麻醉药品管理办法(附英文)

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麻醉药品管理办法(附英文)

1987年11月28日，国务院

第一章总则
第一条为严格管理麻醉药品，保证医疗、教学、科研的安全使用，根据《中华人民共和国药品管理法》的规定，制定本办法。
第二条麻醉药品是指连续使用后易产生身体依赖性、能成瘾癖的药品。
第三条麻醉药品包括：阿片类、可卡因类、大麻类、合成麻醉药类及卫生部指定的其他易成瘾癖的药品、药用原植物及其制剂。
第四条国家严格管制麻醉药品原植物的种植和麻醉药品的生产、供应、进出口，非医疗、教学、科研需要一律不得使用麻醉药品。

第二章麻醉药品的种植和生产
第五条麻醉药品原植物的种植单位，必须经卫生部会同农牧渔业部、国家医药管理局审查批准，并抄报公安部。
麻醉药品的生产单位，必须经卫生部会同国家医药管理局审查批准。未经批准的任何单位和个人，一律不得从事麻醉药品的生产活动。
第六条麻醉药品原植物的年度种植计划由卫生部会同农牧渔业部审查批准，麻醉药品的年度生产计划由卫生部会同国家医药管理局审查批准并联合下达执行，种植和生产单位不得擅自改变计划。对成品、半成品、罂粟壳及种子等，种植或生产单位必须有专人负责，严加保管，严禁自行销售和使用。
第七条麻醉药品的生产，要加强质量管理，产品质量必须符合国家药品标准。
第八条麻醉药品新品种的研究试制，必须由研制单位编制计划，报经卫生部审定批准后，方可进行。研究试制完毕后按有关新药审批的办法办理，并要严格试制品的保管与使用手续，防止流失。

第三章麻醉药品的供应
第九条麻醉药品的供应必须根据医疗、教学和科研的需要；有计划地进行。全国麻醉药品的供应计划由国家医药管理局指定的部门提出，报卫生部、国家医药管理局审查批准后下达执行。
第十条麻醉药品经营单位的设置由各省、自治区、直辖市卫生行政部门会同医药管理部门提出，报卫生部、国家医药管理局审核批准。经营单位只能按规定限量供应经卫生行政部门批准的使用单位，不得向其他单位和个人供应。
第十一条药用罂粟壳的供应业务由国家医药管理局及各省、自治区、直辖市的医药管理部门指定的经营单位办理，其他单位一律不准经营。罂粟壳的分配必须根据卫生部和国家医药管理局共同审查批准的计划调拨。罂粟壳可供医疗单位配方使用和由县以上卫生行政部门指定的经营单位凭盖有医疗单位公章的医生处方配方使用，不准零售。药品生产企业为配制中成药所需罂粟壳计划，由所在省、自治区、直辖市医药管理部门审核后，报卫生行政部门核定下达执行。
第十二条各麻醉药品经营单位必须设置具有相应储藏条件的专用仓库或专柜，并指定专职人员承担麻醉药品的储运和供应工作。

第四章麻醉药品的运输
第十三条运输药用阿片时，必须凭卫生部签发的国内运输凭照办理运输手续，原植物的种植单位调给国家医药管理局仓库的药用阿片由发货单位派人押运，由仓库调往药品生产企业的由收货单位派人押运。押运员人数，按照运输部门的规定确定。
运输凭照由卫生部统一印制。
第十四条运输麻醉药品和罂粟壳，除药用阿片外，生产和供应单位应在运单货物名称栏内明确填写“麻醉药品”，并在发货人记事栏加盖“麻醉药品专用章”，凭此办理运输手续。
第十五条运输单位承运麻醉药品和罂粟壳，必须加强管理，及时运输，缩短在车站、码头、机场存放时间。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。
第十六条运输途中如有丢失，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。

