Regulatory Restructuring of medical cannabis by Anvisa
By Bernadete de Figueiredo Dias, Bruna Morais Conceição, Maria Vitoria Barbosa de Castro and Thais Amaral Fernandes.
Today, February 3, 2026, ANVISA published RDCs No. 1,013/2026, 1,014/2026, and 1,015/2026 a new regulatory framework for medical cannabis in Brazil, with rules that now govern the entire production chain—from cultivation to traceability—and expand access for patients. The initiative complies with a decision by the Superior Court of Justice (2024) and represents a significant step forward for the development of the medical and pharmaceutical sector in the country.
In addition, the Agency repealed RDC No. 327/2019 through Article 75 of 1.015/2026, expanding the routes of administration, authorizing the sale of products in compounding pharmacies, and easing access to medications with higher THC content, which contributes to an increase the therapeutic alternatives available to patients.
Has cannabis cultivation been authorized in Brazil?
Yes. For the first time, ANVISA has authorized the cultivation of cannabis in Brazil, exclusively for medicinal and pharmaceutical purposes. Authorization is restricted to legal entities, including companies, universities, and legally constituted patient associations. The model provides for strict regulatory control, with complete traceability of production and a maximum THC limit of 0.3% in plants.
What changes for compounding pharmacies?
With the new regulations, compounding pharmacies are now officially part of the supply chain for cannabis-based products. These establishments will now be able to compound and sell CBD products, which significantly expands the reach and access of treatments to patients.
What forms of administration are now permitted?
ANVISA has expanded the forms of administration for cannabis-based products. In addition to oral and nasal/inhalation, buccal, sublingual, and dermatological administration are now permitted, offering greater therapeutic flexibility and potential gains in bioavailability.
Who will be able to access medications with higher THC content?
Access to products with higher THC content is no longer restricted to patients in palliative care or with terminal illnesses. The new rule extends this possibility to patients with serious debilitating diseases, significantly expanding the therapeutic reach of these medications.
What about the importation of inputs and extracts?
The importation of plants and extracts remains authorized, allowing the sector to operate in a hybrid model while domestic cultivation does not reach full scale.
In this context, only inputs that prove THC content within the 0.3% limit may be imported.
Is advertising still prohibited?
Not entirely. The new regulations authorize advertising directed exclusively at prescribing professionals, provided that it is restricted to information previously approved by ANVISA.
What are the main control and safety requirements?
The new regulatory framework establishes a robust inspection system, which includes:
- prior health inspection;
- detailed tracking of the entire production chain;
- requirement for special authorization (AE) for production;
- strict control of THC content (max. 0.3%);
- possibility of immediate suspension and destruction of material in case of irregularities;
- georeferenced registration of cultivation areas, with photographic documentation.
Are the rules already in effect?
RDC No. 1,014/2026, which establishes the Experimental Regulatory Environment (Regulatory Sandbox) for controlled testing of activities related to Cannabis for medical purposes, is already in force.
RDC No. 1,013/2026, which sets forth the requirements for the cultivation of the Cannabis plant species, and RDC No. 1,015/2026, which provides for the Health Authorization for the manufacturing and importation of Cannabis products for human medicinal use, establishes requirements related to their commercialization and will be effective as of May 4, 2026.
Comparative Table of Regulatory Restructuring
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