if the application is submitted in parallel with an application for a clinical trial in accordance with Regulation (EU) No 536/2014, reference to the official registration number of the clinical trial;
má dhéantar an t-iarratas a thíolacadh go comhuaineach le hiarratas ar thriail chliniciúil i gcomhréir le Rialachán (AE) Uimh. 536/2014, tagairt do chláruimhir oifigiúil na trialach cliniciúla;