inary sanctions imposed by the administrative department of healthat or above county level with a written penalty notice. It is required tostate a quality inspection result on a penalty notice for fake medicineand medicine of inferior quality. All the forfeit shall be turned in tothe national treasury.Article 48Those who make or sell or use fake medicine shall have their fakemedicines and illegal gains confiscated. The administrative department ofhealth shall impose a maximum fine five times or less the price of thestandard medicine which the fake equivalent is used to pass off foraccording to the seriousness of the case.Article 49Those who make or sell or use medicine of inferior quality shall havetheir inferior medicine and illegal gains confiscated. The administrativedepartment of health shall impose a maximum fine three times or less theprice of the standard medicine which the inferior equivalent is used topass off for according to the seriousness of the case.Article 50Any one of the following acts of making, selling or using fake or inferiormedicines shall be considered as a serious case on which theadministrative department of health shall impose severe disciplinarysanctions:1. a counterfeit of other medicine with narcotics, psychotropicsubstances, toxic drugs or radioactive drug or vice versa;2. an act of making or selling fake medicine or inferior medicine to bemainly administered to babies or infants;3. an act of making, selling or using fake or inferior medicine which hasproduced harmful results as to endanger people's health;4. repetition of an act of making, selling or using fake or inferiormedicine after being penalized;5. any act that shall be imposed with severe punishment as stipulated inother state laws and regulations.Article 51Any units engaged in the production, trading or preparation of medicineswithout obtaining the Pharmaceutical Producer Licence, Pharmaceuticaltrading Enterprise Licence or Dispensing Permit shall be ordered tosuspend production, business operations or preparation of such medicines.The medicines and the illegal gains therefrom shall all be confiscated andthe administrative department of health may impose a maximum fine fivetimes the price of the standard medicine or medicament, according to theseriousness of the case.
Article 52Units or individuals that have committed any of the following violationsshall be given a disciplinary warning or penalized with a maximum fine of20,000 RMB yuan according to the seriousness of the case:1. to import medicines from abroad for the first time without approval bythe administrative department of health under the State Council;2. to import medicines from abroad without inspection by the medicineinspection organ at the border port;3. to conduct clinical testing or verification of new medicine withoutauthorization;4. to change the technological process of production without approval bythe administrative department of health and, as a result, the quality ofthe medicine has been degraded;5. to prepare medicaments for sale or for sale in devious manner bymedical treatment units.Article 53Any unit or individual that has committed any one of the following actsshall be given a disciplinary warning or penalized with a maximum fine of10,000 RMB yuan according to the seriousness of the case:1. fail to indicate the expiry date of the medicine which ought to beindicated;2. violate the regulations concerning inner packaging of Chinese medicinalmaterials or protective packaging of pharmaceuticals for shipment;3. fail to label the packing as required or the items printed on the labelor on the package insert are not in conformity with the requirements;4. to purchase or sell newly discovered Chinese medicinal materials orthose introduced from abroad that have not been examined and approved.Article 54Any individual at the medicine inspection organs or any medicinesupervisor who abuses his power or engages in malpractices for personalgains shall be given a disciplinary sanction by the administrativedepartment if the offence is not very serious; if the case is serious asto constitute a crime, he shall be prosecuted for criminal responsibilityaccording to law.
【章名】Chapter X Supplementary Provisions
Article 55Labels for narcotics, psychotropic substances, toxic drugs, radioactivedrugs and medicines for external application shall be designed as follows(See the attached drawings [*1]).Article 56The right to interpret these Measures resides in the administrativedepartment of healthArticle 57These Measures shall go into effect as of the date of promulgation.Note:[*1] The attached drawings see page 1505. -The Editor