NOM-012
Mexico's official standard for pharmacovigilance, including safety reporting in Spanish.
What it means
NOM-012 (Norma Oficial Mexicana) sets the requirements for pharmacovigilance in Mexico. It includes standards for collecting, reporting, and documenting adverse events and safety data. Spanish translations of SAE/SUSAR narratives and safety updates must align with NOM-012 terminology.
Why it matters for LATAM submissions
Pharmacovigilance documents are subject to both regulatory review and audit. NOM-012-aligned Spanish reduces the risk of safety-report queries and inspection findings.
Relevant regulators
COFEPRIS
Related terms
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