New guidance on medicinal products used in clinical trials

The EU Commission has published new guidelines for investigational medicinal products and other medicinal products used in clinical trials.

The document provides guidance on the definition of investigational medicinal products and the use of other medicinal products than investigational medicinal products used in clinical trials.

The guidance is available on the website of the European Commission under Eudralex, Volume 10, Clinical Trials, Chapter V, see the factbox to the right.

For further information, please contact Lene Grejs Petersen, telephone +45 4488 9305.

The Danish Medicines Agency, 11 May 2007