Den medlemsstat, der gjorde indsigelse, fandt, at udstedelse af en markedsføringstilladelse kunne udgøre en sundhedsfare, fordi bioækvivalens kun var påvist fastende, ikke postprandialt.
The objecting Concerned Member States raised public health objections on the grounds that while bioequivalence was proven in the fasting state, the same was not the case under fed conditions.