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对现行药品经营市场准入法律制度的思考

Consideration of current legal system for market access of drug supplying

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对我国现行药品经营市场准入法律制度进行分析,认为现行法律在"药品经营企业"等相关名词术语的定义方面、GSP认证的强制性性质表述方面和市场准入程序的制度设计方面存在着立法缺陷.我国应修改现行药品管理法,明确"药品经营企业"等相关名词术语的具体含义,明确GSP认证的强制性性质并以GSP认证检查程序取代许可证验收程序.
By analyzing the Chinese current legal system for market access of drug supplying, this author concluded that there are some legislative defects included the definition of some terms such as "drug supplying enterprise", the expression of obligatory GSP inspection and the system design of legal procedure for market access in the current law .The congress should amend the current drug administration law to confirm the specific definition of drug supplying enterprise and correlative definitions and the obligatory character of GSP inspection. The drug administration law also should substitute the GSP inspection procedure for the inspection procedure of drug supply certificate.

drug supplyingmarket accesslegislative defects

李歆

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南京医科大学药学院,江苏南京,210029

药品经营 市场准入 立法缺陷

2008

国际医药卫生导报
中华医学会,国际医药卫生导报社

国际医药卫生导报

影响因子:0.781
ISSN:1007-1245
年,卷(期):2008.14(7)
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