Commission Implementing Regulation (EU) No 520/2012 Article 38

Format of post-authorisation safety studies

Article 38

Protocols, abstracts and final study reports for non-interventional post-authorisation safety studies shall be submitted in the format set out in Annex III.

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Other provisions in CHAPTER VIII — Post-authorisation safety studies

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

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