Susanne Hense

Dear Carlotte,
thank you for this information.
May I ask you to provide definitions for these new data fields?
What is a contact for public enquiries in context of Authorised Products or Orphan Drug Designations?
Do you expect us to fill the contacts details retrospectively for all our REs?
In OD procedure the following data fields are available:
"E-mail address for general public enquiries (after designation)" and "Contact number for public enquiries"
Will contact details entered in OD procedure appear in RE in the OD list?
Kind regards, Susanne
 

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

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

Dear Carlotte,
thank you for this nice overview on what is new!
I did a transfer of a RPI - and it work well.

With the update of the "Regulatory Entitlement" tab the attribute "Status" is no longer available: now it is no more possible to distinguish between active or withdrawn applications.
Is it planned to add this attribute again?
Kind regards, Susanne

Thank you, Paolo!
For SPOR also the technical doucments are available on the SPOR homepage. Perhaps IRIS techincal documents could also be made public available on the nice new IRIS homepage?
Kind regards, Susanne

Where can I find the technical specification document for IRIS?