SmPC / Bula
The Summary of Product Characteristics; in Brazil, the professional prescribing information is called the Bula.
What it means
The SmPC is the reference document for prescribers. In Brazil it is split into the Bula Profissional (for prescribers) and Bula Paciente (for patients), with mandatory ANVISA templates. In other LATAM markets, the equivalent is the Ficha Técnica or Prospecto.
Why it matters for LATAM submissions
Bula format is prescriptive: any deviation from the ANVISA template triggers a technical requirement. The Bula is also the reference for advertising claims, so translation choices persist for the product life cycle.
Relevant regulators
Related terms
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