Where an interventional clinical performance study or another performance study involving risks for the subjects is to be conducted in more than one Member State, the sponsor should have the possibility of submitting a single application in order to reduce administrative burden.
Maidir le staidéar idirghabhálach ar fheidhmíocht chliniciúil nó staidéar eile feidhmíochta lena mbaineann rioscaí do na hábhair, i gcás ina mbeidh na staidéir le déanamh i níos mó ná Ballstát amháin, ba cheart an deis a bheith ag an urraitheoir iarratas aonair a thíolacadh chun an t-ualach riaracháin a laghdú.