精神药品管理办法(附英文)

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精神药品管理办法(附英文)

1988年12月27日，国务院

第一章总则
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。
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。
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。

第二章精神药品的生产
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。
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。
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。
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。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。
精神药品的生产单位未经批准，不得擅自改变生产计划。
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。
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，设立原料和制剂的专用仓库，并指定专人管理；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。
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。

第三章精神药品的供应
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；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，其他任何单位和个人均不得经营。
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。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。
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。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。
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。
《精神药品购用卡》由卫生部统一制定。
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。

第四章精神药品的运输
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。
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。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。

第五章精神药品的使用
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。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。
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。
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。
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。
医疗单位购买的精神药品只准在本单位使用，不得转售。

第六章精神药品的进出口
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。
精神药品进出口的年度计划应当报卫生部审批。
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。
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，发给《精神药品出口准许证》后，方可办理出口手续。
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。

第七章罚则
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：
（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；
（二）擅自经营精神药品的；
（三）擅自配制和出售精神药品制剂的；
（四）将兽用精神药品供人使用的；
（五）未经批准擅自进口、出口精神药品的。
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。
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。
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。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。
第二十七条本办法由卫生部解释。
第二十八条本办法自发布之日起施行。

MEASURES FOR THE CONTROL OF PSYCHOTROPIC 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 PSYCHOTROPIC DRUGS
(Approved by the 25th Executive Meeting of the State Council on
November 15, 1988 and promulgated 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)

Chapter I General Provisions
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.
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.
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.

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 jointly 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
provincial, autonomous regional or municipal (directly under the Central
Government) level and the administrative 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 authorization, 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
allotted 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) specially appointed for the purpose. 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.
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 dealer 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 retail 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 prescription with an official seal of a medical treatment
unit stamped on. The prescriptions 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 solely by the Ministry of Public Health.
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.

Chapter IV Transportation of Psychotropic Drugs
Article 12
When consigning 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 wagons 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 promptly
to the local public security organ and the health administrative
department for investigation.

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 strictly forbidden. Normally, a
prescription for the psychotropic drugs of category I shall not exceed the
therapeutical 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 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.
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 License 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 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:
(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, 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.
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 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.

Chapter VIII Supplementary 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.

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