Bioequivalence and Bioavailability Forum

Dear all,
I have a question about a new formulation of vit D cholecalciferol capsule 50 000 UI : is it necessary to conduct a bioequivalence study to compare this new formulation with the reference drug vitamin D3 50 000 IU oral solution in ampoule ?
knowing that the producer of this generic formulation said that the clinical and non clinical studies can be waived for medicinal product with well established medicinal use according to articlr 10A in the DIRECTIVE 2001/ 83/EC of THE EUROPEAN PARLIAMENT
we don't have guideline in Algeria , but we follow FDA and EMA guideline, or I didnt find an answer to this question
thank you