Posted Thu, 07 Jul 2022 06:09:36 GMT by Betina Berthelsen Regulatory Compliance Manager
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 ?
Posted Tue, 12 Jul 2022 07:27:07 GMT by Virginia Rojo Guerra
The Marketing Status in IRIS should only be reported for Centrally Authorised Product for Human use. National authorities from the individual member states may have specific requirements to report the Marketing status in their countries. National legislation should be followed for Nationally Authorized Products and those authorised with a Mutual Recognition Procedure (MRP), or a DeCentralised Procedure (DCP). 
Posted Wed, 13 Jul 2022 05:15:07 GMT by 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) ?
Posted Wed, 13 Jul 2022 07:24:52 GMT by Paolo Tomasi EMA
Dear Betina Berthelsen, this "followup" question is about a different issue altogether, and should be asked in a separate thread with an appropriate subject.

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