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EudraLex is the collection of rules and regulations governing medicinal products in the European Union.



EudraLex consists of 10 volumes:

  • Concerning Medicinal Products for Human use:
    • Volume 1 - Pharmaceutical Legislation.
    • Volume 2 - Notice to Applicants.
      • Volume 2A deals with procedures for marketing authorisation.
      • Volume 2B deals with the presentation and content of the application dossier.
      • Volume 2C deals with Guidelines.
    • Volume 3 - Guidelines.
  • Concerning Medicinal Products for human use in clinical trials (investigational medicinal products).
    • Volume 10 - Clinical trials.
  • Concerning Veterinary Medicinal Products:
    • Volume 5 - Pharmaceutical Legislation.
    • Volume 6 - Notice to Applicants.
    • Volume 7 - Guidelines.
    • Volume 8 - Maximum residue limits.
  • Concerning Medicinal Products for Human and Veterinary use:
  • Miscellaneous:
    • Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03)


See alsoEdit


  • 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

External linksEdit