Last week, Brazilian policymakers announced plans to legalise the sale of medical Cannabis across the country. The country will become the third in Latin America, after Colombia and Uruguay, to make the move.
On Tuesday, ANVISA (the National Agency for Health Supervision) unanimously voted in favour of the regulation of Brazilian medical Cannabis. The new measures are expected to come into effect 90 days from the date of approval. ANVISA’s regulations were published in Brazil’s National Gazette.
In order to sell Cannabis products under ANVISA’s new regulations, producers must gain all necessary operating authorisations, including a Company Operation Authorisation (AFE) and a Special Authorisation (SA). All authorisations are granted by ANVISA. In addition, companies must also receive a Certificate of Good Manufacturing Practises.
All companies should also have technical data and information available to prove the quality and specification limits of the Cannabis products.
Brazil originally implemented legislation allowing medical Cannabis in 2015. However, products were only available through import with a strict license from ANVISA. This meant that few people were granted access to the medicines. Those that are granted a license often face a long wait for the product to be available.
Caroline Heinz, vice president of HempMeds Brasil, explained:
“This change will allow patients almost immediate access to CBD products – a huge difference from today where the process takes three months.”
The new regulations from ANVISA allows the sale of both CBD and THC-high Cannabis products via chemists and pharmacies across the country. However, domestic cultivation of the plant is still not permitted on a large scale. Only one company has successfully gained a license to import hemp seeds to grow plants with lower than 0.3%THC content.
All Cannabis products which will be available under the new regulations will require a prescription for purchase. Products that contain levels of less than 0.2% THC will be available on regular prescriptions. In comparison, products with higher levels of THC will only be available to patients of terminal illness. Patients who do not respond to traditional treatments for other conditions may also be prescribed high-THC products.
Home cultivation and possession of small amounts of Cannabis is decriminalised in Brazil. The new regulations may mean that Brazil beats Mexico to become the third Latin American country to legalise medical Cannabis.
