Scope of Application

This applies to the manufacture, import, distribution, marketing, prescription, dispensing, monitoring, and inspection of cannabis-based products (Article 2). These are defined as industrialized pharmaceutical products for medical use containing exclusively the phytopharmaceutical CBD or an extract from the CBD-dominant chemotype of Cannabis sativa L. as the active ingredient (Article 3, VII).

Excluded from its application are cosmetics, tobacco products, medical devices, and foodstuffs based on Cannabis sativa L. or any of its derivatives (Article 2, Paragraph 1), as well as drugs based on phytopharmaceuticals or extracts obtained from Cannabis sativa L. (Article 2, Paragraph 2).

Effective date

On May 4, 2026, it will completely revoke RDC #327/2019, which currently regulates the manufacture, import, and marketing of cannabis-based products (Article 77).

Review Process

The replacement of RDC #327 was long-awaited, as its own text (Article 77, sole paragraph) stipulated a transitional nature and a mandatory review within three years (a period that ended on December 9, 2022).

The review process began in 2022, involving intense dialogue with the regulated sector. This included Call for Contributions #1,316 on March 28, 2025, which received over 1,450 inputs. A preliminary draft was discussed at the 20^th Ordinary Public Meeting of Dicol on December 10, 2025, where Director Thiago Campos requested revisions leading to adjustments. The final version, subsequently approved and published as RDC #1,015, differs from the earlier market proposal in key aspects (e.g., it allowed for compounding and made the adoption of a trade name conditional on a future specific regulatory act which will have specific requirements for cannabis-based products, not applying RDC #59/2014 which already concerns medicines).

What Was Maintained

The requirement for an MA to conduct regulated activities involving cannabis-based products (Article 10).

The MA's validity remains conditional on the product being registered as a “specific drug” (drugs that are not classified under any other category) or “botanical drug” by the end of its term, under penalty of cancellation (Article 11, Paragraph 1 in conjunction with Article 64).

Mandatory marketing of the product within the first year of the MA's validity (Article 60).

Documentation requirements for MA applications, largely similar to the requirements under RDC #327, such as application form, the product’s technical and scientific basis; quality control specifications and report (Article 13). Other documents (e.g., method validation protocols and reports) and more detailed technical information (e.g., complete data on the plant species) were added as requirements.

Mandatory Good Manufacturing Practice (GMP) certification for companies manufacturing cannabis-based products (Article 12, Paragraph 1).

Maintenance of the normative structure concerning labeling, packaging and information leaflet, providing the information which cannot be included (e.g., terms such as “drug” and “remedy”, and seals or nominative trademarks), information which must be included (e.g., product name and expiry date) and that may be included (e.g., description of the product’s taste or aroma and logo or trademark of the company holding the MA) (Articles 17 to 25).

Prohibition on distributing “free samples” (Article 9, Paragraph 4).

Mandatory quality control of finished imported batches within Brazil, plus a new requirement for controlling imported API or plant-based API batches (Article 16).

Mandatory traceability and security mechanisms on packaging of cannabis-based products to ensure traceability (Article 27).

Mandatory implementation of post-marketing monitoring to enable the adoption of regulatory measures or recalls of cannabis-based products, when necessary (Article 47).

Obligation to report any relevant information concerning the safety of cannabis-based products to Anvisa (Article 50), though the 72-hour urgent reporting requirement was removed.

Main New Features

Possibility of renewing the MA for 5 years(Article 11, Paragraph 2), primarily conditioned on demonstrating that clinical development toward full drug approval will be completed within the renewal period. Such proof will be provided by the company through the submission of the Clinical Development Plan for the drug; the clinical study timeline; the supporting documentation of the plan's commencement, including ethical approval for the research protocol; and the approval of the Drug Clinical Development Dossier (DDCM) by Anvisa or equivalent document from the regulatory authority of the country in which the studies will be conducted (Article 34). RDC #327 did not provide for MA renewal.

MA renewal during its term requires submitting annual reports demonstrating compliance with the Clinical Development Plan (Article 34, Paragraph 5). RDC #327 did not provide for MA renewal.

