DE.AE-08 Incidents are declared when adverse events meet the defined incident criteria
StatementIncidents are declared when adverse events meet the defined incident criteria GuidanceApply incident criteria to known and assumed characteristics of activity in order to determine whether an incident should be declared GuidanceTake known false positives into account when applying incident criteria
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1.2 Requisitos identificados
1.3 Regulamentos relacionados
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3. Regulamentos relacionados
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