veterinary medicinal products containing an active substance which has not been authorised as a veterinary medicinal product within the Union at the date of the submission of the application;
táirgí íocshláinte tréidliachta ina bhfuil substaint ghníomhach nach bhfuil ceadaithe mar tháirge íocshláinte tréidliachta laistigh den Aontas tráth a ndéantar an t-iarratas a chur isteach;