Guido Holzem Mr.

Thanks a lot for the detailed explanations. Nevertheless I have two additional questions that may be useful for a further interpretation of the "User" role for GMP inspections.
Referring to your above response to question 1 on the "User" definition it is well understood that the "User" is the product contact already mentioned in the application to EMA.

1. By "User" we mean the Product Contact for the application already notified to EMA, and the Portal Contact (a.k.a. Submission Contact) for the Marketing Authorisation Holder/Applicant.

Could you please confirm that for an existing registration the above referenced definition refers to the "Person authorized for communication between MAH and EMA", as provided in attachment 6.3 of the submission dossier (understood as the Submission Contact)? 
Furthermore, since the application  includes further contact persons e.g. "the authorized person for quality defects and batch recall" are there any plans to include this roles directly into IRIS for GMP inspections to allow a direct assignment?

Thanks in advance,

Guido