Betina Berthelsen Regulatory Compliance Manager

Thank you for your response. I just have a follow-up question regarding 'industry single point of contact (i-SPOC) for each organisation'. Can you confirm that this is only relevant to enter for Centrally Authorised Product for Human use ? industry single point of contact (i-SPOC) for each organisation' should not be entered for Nationally Authorized Products and those authorised with a Mutual Recognition Procedure (MRP), or a DeCentralised Procedure (DCP) ?

Are marketing status data to be entered in IRIS solely for products approved centrally via EMA procedure ? What about products approved nationally or via a MRP/DCP procedure ?