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EudraLex
| European Union |
This article is part of the series:
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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:
- Miscellaneous:
- Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03)
Directives
See also
References
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This article is licensed under the GNU Free Documentation License. It uses material from the Wikipedia article "EudraLex". A list of authors is available in Wikipedia.
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