EudraLex

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

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Volumes

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)

Directives
  • Directive 65/65/EEC1, requires prior approval for marketing of proprietary medicinal products
  • Directive 75/318/EEC, clarifies requirements of 65/65/EEC1 and requires member states to enforce them
  • Directive 75/319/EEC, requires marketing authorization requests to be drawn up only by qualified experts
  • Directive 93/41/EEC, establishes the European Agency for the Evaluation of Medicinal Products
  • Directive 2001/20/EC, defines rules for the conduct of clinical trials
  • Directive 2001/83/EC
  • Directive 2005/28/EC, defines Good Clinical Practice for design and conduct of clinical trials

See also

References
  • 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
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