bioavailability studies have demonstrated bioequivalence of a generic veterinary medicinal product with the reference veterinary medicinal product or a justification is provided as to why such studies were not performed;
léiríodh i staidéir bhith-infhaighteachta bithchoibhéis táirge íocshláinte tréidliachta cineálaigh leis an táirge íocshláinte tréidliachta tagartha nó cuirtear réasúnú ar fáil maidir leis an gcúis nach ndearnadh staidéir den sórt sin;