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Sonia Ouarti

Sonia Ouarti

Joined: 12/19/2022

  • Worksharing - High Level Submission Number and procedure tracking number

    Mon, 30 Jun 2025 07:00:53 GMT – Worksharing - High Level Submission Number and procedure tracking number
    In case of worksharing, can we use the same number - across all applications - in eCTD envelope of M1 for “High Level Submission Number “ and “procedure tracking number” ? 
    Example EMA/VR/0000123456 will be assigned in “High Level Submission Number “ and “procedure tracking number” in all applications of the WS.
    According to EU eCTD M1 Specification version 3.1.1 - individual tracking numbers cannot be the same across applications : “In case of worksharing […], a separate eCTD submission must be built for each MA covered by the variation. In the envelope of each of the eCTD submissions, the high-level submission number will be the same, but the individual tracking numbers listed here should be specific to the MA in question”
     

  • Procedure Tracking Number in EU M1 envelope - IRIS number

    Fri, 07 Mar 2025 09:45:07 GMT – Procedure Tracking Number in EU M1 envelope - IRIS number
    At time of submission (submission unit = initial), the final submission number generated by IRIS is not yet known.
    Question : In EU M1 envelope, field “procedure tracking number”, should we indicate :
    • EMA/VR/0000XXXXXX    
    • Or is the previous format still accepted ? eg EMEA/H/C/000123/II/xxxx

    Thank you for your answer