les Nouvelles - March 2006

Optimizing Your Business Development Of Pharmaceuticals In The EU: Some Regulatory Changes You Should Know

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

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