IMPStudy object

IMP - Definition available in national law

Yes

IMP - Definition

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 authorization 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.
Medicinal products with a marketing authorisation (MA) are classified as IMPs when they are to be used as the test substance or reference substance in a clinical trial, provided they are used or assembled (formulated or packaged) in a way different from the authorised form, or used for an unauthorised indication, or used to gain further information about the authorised form. On this basis, provided that the requirement(s) are met, reference products used as comparators should be considered as IMPs.

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