A 74-page Anvisa document details authorizations, MAPA requirements, import, traceability, and THC control provided for in the new rules.
The National Health Surveillance Agency (Anvisa) has released the first edition of the guide “Guidelines for the implementation of RDCs No. 1,012 and No. 1,013/2026.” This 74-page document outlines the steps for legalizing the cultivation of *Cannabis sativa* L. by legal entities in Brazil.
Developed by Anvisa and the Ministry of Agriculture and Livestock (MAPA), the material compiles guidelines regarding Special Authorization, cultivar registration, access to seeds and seedlings, importation, exportation, traceability, and THC content monitoring.
The guide is primarily intended for companies and institutions interested in cultivation, but it may also be consulted by health authorities, public agencies, and professionals involved in the implementation and oversight of these activities.
The publication emphasizes that these guidelines do not replace the need to consult Anvisa and MAPA regulations, nor do they waive other legal, sanitary, agricultural, environmental, or administrative requirements applicable to specific projects.
Guide distinguishes between cultivation for research and medicinal purposes
The first step outlined in the material is to identify which of the two regulations applies to the project. The classification depends on the purpose of the cultivation, the profile of the legal entity, and the characteristics of the plant material.
RDC No. 1,012/2026 regulates cultivation intended exclusively for research and permits varieties with any THC content. However, authorization is restricted to:
Public scientific, technological, and innovation institutions;
Higher education or technical institutions recognized by the Ministry of Education;
State defense or drug enforcement agencies or institutions;
Establishments holding Special Authorization to manufacture pharmaceutical inputs or medicines.
In contrast, RDC No. 1,013/2026 regulates the cultivation of varieties proven to produce THC at a concentration of 0.3% or less. The material may be intended for research or for use as raw material for medicines, cannabis products authorized by Anvisa, and medicinal products regulated by MAPA.
Both resolutions address cultivation carried out by legal entities. According to the guide, these regulations do not provide for cultivation by individuals.
Authorization depends on sanitary inspection
Cultivation may only begin after Anvisa grants the Special Authorization and requirements set by MAPA, local sanitary surveillance authorities, and other competent bodies are met.
Before requesting authorization, the establishment must:
Define the cultivation project and purpose;
Develop a Control and Monitoring Plan;
Prepare the physical and operational infrastructure;
Gather technical and administrative documentation;
Request an inspection from the local sanitary authority;
Obtain a favorable inspection report;
File the Special Authorization request via the *Solicita* System.
A favorable report from the local sanitary surveillance authority does not automatically grant the authorization; it is a mandatory document required for Anvisa to review the application.
For new authorizations, the application codes are 71000 (for research cultivation) and 71001 (for medicinal or research cultivation with THC levels of 0.3% or less). Companies that already hold a Special Authorization must request an expansion using codes 71002 or 71003.
Cultivation authorization covers up to the herbal drug stage
The guide also defines the scope of the Special Authorization. It permits the cultivation cycle—starting with seeds, seedlings, cuttings, clones, or other propagation materials—to proceed up to the point of obtaining the herbal drug.
The authorization does not automatically cover subsequent activities, such as the extraction or manufacturing of:
Oils and extracts;
Fractions and isolated substances;
Phytopharmaceuticals;
Active pharmaceutical ingredients (APIs);
Cannabis products;
Medicines. To carry out these steps, the company must include the corresponding activities in its Special Authorization and meet specific sanitary requirements.
The cultivation authorization does not permit the direct transport of the material. The establishment must hold a specific authorization to transport controlled products or contract a duly authorized carrier.
Cultivars must also comply with MAPA regulations.
After obtaining authorization from Anvisa, the establishment must verify the registrations and clearances required by MAPA. The two main instruments are the National Cultivar Registry (RNC) and the National Registry of Seeds and Seedlings (Renasem).
Cultivars intended for medicinal or pharmaceutical production must be registered in the RNC and demonstrate THC production of 0.3% or less. For materials used exclusively in research, RNC cultivar registration is not required.
Registration with Renasem is required for producers of seeds, seedlings, or other propagation materials intended for supply to third parties, as well as for importers. The production of propagation material…
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