Arcuri Consultoria

CANNABISONTOLOGY

Regulations, authorizations and activities of the sector, defined and connected.

Which authorizations does my company need to grow cannabis?

Cannabis cultivation

  1. requires

    AE

    Special Authorization

    Anvisa (Brazil’s Health Regulatory Agency)
  2. may require

    AFE

    Company Operating Authorization

    Anvisa
  3. requires

    Health inspection

    Local health authority
  4. may require

    RNC · RENASEM

    Registrations and approvals: RNC (National Cultivar Registry) and RENASEM (National Seed and Seedling Registry)

    MAPA (Ministry of Agriculture)

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.

Cannabis
Ontology
People, organizations
and powers
Anvisa · Law No. 9,782/1999
Activities and productsDrug prescription
RDC (Anvisa Collegiate Board Resolution) No. 80/2006
Regulations and authorizationsSpecial Authorization
RDC No. 16/2014
Obligations and conditionsKeep documentation
RDC No. 1,012/2026
representsrepresentsrepresentsrepresents

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.

SubjectCultivation
ObjectResearch
RDC No. 1,012/2026
Special Authorization
Keep documentation
Control and monitoring plan
Predicatehas purpose depends on regulates imposes involves
Cultivation is the subject, has purpose is the predicate and research is the object. Cultivation depends on Special Authorization (Autorização Especial). RDC No. 1,012/2026 regulates cultivation and imposes the obligation to keep documentation. That obligation involves a control and monitoring plan. The purpose and authorization relations summarize the context of the recorded obligations.

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.