EudraLex

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)

Posted in: EU