Blog posts


Avoiding deviations

Also of interest to QRD are the deviations between leaflets on the market and those user tested. In a retrospective review of all 2011’s marketing authorisation applications, 64 of the 83 leaflets appeared on the market with one or more "key readability factors" changed from the version tested (EMA defined the key factors as type size, type face, layout, leaflet size etc). Ten were identical, and nine were modified without changing readability factors. The presentation was made in open meeting, and it's clear that QRD will be looking for these sorts of deviations in the future. Moral: make sure the final version of your PL is user tested to avoid trouble from the EMA!