IMPStudy object

Yes

"Medicinal products” according to Art. 4 (1a) TPA:
“…products of chemical or biological origin which are intended to have or are presented as having a medicinal effect on the human or animal organism, in particular in the diagnosis, prevention or treatment of diseases, injuries and handicaps; blood and blood products are also considered to be medicinal products.”

In order to classify a "medicinal product" as an "investigational medicinal product" a sponsor must consider both its intended use: a pharmaceutical form of an active substance as test or reference standard, active comparator or placebo, & the objectives of the clinical trial such as: to discover or verify: (a) its clinical, pharmacological and/or other pharmacodynamic effects or (b) to identify any adverse reactions associated with its use or (c) to study its absorption, distribution, metabolism and excretion; with the objective of ascertaining its safety or efficacy,

Yes

The definition of a “clinical trial” is provided in Art. 3 HRA.

Clinical trial categories with a medicinal product pursuant to Art.19 KlinV/ClinO as of 01-01-2014:
Cat. A: Trials with medicinal products authorised in Switzerland, used according to the SmPC (Summary of Product Characteristics: indication, dose, population, etc.)
Cat. B: Trials with medicinal products authorised in Switzerland, not used according to the SmPC.
Cat. C: Trials with medicinal products not authorised in Switzerland.

Definitions for clinical trials with transplant products and ATMP are provided in Art. 21 and 22 KlinV/ClinO.
The website of KOFAM (Koordinationsstelle Forschung am Menschen) provides a tool for assessing the category of a trial. The EC (not Swissmedic!) are responsible to check if the category is correct.