Claudia Donnarumma

As expected, at the end of the validation phase of a paediatric procedure recently submitted via IRIS, the portal contact received the communication related to the start of this procedure. However, the portal contact received two identical emails just seconds away, which differ only in the number (XXXXXXXXXXXXX) reported at the end of the subject of the email. Indeed, the Submission number EMA/PE/XXXXXXXXXX included in the subject of both emails is the same, as well as all details included in the text of these two emails. May we kindly ask you to clarify what the final number refers to and why two different numbers are related to the same submission number? Thanks in advance for your feedback.

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