For the purposes of this Article, “unmet medical needs” means a condition for which there exists no satisfactory method of diagnosis, prevention or treatment authorised in the Union or, even if such a method exists, in relation to which the medicinal product concerned will be of major therapeutic advantage to those affected.
Chun críocha an Airteagail seo, ciallaíonn “riachtanais liachta nach bhfuiltear ag freastal orthu” riocht nach ann d’aon mhodh diagnóise, coisc nó cóireála sásúil ina leith atá údaraithe san Aontas nó, fiú más ann do mhodh den sórt sin, riocht a mbeidh an táirge íocshláinte lena mbaineann ina mhórbhuntáiste teiripe do na daoine a bhfuil an riocht sin ag gabháil dóibh.