EudraLex
Sign in to saveEudraLex is the collection of rules and regulations governing medicinal products in the European Union.
In the Vinony graph
Vinony's link graph records 37 inbound references to EudraLex, and connects out to European Economic Community, clinical trial and presidency of the Council of the European Union.
It sits within the topics European Union health policy, European Union law and National agencies for drug regulation.
Vinony links it to 6 Wikipedia language editions.
~3 min read
Encyclopedic overview
5 sectionsContents
- Volumes
- Directives
- See also
- References
- External links
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)
Excerpted from Wikipedia’s “EudraLex” article, available under the CC BY-SA 4.0 licence.