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中华人民共和国药品管理法(双语)(18)

2014-03-07    来源:网络    【      美国外教 在线口语培训

第四十七条药品监督员有权按照规定对辖区内的药品生产企业、药品经营企业和医疗单位的药品质量进行监督、检查、抽验,必要时可以按照规定抽取样品和索取有关资料,有关单位不得拒绝和隐瞒。
[Article 47] A Drug Controller has the power, in accordance with regulations, to control, inspect and test the quality of drugs in drug-producing enterprises, drug-handling enterprises and medical treatment units within the Controller's area of jurisdiction. If necessary, the Drug Controller may, in accordance with regulations, take samples and obtain relevant data which the relevant unit may not refuse to provide and may not conceal.

药品监督员对药品的生产企业和科研单位提供的技术资料,负责保密。
Drug Controllers are responsible for keeping the technical data provided by drug-manufacturing enterprises or scientific research units confidential.

第四十八条药品生产企业、药品经营企业和医疗单位,应当经常考察本单位所生产、经营、使用的药品的质量、疗效和不良反应。
[Article 48] Drug-producing enterprises, drug-handling enterprises and medical treatment units shall regularly inspect and study the quality, efficacy and side-effects of drugs produced, handled or used by them.

医疗单位发现药品中毒事故,必须及时向当地卫生行政部门报止。
If a medical treatment unit discovers a case of poisoning in relation to a drug, it must immediately report it to the department administering health in that area.

第四十九条药品生产企业和药品经营企业的药品检验机构或者人员,受当地药品检验机构的业务指导。
[Article 49] The drug-inspection body or personnel of a drug-producing enterprise or drug-handling enterprise will receive guidance in their professional work from the drug-inspection organ of that area.



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