Paule Drouault-Gardrat
Juliette Peterka
In March 2004, the EU adopted a package reforming the European pharmaceutical legislation comprising Directive 2001/83/EC of 6 November 2001 of the Community code relating to medicinal products for human use and Regulation 2309/93/EC of 22 July 1993 establishing Community procedures for the authorization (the centralized procedure) and supervision of medicinal products for human and veterinary use and establishing the EMEA