII Penalty Provisions

  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 confiscation29 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 rectification30 or revocation31 of the License for Pharmaceutical20 Production Enterprise, License for Pharmaceutical Business Enterprise or License for Medicaments:

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

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

  (3) those who prepare and sell any form of psychotropic drugs without authorization;

  (4) those who use veterinary psychotropic drugs on the human beings;

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

  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.

  Article 24 Those who violate these rules by producing, shipping32 or trading psychotropic drugs illegally, if the circumstances are serious enough to constitute a crime, shall be prosecuted33 for criminal responsibility to be investigated by the judicial34 organs according to law.

  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.

  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. if, upon the expiration35 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 compulsory36 enforcement.

  Chapter VIII Supplementary37 Provisions

  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.

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

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



点击收听单词发音收听单词发音  

1 promulgated a4e9ce715ee72e022795b8072a6e618f     
v.宣扬(某事物)( promulgate的过去式和过去分词 );传播;公布;颁布(法令、新法律等)
参考例句:
  • Hence China has promulgated more than 30 relevant laws, statutes and regulations. 中国为此颁布的法律、法规和规章多达30余项。 来自汉英非文学 - 白皮书
  • The shipping industry promulgated a voluntary code. 航运业对自律守则进行了宣传。 来自辞典例句
2 formulated cfc86c2c7185ae3f93c4d8a44e3cea3c     
v.构想出( formulate的过去式和过去分词 );规划;确切地阐述;用公式表示
参考例句:
  • He claims that the writer never consciously formulated his own theoretical position. 他声称该作家从未有意识地阐明他自己的理论见解。 来自《简明英汉词典》
  • This idea can be formulated in two different ways. 这个意思可以有两种说法。 来自《现代汉英综合大词典》
3 dependence 3wsx9     
n.依靠,依赖;信任,信赖;隶属
参考例句:
  • Doctors keep trying to break her dependence of the drug.医生们尽力使她戒除毒瘾。
  • He was freed from financial dependence on his parents.他在经济上摆脱了对父母的依赖。
4 ministry kD5x2     
n.(政府的)部;牧师
参考例句:
  • They sent a deputation to the ministry to complain.他们派了一个代表团到部里投诉。
  • We probed the Air Ministry statements.我们调查了空军部的记录。
5 jointly jp9zvS     
ad.联合地,共同地
参考例句:
  • Tenants are jointly and severally liable for payment of the rent. 租金由承租人共同且分别承担。
  • She owns the house jointly with her husband. 她和丈夫共同拥有这所房子。
6 provincial Nt8ye     
adj.省的,地方的;n.外省人,乡下人
参考例句:
  • City dwellers think country folk have provincial attitudes.城里人以为乡下人思想迂腐。
  • Two leading cadres came down from the provincial capital yesterday.昨天从省里下来了两位领导干部。
7 autonomous DPyyv     
adj.自治的;独立的
参考例句:
  • They proudly declared themselves part of a new autonomous province.他们自豪地宣布成为新自治省的一部分。
  • This is a matter that comes within the jurisdiction of the autonomous region.这件事是属于自治区权限以内的事务。
8 administrative fzDzkc     
adj.行政的,管理的
参考例句:
  • The administrative burden must be lifted from local government.必须解除地方政府的行政负担。
