Investigational Medicinal Product Dossier

The Investigational Medicinal Product Dossier is the basis for approval of clinical trials by the competent authorities in the EU. The IMPD includes summaries of information related to the quality, manufacture and control of the Investigational Medicinal Product, data from non-clinical studies and from its clinical use. An overall risk-benefit assessment, critical analyses of the non-clinical and clinical data in relation to the potential risks and benefits of the proposed study have to be part of the IMPD. In certain situations, e.g. where the Investigational Medicinal Product has already been authorized as a medicinal product in one of the EU Member States or where clinical studies with the IMP have already been approved by a Member State, a simplified IMPD will be sufficient.