
CANNABISONTOLOGY
Regulations, authorizations and activities of the sector, defined and connected.
Which authorizations does my company need to grow cannabis?
Cannabis cultivation
- requires
AE
Special Authorization
- may require
AFE
Company Operating Authorization
- requires
Health inspection
- may require
RNC · RENASEM
Registrations and approvals: RNC (National Cultivar Registry) and RENASEM (National Seed and Seedling Registry)
Why a cannabis ontology?
Not every cannabis oil sold in pharmacies with a prescription is a medicine.
Many of them reach the market as a “cannabis product” (produto de cannabis), a category Anvisa created with its own regulations, different from those that apply to drug registration.
For buyers, the difference is barely visible. For those who manufacture, import or inspect, it determines which requirements apply.
Each group that deals with the subject, from government agencies to doctors’ offices, uses these terms in its own way. The Cannabis Ontology fixes the meaning of each concept, shows where it comes from and gathers its alternative names. Whatever its source, each piece of information then has a single meaning.
What is the Cannabis Ontology?
An ontology describes, explicitly, how we understand a subject. It defines the concepts we use, what they mean, and the relations and rules that connect them. These definitions are written in a language that both people and programs can interpret.
In the Cannabis Ontology, we represent knowledge about the sector, from the powers of public agencies to the activities of companies and the requirements for products. This includes regulations, authorizations, obligations, prohibitions, exceptions, deadlines and responsibilities, along with the relations between them and the sources behind them.
Ontology
and powersAnvisa · Law No. 9,782/1999
RDC (Anvisa Collegiate Board Resolution) No. 80/2006
RDC No. 16/2014
RDC No. 1,012/2026
How triples form a graph
Each statement is recorded in three parts: subject, predicate and object. Here, cultivation has the purpose of research.
We can add other statements about this cultivation: which authorization it depends on, which conditions it must meet and which documents support those conditions. Triples connect through the elements they share and form a graph.
Can the same crop serve both research and medical purposes?
Yes, with conditions. Research and medical purposes can coexist in the same crop. This is provided for under the Special Authorization (Autorização Especial, AE) regime for cultivation in RDC No. 1,013/2026 (in Portuguese).
Conditions: plant material proven to produce total THC of 0.3% or less; compliance with the conditions set out in the research project; compliance with the other requirements of the regulation.
“Este cultivo pode ter a finalidade medicinal comercial, de pesquisa, ou ambos.”
“This crop may serve commercial medical purposes, research, or both.” (our translation)
Source: Anvisa, Orientações sobre o cultivo de cannabis (Guidance on cannabis cultivation, in Portuguese), section 2.2, page 11.