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Karin Vandenborre

Karin Vandenborre

Joined: 6/14/2019

  • ZIP files for Day +25 via IRIS

    Fri, 11 Jul 2025 15:06:50 GMT – ZIP files for Day +25 via IRIS
    We noticed that there seems to be a discrepancy relating to the submission of the full set of annexes at Day +25 via IRIS.
    According to the "QRD Form 2" full set of annexes should be provided in 1 ZIP folder (containing the 25 languages).
    Linguistic review - Human | European Medicines Agency (EMA)

    However according to the "IRIS guide for the applicants" ZIP folders should only be used for references and other files should be submitted individually.
    iris-guide-applicants-how-create-submit-scientific-applications-industry-individual-applicants_en.pdf
    Can you please confirm we can submit the PI's at Day +25 in ZIP files.

    Looking forward to your feedback.
    Kind regards.
    Karin Vandenborre