Article 23 Signal detection supportF1

The Agency shall support the monitoring of the Eudravigilance database by providing national competent authorities with access to the following information:

1. (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;

2. (b)

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

3. (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;

4. (d)

   statistical signal detection methods.

The Agency shall also ensure appropriate support for the monitoring of the Eudravigilance database by marketing authorisation holders.