IRIS Release Information - Week of 7 December (R2.3)

Posted Thu, 10 Dec 2020 09:33:53 GMT by Carlotte Lucas

The following update has been made to the IRIS platform:

1. Industry users can now edit the contact details in Regulatory Entitlements:

Three new fields have been added to all Regulatory Entitlements (RE) - "Contact Person for Entitlement" (this person must have an IRIS role), "Contact email for public enquiries" (any email acceptable), and "Contact phone for public enquiries" - which are editable from the "My Individual RE" and "My Organization RE" tabs.

Posted Tue, 19 Jan 2021 14:52:22 GMT by 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

Answer

Posted Wed, 20 Jan 2021 11:04:53 GMT by Paolo Tomasi EMA

The function is at present intended to support Orphan Designations only. The process will be expanded to allow self-management by Industry of the contact points for public enquiries regarding orphan designations, currently managed via the standard EMA website. While the process is being improved, sponsors of Orphan-designated medicinal products are welcome to update the data in the Industry portal.