The directives and guidelines listed below represent the minimum standards by which European Vaccine Initiative (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 2005/28/EC of 8 April 2005
Laying down principles and detailed guidelines for Good Clinical Practice (GCP) as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.
- Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001
On the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of GCP in the conduct of clinical trials on medicinal products for human use.