Commission Implementing Regulation (EU) No 520/2012 Article 24

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.

Read the full instrument → · Read this in context: CHAPTER III — Minimum requirements for the monitoring of data in the Eudravigilance database →

Other provisions in CHAPTER III — Minimum requirements for the monitoring of data in the Eudravigilance database

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗ · Data as of 2026-07-04

CitationArticle 24 of Commission Implementing Regulation (EU) No 520/2012 (LawPlayer, data as of 2026-07-04)

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