Question: 1 . In the EU , how soon after a Manufacturer / Responsible Person learns about a Serious Undesirable Event ( SUE ) must it

1. In the EU, how soon after a Manufacturer / Responsible Person learns about a Serious Undesirable Event (SUE) must it be reported to the national Competent Authority?
a.15 calendar days
b.15 business days
c.20 calendar days
d.20 business days

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