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
ANVISACOFEPRISANMATINVIMADIGEMIDARCSAISPMINSA
Related terms
Translating this concept for a submission?
Send one document to Amavita and we'll return it with the correct terminology, certification, and formatting for the regulator you're targeting. No charge, no commitment.
Start your LATAM pilot