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:
- Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03)