10. Will a sample be considered for market availability as well?

No. Pursuant to Section 5b (7) of the Act No. 40/1995 Coll., on Advertising Regulation, as amended, samples of medicinal products may only be provided exceptionally to individuals authorized to prescribe them in a limited number for one calendar year at most. Every sample must correspond to the smallest pack of a humane medicinal product introduced to the market and must be labelled “Unsalable sample” or “Free sample”. Samples may not be used for a continuous treatment of patients, and patients themselves do not have any access to samples. In case of new pharmaceuticals in the market, samples of medicinal products are provided in order to test the new drug in practice.