英文本源自中華人民共和國務(wù)院法制局編譯, 中國法制出版社出版的《中華人民共和國涉外法規(guī)匯編》(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.

當發(fā)生歧意時, 應(yīng)以法律法規(guī)頒布單位發(fā)布的中文原文為準
In case of discrepancy, the original version in Chinese shall prevail

第一章　總　則
Chapter I General Provisions

第一條　為了加強精神藥品的管理，根據(jù)《中華人民共和國藥品管理法》的規(guī)定，制定本辦法。
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.

第二條　精神藥品是指直接作用于中樞神經(jīng)系統(tǒng)，使之興奮或抑制，連續(xù)使用能產(chǎn)生依賴性的藥品。
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.

第三條　依據(jù)精神藥品使人體產(chǎn)生的依賴性和危害人體健康的程度，分為第一類和第二類，各類精神藥品的品種由衛(wèi)生部確定。
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　精神藥品的生產(chǎn)
Chapter II The Production of Psychotropic Drugs

第四條　精神藥品由國家指定的生產(chǎn)單位按計劃生產(chǎn)，其他任何單位和個人不得從事精神藥品的生產(chǎn)活動。
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.

精神藥品的原料和第一類精神藥品制劑的生產(chǎn)單位，由衛(wèi)生部會同國家醫(yī)藥管理局確定。
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.

第二類精神藥品制劑的生產(chǎn)單位，由省、自治區(qū)、直轄市衛(wèi)生行政部門會同同級醫(yī)藥管理部門確定。
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.

第五條　精神藥品的原料和第一類精神藥品制劑的年度生產(chǎn)計劃，由衛(wèi)生部會同國家醫(yī)藥管理局聯(lián)合下達。
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.

第二類精神藥品制劑的年度生產(chǎn)計劃，由省、自治區(qū)、直轄市衛(wèi)生行政部門會同同級醫(yī)藥管理部門聯(lián)合下達。
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.

精神藥品的生產(chǎn)單位未經(jīng)批準，不得擅自改變生產(chǎn)計劃。
Without authorization, no production unit shall be allowed to change the production plan of psychotropic drugs.

第六條　精神藥品的原料和制劑，按國家計劃調(diào)撥，生產(chǎn)單位不得自行銷售。
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.

第七條　精神藥品的原料和制劑的生產(chǎn)單位必須建立嚴格的管理制度，
Article 7 The units that produce raw materials of psychotropic drugs and the units that produce psychotropic drugs must establish a strict control system.

設(shè)立原料和制劑的專用倉庫，并指定專人管理；
The raw materials and the drugs must be kept in separate storage under the charge of person(s) specially appointed for the purpose.

建立生產(chǎn)計劃執(zhí)行情況的報告制度，按季度報省、自治區(qū)、直轄市衛(wèi)生行政部門和同級醫(yī)藥管理部門，并報衛(wèi)生部和國家醫(yī)藥管理局備案。
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.

在生產(chǎn)精神藥品的過程中產(chǎn)生的廢棄物，必須妥善處理，不得污染環(huán)境。
Waste materials discharged during the production of psychotropic drugs must be treated properly so as not to pollute the environment.

第三章　精神藥品的供應(yīng)
Chapter III the Supply of Psychotropic Drugs

第八條　精神藥品的原料和第一類精神藥品制劑，由衛(wèi)生部會同國家醫(yī)藥管理局指定的經(jīng)營單位統(tǒng)一調(diào)撥或者收購；
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.

第二類精神藥品制劑，由縣以上衛(wèi)生行政部門會同同級醫(yī)藥管理部門指定的經(jīng)營單位經(jīng)營，
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.

其他任何單位和個人均不得經(jīng)營。
No other unit or individual shall be allowed to engage in the trading of psychotropic drugs.

第九條　精神藥品的原料和第一類精神藥品制劑的供應(yīng)計劃，由衛(wèi)生部會同國家醫(yī)藥管理局，根據(jù)省、自治區(qū)、直轄市醫(yī)藥管理部門提出的計劃，綜合平衡后與生產(chǎn)計劃一并下達。
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.

第二類精神藥品制劑的供應(yīng)計劃，由省、自治區(qū)、直轄市衛(wèi)生行政部門會同同級醫(yī)藥管理部門聯(lián)合下達。
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.

第十條　第一類精神藥品只限供應(yīng)縣以上衛(wèi)生行政部門指定的醫(yī)療單位使用，不得在醫(yī)藥門市部零售。
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.

第二類精神藥品可供各醫(yī)療單位使用，醫(yī)藥門市部應(yīng)當憑蓋有醫(yī)療單位公章的醫(yī)生處方零售。處方應(yīng)留存兩年備查。
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.

醫(yī)療單位購買第一類精神藥品，需持縣以上衛(wèi)生行政部門核發(fā)的《精神藥品購用卡》在指定的經(jīng)營單位購買。
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.

《精神藥品購用卡》由衛(wèi)生部統(tǒng)一制定。
The Purchasing Card for Psychotropic Drugs shall be made solely by the Ministry of Public Health.

第十一條　科研和教學(xué)機構(gòu)因科研和教學(xué)需要的精神藥品，需經(jīng)縣以上衛(wèi)生行政部門批準后，由指定的醫(yī)藥經(jīng)營單位供應(yīng)。
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　精神藥品的運輸
Chapter IV Transportation of Psychotropic Drugs

第十二條　生產(chǎn)單位和供應(yīng)單位托運精神藥品（包括郵寄），應(yīng)當在貨物的運單上，寫明該精神藥品的具體名稱，并在發(fā)貨人記事欄內(nèi)加蓋“精神藥品專用章”，憑此辦理運輸手續(xù)。
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.

