the obligation to submit paediatric studies to the Agency, including the obligation to enter information on third country clinical trials into the European database, as provided for in Articles 41(1) and (2), 45(1) and 46(1) of Regulation (EC) No 1901/2006;
an oibleagáid staidéir phéidiatraice a thíolacadh don Ghníomhaireacht, lena n-áirítear an oibleagáid faisnéis i dtaobh trialacha cliniciúla tríú tíortha a iontráil sa bhunachar sonraí Eorpach, amhail dá bhforáiltear in Airteagal 41(1) agus (2), Airteagal 45(1) agus Airteagal 46(1) de Rialachán (CE) Uimh. 1901/2006;