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点击数:   更新日期:2008年10月05日

精神药品管理办法

发 文 号:中华人民共和国国务院令第24号
发布单位:中华人民共和国国务院令第24号
the health administrative department of eachprovince, autonomous region or municipality directly under the CentralGovernment and the administration department for medicine at thecorresponding level.Article 10The psychotropic drugs of category I are available only to those medicaltreatment units appointed by the health administrative department at orabove the county level. No retail sale of these drugs shall be allowed atany drug stores.The psychotropic drugs of category II are available to all medicaltreatment units. Drug stores may sell such drugs by retail on the strengthof a doctor's prescription with an official seal of a medical treatmentunit stamped on. The prescriptions must be kept for two years forreference. Any medical unit in need of psychotropic drugs of category Imust purchase them at a designated drugstore with a Purchasing Card forPsychotropic Drugs issued by the health administrative department at orabove the county level. The Purchasing Card for Psychotropic Drugs shallbe made solely by the Ministry of Public Health.Article 11The psychotropic drugs needed in scientific research or teaching shall beprovided by the appointed drug dealers with an approval by the healthadministrative department at or above the county level.
【章名】Chapter IV Transportation of Psychotropic Drugs
Article 12When consigning psychopharmaceuticals, the production unit or the supplyunit must fill out the full name of the drug on the parcel form, andstamp, in the space for the consigner, a special Seal for Psychotropicdrugs.Article 13The transportation units must strengthen administration work to ensureprompt shipment of psychotropic drugs by shortening its storage time atthe station, on the dock or at the airport. They must not be transportedin open wagons on railways and, if by ship, no top loading is allowed; ifby truck, they must be securely fastened up and safely protected.Article 14In the event that any of the psychotropic drugs is found missing in thecourse of transportation, the freighter-unit must report the case promptlyto the local public security organ and the health administrativedepartment for investigation.
【章名】Chapter V The Use of Psychotropic Drugs
Article 15Doctors must prescribe psychotropic drugs on the basis of the actual needin treatment. Abuse of such drugs is strictly forbidden. Normally, aprescription for the psychotropic drugs of category I shall not exceed thetherapeutical dosage for three days. A prescription for the psychotropicdrugs of category II shall not exceed the therapeutical dosage for sevendays. The prescriptions must be kept for two years for reference.Article 16On a prescription of psychotropic drugs, the name, age, sex of the user,the name of the drug, dosage and administration must be written downclearly. The drug dealer unit and the medical treatment unit are notallowed to alter the purchasing certificates and the prescriptions forpsychotropic drugs.Article 17The drug dealer unit and the medical treatment unit are required to keep abalance account book of psychotropic drugs. An inventory of the drugs mustbe made every three months to ensure the stock conforms to the accountbook. Should anything suspicious is found, a report must be made promptlyto the local health administrative department and the latter must makeimmediate investigation in the matter.Psychotropic drugs purchased by the medical treatment unit can only beused in their unit. No resale of the drugs shall be allowed.
【章名】Chapter VI The Import and Export of Psychotropic Drugs
Article 18The import and export of psychotropic drugs shall be handled by the unitsappointed by the Ministry of Foreign Economic Relations and Trade inaccordance with the State provisions governing foreign trade.The annual plan for the import or export of psychotropic drugs must besubmitted to the Ministry of Public Health for examination and approval.Article 19Medical treatment units, medical colleges or medical science researchinstitutions that are in need of imported psychotropic drugs must submitan application to the Ministry of Public Health for examination andapproval. Only after a License for the Import of Psychotropic Drugs isissued to them can they go through import formalities.Article 20The units that export psychotropic drugs are required to submit anapplication to the Ministry of Public Health, together with an importlicense issued by the competent government department of the importingcountry, for examination and approval. Only after a License for the Exportof Psychotropic Drugs is issued to them can they go through exportformalities.Article 21The License for the Import of Psychotropic Drugs and the License for theExport of Psychotropic Drugs shall be exclusively printed by the Ministryof Public health.
【章名】Chapter VII Penalty Provisions
Article 22Any violator of these Measures for any one of the following acts shall bepunished by the local health administrative department. The penalty shallcover confiscation of all the psychotropic drugs and the illegal gains, afine 5 to 10 times the illegal gains according to the seriousness of thecase, suspension of business operations for rectification or revocation ofthe License for Pharmaceutical Production Enterprise, License forPharmaceutical Business Enterprise or License for Medicaments:(1) those who produce psychotropic drugs or change the production plan orproduce additional kinds of psychotropic drugs without authorization;(2) those who are engaged in the trading of psychotropic drugs withoutauthorization;(3) those who prepare and sell any form of psychotropic drugs withoutauthorization;(4) those who use veterinary psychotropic drugs on the human beings;(5) those who import or export psychotropic drugs without authorization.Article 23Those who take advantage of their professional work by prescribingpsychotropic drugs to other persons without complying with the rules or byprescribing the psychotropic drugs for themselves, and those who aredirectly responsible for cheating to gain or abusing the drugs shall begiven disciplinary sanctions by the authorities of the unit they are in.Article 24Those who violate these rules by producing, shipping or tradingpsychotropic drugs illegally, if the circumstances are serious enough toconstitute a crime, shall be prosecuted for criminal responsibility to beinvestigated by the judicial organs according to law.Article 25A party who is dissatisfied with the decision on an administrativesanction may, within 15 days of receiving the notification on thesanction, make a request for reconsideration to the authorities at thenext higher level who shall make a reply within 15 days after it receivesthe appeal.If he is dissatisfied with the decision of reconsideration, he may, within15 days of receiving reconsideration decision, bring a suit before apeople's court. if, upon the expiration of this period, the party hasneither complied with the sanction nor has brought a suit before apeople's court, the authorities that impose the sanction shall request thepeople's court to issue an injunction for compulsory enforcement.
【章名】Chapter VIII Supplementary Provisions
Article 26Specific measures for the control of veterinary psychotropic drugs shallbe formulated jointly by the Ministry of Agriculture and the Ministry ofPublic Health in accordance with these Measures.Article 27The right to interpret these Measures resides in the Ministry of PublicHealth.Article 28These Measures shall go into effect as of the date of promulgation.
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