The directives and guidelines listed below represent the minimum standards by which EVI conducts all of its operations.
All entities with whom EVI enters into contractual agreements and partnerships, or otherwise collaborates and has dealings with, are expected to adhere to the standards that are laid down in the following documents:
- Commission Directive 2003/94/EC of 8 October 2003
Laying down the principles and guidelines of Good Manufacturing Practice (GMP) in respect of medicinal products for human use and investigational medicinal products for human use.
- EudraLex - Volume 4 Good Manufacturing Practice (GMP) Guidelines
The volume 4 of "The rules governing medicinal products in the European Union" contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use laid down in Commission Directives 91/356/EEC, as amended by Directive 2003/94/EC, and 91/412/EEC respectively.