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.
- *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
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