第十三條　運輸單位承運精神藥品，必須加強管理，及時運輸，縮短在車站、碼頭、機場存放時間。
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.

鐵路運輸不得使用敞車，水路運輸不得配裝倉面，公路運輸應(yīng)當苫蓋嚴密，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.

第十四條　精神藥品在運輸途中如有丟失，承運單位必須認真查找，并立即報告當?shù)毓�安機關(guān)和衛(wèi)生行政部門查處。
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　精神藥品的使用
Chapter V the Use of Psychotropic Drugs

第十五條　醫(yī)生應(yīng)當根據(jù)醫(yī)療需要合理使用精神藥品，嚴禁濫用。
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，第一類精神藥品的處方，每次不超過三日常用量，第二類精神藥品的處方，每次不超過七日常用量。處方應(yīng)當留存兩年備查。
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.

第十六條　精神藥品的處方必須載明患者的姓名、年齡、性別、藥品名稱、劑量、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.

精神藥品的經(jīng)營單位和醫(yī)療單位對精神藥品的購買證明、處方不得涂改。
The drug dealer unit and the medical treatment unit are not allowed to alter the purchasing certificates and the prescriptions for psychotropic drugs.

第十七條　精神藥品的經(jīng)營單位和醫(yī)療單位應(yīng)當建立精神藥品收支帳目，按季度盤點，做到帳物相符，發(fā)現(xiàn)問題應(yīng)當立即報告當?shù)匦l(wèi)生行政部門，衛(wèi)生行政部門應(yīng)當及時查處。
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.

醫(yī)療單位購買的精神藥品只準在本單位使用，不得轉(zhuǎn)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　精神藥品的進出口
Chapter VI the Import and Export of Psychotropic Drugs

第十八條　精神藥品的進出口業(yè)務(wù)由對外經(jīng)濟貿(mào)易部指定的單位按照國家有關(guān)對外貿(mào)易的規(guī)定辦理。
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.

精神藥品進出口的年度計劃應(yīng)當報衛(wèi)生部審批。
The annual plan for the import or export of psychotropic drugs must be submitted to the Ministry of Public Health for examination and approval.

第十九條　因醫(yī)療、教學(xué)和科研工作需要進口精神藥品的，應(yīng)報衛(wèi)生部審查批準，發(fā)給《精神藥品進口準許證》后，方可申請辦理進口手續(xù)。
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.

第二十條　出口精神藥品、應(yīng)當向衛(wèi)生部提出申請，并交驗進口國政府主管部門簽發(fā)的進口許可證，經(jīng)衛(wèi)生部審查批準，
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.

發(fā)給《精神藥品出口準許證》后，方可辦理出口手續(xù)。
Only after a License for the Export of Psychotropic Drugs is issued to them can they go through export formalities.

第二十一條　精神藥品的進口、出口準許證由衛(wèi)生部統(tǒng)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　罰　則
Chapter VII Penalty Provisions

第二十二條　凡違反本辦法的規(guī)定，有下列行為之一的，由當?shù)匦l(wèi)生行政部門沒收全部精神藥品和非法收入，并視情節(jié)輕重，給予非法所得金額五至十倍的罰款，停業(yè)整頓，吊銷《藥品生產(chǎn)企業(yè)許可證》、《藥品經(jīng)營企業(yè)許可證》、《制劑許可證》的處罰：
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）擅自生產(chǎn)精神藥品或者改變生產(chǎn)計劃，增加精神藥品品種的；
(1) Those that produce psychotropic drugs or change the production plan or produce additional kinds of psychotropic drugs without authorization;

（二）擅自經(jīng)營精神藥品的；
(2) Those who are engaged in the trading of psychotropic drugs without authorization;

（三）擅自配制和出售精神藥品制劑的；
(3) Those that prepare and sell any form of psychotropic drugs without authorization;

（四）將獸用精神藥品供人使用的；
(4) Those that use veterinary psychotropic drugs on the human beings;

（五）未經(jīng)批準擅自進口、出口精神藥品的。
(5) Those who import or export psychotropic drugs without authorization.

第二十三條　對利用職務(wù)上的便利，為他人開具不符合規(guī)定的處方，或者為自己開具處方，騙取、濫用精神藥品的直接責任人員，由其所在單位給予行政處分。
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.

第二十四條　凡違反本辦法的規(guī)定，制造、運輸、販賣精神藥品，構(gòu)成犯罪的，由司法機關(guān)依法追究其刑事責任。
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.

第二十五條　當事人對行政處罰不服的，可在接到處罰通知之日起十五日內(nèi)，向作出處理的機關(guān)的上一級機關(guān)申請復(fù)議。上一級機關(guān)應(yīng)在接到申請之日起十五日內(nèi)作出答復(fù)。
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.

對答復(fù)不服的，可在接到答復(fù)之日起十五日內(nèi)，向人民法院起訴。
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.

對處罰決定不服而逾期又不起訴的，原處理機關(guān)可向人民法院申請強制執(zhí)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　則
Chapter VIII Supplementary Provisions

第二十六條　對獸用精神藥品的管理，由農(nóng)業(yè)部會同衛(wèi)生部根據(jù)本辦法制定具體辦法。
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.

第二十七條　本辦法由衛(wèi)生部解釋。
Article 27 the right to interpret these Measures resides in the Ministry of Public Health.

第二十八條　本辦法自發(fā)布之日起施行。
Article 28 These Measures shall go into effect as of the date of promulgation.