《药品管理法实施条例》第八十一条解析

Explanation and Analysis the 81^(st) Provision of Drug Administration Law Implementing Rules

目的通过对《药品管理法实施条例》第"八十一条"的详细分析,提出药事法规条文的完善建议,提高该条款在相关假劣药案件处理过程中适用的准确性。方法从合理行政、科学行政的角度出发,对"八十一条"适用过程中的假定要素、举证责任等问题进行探讨,对条款中有待完善之处进行深入解析。结果与结论"八十一条"在适用时应当充分考虑当事人的主观过错、相关证据以及违法行为与案件发生的关联性等因素;该条款虽具有相当的进步意义,但其立法初衷的实现还需要各级药监部门在执法实践中准确把握,还需要在下一轮修法中对其进行进一步的完善。

Objective Based on a detailed analysis of ＂the 81^st provision＂,suggestions have been put forward to improve laws of pharmaceutical affairs and the accuracy of ＂the 81st provision＂ in handling the relevant cases of counterfeit and inferior drugs.Methods From the point of reasonable and scientific administration,the paper discussed the such issues as assuming elements and burdens of proof,and had a in-depth resolution on points in need of further improvement.Results and Conclusion While applying ＂the 81^st provision＂,we should fully consider the parties＇ subjective faults,relevant evidence,and other elements associated with the legal cases.Though the provision have considerable progressive significance,in order to achieve its original intention of legislation,the drug administration department of all levels should apply this provision accurately in the legal practice,and further amendments should made to perfect the provision.