中药饮片执法程序正当与处罚得当的操作实务——某中药饮片有限公司生产销售劣药案的分析思考

Practices of Appropriate Enforcement Procedures and Penalties for Chinese Herbal Pieces-A Case Study of Certain Chinese Herbal Pieces Company Producing and Distributing Substandard Products

新修订《药品管理法》为药品管理提供了更加有力的法制保障,也对药品监督执法主体提出了更高的要求。本文通过对一起生产销售抽验不合格中药饮片案例的分析,从执法程序认定、中药饮片安全性有效性的事实认定以及法律适用等方面,结合新修订《药品管理法》从严的科学性和合理性有关要求,提出相应监管建议。

The newly-revised Drug Administration Law provides a more powerful legal guarantee for drug regulation,and sets higher requirements for regulators and enforcement officers.Based on a case study of production and distribution of substandard Chinese herbal pieces,this paper analyzes requirements of the Drug Administration Law and puts forward relevant suggestions from the aspects of law enforcement procedure identification,fact determination for the safety and effectiveness of Chinese herbal pieces and legal applicability.