By way of derogation from point (b) of Article 8(1), in exceptional circumstances related to animal or public health, an applicant may submit an application which does not meet all requirements of that point, for which the benefit of the immediate availability on the market of the veterinary medicinal product concerned to the animal or public health outweighs the risk inherent in the fact that certain quality, safety or efficacy documentation has not been provided.
De mhaolú ar phointe (b) d’Airteagal 8(1), in imthosca eisceachtúla a bhaineann le sláinte ainmhithe nó sláinte phoiblí, féadfaidh iarratasóir iarratas a chur isteach nach gcomhlíonann ceanglais uile an phointe sin, dá mbeadh an sochar do shláinte ainmhithe nó don tsláinte phoiblí a bhainfeadh leis an táirge íocsláinte tréidliachta lena mbaineann bheith ar fáil ar an margadh láithreach níos mó ná an riosca a bheadh ann toisc nár cuireadh doiciméadacht cháilíochta, sábháilteachta nó éifeachtúlachta áirithe ar fáil.