a reference to the relevant parts of the clinical evaluation report referred to in Section 4 and to the risk management referred to in Section 3 of Annex I;
tagairt do chodanna ábhartha na tuarascála ar an meastóireacht chliniciúil dá dtagraítear i Roinn 4 agus don bhainistiú riosca dá dtagraítear i Roinn 3 d'Iarscríbhinn I;