IMPStudy object

Yes

'Any pharmaceutical form of an active substance or placebo which is being tested or used as a reference in a clinical trial, including any product which already has a marketing authorization but is used, assembled, formulated or packaged in a way different from the authorized form, or is used in the trial for an unauthorized indication or to gain further information about the authorized form.'
Reference: Section 1(o) WMO (en)

Yes

‘An investigation intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of any investigational medicinal product, and/or to identify adverse reactions to any investigational medicinal product and/or to study the absorption, distribution, metabolism and excretion of any investigational medicinal product with the object of ascertaining its safety and/or efficacy.'
Reference: Section 1(n) WMO (en)