EudraLex

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title: "EudraLex" type: doc version: 1 created: 2026-02-28 author: "Wikipedia contributors" status: active scope: public tags: ["european-union-health-policy", "european-union-law", "pharmaceuticals-policy", "national-agencies-for-drug-regulation"] description: "EU laws on medicinal products" topic_path: "law" source: "https://en.wikipedia.org/wiki/EudraLex" license: "CC BY-SA 4.0" wikipedia_page_id: 0 wikipedia_revision_id: 0

::summary EU laws on medicinal products ::

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

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,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.
  • Vol. 2: Notice to applicants: medicinal products for human use.
  • Vol. 3: Guidelines: medicinal products for human use.
  • Vol. 4: Good manufacturing practices: medicinal products for human and veterinary use.
  • Vol. 5: Pharmaceutical legislation: veterinary medicinal products.
  • Vol. 6: Notice to applicants: veterinary medical products.
  • Vol. 7. Guidelines: Veterinary medicinal products.
• 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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