Vidya Narayanaswami

Hello, I had a follow up question with regard to practical examples provided in the European Medicines Agency policy on changes in scope of paediatric investigation plan (PIP) decisions. The guidance states that-"For marketing authorisation applications subject to article 7 of the Paediatric Regulation, if separate PIP Decisions covering different conditions have been agreed, for example a PIP decision for condition
A and a PIP decision for condition B, and the applicant decides at a later stage to apply for marketing authorisation for conditions A and B simultaneously, then a consolidated Decision covering conditions A
and B would need to be submitted."       

If consolidation of PIP decision for 2 separate conditions A and B is needed, how does one  approach such a modification procedure for  cross reference/consolidation of PIPs in IRIS?