随着药品监督管理工作的不断深入,基层药监部门在日常监管和实际执法中常常会遇到一些困难和困惑,表现在违法行为认定、适用法律、处罚依据等方面,《中华人民共和国药品管理法》(以下简称《药品管理法》)和《药品管理法实施条例》(以下简称《实施条例》)等药事法规及国家食品药 With the deepening of drug supervision and management work, the grassroots drug administration departments often encounter some difficulties and perplexities in routine supervision and actual law enforcement. They are manifested in the aspects of the determination of illegal activities, applicable laws and penalties, etc. The People’s Republic of China Drug Administration (Hereinafter referred to as the “Drug Administration Law”) and the “Regulations for the Implementation of the Drug Administration Law” (hereinafter referred to as the “Implementation Regulations”) and other pharmaceutical laws and regulations and the national food and drug