  • He regarded all these administrative details as beneath his notice.他认为行政管理上的这些琐事都不值一顾。
9 authorization wOxyV     
n.授权,委任状
参考例句:
  • Anglers are required to obtain prior authorization from the park keeper.垂钓者必须事先得到公园管理者的许可。
  • You cannot take a day off without authorization.未经批准你不得休假。
10 allotted 5653ecda52c7b978bd6890054bd1f75f     
分配,拨给,摊派( allot的过去式和过去分词 )
参考例句:
  • I completed the test within the time allotted . 我在限定的时间内完成了试验。
  • Each passenger slept on the berth allotted to him. 每个旅客都睡在分配给他的铺位上。
11 specially Hviwq     
adv.特定地;特殊地;明确地
参考例句:
  • They are specially packaged so that they stack easily.它们经过特别包装以便于堆放。
  • The machine was designed specially for demolishing old buildings.这种机器是专为拆毁旧楼房而设计的。
12 seasonal LZ1xE     
adj.季节的,季节性的
参考例句:
  • The town relies on the seasonal tourist industry for jobs.这个城镇依靠季节性旅游业提供就业机会。
  • The hors d'oeuvre is seasonal vegetables.餐前小吃是应时蔬菜。
13 dealer GyNxT     
n.商人,贩子
参考例句:
  • The dealer spent hours bargaining for the painting.那个商人为购买那幅画花了几个小时讨价还价。
  • The dealer reduced the price for cash down.这家商店对付现金的人减价优惠。
14 retail VWoxC     
v./n.零售;adv.以零售价格
参考例句:
  • In this shop they retail tobacco and sweets.这家铺子零售香烟和糖果。
  • These shoes retail at 10 yuan a pair.这些鞋子零卖10元一双。
15 prescription u1vzA     
n.处方,开药;指示,规定
参考例句:
  • The physician made a prescription against sea- sickness for him.医生给他开了个治晕船的药方。
  • The drug is available on prescription only.这种药只能凭处方购买。
16 prescriptions f0b231c0bb45f8e500f32e91ec1ae602     
药( prescription的名词复数 ); 处方; 开处方; 计划
参考例句:
  • The hospital of traditional Chinese medicine installed a computer to fill prescriptions. 中医医院装上了电子计算机来抓药。
  • Her main job was filling the doctor's prescriptions. 她的主要工作就是给大夫开的药方配药。
17 solely FwGwe     
adv.仅仅,唯一地
参考例句:
  • Success should not be measured solely by educational achievement.成功与否不应只用学业成绩来衡量。
  • The town depends almost solely on the tourist trade.这座城市几乎完全靠旅游业维持。
18 dealers 95e592fc0f5dffc9b9616efd02201373     
n.商人( dealer的名词复数 );贩毒者;毒品贩子;发牌者
参考例句:
  • There was fast bidding between private collectors and dealers. 私人收藏家和交易商急速竞相喊价。
  • The police were corrupt and were operating in collusion with the drug dealers. 警察腐败,与那伙毒品贩子内外勾结。
19 consigning 9a7723ed5306932a170f9e5fa9243794     
v.把…置于(令人不快的境地)( consign的现在分词 );把…托付给;把…托人代售;丟弃
参考例句:
  • By consigning childhood illiteracy to history we will help make poverty history too. 而且,通过将儿童文盲归于历史,我们也将改变贫穷的历史。 来自互联网
20 pharmaceutical f30zR     
adj.药学的,药物的;药用的,药剂师的
参考例句:
  • She has donated money to establish a pharmaceutical laboratory.她捐款成立了一个药剂实验室。
  • We are engaged in a legal tussle with a large pharmaceutical company.我们正同一家大制药公司闹法律纠纷。
21 wagons ff97c19d76ea81bb4f2a97f2ff0025e7     
n.四轮的运货马车( wagon的名词复数 );铁路货车;小手推车
参考例句:
  • The wagons were hauled by horses. 那些货车是马拉的。
  • They drew their wagons into a laager and set up camp. 他们把马车围成一圈扎起营地。
22 promptly LRMxm     
adv.及时地,敏捷地
参考例句:
  • He paid the money back promptly.他立即还了钱。
  • She promptly seized the opportunity his absence gave her.她立即抓住了因他不在场给她创造的机会。
23 investigation MRKzq     
n.调查,调查研究
参考例句:
