I have a few questions regarding the assignment and role of the Lead Marketing Authorization Holder (MAH) in the PSUSA procedure as per the EMA guidelines:

  1. Where should the assignment of the Lead MAH be captured? Is it required to be included in the XML delivery file?
  2. How and where will the Lead MAH be displayed within the IRIS system?
  3. Is there any change to the payment of fees due to the assignment of a Lead MAH? Specifically, will the fees still be divided among all the MAHs concerned proportionately to the number of chargeable units?
I would appreciate your clarification of the above points.