Dear All
My colleagues in regulatory affairs have several questions concerning the upcoming use of IRIS for marketing status reporting e.g. :
is it still planned to launch of marking status reporting in IRIS in the first week of December (this date is mentioned here in the forum)?
Will there be a staggered roll-out? Meaning the newly granted MA first, followed by older authorised CP products?
Will the launch data be available for the public?
Will the use become immediately mandatory or optional?
Will marking status data of CP products be migrated or do users have the enter all dates?
Will the same granularity be used as for the current EMA template/notification?
Will training to be offered?
Kind regards, Susanne