Where a variation entails consequential changes to the summary of the product characteristics, the labelling or the package leaflet, those changes shall be considered as part of that variation for the purposes of the examination of the application for a variation.
I gcás ina mbíonn athruithe iarmhartacha ar an achoimre ar shaintréithe an táirge, ar an lipéadú nó ar an mbileog phacáiste mar thoradh ar mhodhnú, measfar na hathruithe sin a bheith mar chuid den mhodhnú sin chun críocha scrúdú a dhéanamh ar an iarratas ar mhodhnú.