Paolo Tomasi EMA

For technical issues with IRIS, please Report an issue with IRIS in the EMA ServiceNow system. Please provide as much information as possible, including the procedure type, submission number, and relevant screenshots. 

When creating a new submission in IRIS, on behalf of a specific Location of a parent Organization, the system will show RPIs and Regulatory entitlements belonging to that location. For follow-up Scientific Advice, this is described in page 22 of the IRIS Guidance for Applicants. For this reason, it is recommended that all RPIs and all REs belonging to an Organization are transferred to a single location, which should be the one matching the legal seat of the organisation. This simplifies the creation of new submissions in IRIS. 

It was made publicly available today. Please use the EMA website link, as the YouTube URL may change again in a few weeks. 

The video has been temporarily set as private, since it required editing, but soon it will be made available as public again. Please try again on Monday, and let us know the outcome. 

The video recording of the System Demo Q4 2023 is available here. Please set resolution to 720p or 1080p for better quality/ The demo of IRIS for Paediatrics (Industry Portal) part starts at 1h08 min and lasts about 12 minutes.

The IRIS system currently does allow holders of Paediatric Regulatory entitlements to add/edit contact data for EMA and for interested parties, for PIP and waivers. However, for technical reason at present most Paediatric Regulatory entitlements are not assigned to the actual holder, but to EMA; therefore, they will not be visible to the holder until data are reconciled to the correct organisation and location ID. The reconciliation is foreseen to be completed by June next year.

There is the intention to create a "Paediatric register" similar to the already existing List of Opinions on Orphan Medicinal Product Designation in the IRIS public website, which would replace the information currently published in the standard EMA website. Until this happens, the standard procedure to amend contact information for interested parties remains unchanged.

The Quarterly Systems Demo on 19 December 2023 will include, among others, a brief preview of the development being done in IRIS for the submission of applications for Paediatric Investigation Plans and their modifications, Product-specific waivers, Compliance Check, Annual Reports on deferred measures, and other procedures managed by the Paediatric Medicines office and the Paediatric Committee. More information is available on the Quarterly System Demo webpage on the EMA website. 

Contact email and phone numbers for interested parties can be edited directly by the owner of the Regulatory Entitlement, in the IRIS Industry Portal under the "Org. Reg. Entitl." tab. The change should be immediately visible in the Orphan Register. The EMA standard website will contain references to the register, and the contacts will be removed from there eventually. There is no need to update both entries, the IRIS entry is sufficient. 

As an Industry Coordinator, you should be able to change the submission contact for a GMP Inspection, and to add Managers/Contributors to it. If this is not the case, please submit a ServiceNow ticket here: IRIS – Report an issue - Employee Center (service-now.com). 

Q&A updated 07 November 2023