IMPStudy object

IMP - Definition available in national law

Yes

IMP - Definition

The investigational medicinal product 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.
(pursuant to Art 2 (19) Law 7 May 2004)

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