第五章麻醉药品的进出口
第十七条麻醉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外贸的规定办理，其他部门一律不得办理麻醉药品的进出口业务。麻醉药品进出口的年度计划应当报卫生部审批。
第十八条因医疗、教学和科学工作需要进口麻醉药品的，应报卫生部审查批准，发给《麻醉药品进口准许证》后，方可申请办理进口手续。
第十九条出口麻醉药品，应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准许证，经卫生部审查发给《麻醉药品出口准许证》后，方可办理出口手续。
第二十条麻醉药品进出口准许证由卫生部统一印制。

第六章麻醉药品的使用
第二十一条麻醉药品只限用于医疗、教学和科研需要。设有病床具备进行手术或一定医疗技术条件的医疗单位，可向当地卫生行政部门办理申请手续，经上一级卫生行政部门批准，核定供应级别后，发给“麻醉药品购用印鉴卡”，该单位应按照麻醉药品购用限量的规定，向指定的麻醉药品经营单位购用。
教学、科研单位所用的麻醉药品，由需用单位向当地卫生行政部门的上一级卫生行政部门提出申请，经批准后，向麻醉药品经营单位购用。
限量单位的级别标准由卫生部制定。
第二十二条麻醉药品使用单位在采购麻醉药品时，须向麻醉药品经营单位填送“麻醉药品申购单”。麻醉药品经营单位在供应时，必须详细核对各项印章及数量。供应数量按照卫生部规定的麻醉药品品种范围及每季购用限量的规定办理。
第二十三条麻醉药品使用单位采购麻醉药品，除直接到麻醉药品经营单位采购外，也可邮购。但往来单据、证件均须挂号寄发。邮寄麻醉药品时，麻醉药品经营单位应在包裹详情单上加盖“麻醉药品专用章”。并凭盖有“麻醉药品专用章”的发票作为向邮局办理邮寄的证明。
第二十四条凡麻醉药品管理范围内的各种制剂，必须向麻醉药品经营单位购用。管理范围内没有的制剂或因医疗单位特殊需要的制剂，有麻醉药品使用权的医疗单位经县以上卫生行政部门批准，可以自行配制，其他任何单位不得自行配制。
第二十五条使用麻醉药品的医务人员必须具有医师以上专业技术职务并经考核能正确使用麻醉药品。
进行计划生育手术的医务人员经考核能正确使用麻醉药品的，在进行手术期间有麻醉药品处方权。
第二十六条麻醉药品的每张处方注射剂不得超过二日常用量，片剂、酊剂、糖浆剂等不超过三日常用量，连续使用不得超过七天。麻醉药品处方应书写完整，字迹清晰，签写开方医生姓名，配方应严格核对，配方和核对人员均应签名，并建立麻醉药品处方登记册。医务人员不得为自己开处方使用麻醉药品。
第二十七条经县以上医疗单位诊断确需使用麻醉药品止痛的危重病人，可由县以上卫生行政部门指定的医疗单位凭医疗诊断书和户籍簿核发《麻醉药品专用卡》，患者凭专用卡到指定医疗单位按规定开方配药。由于持《麻醉药品专用卡》的病人用药增加，医疗单位每季度供应限量不足时，经所在地卫生行政部门的上一级卫生行政部门批准后，可增加供应量。
第二十八条医疗单位应加强对麻醉药品的管理。禁止非法使用、储存、转让或借用麻醉药品。医疗单位要有专人负责，专柜加锁，专用帐册，专用处方，专册登记。处方保存三年备查。医疗单位对违反规定，滥用麻醉药品者有权拒绝发药，并及时向当地卫生行政部门报告。
第二十九条因抢救病人急需麻醉药品的，有关医疗单位和麻醉药品经营单位应立即迅速办理，但只限于该病例一次性使用剂量，手续不完备的，可事后补办。

