In Brazil, Natural Health Products are a subset of drugs and are regulated by the Brazilian Health Ministry through Anvisa, the Brazilian Health Surveillance Agency.
Natural products or supplements are most likely to be classified as a category of medication. Each category is defined by the identity of the ingredients that make up a product, its intended use, daily dosage, recommended dose, and label. Depending on product classification, a notification or registration is legally required prior to importation and market access and is subject to application assessment fees. Anvisa makes all notifications and registrations publicly available.
Applicants are required to provide documentation to support safety, efficacy and quality. Safety and efficacy are primarily supported by clinical and pharmacopoeial evidence; traditional evidence is accepted for certain categories of medications. Quality is supported by submission of GMP/GMP-equivalence through the submission of an import permit application through a licensed importer.
There are nine possible categories of medications with their own subsets and rules. The complexity of this system can make Brazilian registration a true regulatory challenge. Contact us to find out how our firm can help you maneuver the road to Brazilian market access