In accordance with the requirements of Guideline ST-N MoHU 42-7.1:2016 "Medicinal products. Bioequivalence studies" or CPMP/EWP/QWP/1401/98 Rev.1 Guideline on the Investigation on Bioequivalence, p. 4.3.2., the applicant is obliged to provide a statement confirming the absence of changes in the composition of the investigational medicinal product, in the manufacturing process, etc., that could affect the bioavailability of the claimed medicinal product.
