Cannabis law and legislation in Brazil

Medical use

Under Brazilian Federal Law, it is possible to import, manufacture and sell cannabis-based medicines. Previously, only the importation and sale were permitted subject to the authorisation of the Ministry of Health. 

The production and sale of cannabis-based medicines are now permitted. In order to produce and sell, the manufacturers must obtain a Certificate of Good Manufacturing Practice from the Brazilian National Agency for Sanitary Surveillance (ANVISA). The manufacturer must also obtain an operating permit, special authorisation and technical documentation on the product’s quality, as well as meeting other prior requirements imposed by ANVISA. The ANVISA authorisation enables manufacturers to sell to pharmacies across the country. The medicine can only be sold to patients with a medical prescription. 

With regard to importation, only one drug has been authorised for commercial importation. However, there is also a list of cannabis-based medical products that can be imported by patients directly if they have also been authorised to do so. Manufacturers may import cannabis extract or a semi-processed substate to produce medicines in Brazil, but not the plant itself or part of it. 

The use of CDB by patients is not prohibited in Brazil, though its use is limited, restricted and controlled by ANVISA. Patients treated with CDB must have a medical prescription stating the need to use it. As CDB is not produced in Brazil, it must be imported. It is usually prescribed to patients with severe illnesses that have no other satisfactory therapeutic alternative product registered in Brazil. 

It is not legal to grow cannabis in the country. The bill that previously authorised the manufacture of cannabis-based medicines in Brazil, also proposed to permit the growing of cannabis. However, that was rejected by ANVISA.

Due to restrictions on cultivating cannabis in Brazil, to enter the medical cannabis business in the country, it is necessary to import either the final medical product or the cannabis extract for manufacturing in Brazil. 

Recreational use

Brazilian Federal Law prohibits the plantation, cultivation and harvesting of drugs, except for medical or scientific purposes. Decree No. 9,761/19 prohibits the plantation, cultivation and importation of plants related to elicit drugs, unless formally and expressly allowed by the Federal Union.

Industrial use

There is no distinction made between industrial cannabis and the rest of the cannabis genus under Brazilian law. It is, therefore, prohibited to plant, cultivate or import the plant even for industrial purposes. It is, however, possible for individuals and companies to import cannabis-based products manufactured outside of the country, such as clothing. In this case, the concentration of both CBD and THC must be limited to 30mg/ml by Ordinance No. 344/98 of the Ministry of Health.

Patentability

It is possible to patent a cannabis-based product in Brazil. A pharmaceutical laboratory patented the first product using a CBD extract manufactured in the country in 2018.

Latest developments

On 3 December 2019, ANVISA approved a resolution authorising the manufacture and sale of cannabis medicines by pharmaceutical companies, but rejected the proposal to authorise the commercial cultivation of cannabis for medicinal and scientific purposes

Portrait of Ted Rhodes
Ted Rhodes
Partner
Rio de Janeiro
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Carolina Vaissman Uribe
Senior Associate
Rio de Janeiro