对“两票制”下境外药品国内总代理视同生产企业的思考——来自《药品管理法》第六条、第三十八条的启示

Thinking on the domestic general agent of overseas drugs as a manufacturer under the Two Invoice System

“两票制”政策下将境外药品国内总代理视同境内药品生产企业,解决了境外药品“两票制”认定起点问题并将其确定为集中采购投标/挂网主体,但这一政策安排所面临的问题也值得我们进一步思考。通过对所面临问题进行研究分析,根据2019版《药品管理法》相关规定,结合实践,对境外药品“两票制”认定提出建议与完善思路,供决策参考。

Under the Two Invoice System,the domestic general agent of overseas production of drugs is regarded as a domestic pharmaceutical manufacturer,it solves the problem of definition of Two Invoice System and determines it as the main body of centralized procurement bidding/online connection.However,the problems faced by this policy are also worthy of further consideration.Based on the research and analysis of the problems faced,combined with the provisions of Pharmaceutical Administration Law of 2019,this paper put forward suggestions and improvement ideas on the definition of Two Invoice System of overseas production of drugs,which can be used as a reference for decision-making.