Use of a trade name is conditional upon a future regulation that will be issued setting the adoption method and applicable criteria. Such use will be limited to health‑related regulatory purposes of identification, safety, traceability, and information – any promotional use or consumption incentive is prohibited (Article 8). RDC #327 prohibited the use of trade names for cannabis-based products (Article 9).

The need to identify the cannabis-based product exactly as per its MA to ensure correct dispensing (Article 39, Sole Paragraph). RDC #327 had no express requirement regarding the product’s identification form on the prescription.

Obligation for the company to maintain an updated Risk Management Plan (RMP) – a document that compiles measures to identify, assess, and minimize product risks – and Periodic Benefit-Risk Assessment Report (RPBR) with the periodic safety and risk-benefit profile assessment. Both may be requested by Anvisa at any time, and the company must provide technical justification when an item is not applicable. RDC #327 did not require the submission of a PGR or RPBR.

Expansion of permitted routes of administration to include buccal, sublingual and dermatological routes (Article 7). RDC #327, authorized only oral and nasal routes (currently called “inhalation”) (Article 10).

Expansion of patient profile authorized to use products with a THC content above 0.2%, extending use to patients with serious debilitating diseases (Article 5). RDC #327 restricted the use of such products to patients in palliative, irreversible, or terminal clinical conditions (Article 4).

Authorization for advertising directed exclusively to prescribing and dispensing professionals, limited to information in the Anvisa-approved labeling and information leaflet (Article 9, Paragraphs 1 and 2). RDC #327 prohibited all advertising for cannabis-based products (Article 12).

Possibility of compounding preparations containing phytopharmaceutical CBD, which will be subject to a future specific rule by Anvisa defining the applicable health-related requirements (Article 72). RDC #327 prohibited compounding preparations containing cannabis-based derivatives or phytopharmaceuticals (Article 15).

Authorization for the importation of the plant (Cannabis sativa L.), extracts, phytopharmaceutical CBD, and intermediates intended for research, development, and manufacture of APIs within Brazil, including for the manufacture of medicines (Article 41). RDC #327 prohibited the importation of the plant or its parts for the purpose of manufacturing cannabis-based products. Only the importation of API in the form of plant derivatives, phytopharmaceuticals, bulk or industrialized products was permitted (Article 18).

Scope of Application

Applies to the cultivation of CannabissativaL. with a total THC content of less than or equal to 0.3%, intended exclusively for medical and research purposes (Article 1). Said total THC content refers to the total THC percentage, expressed as a weight-for-weight ratio, in the dried flower heads.

Effective date

On August 4, 2026 (Article 32).

Key Provisions

The cultivation is restricted to establishments with a Special Authorization (AE) for cultivation (Article 3). To petition for an AE aimed at cultivation for medical or research purposes, the following must be submitted to the local health authority: (i) georeferencing of the cultivation area; (ii) description and photos of the areas intended for activities, including measurements and functions; (iii) estimated cultivation quantity; (iv) proof of origin and access to propagation material; (v) organizational chart of cultivation responsibilities; and (vi) control and monitoring plan in accordance with Anvisa’s guidelines (Article 4, Paragraph 1).

For cultivation, only propagation material with a proven origin ensuring the production of Cannabis sativa L. plants with a THC content equal to or less than 0.3% is permitted (Article 7).

Authorization for practicing related activities of acquisition, research, importation, storage, distribution, and supply of plants with a THC content less than or equal to 0.3%, noting that distribution and supply activities for commercial purposes are permitted exclusively for medical purposes (Article 5).

Exporting Cannabis sativa L., including seeds (Article 9) is prohibited, except when the material returning to the country of origin.

Establishments must maintain complete and traceable records of all activities, in addition to presenting, with each acquisition, a document proving the genetic origin of the propagation material capable of producing plants with a THC content limited to 0.3% (Articles 13 and 14).

Submission of all batches of the plant-based drug obtained from cultivation to laboratory analysis of THC content (Article 16).

Duty to destroy or render unusable plants identified with a THC content greater than 0.3% (Article 18).

Regulatory compliance deadlines until August 5, 2027, for establishments that currently carry out cultivation activities under a court order (Article 28).

Meeting Ministry of Agriculture, Livestock and Food Supply (MAPA)'s requirements for importing and exporting CannabissativaL. plant species, including seeds, with documentation proving genetic origin capable of producing a THC content less than or equal to 0.3% (Article 12).

