Labeling (Primary and Secondary Packaging)
The regulated text and layout on the immediate container and outer carton of a medicinal product.
What it means
Labeling covers immediate containers (vials, blisters) and outer cartons. LATAM regulators require the local official language on every mandatory field: name, strength, dosage form, batch, expiry, storage, and manufacturer. Bilingual labeling is permitted in some markets but the local language must be primary.
Why it matters for LATAM submissions
Label mock-ups are reviewed field by field. A translation change late in the cycle can force re-approval and reprint, delaying launch by months.
Relevant regulators
ANVISACOFEPRISANMATINVIMADIGEMIDARCSAISPMINSA
Related terms
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