第七章罚则
第三十条凡违反本办法的规定，有下列行为之一者，可由当地卫生行政部门没收全部麻醉药品和非法收入，并视其情节轻重给予非法所得的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：
（一）擅自生产麻醉药品或者改变生产计划，增加麻醉药品品种的；
（二）擅自经营麻醉药品和罂粟壳的；
（三）向未经批准的单位或者个人供应麻醉药品或者超限量供应的；
（四）擅自配制和出售麻醉药品制剂的；
（五）未经批准擅自进口、出口麻醉药品的；
（六）擅自安排麻醉药品新药临床，不经批准就投产的。
第三十一条对利用工作方便，为他人开具不符合规定的处方，或者为自己开具处方，骗取、滥用麻醉药品的直接责任人员，由其所在单位给予行政处分。
第三十二条违反本办法规定，擅自种植罂粟的，或者非法吸食麻醉药品的，由公安机关依照治安管理处罚条例或有关的规定给予处罚。
第三十三条违反本办法的规定，制造、运输、贩卖麻醉药品和罂粟壳，构成犯罪的，由司法机关依法追究其刑事责任。
第三十四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日内作出答复。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。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。

第八章附则
第三十五条军队、武装警察部队卫生医疗单位麻醉药品的供应、使用，由卫生部会同中国人民解放军总后勤部、中国人民武装警察部队后勤部根据本办法，制定具体管理办法
第三十六条兽用麻醉药品的供应、使用，由卫生部、农牧渔业部根据本办法，制定具体管理办法。
第三十七条本办法的实施细则由卫生部制定。
第三十八条本办法自发布之日起施行。1978年9月13日国务院颁发的《麻醉药品管理条例》同时废止。

MEASURES FOR THE CONTROL OF NARCOTIC DRUGS

Important Notice: (注意事项)
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).
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.
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 Brueau of Legislative Affairs of the State
Council of the People's Republic of China, and is published by the China
Legal System Publishing House.
In case of discrepancy, the original version in Chinese shall prevail.

Whole Document (法规全文)
MEASURES FOR THE CONTROL OF NARCOTIC DRUGS
(Promulgated by the State Council of the People's Republic of
China on November 28, 1987)

Chapter I General Provisions
Article 1
These Measures are formulated in accordance with the Medicine
Administration Law of the People's Republic of China, for the purpose of
tightening control over narcotic drugs so as to ensure their safe use in
medical treatment units, medical colleges and medical research
institutions.
Article 2
Narcotic drugs refer to those drugs that may cause dependence and
addiction after continuous administration.
Article 3
Narcotic drugs include opium, cocaine, marijuana, synthetic anaesthetic
drugs and those defined by the Ministry of Public Health as addict-forming
drugs, anaesthetic raw herbs and the products made from them.
Article 4
The State shall strictly supervise and control the cultivation of the
mother plants of narcotics and the production, supply, export and import
of narcotic drugs. Narcotic drugs shall not be used except for the purpose
of medical treatment, teaching and research when necessary.

Chapter II The Cultivation of Mother Plants of Narcotics and the Production of Narcotic Drugs
Article 5
The units that cultivate mother plants of narcotics must be examined and
approved jointly by the Ministry of Public Health, the Ministry of
Agriculture, Animal Husbandry and Fishery and the State Administration for
Medicine. A copy of the report shall be sent to the Ministry of Public
Security.
The units that produce narcotic drugs must be examined and approved
jointly by the Ministry of Public Health and the State Administration for
Medicine. Without approval, no unit or individual shall be allowed to
produce narcotic drugs.
Article 6
The annual cultivation plan for mother plants of narcotics shall be
examined and approved jointly by the Ministry of Public Health and the
Ministry of Agriculture, Animal Husbandry and Fishery. The annual
production plan of narcotic drugs shall be examined and approved jointly
by the Ministry of Public Health and the State Administration for
Medicine. The cultivation units and the production units shall not change
the plans without authorization. The cultivation unit and the production
unit must assign a person or persons with the special responsibility for
the storage of the finished products, semi-finished products, poppy
capsules and poppy seeds. Sale or use of these things without
authorization shall be strictly prohibited.
Article 7
Narcotic drugs must be brought under strict quality control. The quality
of the products must meet the standards set for medicines by the State.
Article 8
Before the development of any new kind of narcotic drugs, the research
unit must first of all draw up a plan and submit it to the Ministry of
Public Health for examination and approval. After the new drug is
developed, the research and trial production units must go through the
formalities for the approval of such new drugs. The storage and use of the
trial products must follow strict procedures so as to prevent their loss.

