Medical Access in Belgium

Psilocybin and psilocin are listed in FAMHP Annex IIA, so routine prescribing or private therapeutic access is not available. Belgian access is currently through authorised research only, with visible hospital-based studies in severe alcohol use disorder at CHU Brugmann in Brussels and treatment-resistant depression at Ghent University Hospital. [1]FAMHP Annex II consolidated version [2]ClinicalTrials.gov NCT06160232 [3]ClinicalTrials.gov NCT06378229

No open public Belgian compassionate use or medical need programme for psilocybin was identified in the reviewed sources. FAMHP states that CUP/MNP routes do not replace clinical trials and that patients should be considered for trials first. [4]FAMHP FAQ on unmet medical need

MDMA is expressly listed in FAMHP Annex IIA. No Belgian market authorisation or routine therapeutic pathway for MDMA-assisted therapy was identified in the public sources reviewed. [1]FAMHP Annex II consolidated version [2]FAMHP legislation for narcotics and psychotropics

Esketamine is the clearest legal psychiatric access route. Spravato is authorised in the EU for adults with treatment-resistant major depressive disorder in combination with an SSRI or SNRI, and EMA states that it must be prescribed and administered under direct professional supervision. [1]EMA Spravato EPAR

Belgian reimbursement is narrower than authorisation. The public Belgian medicines listing identifies a restricted Chapter IV reimbursement pathway for Spravato, while CBIP describes intranasal esketamine as a hospital-use medicine with strict clinical monitoring requirements. [2]CBIP Spravato reimbursement entry [3]CBIP Folia on esketamine

Ketamine should not be described as research-only in Belgium. It is an authorised anaesthetic/pain medicine, and CBIP discusses intravenous ketamine as being used off-label in resistant depression and acute severe suicidal ideation. [1]CBIP ketamine medicines information

That access remains materially different from an approved antidepressant indication. CBIP guidance treats off-label prescribing as a prescriber-responsibility pathway, and no dedicated nationwide psychiatric reimbursement route for off-label ketamine was identified in the reviewed public sources. [2]CBIP Folia on off-label prescribing

DMT is expressly listed in FAMHP Annex IIA. No Belgian market authorisation, reimbursement route or routine medical access pathway for DMT-assisted therapy was identified in the public sources reviewed. [1]FAMHP Annex II consolidated version

No Belgian market authorisation, reimbursement route or routine medical access pathway for 5-MeO-DMT was identified in the reviewed public sources. Substance-by-substance scheduling should be checked manually before publishing a detailed legal table for this compound. [1]FAMHP legislation for narcotics and psychotropics

No Belgian market authorisation, reimbursement route or routine medical access pathway for ibogaine was identified in the reviewed public sources. Any claim about Belgian scheduling for ibogaine should be verified against the current annexes before publication. [1]FAMHP legislation for narcotics and psychotropics

Ayahuasca preparations contain DMT, and DMT is expressly listed in FAMHP Annex IIA. No Belgian authorised therapeutic or reimbursement pathway for ayahuasca was identified in the reviewed public sources. [1]FAMHP Annex II consolidated version

Mescaline is expressly listed in FAMHP Annex IIA. No Belgian market authorisation, reimbursement route or routine medical access pathway for mescaline-assisted therapy was identified in the public sources reviewed. [1]FAMHP Annex II consolidated version

The current FAMHP Annex II material includes specific 2C-series substances such as 2C-B, but the reviewed sources do not support a broad medical access claim for the 2C-X category. No Belgian market authorisation or reimbursement route for 2C-X therapy was identified. [1]FAMHP Annex II consolidated version