Brazil’s health regulator grants Fiocruz approval to produce cannabidiol

RIO DE JANEIRO, BRAZIL – On Thursday, May 13, Fiocruz’s Institute of Technology in Pharmaceuticals was granted final approval by the Brazilian Health Regulatory Agency (ANVISA) to produce cannabidiol – a medicinal derivative of marijuana.

The institution is the third to be granted this permission in the country. Currently, in Brazil, only the pharmaceutical company Prati-Donaduzzi and the newcomer to the market Nunature were authorized to produce or commercialize products derived from marijuana.

Prati has cannabidiol in three versions in its pharmacies, and Nunature is expected to hit the shelves only in July.

Cannabidiol is only one of the components of the cannabis sativa plant. Research shows good results in refractory epilepsy in children, anxiety and insomnia.

The product receiving ANVISA authorization has 200 milligrams of the active substance per milliliter.

ANVISA’s authorization falls within RDC 327, from 2020, which in practice allows companies to extract the medicinal derivative of marijuana in Brazil, develop a product, and place it on pharmacy shelves, but they need to import the raw material. In other words, planting marijuana in Brazil is not allowed.

The authorization is only the first step in Fiocruz’s research plans with medicinal cannabis, as it is interested in becoming a supplier of cannabidiol for the country’s National Health System (SUS).

Source: Exame

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