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.