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Laws of the People's Republic of China |
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| Category | PUBLIC HEALTH AND MEDICINE | Organ of Promulgation | The State Council | Status of Effect | In Force |
| Date of Promulgation | 1988-12-27 | Effective Date | 1988-12-27 |
|
Measures for the Control of Psychotropic Drugs |
|---|
Article 1 These Measures are formulated in accordance with the Medicine
Administration 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 Article 4 Psychotropic drugs shall be produced according to the plan by The units that may produce raw materials of psychotropic drugs and The units that may produce psychotropic drugs of category II shall be Article 5 The annual production plan for raw materials of psychotropic Without authorization, no production unit shall be allowed to change the Article 6 Raw materials of psychotropic drugs and psychotropic drugs Article 7 The units that produce raw materials of psychotropic drugs and Waste materials discharged during the production of psychotropic drugs Article 8 Raw materials of psychotropic drugs and psychotropic drugs of Article 9 The plan for the supply of raw materials of psychotropic drugs Article 10 The psychotropic drugs of category I are available only to The psychotropic drugs of category II are available to all medical The Purchasing Card for Psychotropic Drugs shall be made solely by the Article 11 The psychotropic drugs needed in scientific research or Article 12 When consigning psychopharmaceuticals, the production unit or Article 13 The transportation units must strengthen administration work Article 14 In the event that any of the psychotropic drugs is found Article 15 Doctors must prescribe psychotropic drugs on the basis of the Article 16 On a prescription of psychotropic drugs, the name, age, sex of Article 17 The drug dealer unit and the medical treatment unit are Psychotropic drugs purchased by the medical treatment unit can only be Article 18 The import and export of psychotropic drugs shall be handled The annual plan for the import or export of psychotropic drugs must be Article 19 Medical treatment units, medical colleges or medical science Article 20 The units that export psychotropic drugs are required to Article 21 The License for the Import of Psychotropic Drugs and the Article 22 Any violator of these Measures for any one of the following (1) to produce psychotropic drugs or change the production plan or (2) to engage in the trading of psychotropic drugs without authorization; (3) to prepare and sell any form of psychotropic drugs without (4) to use veterinarypsychotropic drugs on the human beings; (5) to import or export psychotropic drugs without authorizations. Article 23 Those who take advantage of their professional work by Article 24 Those who violate these rules by producing, shipping or Article 25 A party who is dissatisfied with the decision on an Article 26 Specific measures for the control of veterinary psychotropic Article 27 The right to interpret these Measures resides in the Ministry Article 28 These Measures shall go into effect as of the date of
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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
the production units appointed by the State. No other unit or individual shall
be allowed to engage in the production of psychotropic drugs.
psychotropic drugs of category I shall be appointed jointly by the Ministry of
Public Health and the State Administration for Medicine.
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.
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.
production plan of psychotropic drugs.
shall be allotted by the State according to plan. No production unit shall be
allowed to sell them without authorization.
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 fulfilment 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.
must be treated properly so as not to pollute the environment.
Chapter III The Supply of Psychotropic Drugs
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.
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.
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.
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.
Ministry of Public Health.
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
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.
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.
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
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.
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.
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.
used in their unit. No resale of the drugs shall be allowed.
Chapter VI The Import and Export of Psychotropic Drugs
by the units appointed by the Ministry of Foreign Economic Relations and Trade
in accordance with the State provisions governing foreign trade.
submitted to the Ministry of Public Health for examination and approval.
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.
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.
License for the Export of Psychotropic Drugs shall be exclusively printed by
the Ministry of Public Health.
Chapter VII Penalty Provisions
acts shall be punished by the local health administrative department, and 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:
produce additional kinds of psychotropic drugs without authorization;
authorization;
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.
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.
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
drugs shall be formulated jointly by the Ministry of Agriculture and the
Ministry of Public Health in accordance with these Measures.
of Public Health.
promulgation.
URL: http://www.asianlii.org/cn/legis/cen/laws/mftcopd487