I am drafting a PIP Annual report in IRIS and I have some issues with section "Forecast for submission of the (next) Marketing Authorisation applicant". Indeed, our RPI already has an authorisation product and no new MAA submission are in plan: however fields "Applicant's reason for changing the MAA forecast date / route / legal basis", "Foreseen legal basis of next MAA submission for this RPI" and "Foreseen eligibility basis of next MAA submission for this RPI" are mandatory and they do not include the option "Not applicable". So, we must choose an option in order to proceed with the submission of the application but the list does not include the proper one for our situation. How can we proceed?
Thanks and regards
Claudia