The sponsor shall identify all of the changes from the previous application together with a rationale for those changes, in particular, whether any changes have been made to address conclusions of previous competent authority or ethics committee reviews;
Sainaithneoidh an t-urraitheoir na hathruithe uile ón iarratas roimhe chomh maith leis an réasúnaíocht do na hathruithe sin, go háirithe, an ndearnadh athruithe ar bith le haghaidh a thabhairt ar na conclúidí a bhí ar na hathbhreithnithe a rinneadh roimhe ón Údarás Inniúil nó ón gCoiste Eitice;