摘要
通过分析上市持有人与流通企业在不同的商业模式、资质确认、药品溯源、药品信息披露、损害赔偿、行政处罚等方面不同的质量职责,提出了药品上市许可人制度已经改变了现有供应链分工模式,需进一步在法律法规中对这些质量职责进行明确,确保上市持有人制度对供给侧改革的积极效应。
It is realized that the supply chain division pattern has been changed due to implementation of marketing authorization holder system based on analysis of the different quality responsibilities of marketing authorization holder and pharmaceutical distribution enterprise in different commercial models, qualification confirmation, drug traceability, drug information disclosure, damage compensation and administrative penalties.These duties need to be further clarified in the laws and regulations so as to guarantee its positive effect on supply-side reform.
出处
《上海医药》
CAS
2017年第15期58-60,94,共4页
Shanghai Medical & Pharmaceutical Journal
关键词
药品上市持有人
流通企业
质量职责
供给侧改革
marketing authorization holders
pharmaceutical distribution enterprises
responsibilities
supply-side reform
