The document discusses the requirements and contents of an Investigational Medicinal Product Dossier (IMPD) which provides information on the quality, manufacture, and control of investigational medical products (IMPs) used in clinical trials in the European Union. An IMPD includes summaries of nonclinical and clinical data and is required for authorization to perform clinical trials in EU member states. It must provide an overall risk-benefit assessment of the proposed trial based on nonclinical and clinical analyses. A simplified IMPD may be acceptable in some cases such as if the IMP is already authorized. The IMPD covers quality data, nonclinical pharmacology and toxicology data, previous clinical experience, and an overall risk assessment.