Brazil

ANVISA registered esketamine (Spravato) in November 2020 for treatment-resistant depression, adding the suicidal-ideation indication in December 2020 — one of the first approvals outside the US/EU (scheduled on Portaria 344 Lista B1 via RDC 676/2022). It is not incorporated into SUS (no CONITEC decision); access runs through private psychiatric care, and health-plan coverage is actively litigated in Brazilian courts.

IV ketamine is used off-label for depression at private clinics in major cities — legal under the federal medical council’s off-label doctrine (CFM/CRM-SC Parecer 034/2021) with ketamine on Lista B1; self-pay, screening quality varies by provider.

Psilocybin and psilocin are scheduled (Portaria 344, Lista F2); research requires special ANVISA authorization. A documented quirk: only the molecules are listed — mushrooms as such sit in legal limbo. Brazil has a serious research tradition (ayahuasca and psilocybin studies at UFRN and other universities).

MDMA is scheduled (Portaria 344, Lista F2); no medical route outside research.

Medical: cannabis-derived products via ANVISA authorization (RDC 327/2019, revision approved Jan 2026; individual imports via RDC 660/2022); domestic cultivation only through individual court orders. Non-medical: the Supreme Court decriminalized possession of ≤40 g or 6 female plants (June 2024) administrative, not a market.

Ibogaine is unscheduled and unregistered in Brazil. ANVISA authorizes its import solely for clinical research. The only reported case acquitted a doctor for administering ibogaine as in-clinic treatment, not for importing it. Case-by-case criminal tolerance for treatment, not a prescription import route, and not an open market.

Ayahuasca RCTs at UFRN (a world first), plus esketamine and psilocybin studies — Latin America’s strongest research base. Participation is free; screening is strict; never pay for “trial access”.