In that case, the variation or marketing authorisation application may refer partly to data submitted in a former marketing authorisation or variation applications, and should include new data specifically developed to support the required innovation of the existing product.
Sa chás sin, féadfaidh an t-iarratas ar mhodhnú nó ar údarú margaíochta tagairt a dhéanamh i bpáirt do shonraí a cuireadh isteach in údarú margaíochta roimhe sin nó in iarratais roimhe sin ar mhodhnú, agus ba cheart sonraí nua a bheith san iarratas sin a forbraíodh go sonrach chun tacú leis an nuálaíocht atá de dhíth ar an táirge atá ann cheana féin.