CHAPTER III

Minimum requirements for the monitoring of data in the Eudravigilance database

Signal detection support
Article 23
The Agency shall support the monitoring of the Eudravigilance database by providing national competent authorities with access to the following information:
1. 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. customised queries supporting the evaluation of individual case safety reports and case series;
3. 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. statistical signal detection methods.
The Agency shall also ensure appropriate support for the monitoring of the Eudravigilance database by marketing authorisation holders.
Regulation revoked in part (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 9 para. 1(t) (subject to transitional provisions in S.I. 2012/1916, Sch. 33A); 2020 c. 1, Sch. 5 para. 1(1)