试论药监部门能否依据《产品质量法》处理药品或医疗器械案件  

Study on Whether Drug Administration Department can Deal with Administrative Issues of Drugs or Medical Devices According to The Product Quality Law

作　　者：于培明[1] 冯项丽 

机构地区：[1]河南大学药学院医药法律研究所,开封475004 [2]河南省伊川县食品药品监督管理局

出　　处：《中国药事》2010年第11期1054-1057,共4页Chinese Pharmaceutical Affairs

摘　　要：目的探讨药监部门能否依据《产品质量法》处理药品或医疗器械案件,为正确适用法律法规提供参考。方法通过案例研究、探索性逻辑分析和法条分析方法,对相关产品之间的关系以及相关法律规定之间的关系进行解析,得出结论。结果与结论药监部门应当首先依据药品和医疗器械管理法律法规对药品和医疗器械案件进行处理;在药品和医疗器械管理法律法规没有规定或者规定不明确的情况下,可以适用《产品质量法》及其配套法律法规对药品或医疗器械案件进行处理。Objective To investigate whether drug administration departments can deal with administrative issues of drugs or medical devices according to The Product Quality Law and provide references for correct application of laws and regulations.Methods Case study,exploratory analysis and article analysis of laws and regulations were used.Results and Conclusion Firstly drug administration departments should deal with administrative issues of drugs or medical devices according to the laws and regulations on drugs and medical devices.If provisions in these laws and regulations do not provide clear guidance,drug administration departments can deal with these issues according to The Product Quality Law and related regulations.

关 键 词：药监部门 产品质量法 药品 医疗器械 案件 

分 类 号：R95[医药卫生—药学]