EudraLex is the collection of rules and regulations governing medicinal products in the European Union.
[edit] 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:
- Miscellaneous:
- Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03)
[edit] Directives
[edit] See also
[edit] References
- Eudralex,The Rules Governing Medicinal Products in the European Union, European Communities Commission. Directorate-General for Industry, Pharmaceuticals and Cosmetics.
- Vol. 1: Pharmaceutical legislation: medicinal products for human use. ISBN 9282820327
- Vol. 2: Notice to applicants: medicinal products for human use. ISBN 011975780X
- Vol. 3: Guidelines: medicinal products for human use. ISBN 9282824365
- Vol. 4: Good manufacturing practices: medicinal products for human and veterinary use. ISBN 9282820297
- Vol. 5: Pharmaceutical legislation: veterinary medicinal products. ISBN 9282820378
- Vol. 6: Notice to applicants: veterinary medical products. ISBN 0119853515
- Vol. 7. Guidelines: Veterinary medicinal products. ISBN 0119853663
- Markus Hartmann and Florence Hartmann-Vareilles, The Clinical Trials Directive: How Is It Affecting Europe's Noncommercial Research?, PLoS Clin Trials. 2006 June; 1(2): e13
[edit] External links
