The Evolution of Brazilian Legislation on Cannabidiol Products: Where We Are and Where We Are Heading

In recent years, Brazil has undergone a significant transformation in its legal approach to medical cannabis, particularly concerning products based on cannabidiol (CBD) and cannabis-derived extracts. What was once limited to exceptional importation decisions has evolved into a more structured regulatory framework. This shift allows for regulated access to these products within the country, providing greater legal security for patients, healthcare professionals, and companies.

Below, we present an overview of the main advances in legislation and regulation, focusing on the purchase and use of medical cannabis products.

From Prohibited to Permitted in Specific Hypotheses

For many years, any cannabis-derived product was automatically associated with the Brazilian Drug Law (Law No. 11.343/2006), making access practically unfeasible, even for therapeutic purposes. The turning point came with:

•Judicial decisions determining that ANVISA authorize the exceptional importation of CBD-based products for patients with severe diseases, when conventional therapeutic alternatives were exhausted.

•The subsequent reclassification of cannabidiol by ANVISA, which stopped treating it solely as a prohibited substance and began allowing its controlled use in medications.

This movement inaugurated, in practice, the possibility of purchasing and using products with CBD through specific authorization, although in a highly restricted and bureaucratic manner.

RDC 327/2019: The First Major Regulatory Milestone

A leap in quality occurred with the publication of ANVISA’s RDC No. 327/2019, which established the foundations for:

•Sanitary authorization of cannabis products for medicinal use;

•Rules for national manufacturing (in a controlled environment and with imported inputs);

•Requirements for importation, marketing, prescription, dispensing, monitoring, and inspection.

Among the central points of this standard, we highlight:

•Creation of the specific category of “cannabis products for medicinal purposes,” distinct from traditional medications;

•Necessity of registration or sanitary authorization at ANVISA, requiring proof of quality, safety, and traceability;

•Requirement of prescription by a qualified professional, initially only doctors, based on individualized patient evaluation;

•Mandatory informed consent form (TCLE), where the patient is informed about the risks, benefits, and limitations of scientific evidence;

•Dispensing in duly regulated pharmacies and drugstores, under the technical responsibility of pharmacists, with registration in the control system (SNGPC).

In practice, RDC 327/2019 paved the way for the presence of cannabis products in Brazilian pharmacies, albeit with strong control and clear limits for indications and THC content.

Expansion of Access and Gradual Flexibility

Since the entry into force of RDC 327/2019, a progressive expansion has been observed:

•Increase in the number of products authorized by ANVISA, especially those based on CBD;

•Consolidation of medical protocols and greater safety for healthcare professionals in prescribing;

•Strengthening of patient associations, which began to play an active role in the discussion about access, prices, and legal security.

In addition, ANVISA itself began to:

•Admit products with higher THC levels in specific cases (for example, debilitated patients with severe and refractory diseases);

•Review prescription criteria in order to balance sanitary control and the right of access to potentially beneficial treatments.

Recent Updates: A More Mature Framework for Medical Cannabis

In recent years, the regulatory framework has been improved, with:

•Update of technical standards on quality, labeling, safety proof, and post-marketing monitoring;

•Greater clarity on the requirements for sanitary authorization of new products, including defining minimum standards for plant extracts, CBD and THC concentrations, solvents, and impurities;

•Adjustments in the rules for prescription and dispensing, reinforcing:

•The need for a qualified professional (doctor, and in certain cases dentist) to prescribe;

•The collection and storage of TCLE;

•Dispensing by a pharmacist in a regulated establishment, with registration in a control system.

These measures expand access safely, while at the same time inhibiting the circulation of products without quality control or sold as “supplements” without sanitary backing.

How the Purchase and Use of Medical Cannabis Products Are Today

In a simplified way, the current scenario for patients and professionals is as follows:

1. Who can prescribe

Doctors duly registered with the CRM can prescribe medical cannabis products. In some hypotheses, dentists can also prescribe, when the product is related to their area of expertise and according to the rules of ANVISA and the respective professional council.

2. For which patients

Patients with specific clinical conditions (for example, refractory epilepsy, chronic pain, spasticity, some neurological diseases, among others), when:

•Conventional treatments prove ineffective or insufficient; or

•The doctor understands that the use of CBD or cannabis extracts can bring clinical benefit, based on available scientific evidence and case evaluation.

3. Where and how to buy

Today there are basically three channels:

•Products authorized by ANVISA, available in regular pharmacies and drugstores, through a specific prescription and presentation of necessary documents; with price and commercial conditions defined by the holders of the sanitary authorization.

