Anvisa updates registrations of medical cannabis products
Anvisa changes shelf life and commercial presentations of CBD-based products. See what changes for Herbarium and Fiocruz on Portal Sechat.
Which companies had changes in the sanitary authorizations for medical cannabis products?
Anvisa extended the shelf life of Canabidiol Herbarium, authorized new commercial presentations, and renewed the sanitary authorization for Fiocruz's Canabidiol Farmanguinhos.
The Agência Nacional de Vigilância Sanitária (Anvisa) has published two resolutions related to medical cannabis products based on cannabidiol (CBD). The acts address extending the shelf life of one product and including new commercial presentations and renewing the sanitary authorization of another.
Resolution-RE No. 3,981, of October 8, 2026, published in the Diário Oficial da União (DOU) on October 13, granted the request to extend the shelf life of Canabidiol Herbarium, an oral solution with a concentration of 20 mg/mL. The registered presentation, in a 30 mL bottle accompanied by a dosing syringe and adapter, now has a shelf life of 24 months.
Meanwhile, Resolution-RE No. 3,901, of October 2, 2026, published in the DOU on October 5, authorized two new commercial presentations of Canabidiol Farmanguinhos, produced by Fundação Oswaldo Cruz (Fiocruz). Both have a concentration of 200 mg/mL and are marketed in 30 mL bottles, accompanied by two or three dosing syringes.
The same act also approved the renewal of the sanitary authorization for the 200 mg/mL presentation with one dosing syringe. For all three presentations, the shelf life indicated in the annex to the resolution is 24 months.
What changes in commercial presentations
The dosing syringes accompanying the products are accessories used to measure and administer the oral solution. They do not contain cannabis separately: the cannabidiol is in the solution packaged in the bottle.
In the case of Canabidiol Farmanguinhos, the resolution provides for presentations with one, two, or three dosing syringes. The quantity of accessories varies according to the commercial presentation, while the reported concentration remains at 200 mg/mL.
The inclusion of commercial presentations corresponds to a change in how the product is made available, without indicating, in itself, any change in the composition or concentration of the solution.
Regulatory updates in the medical cannabis market
Both resolutions are part of the administrative acts of Anvisa's Gerência-Geral de Medicamentos and address specific changes in the conditions of sanitary authorization for the products.
The extension of the shelf life of Canabidiol Herbarium and the addition of new commercial presentations of Canabidiol Farmanguinhos are relevant changes for regulatory oversight of the sector, including manufacturers, distributors, and other stakeholders involved in making these products available.
The decisions, however, do not represent, in themselves, the approval of new therapeutic indications or proof of greater clinical efficacy. The published acts are restricted to the changes described in their respective annexes.
Sources: Diário Oficial da União. Resolution-RE No. 3,901, of October 2, 2026, published on October 5, 2026; Resolution-RE No. 3,981, of October 8, 2026, published on October 13, 2026.