Marketing authorization
Regulatory approval to sell a medicine, device, or biologic in a country.
What it means
Marketing authorization is the formal approval granted by a national regulator to market a medicine, medical device, biologic, or other health product. The marketing authorization dossier includes administrative, quality, nonclinical, and clinical data, all translated into the local language where required by the regulator.
Why it matters for LATAM submissions
Marketing authorization is the commercial endpoint for product development. Translation delays or errors in the dossier directly delay revenue and market access.
Relevant regulators
ANVISACOFEPRISANMATINVIMADIGEMIDARCSAISPMINSA
Related terms
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