•Exceptional importation: still provided for in certain cases, when the product is not available on the national market; requires ANVISA authorization and compliance with requirements (prescription, report, TCLE, patient registration, etc.).

•National production in a regulated environment: companies with ANVISA authorization can manufacture, formulate, and distribute products in the country, always under sanitary control and with defined quality standards.

It is important to highlight that sales in informal markets, unauthorized websites, social networks, or CBD “supplements” without registration remain irregular and may represent a significant sanitary risk.

What Has Not Yet Been Released: Recreational Use and Domestic Cultivation

Despite advances in the medicinal field, two points remain outside the scope of broad legalization:

•Recreational use of cannabis: remains prohibited in Brazil. The regulatory focus is strictly medicinal and, in certain cases, pharmaceutical.

•Domestic cultivation for personal medicinal use: remains a controversial issue. In general: some patients obtain individual judicial authorizations for domestic or associative cultivation, under specific conditions; eventual decisions of higher courts on production for exclusively medicinal and/or pharmaceutical purposes are still interpreted in a restricted context, not meaning a general legalization of home growing.

That is, the fact that there are advances does not automatically authorize any form of cultivation or use, and criminal legislation and ANVISA regulations must always be observed.

Impacts for Patients, Professionals, and Companies

1. For patients

•Greater legal security to buy and use regulated products.

•Access to products with quality standards, known CBD/THC concentration, and pharmaceutical follow-up.

•Reduction, although still insufficient, of dependence on expensive and bureaucratic imports.

2. For doctors and dentists

•A more solid normative basis for prescribing medical cannabis, with the backing of ANVISA resolutions and professional councils.

•Need to pay attention to: indication criteria, choice of regulated products, adequate documentation (prescription, report, TCLE, clinical follow-up).

3. For companies and investors

•A regulated field, although still in consolidation, with opportunities in: research and development; production and formulation of standardized extracts; pharmaceutical distribution and retail; continuing medical education and technical-scientific support.

•At the same time, an environment that demands: rigorous regulatory compliance; pharmacovigilance structure; constant monitoring of ANVISA updates and relevant judicial decisions.

Perspectives: What to Expect in the Coming Years

The regulatory path of medical cannabis in Brazil tends to evolve in three main directions:

•Greater consolidation and detailing of ANVISA rules: With more products in circulation, the tendency is for the agency to refine quality requirements, labeling, adverse event monitoring, and information transparency.

•Expansion of national scientific evidence: Clinical and observational studies conducted in Brazil should enrich the knowledge base and allow: more precise indications; more standardized use protocols; real evaluation of efficacy and safety in our population.

•More mature legislative debate: The accumulated experience may accelerate discussions in Congress about: public access policies; financing or reimbursement in certain cases by the SUS (Unified Health System) or health insurance plans; clearer rules for cultivation and production for exclusively medicinal and/or pharmaceutical purposes.

Conclusion

Brazilian legislation on medical cannabis moved, in a few years, from a scenario of almost absolute prohibition to a regulated model, with products based on cannabidiol and cannabis extracts available by prescription, authorized by ANVISA, and dispensed in pharmacies.

Although challenges still exist – cost, unequal access, insecurity around cultivation, and divergences in the medical community – it is undeniable that there have been consistent advances in the regulatory framework for the purchase and use of these products.

For patients, healthcare professionals, and companies, the message is clear: closely monitor ANVISA updates, always act within current standards, and prioritize regulated products, with proven quality and traceability.

If you work in the healthcare area or the business sector and need a more strategic reading of this scenario (for example, regulatory impacts for a new product or service), it is worth investing in continuous legal-regulatory follow-up – the topic is evolving and tends to gain even more relevance in the coming years.

A Strategic Partner for Pharmaceutical Investors

For international pharmaceutical companies looking to enter the Brazilian market, navigating this complex and evolving regulatory landscape requires more than just a great product; it requires a trusted local presence. PCREPS is the perfect partner for pharmaceutical industry investors who want to expand their business in Brazil.

As a trusted local partner, PCREPS provides the essential operational infrastructure and strategic support needed to succeed. We offer legal representation for non-resident directors, ensuring your company has a formal, compliant presence. Our registered office address services meet ANVISA’s strict localization requirements, while our subsidiary administration ensures your operations run smoothly and in accordance with Brazilian corporate governance standards. By partnering with PCREPS, international companies can secure their operations, ensure compliance, and focus on bringing innovative treatments to the Brazilian market.