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