I know that we can submit protocol for a product registration only with an ANVISA inspection request. So a B-GMP is not more needed for a protocol submission.
However, could we submit a protocol for a product registration with a "MDSAP inspection request" requested to a Canadian Registrar (organism recognized by health canada) ?
Good question! The option to submit with the ANVISA inspection request is the only clear option. There?s no formal option right now in the case of using the alternative MDSAP route. So you cannot do it now. I?m not sure if ANVISA intends to change to include this option, for example, including the option in a revision of RDC 15. I will ask them when I have the change, but this may take time.