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GM1 CAMO.B.125(b) Information to the Agency

ED Decision 2020/002/R

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

‘Safety-significant information stemming from occurrence reports’ means:

(a) a conclusive safety analysis which summarises individual occurrence data and provides an in-depth analysis of a safety issue, and which may be relevant for the Agency’s safety action planning; and

(b) individual occurrence data for the cases where the Agency is the competent authority and which fulfils the reporting criteria of GM3 CAMO.B.125(b).