information on the variations introduced since the grant of the marketing authorisation by decentralised procedure laid down in Article 49(7) or by mutual recognition procedure laid down in Article 52(8);
faisnéis faoi na modhnuithe a tugadh isteach ó deonaíodh an t-údarú margaíochta leis an nós imeachta díláraithe arna leagan síos in Airteagal 49(7) nó leis an nós imeachta um aitheantas frithpháirteach arna leagan síos in Airteagal 52(8);