Where the application concerns a veterinary medicinal product containing or consisting of genetically modified organisms within the meaning of Article 2 of Directive 2001/18/EC of the European Parliament and of the Council, the application shall, in addition to the information, technical documentation and summary listed in paragraph 1 of this Article, be accompanied by:
I gcás ina mbaineann an t-iarratas le táirge íocshláinte tréidliachta ina bhfuil orgánaigh ghéinmhodhnaithe nó atá comhdhéanta astu de réir bhrí Airteagal 2 de Threoir 2001/18/CE ó Pharlaimint na hEorpa agus ón gComhairle, beidh an méid seo a leanas ag gabháil leis an iarratas, sa bhreis ar an bhfaisnéis, ar an doiciméadacht theicniúil agus ar an achoimre a liostaítear i mír 1 den Airteagal seo: