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GM1 ARGH.GEN.125(b) Information to be provided to the Agency

ED Decision 2025/006/R

MEANING OF ‘SAFETY-SIGNIFICANT INFORMATION STEMMING FROM OCCURRENCE REPORTS’

‘Safety-significant information stemming from occurrence reports’ means a safety analysis summarising individual occurrence data and providing an in-depth analysis of a safety issue, which may be relevant to the Agency’s safety-related action planning.

More information can be found in the Guidance Material to Regulation (EU) No 376/2014[9], specifically Section 4 ‘Competent authorities’ and in particular Section 4.3 ‘How is the information shared among the competent authorities?’.