An application for the approval of a clinical trial shall be submitted in accordance with the applicable national law to a competent authority of the Member State in which the clinical trial is to take place.
Déanfar iarratas ar fhormheas ar thriail chliniciúil a chur faoi bhráid údarás inniúil de chuid an Bhallstáit ina mbeidh an triail chliniciúil ar siúl i gcomhréir leis an dlí náisiúnta is infheidhme.