Commission Implementing Regulation (EU) No 520/2012Show full title

[F1 Article 23 U.K. Signal detection support

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.]

Textual Amendments

F1 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)