You’re offline. This is a read only version of the page.
Toggle navigation
Home
Forums
Products
PLM
Sign in
Home
IRIS Stakeholder Forums
General Discussion and self-help
Product specific waiver
Product specific waiver
Posted
Mon, 24 Mar 2025 17:35:19 GMT
by
Zdenka Benesova
There exists
PIP product specific waiver granted to another company that does not belong to our.
Do we have to apply again for this product specific waiver or can we refer to it?
Answer
Posted
Wed, 26 Mar 2025 21:32:11 GMT
by
Paolo Tomasi
EMA
The question is not completely clear, but it does not seem to be related to IRIS. Product-specific waivers (and Paediatric Investigation plans) are granted for specific conditions, they do not cover all possible indications and conditions for a given product. Please also consult available information in
Paediatric investigation plans | European Medicines Agency (EMA)
.
For more specific issues, please submit your question with as much detail as possible, to
Ask EMA.
You must be signed in to post in this forum.
