Dear IRIS Support Team,
I am currently completing a PIP waiver application in IRIS and need clarification regarding the Research Product Data Update section, specifically the information required in the field:
“Forecast for submission of the (next) Marketing Authorisation application for this RPI.”
The planned registration procedure is the decentralised procedure (DCP), and the legal basis is:
Fixed combination application (Article 10b of Directive 2001/83/EC).
However, none of the available options in the field: “Foreseen eligibility basis of next MAA submission for this RPI” seem applicable to this type of application. Unfortunately, there is no “Not applicable” option available either.
Could you please advise what the Applicant should select in this case?
Thank you in advance for your support.