浅析我国-药品管理法-对假劣药的界定.pdfVIP

　2004 年第 28 卷 　第 8 期 　第　　379 页 　 ·药事论坛 · 药学进展 Progress in Pharmaceutical Sciences 　2004 , Vol . 28 , N o . 8 　　　379 药事论坛 浅析我国《药品管理法》对假劣药的界定 赵 　健 , 　邵 　蓉 ( 中国药科大学 ,江苏 南京 2 10009) [摘 　要] 　修订后的《药品管理法》的一个重要特点就是扩大了假劣药定义的外延并加大了对制售假劣药品的处 罚力度 ,而要如实恰当地对违法行为量刑处罚 ,就必须对假劣药品赋以明确概念 。因此 ,界定假劣药品的意义十分 重要和必要 。以美国对不合格药品的划分为对照 ,探究我国对假劣药的界定及存在问题 ,并提出一些建议 。 [ 关键词] 　假药 ;劣药 ;界定 ( ) [ 中图分类号] 　R951 　　[文献标识码] 　C 　　[文章编号] 　1001 - 5094 2004 08 - 0379 - 03 Sample Int erpret ation of Definition of Adult erat e d Drug and Mi sbrande d Drug in Drug Mana gement Law ZHAO Jian , 　SHAO Rong ( China Pharmaceutical University , N anj ing 2 10009 , China) [ Abstract] 　A significant characteristic of the Revised Drug Administration Law is that it extends the defini tion of adulterated drug and misbranded drug , and increases the punishment of manufacturer and seller of them. Only by making a clear definition of adulterated drug and misbranded drug can we deal with illegal ac tivities accurately and properly . Therefore , it is particularly important and necessary to define adulterated drug and misbranded drug. This paper compares the definition of adulterated drug and misbranded drug of China with those of U . S. A . , probes into the problems of the definition in the Drug Administration Law , and makes some suggestions. [ Key words] 　Adulterated drug , Misbranded drug , Definition 　　药品是与人类生命和健康息息相关的特殊商品 , 因此对 1 　美国对不合格药品的有关规定 其质量的管理一直是我国药品监督管理工作的重要组成