Preparation of Investigational Medicinal Product Dossier (IMPD)

The investigational medicinal product dossier (IMPD) provides information on each investigational medicinal product's quality, manufacturing and control, and data from preclinical and clinical trials with it. Presenting the data in tabular form is preferable, accompanied by a brief description highlighting the main aspects. Data on the quality of the investigational medicinal product shall be presented following a logical structure such as that of Module 3 of the Common Technical Document.