Welcome

This forum is for IRIS Industry users' discussion and self-help. You need to login to the portal with an IRIS account to post a new thread or reply to an existing one.
EMA staff monitors the forum and may intervene in conversation, however a reply cannot be guaranteed. This Forum does not replace the existing communication channels:
  • Questions on ongoing procedures at EMA should be submitted as a reply to any email received from IRIS regarding the specific case.
  • Use this form to send a request for information from the European Medicines Agency or to make a formal request for access to EMA documents that are not already published on the EMA website
  • Problems and technical issues about IRIS should be reported to the EMA ServiceNow. If you have difficulties in obtaining a role or affiliation to access IRIS, please select "IRIS account access and management" as the service, in the specific ServiceNow page.
Please do not post confidential information in the forum.
Thread Author Last post Replies
How do I know when my IRIS Market status report baseline has been accepted, and other questions Margit Pelcman
Paolo Tomasi
1
Bulk Upload into IRIS isnt really Bulk Upload, it is per product Stephen Mackenzie
Virginia Rojo Guerra
1
Reason for Cessation in Marketing status report Sampada Tupe
Paolo Tomasi
6
11 reasons for cessation vs 8 in the guidance Stephen Mackenzie
Paolo Tomasi
3
Initial Submission Questions Stephen Mackenzie
Virginia Rojo Guerra
1
IRIS - Forced to put a "Marketing Status Change Date" in for a product we never launched Stephen Mackenzie
Virginia Rojo Guerra
1
Fields in Marketing Status Report not Present in Submission or Bulk Upload form Stephen Mackenzie
Virginia Rojo Guerra
3
Questions on access to IRIS for Product Contacts (for Inspections procedures) Paolo Tomasi
Paolo Tomasi
12
EAF Form Smita Annie Maliekal
Paolo Tomasi
1
How to change an IRIS Sponsor Contact Kathryn Brouder
Monica Gomar Mengod
3
IRIS for Inspections - materials from webinar Patrizia Oelker
Paolo Tomasi
2
Annual report - Other marketing authorisations Victor Säbb
Monica Gomar Mengod
1
How to amend assigned information under RPI - Products Monica Pagni
Paolo Tomasi
1
IRIS for Inspections - really live ? Patrizia Oelker
Paolo Tomasi
1
Proposing an IRIS Platform Map Viviana Mascilongo
Viviana Mascilongo
2
Export List of substances Nikoletta Sirivianou
Paolo Tomasi
1
Change in Sponsors Primary Contact Rainer Paffenholz
Kathryn Brouder
2
Wrong MAH address in IRIS Baptiste Rousseau
Paolo Tomasi
1
Translations of registered active substances for OMPD submission Liron Gibbs-Bar
Liron Gibbs-Bar
4
Use of RPI in paediatric submissions Susanne Hense
Joanna Summer
1

You must be signed in to post in this forum.