欧盟兽药注册管理体系初探

Study on European Union system of Veterinary Drug Marketing Authorisation

关键词:  欧盟  兽药  注册  初探

Key words:  European Union  veterinary durg  marketing authorisation  study

摘要:

通过从立法基础、管理机构、注册模式、注册资料和注册后监管等方面介绍欧盟兽药注册管理体系，思考我国现行兽药注册管理体系存在的问题，并提出合理化建议。

Abstract:

The problems of veterinary drug marketing authorization in china are analysed and effective suggestions are proposed through the studies on the European Union system of veterinary drug marketing authorization from the aspects of legislation, regulatory authority, authorization procedure, dossier requirements and post-authorization procedures.