Bioequivalence and Bioavailability Forum

Hi...

With one Bio equivalence study dossier, is there any possibilities to submit the same dossier to other regulatory (if the innovator is same in the other regulatory) for marketing application?

For illustration I have conducted the study intended for USFDA ANDA submission, and submitted the same, and got approvals even, for marketing, then I want to market the same product in the Europe or Canada or any other regulatory, is it possible to submit the same to other regulatory? or I need to conduct the separate BE study? Kindly clarify, if possible.

Thanks & Regards,
B.K.RAO.