Synonym(s)
Investigator Medicinal Product Dossier
DefinitionThis section has been translated automatically.
The Investigator Medicinal Product Dossier (IMPD) contains information on the quality and manufacture of the investigational product, toxicological and pharmacological studies, and data from previous clinical trials. According to the joint announcement of the BfArM (Federal Institute for Drugs and Medical Devices) and the Paul Ehrlich Institute, the IMPD must be submitted when applying for approval of a clinical trial.