9.
Following notification of an occurrence, each organisation established in a Member State which is certified or approved by the Agency shall report to the Agency the details of occurrences collected in accordance with paragraph 2 as soon as possible, and in any event no later than 72 hours after becoming aware of the occurrence.
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Source: EUR-Lex (Cellar) · retrieved 2026-11-02 · Text as adopted (Official Journal); later amendments are not incorporated in this text.