The Directives/Guidelines listed below represented the minimum standards by which EMVI conducts all its operations.
All entities with whom EMVI enteres into contractural agreements, partnerships, or otherwise collaborates and has dealings, is expected to adhere to the standards laid down in the following:
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.
All entities with whom EMVI enteres into contractural agreements, partnerships, or otherwise collaborates and has dealings, is expected to adhere to the standards laid down in the following:
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.