Where the application is submitted in accordance with the national procedure set out in Articles 46 and 47, the applicant shall, in addition to the information, technical documentation and summary listed in paragraph 1 of this Article, submit a declaration stating that he or she has not submitted an application for a marketing authorisation for the same veterinary medicinal product in another Member State or in the Union and, if applicable, that no such marketing authorisation has been granted in another Member State or in the Union.
I gcás ina gcuirtear an t-iarratas isteach i gcomhréir leis an nós imeachta náisiúnta a leagtar amach in Airteagal 46 agus Airteagal 47, cuirfidh an t-iarratasóir isteach, sa bhreis ar an bhfaisnéis, ar an doiciméadacht theicniúil agus ar an achoimre a liostaítear i mír 1 den Airteagal seo, dearbhú ina maíonn sé nó sí nár chuir sé nó sí iarratas isteach ar údarú margaíochta don táirge íocshláinte tréidliachta céanna i mBallstát eile nó san Aontais agus, más infheidhme, nár deonaíodh údarú margaíochta den sórt sin i mBallstát eile nó san Aontas.