the obligation to submit periodic safety update reports, in accordance with Article 28(2) of this Regulation in conjunction with Article 107b of Directive 2001/83/EC;
an oibleagáid tuarascálacha nuashonraithe tréimhsiúla maidir le sábháilteacht a thíolacadh, i gcomhréir le hAirteagal 28(2) den Rialachán seo arna léamh in éineacht le hAirteagal 107b de Threoir 2001/83/CE;