EudraLex

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

Additional recommended knowledge

Daily Sensitivity Test

Essential Laboratory Skills Guide

Weighing the right way

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
• Directive 75/318/EEC
• Directive 75/319/EEC
• Directive 93/41/EEC
• Directive 2001/20/EC
• Directive 2001/83/EC
• Directive 2005/28/EC

See also

• European Union law
• European Union directive
• European Commission
• Directorate-General
• EUR-Lex
• Regulatory requirement
• Regulation of therapeutic goods
• International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
• Good clinical practice
• European Medicines Agency
• EUDRANET
• EudraVigilance
• Title 21 of the Code of Federal Regulations (USA)
• Drug development

References