  • In an investigation,a new fact became known, which told against him.在调查中新发现了一件对他不利的事实。
  • He drew the conclusion by building on his own investigation.他根据自己的调查研究作出结论。
24 strictly GtNwe     
adv.严厉地,严格地;严密地
参考例句:
  • His doctor is dieting him strictly.他的医生严格规定他的饮食。
  • The guests were seated strictly in order of precedence.客人严格按照地位高低就座。
25 therapeutical 96d53d5152fba3c5a5f8c7c79936286b     
adj.治疗(学)的
参考例句:
  • Objective:To investigate the clinical characteristics,therapeutical approaches and outcome of infective endocarditis(IE). 目的:探讨感染性心内膜炎(infective endocarditis,IE)的临床特点、治疗方法及转归。 来自互联网
  • What does TGA mean or stand for:Therapeutical Goods Administration. TGA的含义:治疗产品管理(澳大利亚)。 来自互联网
26 inventory 04xx7     
n.详细目录,存货清单
参考例句:
  • Some stores inventory their stock once a week.有些商店每周清点存货一次。
  • We will need to call on our supplier to get more inventory.我们必须请供应商送来更多存货。
27 immediate aapxh     
adj.立即的;直接的,最接近的;紧靠的
参考例句:
  • His immediate neighbours felt it their duty to call.他的近邻认为他们有责任去拜访。
  • We declared ourselves for the immediate convocation of the meeting.我们主张立即召开这个会议。
28 license B9TzU     
n.执照,许可证,特许;v.许可,特许
参考例句:
  • The foreign guest has a license on the person.这个外国客人随身携带执照。
  • The driver was arrested for having false license plates on his car.司机由于使用假车牌而被捕。
29 confiscation confiscation     
n. 没收, 充公, 征收
参考例句:
  • Confiscation of the property of all emigrants and rebels. 没收一切流亡分子和叛乱分子的财产。 来自英汉非文学 - 共产党宣言
  • Confiscation of smuggled property is part of the penalty for certain offences. 没收走私财产是对某些犯罪予以惩罚的一部分。
30 rectification NUwx3     
n. 改正, 改订, 矫正
参考例句:
  • The process of producing a shift of the average value is called rectification. 产生平均值移动的过程叫做整流。
  • This effect, in analogy to its radiofrequency counterpart, is known as optical rectification. 同它的射频对应物相仿,这种现象称为光学整流。
31 revocation eWZxW     
n.废止,撤回
参考例句:
  • the revocation of planning permission 建筑许可的撤销
  • The revocation of the Edict of Nantes was signed here in 1685. 1685年南特敕令的废除是在这里宣布的。 来自互联网
32 shipping WESyg     
n.船运(发货,运输,乘船)
参考例句:
  • We struck a bargain with an American shipping firm.我们和一家美国船运公司谈成了一笔生意。
  • There's a shipping charge of £5 added to the price.价格之外另加五英镑运输费。
33 prosecuted Wk5zqY     
a.被起诉的
参考例句:
  • The editors are being prosecuted for obscenity. 编辑因刊载污秽文字而被起诉。
  • The company was prosecuted for breaching the Health and Safety Act. 这家公司被控违反《卫生安全条例》。
34 judicial c3fxD     
adj.司法的,法庭的,审判的,明断的,公正的
参考例句:
  • He is a man with a judicial mind.他是个公正的人。
  • Tom takes judicial proceedings against his father.汤姆对他的父亲正式提出诉讼。
35 expiration bmSxA     
n.终结,期满,呼气,呼出物
参考例句:
  • Can I have your credit card number followed by the expiration date?能告诉我你的信用卡号码和它的到期日吗?
  • This contract shall be terminated on the expiration date.劳动合同期满,即行终止。
36 compulsory 5pVzu     
n.强制的,必修的;规定的,义务的
参考例句:
  • Is English a compulsory subject?英语是必修课吗?
  • Compulsory schooling ends at sixteen.义务教育至16岁为止。
37 supplementary 0r6ws     
adj.补充的,附加的
参考例句:
  • There is a supplementary water supply in case the rain supply fails.万一主水源断了,我们另外有供水的地方。
  • A supplementary volume has been published containing the index.附有索引的增补卷已经出版。
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