Brazil’s health regulator authorizes new cannabis-based medicine

RIO DE JANEIRO, BRAZIL – The Brazilian Health Regulatory Agency (ANVISA) on Friday authorized a new cannabis-based drug. The decision was released in a statement by the agency.

Alafiamed 200 mg/ml Cannabis Sativa Extract is obtained from the plant extract of Cannabis sativa, popularly known as marijuana.

The text says the drug is manufactured in Switzerland and will be imported and distributed in Brazil as a finished product ready for use. According to the agency, the drug will be available as a drop solution, containing cannabidiol (CBD) tetrahydrocannabinol (THC) – substances from the plant.

With this new approval, in all there are 9 cannabis-based products available in Brazil based on ANVISA’s resolution.

The agency reports that the composition of plant extracts is complex and may contain many active substances that act in different ways on the human body. Therefore, ANVISA emphasizes that there will be control and monitoring of these products by the Brazilian Health Surveillance System (SNVS).

“The absence of contaminants that may exist in plant extracts is also verified, carried out in detail by the manufacturing company and inspected by ANVISA, so that the safe use of these products can be guaranteed,” ANVISA says.

In 2019, a Gallup survey found that 1 in 7 adults in the United States used CBD-based products for a variety of health problems, including pain, inflammation, anxiety, seizures, and arthritis.

According to the Brazilian regulatory agency, the drug will be marketed in pharmacies and drugstores upon medical type B prescription (blue in color) – special for prescribing psychotropic drugs.

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