Where the Member State concerned finds that the clinical investigation applied for does not fall within the scope of this Regulation or that the application dossier is not complete, it shall inform the sponsor thereof and shall set a time limit of maximum 10 days for the sponsor to comment or to complete the application by means of the electronic system referred to in Article 73.
I gcás ina gcinnfidh an Ballstát lena mbaineann nach dtagann an t-imscrúdú cliniciúil a ndearnadh iarratas ina leith faoi raon feidhme an Rialacháin seo nó nach bhfuil sainchomhad an iarratais comhlánaithe, cuirfidh sé an t-urraitheoir ar an eolas faoin méid sin agus socróidh sé teorainn ama arb é 10 lá ar a mhéad í don urraitheoir chun barúil a thabhairt nó chun an t-iarratas a chomhlánú trí bhíthin an chórais leictreonaigh dá dtagraítear in Airteagal 73.