suitable indicators and threshold values that shall be used in the continuous reassessment of the benefit-risk analysis and of the risk management as referred to in Section 3 of Annex I;
táscairí agus luachanna tairsí oiriúnacha a úsáidfear san athmheasúnú leanúnach a dhéanfar ar an anailís tairbhe-riosca agus ar an mbainistiú riosca dá dtagraítear i Roinn 3 d'Iarscríbhinn I;