Chapter III The Supply of Narcotic Drugs
Article 9
Narcotic drugs shall be provided in a planned way according to the demand
of medical treatment units, medical colleges and scientific research
institutions. A national supply plan of narcotic drugs shall be drawn by
a department appointed by the State Administration for Medicine and
submitted to the Ministry of Public Health and the State Administration
for Medicine for examination and approval before it is issued for
implementation.
Article 10
The plan for the setting up of a trading unit of narcotic drugs shall be
put forward jointly by the administrative department of health and
medicine administrative department in each province, autonomous region, or
municipality directly under the Central Government and shall be examined
and approved by the Ministry of Public Health and the State Administration
for Medicine. The trading units shall provide narcotic drugs only to those
consumer units approved by the administrative department of health and
within the prescribed quota. No supply for any other unit or person is
permitted.
Article 11
Poppy capsules used for medical purposes shall be supplied by the trading
units appointed by the State Administration for Medicine and medicine
department in each province, autonomous region, or municipality directly
under the Central Government. No other unit shall be allowed to engage in
such business. Poppy capsules must be allotted to the consumer units in
accordance with the plan examined and approved jointly by the Ministry of
Public Health and the State Administration for Medicine. Poppy capsules
shall be supplied to the medical treatment units for clinical use and to
the trading units designated by the administrative departments of health
at or above the county level for clinical application endorsed with an
office seal of their respective medical treatment units. No retail sale of
poppy capsules is allowed. The pharmaceutical factories that need poppy
capsules in the production of ready made Chinese medicine must submit
plans to the medicine administrative department in their province,
autonomous region, or municipality directly under the Central Government
for examination and then to the administrative department of health for
approval before production.
Article 12
A trading unit of narcotic drugs must have a special storehouse or
counter(s) with good storage conditions and assign a person or persons
with special responsibility for the storage, transportation and supply of
narcotic drugs.

Chapter IV Transportation of Narcotic Drugs
Article 13
A permit for domestic consignment issued by the Ministry of Public Health
is needed when going through shipment formalities for transporting
medicinal opium. Shipment of medicinal opium from the cultivation unit to
the storehouse of the State Administration for Medicine shall be escorted
by the people sent by the consignor unit. Shipment of medicinal opium from
the storehouse to the production enterprises shall be escorted by the
people sent by consignee unit. The number of escorts shall be decided in
accordance with the regulations of the transportation department.
Permit for domestic transportation of such drugs shall be printed solely
by the Ministry of Public Health.
Article 14
When consigning narcotic drugs or poppy capsules (not including medicinal
opium), the production unit or the supply unit must put down clearly the
words of Narcotic Drug in the blank for the name of goods on the shipping
document and a seal for consignment of Narcotic Drug must be stamped in
the space left for the consignor.
Article 15
The freighter unit must tighten control over the shipment of narcotic
drugs and poppy capsules by dispatching the consignment promptly and
shortening its storage time at the station, on the dock or at the airport.
They must not be transported in open wagons on railways and, if by ship,
no loading on hold surface is allowed and, if by truck, they must be
securely fastened up and safely protected.
Article 16
In the event that any of the narcotic drugs or poppy capsules are found
missing in the course of transportation, the freighter-unit must report
the case promptly to the local public security organ and the
administrative department of health for investigation.

