the obligation to provide within the time limit set at the request of a competent authority or the Agency any data demonstrating that the benefit-risk balance remains positive, as provided for in Article 58(9);
an oibleagáid chun aon sonraí a léiríonn go bhfanann an chothromaíocht sochair-riosca dearfach a sholáthar laistigh den teorainn ama a socraíodh ar iarratas ó údarás inniúil nó ón nGníomhaireacht, dá bhforáiltear in Airteagal 58(9);