中华人民共和国药品管理法(双语)(13)

作者:admin

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2014-3-5 09:18

(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.