Commission Implementing Regulation (EU) No 520/2012 Article 27

Individual case safety reports

Article 27

Individual case safety reports shall be used for reporting to the Eudravigilance database suspected adverse reactions to a medicinal product that occur in a single patient at a specific point in time.

Read the full instrument → · Read this in context: CHAPTER V — Transmission of reports of suspected adverse reactions →

Other provisions in CHAPTER V — Transmission of reports of suspected adverse reactions

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

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