Puneet Varma (Editor)

EudraLex

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EudraLex

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

Contents

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:
  • Volume 4 - Good Manufacturing Practices.
  • Volume 9 - Pharmacovigilance.
  • 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

    • References

    EudraLex Wikipedia
    (Text) CC BY-SA


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