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
    • Directive 2008/29/EC of 11 March 2008
    • Directive 2009/53/EC of 18 June 2009
    • Directive 2010/84/EU of 15 December 2010
    • Directive 2012/26/EU of 25 October 2012
  • 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.
  • Regulation  (EC)  No  1901/2006  of  the  European  Parliament  and  of  the   Council  of  12  December  2006
  • Regulation  (EC)  No  1394/2007  of  the  European  Parliament  and  of  the   Council  of  13  November  2007
  • Regulation  (EU)  No  536/2014  of the European Parliament and of the Council by specifying principles of and guidelines for good  manufacturing  practice  for  investigational  medicinal  products  for  human  use  and  arrangements for inspections
  • Commission Delegated Regulation (EU) 2017/1569 of 23 May 2017 supplementing Regulation (EU) No 536/2014.