Brazil approves oral CBD product under new rules

(A version of this story first appeared on Marijuana Business Daily International.)

Brazil’s health authorities have authorized a THC-free oral CBD product, an important milestone for the cannabis industry in Latin America’s largest economy.

The oral solution registered to Brazilian pharmaceutical giant Prati-Donaduzzi is the first medical cannabis product authorized for sale in Brazil under rules created in December 2019.

The solution contains 200 milligrams of CBD per milliliter.

The Paraná-based company promises to have the product available in pharmacies by mid-May.

Brazil does not allow hemp or marijuana cultivation, requiring Prati-Donaduzzi to import raw CBD extract before final manufacturing. Brazil also bans the use of synthetic active ingredients in cannabis products covered by the regulations.

Brazil already allowed the use of a prescription marijuana-derived treatment for multiple sclerosis, Sativex, produced by GW Pharmaceuticals in London.

The new Brazilian CBD product is sold in pharmacies but not regulated the same as other prescription drugs.

More information about the Brazilian rules for cannabis products can be found in Marijuana Business Daily International‘s previous analysis of the regulations here and here.

Alfredo Pascual can be reached at [email protected]

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