# Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council (Text with EEA relevance), Article 23: Signal detection support

Extent: E+W+S+N.I.

The Agency shall support the monitoring of the Eudravigilance database by providing national competent authorities with access to the following information:
(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.
The Agency shall also ensure appropriate support for the monitoring of the Eudravigilance database by marketing authorisation holders.

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Source: https://www.legislation.gov.uk/eur/2012/520/article/23 (the official version)
Page: https://openlegislation.uk/eu-regulation-2012-520/article-23
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.