Within 60 days of receipt of the grounds for the request for re-examination, the competent authority, the Agency, the competent authority agreed in accordance with Article 65(3) or the competent authority in the reference Member State, as applicable, shall re-examine the points of the opinion or the assessment report identified in the request for re-examination by the marketing authorisation holder and adopt a re-examined opinion or assessment report.
Laistigh de 60 lá ó na forais leis an iarraidh ar athscrúdú a fháil, déanfaidh an t-údarás inniúil, an Ghníomhaireacht, an t-údarás inniúil arna chomhaontú i gcomhréir le hAirteagal 65(3) nó an t-údarás inniúil sa Bhallstát tagartha, de réir mar is infheidhme, athscrúdú ar phointí na tuairime nó na tuarascála measúnaithe arna sainaithint san iarraidh ar athscrúdú ag sealbhóir an údaraithe margaíochta agus déanfaidh siad tuairim athscrúdaithe nó tuarascáil mheasúnaithe a ghlacadh.