Regulations on medicinal products

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:

  • Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 On the Community Code Relating to Medicinal Products for Human Use.
    Amendments:
    Directive 2002/98/EC of 27 January 2003
    Directive 2003/63/EC of 25 June 2003
    Directive 2004/24/EC of 31 March 2004
    Directive 2004/27/EC of 31 March 2004
  • Council Regulation (EEC) No EEC/2309/93 of 22 July 1993
    Laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products.
  • Council Directive of 89/105/EEC 21 December 1988
    Relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems.
  • Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31 March 2004
    Laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.