Investigational Medicinal Product (IMP)

A pharmaceutical form of an active substance or placebo being tested, or to be tested, or used, or to be used, as a reference in a Clinical Trial, and includes a medicinal product which has a marketing authorisation but is, for the purposes of the trial –

a) used or assembled (formulated or packaged) in a way different from the form of the product authorised under the authorisation,

b) used for an indication not included in the summary of product characteristics under the authorisation for that product, or

c) used to gain further information about the form of that product as authorised under the authorisation.