The material produced is exclusively intended for establishments holding an AE with cultivation activity (Article 8, I) or, when not intended for cultivation, exclusively for APIs manufacturers, laboratories, research institutions, and drug manufacturers for research purposes, all holding AE, in addition to teaching and research institutions with simplified special authorization (Article 8, II, a – d).

Requirement of continuous traceability, control, and safety procedures in cultivation areas, including the possibility of immediate suspension of activities and destruction of production if irregularities are found (Articles 13 to 21).

Scope of Application

The rule applies to all methods of cultivating the plant species CannabissativaL. intended exclusively for scientific research (Article 1), including in vitro formats or procedures in which there is no vegetative growth (Sole Paragraph). The activity is restricted to authorized legal entities that qualify as: public Institute for Science and Technology (ICTs); higher education or technical institutions recognized by the Ministry of Education; state defense or drug enforcement agencies or institutions; or establishments holding an AE to manufacture pharmaceutical inputs or medicines (Article 3, I – IV).

Effective date

Effective August 4, 2026 (Article 37).

Key Provisions

The practice of cultivation is restricted to establishments with a Special Authorization (AE) for cultivation (Article 4). To petition for an AE aimed at cultivation exclusively for research purposes, the following must be submitted to the local health authority: (i) georeferencing of the cultivation area; (ii) description and photos of the areas intended for activities, including measurements and functions; (iii) estimated cultivation quantity; (iv) proof of origin and access to propagation material; (v) organizational chart of cultivation responsibilities; and (vi) control and monitoring plan in accordance with Anvisa’s guidelines (Article 5, Paragraph 1).

Planting, cultivation, harvesting, handling, transfer, donation, import, export, storage, processing, and product development, including research with co-products, are authorized, provided they are exclusively for research purposes (Article 4, Paragraph 1).

For cultivation, only propagation material obtained through importation is permitted, except for plant varieties with a THC content limited to 0.3% (Article 29).

The commercialization of Cannabis sativa L. plant species and products derived from research activities is prohibited. Sharing is only permitted with other authorized institutions, exclusively for analytical or scientific purposes (Article 7).

Establishments must maintain complete and traceable records of all activities, from the acquisition of seeds and parent plants through to processing or final disposition (Articles 15 and 16).

Regulatory compliance deadlines until August 5, 2027, for establishments that currently carry out cultivation activities under a court order (Article 35).

A prior control plan is required, including site analysis and appropriate security measures to ensure continuous surveillance, controlled research activities, restricted access, mechanisms to mitigate diversion risk (with incident response procedures), and containment measures to prevent the spread of the plant (Article 6).

Mandatory implementation of physical security barriers at the cultivation site and adjacent areas (Article 9), access control (Article 11), and continuous video monitoring (Article 10) is required to ensure security and traceability.

Scope of Application

The regulation establishes an experimental regulatory environment (Regulatory Sandbox), which is exceptional, transitional, temporary, and supervised, intended for the controlled testing of experimental techniques and technologies related to the cultivation of Cannabis sativa L. for medical purposes, the production of plant-based pharmaceutical inputs, and the development, preparation, and supply of cannabis-based preparations for medical use (Article 1 and Article 5, I).

The Sandbox aims to assess health risks and generate evidence to improve the regulatory model. It operates under a temporary authorization with specific criteria and safeguards and does not constitute a permanent framework or authorization for commercial activity (Articles 2 and 3).

Effective date

Publication date, February 3, 2026 (Article 29).

Key Provisions

Participating projects will be selected via a public call, with a maximum number per cycle defined by technical and health-related criteria, including limits on production and number of patients served. Participation is restricted to legal entities duly constituted in the country for at least two years (Articles 8 and 9).

Small-scale cultivation and production are permitted outside the industrial model (Article 10, III) but are limited to the scope approved for each project (Article 6).

Marketing and advertising are prohibited (Article 3), products may only be dispensed to patients affiliated with the authorized association (Article 10, II and IV).

The Sandbox will last up to five years from the start date of the Experimental Regulatory Compliance Protocol execution (Article 23), which is a document signed by Anvisa and the participating association detailing the project conditions. It may be terminated early by a reasoned decision from Anvisa (Article 23, Paragraph 2).