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新版《药品经营质量管理规范》与新修订《医疗器械监督管理条例》已正式施行,各地食品药品监管部门也都在重新审视法律法规的要求,提高原有药械零售经营的准入门槛。长期以来,在食品药品监管部门实施药品、医疗器械零售经营许可的过程中,对个体工商户的经营主体资格存在很大的争议,继而不可避免地对申请人(行政相对人)的权益产生影响。如何做到准入门槛的均衡与统一?为此,笔者回顾了药械零售经营许可的历史,同时对照国家有关规
The new version of “Good Manufacturing Practices” and the newly revised “Regulations on the Supervision and Administration of Medical Devices” have been formally implemented. Food and drug regulatory authorities across the country are also re-examining the requirements of laws and regulations and increasing the barriers to entry for the original retailers. For a long time, in the process of food and drug administrations carrying out licenses for the retail sale of pharmaceuticals and medical devices, there is a great deal of dispute over the qualifications of individual business operators, which in turn inevitably affects the rights and interests of the applicant (administrative counterpart) . How to achieve a balance of access threshold and unity? To this end, the author reviewed the history of drug retailers operating license, at the same time control the relevant state regulations