web
You’re offline. This is a read only version of the page.
close

  • Home
  • Forums
  • Products
  • PLM
  • Sign in
  • Home
  • Public Profile

Adriana Andric

Adriana Andric

Joined: 8/29/2022

  • Forum Posts
  • RE: Submission receipt notifications sent in error by IRIS for old, closed Paediatric procedures

    Mon, 08 Jul 2024 09:31:49 GMT – Submission receipt notifications sent in error by IRIS for old, closed Paediatric procedures
    Thank you for the clarification, much appreciated.
  • RE: Submission receipt notifications sent in error by IRIS for old, closed Paediatric procedures

    Fri, 05 Jul 2024 13:06:27 GMT – Submission receipt notifications sent in error by IRIS for old, closed Paediatric procedures
    Dear EMA IRIS Support Team,

    I would like to report that at least for one such case of migration of a closed PIP for which a notification was sent out yesterday, apart from the PIP becoming visible as a regulatory entitlement, a draft procedure request with the Submission Number identical to the previous PIP procedure number (in the format EMEA-00XXXX-PIP0X-XX) was automatically generated by the system as a draft submission, with the submission type being 'Modification of Paediatric Investigation Plan'.
    Could you kindly advise if such drafts are safe to be deleted, and that in doing so there is no risk of automatically deleting the corresponding regulatory entitlement.
    Thank you for your guidance.

© 2025. European Medicines Agency. All rights reserved.   Contact-Us   Report an issue with IRIS    Legal

For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.