EudraLex欧盟一系列关于药物规则和规章。

分册

EudraLex共分10册:

  • 有关人类用的药物分册:
    • 第1册 - 制药法例
    • 第2册 - Notice to Applicants.
      • 第2A册 deals with procedures for marketing authorisation.
      • 第2B册 deals with the presentation and content of the application dossier.
      • 第2C册 deals with Guidelines.
    • 第3册 - 指引
  • 有关动物用的药物:
    • 第5册 - 制药法例
    • 第6册 - Notice to Applicants.
    • 第7册 - 指引
    • 第8册 - 最大残留限制
  • 其他:
    • Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03)

指令

参见

参考资料

  • Eudralex,The Rules Governing Medicinal Products in the European Union, European Communities Commission. Directorate-General for Industry, Pharmaceuticals and Cosmetics.
  • Markus Hartmann and Florence Hartmann-Vareilles, The Clinical Trials Directive: How Is It Affecting Europe's Noncommercial Research?, PLoS Clin Trials. 2006 June; 1(2): e13

外部链接

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