По силата на Член 33( 4) от Директива 2001/ 82/ EC с приетите изменения въпросът беше отнесен към Комитетът по ветеринарномедицински продукти (КВМП).
The reason for this was that the national competent authorities of Belgium and Norway considered that this medicinal product could present a potential serious risk to animal health on the ground that the efficacy has not been sufficiently substantiated in the dossier.