Within 10 days of it receiving the application, the Member State concerned shall notify the sponsor as to whether the clinical investigation falls within the scope of this Regulation and as to whether the application dossier is complete in accordance with Chapter II of Annex XV.
Laistigh de 10 lá tar éis dó an t-iarratas a fháil, tabharfaidh an Ballstát lena mbaineann fógra don urraitheoir maidir le cibé acu an dtagann an t-imscrúdú cliniciúil laistigh de raon feidhme an Rialacháin seo agus maidir lena bhfuil sainchomhad an iarratais comhlánaithe i gcomhréir le Caibidil II d'Iarscríbhinn XV.