Analysis of the draft update of the RDC on cannabis products - Anvisa

This analysis was prepared on 01/26/2026 to clearly and objectively translate the content of the disclosed material. It is important to highlight that this is a “RDC draft” (proposal) — meaning it is not necessarily the final version published in the Official Gazette of the Union (DOU). Nevertheless, the text already outlines the regulatory direction and allows for a reasonable anticipation of the practical effects on the medicinal cannabis ecosystem (industry, retail, prescribers, and patients).

The RDC draft presented by ANVISA signals a significant change in the regulatory model for “Cannabis products” in Brazil, with a direct impact on portfolio, go-to-market strategies, compliance, and how prescribers engage with treatments. The central point is the transition to a more “pharmaceutical” regime: increased technical requirements, enhanced traceability, and an explicit trajectory to evolve, over time, from an “authorized product” to a “registered medication.”

Regulatory context and what the draft establishes

The draft expressly revokes RDC 327/2019 and defines that the new standard will come into effect 90 days after its publication. This, in itself, creates a transition milestone that is likely to pressure companies (and their chain partners) to revalidate dossiers, labeling, quality processes, and access strategies.

The technical scope also becomes more restrictive. “Cannabis product” becomes an industrialized product, with Sanitary Authorization (SA), intended for human medicinal use, containing exclusively CBD phytomedicine or extract of CBD-dominant chemotype (CBD ≥ 5x THC).

Changes compared to RDC 327/2019 (current legislation)

1. Portfolio composition and positioning
In RDC 327/2019, the central rationale was “predominantly CBD” and a THC limit (with specific exceptions), as consolidated in technical documents from Anvisa.
In the draft, in addition to reinforcing CBD as the axis, the definition formalizes the “CBD-dominant” criterion (CBD at least 5 times THC) and narrows the regulatory universe of eligible products.

2. THC above 0.2%: a more “medicalized” rule with explicit safeguards
The draft allows THC >0.2% only when the product is developed exclusively for severe debilitating diseases (RDC 38/2013) or life-threatening conditions, and adds explicit contraindications and cautions (including prohibition for individuals under 18, pregnant or lactating women; and benefit-risk assessment in the elderly and those with a history of dependence/non-medicinal use). However, medical prescription remains sovereign and the responsibility of the prescriber.

3. Technology/forms: cutting down on “premium” differentiation
The draft prohibits modified release, nanotechnological, and pegylated products. In practice, this reduces paths for technological differentiation and shifts competition towards pharmaceutical quality, batch consistency, documentation, and service to prescriber/patient.

4. Labeling and communication: reinforcement of “no claims” and no commercial narrative
The draft strengthens labeling and leaflets, prohibiting common market terms (“CBD oil”, “full spectrum”, “broad spectrum”, etc.) and forbidding any direct or indirect mention of medicinal purposes, indications, and dosage in product materials.
Additionally, the leaflet must prominently display warnings such as “this product is not a medication and its efficacy and safety have not been evaluated by Anvisa”, as well as alerts about drowsiness/alertness and age/risk restrictions (includes the requirement of a red stripe and the phrase “sale by prescription with prescription retention” for THC ≤0.2%).

5. Evidence and regulatory life cycle: clearer “bridge” towards becoming a medication
The draft maintains the logic of Sanitary Authorization per product, but when addressing renewal, it now requires a Clinical Development Plan, schedule, evidence of initiation (ethical approval), and even references to DDCM/equivalent approval depending on where the development takes place. This changes the sector's economy: entering and remaining now depends on a clinical-regulatory strategy and not just on supply.

Changes for the prescribing physician (in operational practice and risk)

1. Type of prescription: relevant operational change
For products with THC ≤0.2%, the draft requires a Special Control Prescription (white, controlled prescription); for THC >0.2%, it requires a “A” Prescription Notification. This alters the workflow in offices/telemedicine and the documentary standardization in clinics that currently operate with other prescription models, and also impacts the flow in pharmacies.

2. Mandatory patient information and IC process with prescriber record-keeping
The draft details the duty to inform risks, regulatory condition (including the absence of efficacy/safety evaluation), potential adverse events (sedation/cognitive impairment and implications for driving/operating machinery), and requires an IC in duplicate, with one copy archived by the prescriber and no requirement for presentation/retention upon dispensing.
In practice, this increases the importance of a robust consent process, clinical traceability, and a well-constructed medical record — both for patient safety and medical-legal risk management.

3. Dispensing and traceability: more chain discipline, less “improvisation”
Dispensing is restricted to pharmacies/drugstores by a pharmacist, and the movement must be recorded in the SNGPC. For the physician, this reduces variations in dispensing but increases the likelihood of returns due to incomplete filling and requires greater precision in the prescription (exact product as per SA).

Market outlook for executives and decision-makers

In terms of the market, the draft is likely to produce three effects: (i) consolidation (fewer players capable of meeting quality, documentation, and pharmacovigilance requirements), (ii) partial commoditization in retail (less differentiation by “narrative” and more by consistency, service, and compliance), and (iii) acceleration of an evidence agenda (RWE and clinical studies) as a “currency” for renewal and the path to registration as a medication. The consequence is that companies treating cannabis as a “pharmaceutical platform” (and not as a “product category”) are likely to capture more value and reduce risk.

Conclusion and impacts on RDC 660 (exceptional importation by individuals)

RDC 660, dated March 30, 2022, regulates exceptional importation by individuals for personal use, with a prescription from a legally qualified professional. If the new RDC on “Cannabis products” is published with this design (more restrictive in scope and stricter in labeling/composition), it is plausible to expect a redistribution of demand between the two channels: there is likely to be a shift to the national market when accessible and available equivalents are present in pharmacies, but importation under RDC 660 may persist (or even grow in niches) when patients require cannabinoid profiles, presentations, or therapeutic strategies that do not fit the “CBD/CBD-dominant” concept or are not available in the national retail.

From a corporate perspective, this reinforces the need for a well-segmented portfolio, a clear evidence strategy, and a compliance governance that treats both channels (national and exceptional importation) as complementary routes — each with distinct regulatory and reputational risks.