Chapter V Import and Export of Narcotic Drugs
Article 17
The import and export of narcotic drugs shall be handled by the units
appointed by the Ministry of Foreign Economic Relations and Trade in
accordance with State regulations concerning foreign trade.
No other units shall be allowed to engage in the business. The annual plan
for import and export of narcotic drugs shall be subject to examination
and approval by the Ministry of Public Health.
Article 18
The import of narcotic drugs needed in medical treatment units, medical
colleges of or medical science research institutions must be verified and
approved by the Ministry of Public Health. Only after an Import License
for Narcotic Drugs is granted can these units apply to go through import
formalities.
Article 19
The export of narcotic drugs must be verified and approved by the Ministry
of Public Health. An application and an import license which is a
prerequisite to going through import formalities for narcotic drugs issued
by the competent government department of the importing country must be
presented before the Ministry of Public Health issues an Export License
for Narcotic Drugs.
Article 20
Import and export licenses for narcotic drugs shall be printed exclusively
by the Ministry of Public Health.

Chapter VI The Use of Narcotic Drugs
Article 21
Narcotic drugs shall only be used for medical treatment, in teaching at
medical colleges and in medical science research. Any medical treatment
unit with medical wards and with surgical or other necessary medical
treatment facilities may file an application to the local administrative
department of health. Upon approval by the administrative department of
health at a higher level, and after the level of supply is verified, a
Purchase Card for Narcotic Drugs shall be issued. The aforesaid unit may
purchase the needed narcotic drugs from the designated trading units
according to the fixed quota. When the medical colleges or scientific
research institutions are in need of narcotic drugs, they shall file an
application to the administrative department of health at a higher level
and, upon approval, may purchase these drugs from the trading units of
narcotic drugs. The Ministry of Public Health is the authority to make out
the grading standard of rations.
Article 22
Narcotic consuming unit must fill out an application form for when
purchasing, narcotic drugs and the supplying unit must check the various
seals and the number of seals stamped on the form before supplying them
with the kind of drugs on quarterly ration as stipulated in the
regulations set by the Ministry of Public Health.
Article 23
The unit in need of narcotic drugs can either purchase them directly from
the trading units or by mail order. In the latter case, however, the
shipping documents and certificates must be sent out by registered mail.
When sending the narcotic drugs by post, the sender-trading unit is
required to stamp a Seal for Narcotic Drugs on the parcel form and to
present to the post office the invoice with a Seal for Narcotic Drugs
stamped on.
Article 24
Preparations that fall under the category of narcotic drugs must be
purchased from the trading units of narcotic drugs. In case that they are
not available or special preparations are needed by the medical treatment
units, the authorized consuming medical units may prepare them by
themselves with approval by the administrative department of health at or
above the county level. No other unit shall be allowed to prepare any form
of anaesthetic.
Article 25
The medical worker who prescribes any anaesthetics for the patient must be
a qualified physician or a surgeon, who is tested to have been able to use
such drugs properly. The surgeon at the induced abortion ward who is
tested to have been able to use such drugs properly may have the right to
prescribe anaesthetics for the person to be operated on.
Article 26
Dosage for injection in each prescription must not exceed two days of
daily dose, as for the tablet, tincture, syrup, the dosage must not exceed
three days of daily dose. Administration of narcotic must not exceed a
period of seven days running. Prescription of narcotic drugs must be fully
and clearly stated with signature of the physician or surgeon on. When
preparing a narcotic drug, the pharmacist and the checker are required to
sign their names and keep the prescription of the narcotic drug on file.
No medical worker is allowed to prescribe any narcotic drug for
him/herself.
Article 27
In the case of a patient in serious conditions who is diagnosed by a
hospital at or above county level to be in need of narcotic drugs as a
pain killer, the hospital appointed by the administrative department of
health at or above the county level may issue the patient with a Special
Purchasing Card for Narcotic on the basis of the Prescription and by
checking his permanent residence booklet, and the patient may take this to
the appointed medical treatment unit to have the drug prepared. If the
patient holding a Special Purchasing Card for Narcotic is in need of a
larger dose and the seasonal ration of the medical treatment unit fails to
meet the demand, additional amount of narcotic shall be made available
only with the approval by the administrative department of health at a
higher level.
Article 28
Medical treatment units are required to tighten control over narcotic
drugs. Any illegal use, storage, transfer or borrowing of narcotic drugs
is prohibited. Narcotic drugs must be put under the charge of a person
specially appointed for the purpose and kept in a separate place under
lock. The distribution and prescriptions of narcotic drugs must be kept in
record separately from those of other medicine.
The prescriptions must be kept on file for a period of three years. The
medical treatment unit shall have the right to refuse dispensing of drugs
to those who abuse them in violation of relevant rules and regulations and
shall report the case to the local administrative department of health
promptly.
Article 29
In the event of an emergency case which is in need of narcotic drugs, the
medical treatment unit so involved and the trading unit of narcotic drugs
are required to supply a dose of narcotic promptly for the case only, and
the necessary formalities shall be done after the event.

