Certificate of Pharmaceutical Product (CPP)
A WHO-format certificate issued by the exporting country's regulator, used to support foreign marketing authorizations.
What it means
The Certificate of Pharmaceutical Product follows the WHO Certification Scheme and attests to a product's registration status, GMP compliance, and labeling in the exporting country. LATAM regulators require an apostilled or consular-legalized CPP, translated by a sworn or authorized translator into the local language.
Why it matters for LATAM submissions
A missing apostille or a non-sworn translation of the CPP is one of the most common causes of a marketing authorization stopping at intake.
Relevant regulators
Deciding between an apostille, a sworn translation, or both for this document? Read the apostille vs. sworn translation guide for LATAM — it has a per-country table for all eight regulators.
Related terms
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