Paolo Tomasi EMA

Problems and technical issues about IRIS should be reported to the EMA ServiceNow.

Resubmissions for PIP applications in clock-stop should be done in IRIS. The vast majority of PIP procedures in clock-stop have been migrated to IRIS, except a few that went in clock-stop after 1 May 2024. The migrated submissions should be visible in the IRIS Industry Portal under "Draft submissions" or "Ongoing submissions". If the submission is visible, it can be edited, completed and resubmitted there, and new documents can be uploaded directly. 

However, as usual in IRIS, procedures are only visible to the portal contact (and any other users associated to the submissions, but for migrated PIP applications there is only the portal contact). If the contact person of the originally submitted PIP has left the company, or does not have IRIS credentials, the submission will not be visible in the IRIS portal. Under these circumstances, applicants should proceed as follows:
 

1. The applicant should ensure that at least one individual is affiliated to the organisation with the role of "IRIS Industry Global Coordinator", as this role allows visualisation of all submissions from an organisation. The role and affiliation can be requested, as usual, in the EMA Account Management System.
    
2. The IRIS Industry Global coordinator should check the "Draft submissions" or "Ongoing submissions" to verify that the submission is present. If so, the Global Coordinator should add one or more new IRIS Industry Managers to the submission as applicable, and then assign the Portal Contact role for the submission to one of them.
    
3. If the submission is still not visible in IRIS to the IRIS Industry Global Coordinator, please Report an issue with IRIS. The request will be forwarded to the Paediatric Medicines Office staff at EMA, who will guide you on further steps. 

The list is not updated, as it is now available in the public access area of the IRIS portal, where you can download it as a CSV file from the Paediatric Register of PIPs and waivers. 

In principle, resubmissions for procedures in clock-stop should also be done in IRIS. The vast majority of cases in clock-stop have been migrated to IRIS and therefore the submission is visible in the IRIS Industry Portal under "Draft submissions" or "Ongoing submissions"; in such cases, the submission can be edited, and new documents can be uploaded directly. This applies for example to one of your submissions that went in clock-stop in October 2023. 

Some procedures that went in clock-stop recently (after 1 May 2024) are still in the process of being imported into IRIS; additionally, it is possible that the contact person (portal contact) needs an update. It is advisable to proceed as follows:
 

1. An IRIS user affiliated to the applicant with the role of IRIS Industry Global coordinator should check the "Draft submissions" or "Ongoing submission" to verify if the submission is present, and in this case add new IRIS Industry Managers to the submission as applicable, and change the Portal Contact if appropriate.
    
2. If the submission is not visible in IRIS, please Report an issue with IRIS, this will be forwarded to the Paediatric Medicines Office at EMA who will inform you of further steps. 

Please submit these questions in the other Forum, General Discussion and self-help · IRIS (europa.eu). This forum is intended only for communications from EMA to IRIS users. 

Please submit these questions in the other Forum, General Discussion and self-help · IRIS (europa.eu). This forum is intended only for communications from EMA to IRIS users. 

At present, changes of the public email address for interested parties done directly in the Regulatory Entitlement record in IRIS are not automatically copied also in the EMA website. Once a link to the Decision document and the columns for the email and telephone contact data for interested parties become available in the Register in the IRIS site, the paediatric decisions webpages in the EMA website will be discontinued. Until this happens, if you wish to update also the EMA website details, please inform us via AskEMA once the data have been updated in the IRIS portal, so that we can also update the EMA website. 

As mentioned in the previous answer, the case number is identical to the submission number, for cases with a single product. GMP Inspections however have more than one submission per case, and in that situation the case number is different from all the submission numbers. Applicants may always make reference to the submission number, as this is always related to a case, once the application has been submitted. The case number is not currently displayed in IRIS. Please raise a ServiceDesk ticket to request the inclusion of the case number in the IRIS portal, for GMP cases, or alternatively the inclusion of the submission number in the notification received. 

Please note that at the conclusion of a procedure of transfer of Marketing Authorisation, only the Authorisation Product is transferred to the new Marketing Authorisation Holder, but not the parent RPI of the Authorisation product. The owners of the RPI and of the child Authorisation Products do not need to be the same. To transfer the RPI, a specific procedure exists in IRIS; the procedure is completely automated, as it does not require an EMA Opinion or EC decision, and is completed in a few minutes. 

Please report this type of issues and requests via the EMA Servicedesk platform: Report an issue with IRIS.