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. See also EC/540/95.
Commission Regulation (EC) No. EC/540/95 of 10 March 1995
laying down the arrangements for reporting suspected unexpected adverse reactions which are not serious, whether arising in the Community or in a third country, to medicinal products for human or veterinary use authorized in accordance with the provisions of Council Regulation (EEC) No 2309/93.
Council Directive 89/105/EEC of 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. See also 726/2004 below.
Commission Regualation No. 726/2004 31 March 2004
Commission regulation laying down the procedure to adopt the maximum amounts and the conditions and methods for collection of financial penalties imposed by the Commission under Regulation No. (EC) 726/2004 - see also 726/2004 above.
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. See also EC/540/95.
Commission Regulation (EC) No. EC/540/95 of 10 March 1995
laying down the arrangements for reporting suspected unexpected adverse reactions which are not serious, whether arising in the Community or in a third country, to medicinal products for human or veterinary use authorized in accordance with the provisions of Council Regulation (EEC) No 2309/93.
Council Directive 89/105/EEC of 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. See also 726/2004 below.
Commission Regualation No. 726/2004 31 March 2004
Commission regulation laying down the procedure to adopt the maximum amounts and the conditions and methods for collection of financial penalties imposed by the Commission under Regulation No. (EC) 726/2004 - see also 726/2004 above.