Article 23: Signal detection support

(a)

data outputs and statistical reports allowing a review of all adverse reactions reported to the Eudravigilance database in relation to an active substance or a medicinal product;

(b)

customised queries supporting the evaluation of individual case safety reports and case series;

(c)

customised grouping and stratification of data enabling the identification of patient groups with a higher risk of occurrence of adverse reactions or with a risk of a more severe adverse reaction;

(d)

statistical signal detection methods.