Posted Mon, 19 May 2025 12:27:52 GMT by Pierre Bonsergent
Dear IRIS colleagues,

I am currently looking for some support to populate 2 parts of the section on "Scientific Information" in IRIS for a PIP where a (full) waiver is requested for all subsets of the paediatric population:
 
  1. Proposed date for completion of the PIP (must be the date of completion of the latest study/measure, or later) --> As a full waiver is requested, no measures are proposed for full waiver PIP. As you cannot put "NA" in this field, could you please let us know if putting 01/01/1900 is acceptable?
  2. Please provide details on each proposed study/measure (at least one), including appropriate key elements --> As above, no measures are proposed for a full waiver PIP. As the system is still requiring to populate this section, could you please inform what type of information should be provided there?
Many thanks in advance for your kind support.
 

Posted Mon, 19 May 2025 13:18:55 GMT by Paolo Tomasi EMA
The fields you mention should not be visible in a request for a product-specific waiver. Please check that the submission type selected for the draft submission is the correct one (Product-specific waiver) - from a check of IRIS it seems that the only draft submission in your name is an Initial Paediatric Investigation Plan, not a waiver. Please note that you cannot change the submission type after creation of a submission, you need to delete the existing one and create a new submission of the correct type if the initial submission type is incorrect. If there are further issues, please raise an incident in Report an issue with IRIS, mentioning the submission number.
Posted Mon, 19 May 2025 13:53:02 GMT by Pierre Bonsergent
Dear Paolo,
Many thanks for your kind feedback. 
It is indeed due to the wrong classification of the submission type. All fixed.
 

You must be signed in to post in this forum.