Guidelines for good clinical practice

The European Commission has published the GCP directive 2005/28/EC on principles and detailed guidelines for good clinical practice as regards investigational medicinal products in connection with test preparations for human use and requirements, as well as the requirements for in connection with authorisation of the manufacturing for manufacture or import ation of such products. The directive is available at http://pharmacos.eudra.org/F2/pharmacos/new.htm under the date: 12/04/05.

For further information, please contact Lene Grejs Petersen on tel.: +45 4488 9305.

The Danish Medicines Agency, 19 April 2005