（一）药品所含成份的名称与国家药品标准或者省、自治区、直辖市药品标准规定不符合的；

(1) The names of the ingredients contained in the drug do not correspond to the national drug standard or the drug standard set by the province, autonomous region or municipality under the direct control of the Central Government;

（二）以非药品冒充药品或者以他种药品冒充此种药品

(2) A substance that is not a drug is passed off as a drug, or one sort of drug is passed off as another drug.

有下列情形之一，药品按假药处理：

A drug will be treated as a spurious drug if one of the following circumstances exists:

（一）国务院卫生行政部门规定禁止使用的；

(1) The State Council department responsible for health administration has stipulated that its use is forbidden;

（二）未取得批准文号生产的；

(2) It was produced without first obtaining an approval number;

（三）变质不能药用的；

(3) Due to deterioration, it cannot be used for medicinal purposes;

（四）被污染不能药用的。

(4) Due to contamination, it cannot be used for medicinal purposes.

第三十四条禁止生产、销售劣药。有下列情形之一的药品为劣药：

[Article 34] It is forbidden to produce or sell inferior drugs. A drug is inferior if one of the following circumstances exists:

（一）药品成份的含量与国家药品标准或者省、自治区、直辖市药品标准规定不符合的；

(1) The content of its ingredients does not comply with the national drug standard or the drug standard set by the province, autonomous region or municipality under the direct control of the Central Government;

（二）超过有效期的；

(2) Its period of efficacy has expired;

（三）其他不符合药品标准规定的。

(3) It fails in any other way to comply with stipulated drug standards.

第三十五条药品生产企业、药品经营企业和医疗单位直接接触药品的工作人员，必须每年进行健康检查。患有传染病或者其他可能污染药品的疾病的患者，不得从事直接接触药品的工作。

[Article 35] Personnel of drug-producing enterprises, drug-handling enterprises and medical treatment units who come into direct contact with drugs must undergo a medical examination annually. Persons suffering from contagious diseases or any other disease that could contaminate drugs may not engage in work involving direct contact with drugs.

第六章药品的包装和分装

CHAPTER VI THE PACKAGING AND REPACKAGING OF DRUGS

第三十六条药品包装必须适合药品质量的要求，方便储存、运输和医疗使用。规定有效期的药品，必须在包装上注明有效期。

[Article 36] The packaging of drugs must be appropriate to the requirements of the quality of the drug and must facilitate their storage, transportation and use. Where a period of efficacy for a drug has been fixed, the period of efficacy must be clearly indicated on the package.

发运中药材必须有包装。每件包装上必须注明品名、产地、日期、调出单位，并附有质量合格的标志。

Where Chinese medicinal materials are to be transported, they must be packaged. On each package, the name of the product, its place of origin, the date and the name of the dispatching unit must be clearly indicated and it must be marked to indicate that the quality is up to standard.

第三十七条药品包装必须按照规定贴有标签并附有说明书。

[Article 37] Drug packages must, in accordance with regulations, be labelled and have an instruction booklet attached.

标签或说明书上必须注明药品的品名、规格、生产企业、批准文号、产品批号、主要成份、适应症、用法、用量、禁忌、不良反应和注意事项。

The name of the drug, its specifications, the producing unit, approval number, product batch number, principal ingredients, diseases for which it is indicated, manner of use, side-effects and points to note must be clearly set out on the label or in the instruction booklet.

麻醉药品、精神药品、毒性药品、放射性药品和外用药品的标签必须印有规定标志。

The labels of narcotic drugs, psychotropic drugs, poisonous drugs, radioactive drugs and drugs for external use only must bear the prescribed mark.

第三十八条药品经营企业分装药品，必须具有与所分装药品相适应的设施和卫生条件，由药学技术人员负责，分装记录必须完整准确。

[Article 38] A drug-handling enterprise engaged in the repackaging of drugs must have equipment and hygienic conditions appropriate for the quantity of drugs repackaged. It must be under the charge of pharmaceutical technicians; records of the repackaging must be complete and precise.

分装药品必须附有说明书，在包装上注明品名、规格、生产企业和产品批号、分装单位和分装批号。规定有效期的药品，分装后必须注明有效期。

An instruction booklet must be attached to a repackaged drug. The product name, specifications, name of the production unit and product batch number and of the repackaging unit and repackaging batch number shall be set out clearly on the package. Where a period of efficacy has been set for the drug, when it has been repackaged, the period of efficacy must be clearly indicated.

第七章特殊管理的药品

CHAPTER VII DRUGS UNDER SPECIAL CONTROL

第三十九条国家对麻醉药品、精神药品、毒性药品、放射性药品，实行特殊的管理办法。管理办法由国务院制定。

[Article 39] The State imposes special controls on narcotic drugs, psychotropic drugs, poisons and radioactive drugs. The controls will be stipulated by the State Council.

第四十条麻醉药品，包括原植物，只准由国务院卫生行政部门会同有关部门指定的单位生产，并由省、自治区、直辖市卫生行政部门会同有关部门指定的单位按照规定供应。

[Article 40] The production of narcotic drugs, including the original plant, may only be undertaken by units appointed to do so by the department of the State Council administering health and relevant departments acting jointly, and supply may only be undertaken by units appointed by the department of the province, autonomous region or municipality under the direct control of the Central Government administering health and the relevant departments acting jointly.

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