IMPStudy object

Yes

IMP (pursuant to Art 2 (2c) Pharmaceutical Law 2001:
"a substance or a combination of substances, which have been given an active substance or placebo pharmaceutical form, studied or used as a reference product in a clinical trial, including also a product already authorised for marketing but used or prepared differently than the form authorised for marketing, or used in a non-authorised indication, or used to obtain additional information concerning the forms which have already been authorised for marketing"

Yes

Clinical trial (pursuant to Art 2 (2) Pharmaceutical Law 2001 (en):
"each trial conducted in humans to discover or confirm the clinical, pharmacological, including pharmacodynamic, effects of action of one or more investigational medicinal products, or to identify the adverse reactions to one or more investigational medicinal products, or to monitor absorption, distribution, metabolism and excretion of one or more investigational medicinal products, taking into consideration their safety and efficacy;"

Clinical trials must be performed according to the Act of Pharmaceutical Law.
Clinical trials including humans must be performed according to the Physician’s Profession Act 1996.
Clinical trials must be performed according to the Good Clinical Practice.