Article 43
The medical treatment units that prepare their own medicaments are required to have appropriate medicament inspection labs. The medicine inspection lab shall sign and issue a quality certificate for those medicaments that have passed the inspection and may be adopted for clinical application. Rejects shall not be allowed for clinical use.
Article 44
Medical treatment units may prepare only those medicaments that are to be used clinically or in research by themselves and that are not available on the market or insufficiently supplied. These medicaments may not go to the market or do so in a devious manner.
Article 45
Medical treatment units are required to prepare their medicaments for clinical use in conformity with the norms for the preparation of clinical medicaments stipulated by the administrative department of health at the level of the province, autonomous region or municipality directly under the Central Government and report to the local administrative department of health for the record.
Article 46
In medical treatment units, no divisions shall be allowed to prepare and supply clinical medicaments except the division of pharmacy and the division of radioisotope.
Chapter IX Penalty Provisions
Article 47
Violation of Article 15 of the Pharmaceutical Administration Law and violation of Chapter VIII of the same law related to the administration of advertisements shall have disciplinary sanctions imposed by the administration department for industry and commerce; violation of the Pharmaceutical Administration Law and these Measures shall have disciplinary sanctions imposed by the administrative department of health at or above county level with a written penalty notice. It is required to state a quality inspection result on a penalty notice for fake medicine
and medicine of inferior quality. All the forfeit shall be turned in to the national treasury.
Article 48
Those who make or sell or use fake medicine shall have their fake medicines and illegal gains confiscated. The administrative department of health shall impose a maximum fine five times or less the price of the standard medicine which the fake equivalent is used to pass off for according to the seriousness of the case.
Article 49
Those who make or sell or use medicine of inferior quality shall have their inferior medicine and illegal gains confiscated. The administrative department of health shall impose a maximum fine three times or less the price of the standard medicine which the inferior equivalent is used to pass off for according to the seriousness of the case.
Article 50
Any one of the following acts of making, selling or using fake or inferior medicines shall be considered as a serious case on which the administrative department of health shall impose severe disciplinary sanctions:
1. a counterfeit of other medicine with narcotics, psychotropic substances, toxic drugs or radioactive drug or vic versa; 2. an act of making or selling fake medicine or inferior medicine to be mainly administered to babies or infants;
3. an act of making, selling or using fake or inferior medicine which has produced harmful results as to endanger people’s health; 4. repetition of an act of making, selling or using fake or inferior medicine after being penalized;
5. any act that shall be imposed with severe punishment as stipulated in other state laws and regulations.
Article 51
Any units engaged in the production, trading or preparation of medicineswithout btaining the Pharmaceutical Producer Licence, Pharmaceutical trading Enterprise Licence or Dispensing Permit shall be ordered to suspend production, business operations or preparation of such medicines. The medicines and the illegal gains therefrom shall all be confiscated and the administrative department of health may impose a maximum fine five times the price of the standard medicine or medicament, according to the seriousness of the case.
Article 52
Units or individuals that have committed any of the following violations shall be given a disciplinary warning or penalized with a maximum fine of 20,000 RMB yuan according to the seriousness of the case: 1. to import medicines from abroad for the first time without approval by the administrative department of health under the State ouncil; 2. to import medicines from abroad without inspection by the medicine
inspection organ at the border port; 3. to conduct clinical testing or verification of new medicine without authorization;
4. to change the technological process of production without approval by the administrative department of health and, as a result, the quality of the medicine has been degraded; 5. to prepare medicaments for sale or for sale in devious manner by
medical treatment units.
Article 53
Any unit or individual that has committed any one of the following acts shall be given a disciplinary warning or penalized with a maximum fine of 10,000 RMB yuan according to the seriousness of the case: 1. fail to indicate the expiry date of the medicine which ought to be indicated; 2. violate the regulations concerning inner packaging of Chinese medicinal materials or protective packaging of pharmaceuticals for shipment; 3. fail to label the packing as required or the items printed on the label
or on the package insert are not in conformity with the requirements; 4. to purchase or sell newly discovered Chinese medicinal materials or those introduced from abroad that have not been examined and approved.
Article 54
Any individual at the medicine inspection organs or any medicine supervisor who abuses his power or engages in malpractices for personal gains shall be given a disciplinary sanction by the administrative department if the offence is not very serious; if the case is serious as to constitute a crime, he shall be prosecuted for criminal responsibility according to law.
Chapter X Supplementary Provisions
Article 55
Labels for narcotics, psychotropic substances, toxic drugs, radioactive drugs and medicines for external application shall be designed as follows (See the attached drawings [*1]).
Article 56
The right to interpret these Measures resides in the administrative department of health
Article 57
These Measures shall go into effect as of the date of promulgation. 共4页 上一页 1 2 3 4 |