Chapter VII Penalty Provisions
Article 30
Any violation of these Measures shall be subject to penalty by the local
administrative department of health according to the seriousness of the
case. The penalty shall cover confiscation of all the narcotic drugs and
the illegal earnings, a fine ranging from 5-10 times the illegal profits,
closing down of the business or revocation of "License for Pharmaceutical
Production Enterprise", "License for Pharmaceutical Business Enterprise"
or License for Medicaments"
(1) those who, without authorization, are engaged in the production of
narcotic drugs or have changed the production plan and made additional
kinds of narcotic drugs;
(2) those who are engaged in unauthorized trading business of narcotic
drugs and poppy capsules;
(3) those who supply or oversupply narcotics to any unit or person that
has not been granted the permission to use the stuff;
(4) those who prepare and sell any form of narcotic drugs without
authorization;
(5) those who are engaged in unauthorized import or export of narcotic
drugs;
(6) those who apply any new kind of narcotic drugs to patients clinically
or have produced any new kind of narcotic drugs without authorization.
Article 31
Those who have taken advantage of their professional work by prescribing
narcotics to other persons without complying with the rules or by
prescribing narcotics for themselves, and those who are directly
responsible for cheating to obtain or abusing the stuff, shall be given
disciplinary sanctions by the authorities of their units.
Article 32
Those who, in violation of these Measures, cultivate poppy without
authorization or take in narcotic drugs illegally shall be punished by a
public security organ in accordance with the Regulations on Administrative
Penalties for Public Security or other related rules.
Article 33
With respect to any one who produces, transports or sells narcotics or
poppy capsules, if the circumstances are serious enough to constitute a
crime, he shall be prosecuted for criminal liability by the judicial
organs according to law.
Article 34
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
level next higher, which shall make a reply within 10 days of receipt of
the appeal. If he is dissatisfied with the decision on reconsideration, he
may, within 15 days of receiving the reconsideration decision, bring a
suit before a people's court. 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 apply to
the people's court for compulsory enforcement.

Chapter VIII Supplementary Provisions
Article 35
The specific administration rules for the supply and use of narcotic drugs
in the health and medical treatment units of the Chinese People's
Liberation Army and the Chinese People's Armed Police Force shall be
formulated jointly by the Ministry of Public Health, the General Logistics
Department of the Chinese People's Liberation Army and the Logistics
Department of the Chinese People's Armed Police Force in accordance with
these Measures.
Article 36
The specific administration rules for the supply and use of veterinary
narcotic drugs shall be formulated jointly by the Ministry of Public
Health and the Ministry of Agriculture, Animal Husbandry and Fishery in
accordance with these Measures.
Article 37
The rules for the implementation of these Measures shall be formulated by
the Ministry of Public Health.
Article 38
These Measures shall go into effect as of the date of promulgation. The
Provisions for the Administration of Narcotic Drugs, promulgated by the
State Council of the People's Republic of China on September 13, 1978,
shall become null and void on the same day.

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