EudraLex

歐洲聯盟

本文是
歐洲聯盟的政治與政府
系列条目之一

EudraLex歐盟一系列關於藥物規則和規章。

分冊

EudraLex共分10冊:

  • 有關人類用的藥物分冊:
    • 第1冊 - 製藥法例
    • 第2冊 - Notice to Applicants.
      • 第2A冊 deals with procedures for marketing authorisation.
      • 第2B冊 deals with the presentation and content of the application dossier.
      • 第2C冊 deals with Guidelines.
    • 第3冊 - 指引
  • 有關動物用的藥物:
    • 第5冊 - 製藥法例
    • 第6冊 - Notice to Applicants.
    • 第7冊 - 指引
    • 第8冊 - 最大殘留限制
  • 其他:
    • Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03)

參見

參考資料

  • Eudralex,The Rules Governing Medicinal Products in the European Union, European Communities Commission. Directorate-General for Industry, Pharmaceuticals and Cosmetics.
    • Vol. 1: Pharmaceutical legislation: medicinal products for human use. ISBN 92-828-2032-7
    • Vol. 2: Notice to applicants: medicinal products for human use. ISBN 0-11-975780-X
    • Vol. 3: Guidelines: medicinal products for human use. ISBN 92-828-2436-5
    • Vol. 4: Good manufacturing practices: medicinal products for human and veterinary use. ISBN 92-828-2029-7
    • Vol. 5: Pharmaceutical legislation: veterinary medicinal products. ISBN 92-828-2037-8
    • Vol. 6: Notice to applicants: veterinary medical products. ISBN 0-11-985351-5
    • Vol. 7. Guidelines: Veterinary medicinal products. ISBN 0-11-985366-3
  • 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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