对适用新修订《药品管理法》第一百一十七条第二款规定的探讨

Discussion on the application of the provisions of the second paragraph of Article 117 of the newly revised“Drug Administration Law”

新修订《药品管理法》自实施以来对促进医药产业发展、打击药品违法行为等方面起到积极促进作用。但在实际实施运用中会遇到一些政策不明、规定不细的情况,给药品监管执法人员带来困惑。特别是在适用该法第一百一十七条第二款时,存在较大分歧和争议。为落实“四个最严”要求、回应企业呼声和基层关切、更好把握该条款、统一尺度、维护公众利益和企业合法权益,本文对适用新修订《药品管理法》第一百一十七条第二款规定进行探讨。

The newly revised“Drug Administration Law”has played a positive role in promoting the development of the pharmaceutical industry and cracking down on illegal drug behaviors since its implementation.However,in actual implementation and application,some unclear policies and non-detailed regulations often confuse drug supervision and law enforcement personnel.Especially when applying article 117paragraph 2 of the law,there are huge disagreements and disputes.In order to implement the“four strictest”requirements and respond to the voices of enterprises and the concerns of the public,grasp the provisions better,unify the standards and safeguard the public interest and the legal rights of the enterprises,this paper discusses the application of article 117 paragraph 2 of the newly revised“Drug Administration Law”.