EudraLex

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:
  • 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

• Drug development

External links

• EudraLex
• EUR-Lex
• Review of pharmaceutical legislation (EU DG Enterprise and Industry)
• Directorate General Enterprise and Industry (European Comission)