IFU User consultation
During the planned Marketing Authorisation Application (MAA) a Readability User Test was performed on the proposed package leaflet. The package leaflet met all the predefined criteria.
Still in the D150 LoQ requested IFU testing, an additional RUT (2*5) on the IFU was requested by EMA.
In close colloboraton with the sponsor it was decided a full 2*10 RUT test on the IFU part of the PiL was sufficient to show consumers/users understood the IFU.
Therefor KHN deploys the Readability User test design as suggested in the EMA Guideline for IfU testing.
For more information or updates please contact us.
“Do not use if the liquid contains particles and make sure you check the label before you inject”