中华人民共和国药品管理法实施办法

te pharmacopoeia or other pharmaceutical standards. Pharmaceutical factories that plan to use other kinds of materials are required to report their plans to the administrative department of health for the record.

　　Article 35 Pharmaceutical enterprises must strengthen

medicine quality control. All kinds of medicines are subject to quality inspection by their own medicine inspection organs before leaving the production premises. A quality tag or lab testing report shall be put in the interior package of quality products. Those medicines that fail to pass the quality inspection shall not be allowed to leave the production premises.

　　Chapter VII Administration of Pharmaceutical Trading Enterprises

　　Article 36 Pharmaceutical trading enterprises shall be staffed with full time pharmaceutical technical personnel who must meet the following qualifications：

　　（1） A wholesale pharmaceutical trading enterprise shall set up quality inspection organs which shall be put under the charge of professional pharmacists of Chinese or Western medicine.

　　（2） A retail pharmaceutical trading enterprise shall be staffed with a pharmacist or a Chinese medicine pharmacist or a full time pharmaceutical staff worker who has been examined and registered by the administrative department of health at or above county level.

　　（3） Non-pharmaceutical workers newly recruited or staffed to engage in pharmaceutical preparation， purchasing， storage keeping or marketing of medicines are required to go through professional training before they are allowed to work independently.

　　Article 37 The business premises， facilities， storage facility and clean environment of a pharmaceutical trading enterprise must meet the following requirements：

　　（1） The storage facilities must meet the requirements by the physical properties and chemical characters of medicines. The storage must be well equipped against dust， rats and deterioration. For those medicines which need to be kept away from light and in low temperature， there must be light lock and thermal protective storage devices.

　　（2） A pharmaceutical trading enterprise that also deals in other merchandise is required to install separate counters for these merchandise. No medley of medicine and other articles in the same counter shall be allowed.

　　Article 38 Pharmaceutical trading enterprises may prepare or process Chinese medicine （including slicing， roasting， baking， shimmering， etc.） or make up prescriptions for patients. However， they may not make any ready-for-use Chinese medicine for sale.

　　Article 39 Pharmaceutical trading enterprises are required to establish a strict quality checking system and a storage system which includes stock checking in and out and stock protection.

　　Article 40 Pharmaceutical trading enterprises must examine carefully the stock of medicine prior to its purchase. The items for examination shall include its name， producer's name， batch number， quality certificate， registered document （number） of approval， registered trade mark， packing and exterior quality. With respect to Chinese medicinal materials， it is required to examine the packing which must include its name， place of origin， name of consignor and quality inspection mark.

　　Chapter VIII Administration of Medicaments Prepared by Medical Treatment Units

　　Article 41 Medical treatment units that prepare their own medicaments shall meet the following requirements：

　　（1） the post in charge of medicament preparation and inspection in hospitals at or above the county level （including these medical treatment units with more than 100 ward beds in factories， mines， enterprises or institutions） shall be held by a person who bears at least the title of senior pharmacist.

　　Such a post in a hospital under the county level must be held by a person who bears at least the title of pharmacist.

　　（2） preparation of medicaments must be made in a proper building with adequate facilities and in clean and tidy environment. Places for preparation of sterilized medicaments must have a locker room， buffer room， wash room， preparation room， filling and sealing room， sterilization room， packi

ng room and air-conditioning. Places for preparation of infusion and transfusion medicaments are required to have super clean conditions.

　　Article 42 In preparing medicaments， it is required to strictly abide by the operating rules， quality inspection rules and hygiene rules. It is required to have detailed and complete records for the preparation of each batch of medicament.

　　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 vice 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

medicines without obtaining 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 Council；

　　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

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