In response to a decision by the STJ (Superior Court of Justice), Anvisa (National Health Surveillance Agency) presented this Monday (26) a regulatory proposal for the production of medicinal cannabis in the country.
The document establishes standards for all phases of the process, from cultivation to research, and must be finalized by March 31st.
“This is an important stage in the process, a stage in which we have made great progress in dialogue with MAPA [Ministério da Agricultura e Pecuária]who was a great partner during this formulation and this discussion. Brazil has a register of crops and seeds”, explained Anvisa director Thiago Campos.
According to Anvisa, the proposal will be evaluated by the agency’s board next Wednesday (28). If approved, the resolutions become valid from the date of publication, with an initial validity of six months.
The regulations provide that the production of cannabis is permitted only for medical and pharmaceutical purposes and limited to legal entities.
Each production unit will be subject to inspection and will only be able to grow the quantity necessary to meet the demand for previously authorized medicines.
The THC content must be a maximum of 0.3%, and all batches produced will be subject to inspections.
“We are advancing in a very technical way in all these resolutions, with self-debate, with other discussions, and we understand that we are, in this sense, facing this issue and complying with this judicial demand”, said the director of Anvisa Leandro Safatle.
The text also defines limits for cultivation areas. Authorization will follow the criteria of the so-called “compatibility logic”, which prevents planting beyond the volume necessary to manufacture the authorized medicine.
When transporting products, Anvisa informed that there will be a partnership with the PRF (Federal Highway Police).
Data
The medical cannabis sector in Brazil had a significant performance in 2024, reaching revenues of R$853 million, which represents a growth of 22% compared to 2023, when the market generated R$699 million.
The information is part of the 3rd Yearbook of Medicinal Cannabis in Brazil, prepared by the consultancy Kaya Mind, which brings together all the revenue generated by the segment throughout the year.
Financial expansion was accompanied by an increase in the number of patients. According to consultancy estimates, around 672 thousand people used medicinal cannabis in 2024, compared to 431 thousand registered users in the previous year.
