Anvisa publishes proposal to update RDC 327 redefining rules for cannabis products in Brazil

Anvisa published the proposal to update RDC 327/2019, which establishes the rules for the manufacturing, importation, commercialization, prescription, and inspection of cannabis products for medicinal use in Brazil. The draft, which may completely revoke the current regulation, presents a new regulatory framework for the sector.

The text determines that only companies with Operating Authorization (AFE) and, when applicable, Special Authorization (AE) will be able to request Sanitary Authorization (AS), providing complete technical documentation on development, quality control, stability, origin of the input, composition, and product safety dossier.

The proposal maintains that products must exclusively contain cannabidiol (CBD) phytomedicine or CBD-dominant extracts of Cannabis sativa L., and allows the presence of THC in a concentration exceeding 0.2% only in specific cases provided for in the text. The draft also prohibits modified release, nanotechnological, pegylated, or plant-based products, even if crushed or pulverized.

Labeling rules are significantly reinforced. The text prohibits the use of expressions such as “Cannabis oil,” “CBD oil,” “full spectrum,” and “broad spectrum,” in addition to requiring mandatory warnings, such as:

“This product is not a medication and has not been evaluated for efficacy and safety by Anvisa.”

The proposal also defines safety, inviolability, and traceability standards that must be followed by all manufacturers and importers.

One of the most sensitive points of the draft is the explicit prohibition of magistral manipulation of preparations containing cannabis derivatives, as established in the text:

“The magistral manipulation of preparations containing parts, derivatives, or phytomedicines obtained from Cannabis sativa L. is prohibited.”

As a result, compounding pharmacies are prevented from producing formulations with derivatives of the plant.

Prescription will continue to be restricted to cases where there are no regularized therapeutic alternatives in Brazil, and will depend on the signing of an Informed Consent Form (ICF) between the patient and the qualified professional. The draft also reinforces the obligation of pharmacovigilance, with a risk management plan, periodic notifications, and post-commercialization monitoring.

Anvisa may conduct sanitary inspections at any time, and companies must ensure traceability, inviolability, and quality control mechanisms for all batches commercialized in the country. The text also provides additional requirements for the renewal of Sanitary Authorization.

Anvisa Draft brings positive advances for the medicinal cannabis sector

Despite stricter adjustments in some sections, the new draft to update RDC 327 also presents positive points and important modernizations for the cannabis products market in Brazil.

One of the advances is the possibility of using a commercial brand on products. Under the current regulation, labeling only allowed the company's name and the technical identification of the product, such as the CBD or THC content. With the change, products will be able to adopt a brand, similar to what already happens with medications, which professionalizes the market, facilitates patient identification, and provides more predictability to the sector.

Another relevant point is the inclusion of post-authorization changes that can be made without the need for prior approval from Anvisa. This means that, after obtaining Sanitary Authorization, the company can make adjustments considered low-risk — such as minor labeling adaptations or administrative technical changes — by simply notifying the Agency, without having to wait for a formal response. The measure reduces time, streamlines processes, and provides greater operational agility to companies.

What lies ahead?
 

If the normative proposal is published, RDC 327/2019 will be revoked after final approval by the Collegiate Board, and the new regulation will come into effect 90 days after its publication.

The meeting of Anvisa's Collegiate Board, which will define the future of RDC 327, will be held on December 10, when the vote on the item addressing the update of the regulation of cannabis products is scheduled; however, the directors may request additional time for analysis, which would suspend the review and vote — something that will only be decided on December 10 itself.