Investigational Medicinal Product

**Semantic type:** Conceptual Entity

**Definition:** A pharmaceutical form of an active ingredient being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use. Reference products and placebos are also considered investigational medicinal products in a clinical trial. [After E6(R2) Good Clinical Practice (GCP) -- Step 4 (final), 9 November 2016 -- Glossary]

**Synonyms:** - IMP - IMP - Investigational Product - investigational medicinal product - investigational medicine