Marketing Status Reporting

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

Please find our responses to your questions:

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)?
No. we do not have yet a fixed launch yet but we intend to launch I QTR 2021

Will there be a staggered roll-out? Meaning the newly granted MA first, followed by older authorised CP products?
Yes. We plan a staggered approach to be presented and discussed with Industry associations on EMA industry Platform meeting on centralised procedure on 3rd Dec 2020.

Will the launch data be available for the public?
The data will not be publicly available.

Will the use become immediately mandatory or optional?
There is a legal obligation to report marketing status to EMA. This constitutes a new way of reporting the marketing status to EMA.

Will marking status data of CP products be migrated or do users have the enter all dates?
Users will require to enter a baseline data for authorized products. These details are intended to be discussed and agreed with Industry associations on 3rd December

Will the same granularity be used as for the current EMA template/notification?
The level of granularity is similar.

Will training to be offered?
The system for data entry is very intuitive, similar to all other IRIS submissions. The IRIS guidance is being updated to include information on the new procedures. If needed, training could be considered.

 

Thank you very much for this fast and comprehensive answer :-)