Requerimiento
A formal deficiency letter from a LATAM regulator requiring the sponsor to respond within a set timeline.
What it means
A requerimiento (or exigência in Brazil) is a written technical requirement issued by a regulator during review. It suspends the review clock and typically has a 30- to 90-day response window. Translation-related requerimientos are among the most common categories.
Why it matters for LATAM submissions
Every requerimiento adds calendar time. Translation-caused ones are avoidable; regulator counts of them per sponsor influence future review posture.
Relevant regulators
COFEPRISANMATINVIMADIGEMIDARCSAISPMINSA
Related terms
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