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)

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