CHAPTER III

Minimum requirements for the monitoring of data in the Eudravigilance database

Signal detection audit trail
Article 24
1
The national competent authorities and the Agency shall keep an audit trail of their signal detection activities conducted in the Eudravigilance database and of the relevant queries and their results.
2
The audit trail shall allow traceability of how signals have been detected and of how validated and confirmed signals have been assessed.
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)