Investigational Medicinal Product (IMP)

EU: Clinical Trials Directive – An investigational medicinal product (IMP) is a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorisation but used or assembled (formulated or packaged) in a way different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form (As per Article 2(d) of Directive 2001/20/EC)

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