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精神药品管理办法 MEASURES FOR THE CONTROL OF PSYCHOTROPIC DRUGS

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(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)
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 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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