IRImplementing rule
5.5Am I required report occurrences that happened outside of the EU?
5.5 Am I required report occurrences that happened outside of the EU?
| Key principle Occurrences should be reported even if they happen outside of the European Union. |
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IR — Regulation (EU) No 376/2014 · GM to Reg. (EU) No 376/2014 and its IRs · Occurrence Reporting Easy Access Rules · EAR revision 27 Sep 2023