The documentation submitted by the applicant shall cover all aspects of the safety and/or efficacy assessment of the product for the proposed indication in the target species using the proposed route of administration and dosage regimen.
Beidh tuairisc sa doiciméadacht a chuir an t-iarratasóir isteach ar gach gné de shábháilteacht agus/nó de mheasúnú éifeachtúlachta an táirge don tásc molta sa spriocspeiceas ag úsáid bhealach tabhartha molta an táirge agus an chórais dáileoige.