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.