In duly justified cases, to meet unmet medical needs of patients, a marketing authorisation may, for medicinal products intended for the treatment, prevention or medical diagnosis of seriously debilitating or life-threatening diseases, be granted prior to the submission of comprehensive clinical data provided that the benefit of the immediate availability on the market of the medicinal product concerned outweighs the risk inherent in the fact that additional data are still required.
I gcásanna cuí-réasúnaithe, chun freastal ar riachtanais liachta othar nach bhfuiltear ag freastal orthu, féadfar údarú margaíochta, le haghaidh táirgí íocshláinte atá beartaithe chun cóireáil a dhéanamh ar ghalair thromchúiseacha dhíblitheacha nó is baol báis, nó chun na galair sin a chosc nó chun cuidiú lena ndiagnóisiú liachta, a dheonú sula ndéantar sonraí cliniciúla cuimsitheacha a chur isteach ar choinníoll gur mó go mór an tairbhe atá ag gabháil leis an táirge íocshláinte lena mbaineann a bheith ar fáil láithreach ar an margadh ná an baol a ghabhann leis an bhfíoras go bhfuil sonraí breise fós de dhíth.