Good Manufacturing Practice

The directives and guidelines listed below represent the minimum standards that EVI follows for their 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,

    • Commission Delegated Regulation (EU) 2017/1569 of 23 May 2017 supplementing Regulation (EU) 536/2014

    • Commission Directive (EU) 2017/1572 of 15 September 2017 supplementing Directive 2001/83/EC

    • Commission Directive 91/412/EEC of 23 July 1991 for the principles and guidelines of good manufacturing practice for veterinary medicinal products.