Package Insert / Prospecto
The patient-facing leaflet included with a medicinal product, translated into the local official language.
What it means
The package insert (Prospecto in Spanish-speaking LATAM, Bula Paciente in Brazil) must be in the country's official language and follow readability requirements. It derives from the SmPC and must remain consistent with labeling and advertising materials.
Why it matters for LATAM submissions
Readability testing is increasingly enforced. A literal translation that fails plain-language expectations can require a full retest cycle before approval.
Relevant regulators
ANVISACOFEPRISANMATINVIMADIGEMIDARCSAISPMINSA
Related terms
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