Strictly Illegal

Reimbursed Care Access in San Marino

San Marino implements and enforces international narcotics conventions and maintains a national controlled-substance framework administered by its Health Authority (Authority Sanitaria). Classic psychedelic compounds (psilocybin, MDMA, DMT, mescaline, 5‑MeO‑DMT, ibogaine, ayahuasca, 2C‑X) are controlled under San Marino’s updated list of stupefacenti and have no authorised medical/reimbursed use outside tightly regulated clinical research; medically‑used dissociative anesthetics (ketamine) are regulated as controlled medicines under the national medicines framework. The Authority Sanitaria acts as focal point for import/export and for oversight of controlled medicines and therapeutic imports. [https://www.gov.sm/pub2/GovSM/Authority-Sanitaria/Medicinali-stupefacenti-e-psicotropi.html|Authority Sanitaria - Medicinali stupefacenti e psicotropi] [https://www.consigliograndeegenerale.sm/on-line/home/scheda17172091.html|Decreto Delegato 15 April 2021 n.64 - aggiornamento elenco sostanze stupefacenti].

Psilocybin

Strictly Illegal

Currently classified as a strictly controlled substance under San Marino's national drug scheduling (updates via Decreto Delegato 15 April 2021) with no authorised medical use or reimbursement outside of approved clinical research. # #.

MDMA

Strictly Illegal

Currently classified as a strictly controlled substance under national drug scheduling laws, with no authorized medical use outside of approved clinical research. # #.

Esketamine

Clinical Trials Only

No publicly available evidence that esketamine (Spravato®) has been registered, reimbursed, or put on San Marino’s national formulary for routine clinical use as of the latest national medicines and controlled‑substances documents; controlled‑substance and medicine import/authorization in San Marino are managed by the Authority Sanitaria and are subject to the INCB-linked lists and national decrees, meaning new psychoactive medical products require central authorization and specific importation procedures. San Marino’s Authority publishes that it oversees authorisations for import/export and special authorisations for medicines classified as stupefacenti or psychotropi, and the country updated its controlled‑substance list by Decreto Delegato 15 April 2021 — there is no clear public record of Spravato® registration or public reimbursement in San Marino. For the baseline medical status of ketamine/esketamine internationally: ketamine appears on the WHO Model List of Essential Medicines as an anaesthetic, whereas esketamine (marketed as Spravato®) has had product approvals in other jurisdictions but requires national marketing authorisation to be used and reimbursed locally. # # # #.

Ketamine

Off-label Medical

Ketamine is a medically‑authorized anesthetic and emergency medicine globally and appears on the WHO Model List of Essential Medicines for anaesthetic use; in San Marino, medicines containing controlled substances (including anaesthetics) are regulated and their importation/distribution are overseen by the Authority Sanitaria under the national implementation of international conventions. As such, clinical use of ketamine as an anaesthetic and for other approved medical indications (e.g., acute analgesia, emergency medicine) is permitted under standard medicinal authorisation procedures and normal health‑system procurement; these uses are part of routine medical care rather than psychedelic therapy programs, and reimbursement for standard anaesthetic/medical uses would follow Istituto per la Sicurezza Sociale (ISS) and national hospital procurement/reimbursement rules where applicable. # #.

However, the use of racemic ketamine or ketamine infusions specifically as a reimbursed, evidence‑based psychiatric treatment for treatment‑resistant depression (outside of anesthesia/acute care) is not established publicly as a nationally reimbursed indication in San Marino: such psychiatric/off‑label applications would either be provided privately or within experimental/clinical‑trial frameworks and would require individual authorisation, local institutional approval and adherence to controlled‑substances reporting requirements. The national framework requires special authorisation and reporting for substances on the controlled lists; clinicians and institutions must follow Authority Sanitaria procedures for importation, storage and reporting when using controlled medicines. # #.

DMT

Strictly Illegal

Currently classified as a strictly controlled substance under national drug scheduling laws, with no authorized medical use outside of approved clinical research. San Marino’s national legislation implements the UN psychotropic conventions and maintains an updated list of controlled substances; there is no public evidence of authorised medical or reimbursed therapeutic DMT use in San Marino. # #.

5-MeO-DMT

Strictly Illegal

Currently classified as a strictly controlled substance under San Marino's drug scheduling with no authorised medical use or reimbursement outside of approved clinical research. There is no public record of therapeutic authorisation for 5‑MeO‑DMT in San Marino. # #.

Ibogaine

Strictly Illegal

Currently classified as a strictly controlled substance under national drug scheduling laws, with no authorized medical use outside of approved clinical research. There is no public evidence of authorised ibogaine treatment clinics or reimbursement in San Marino. # #.

Ayahuasca

Strictly Illegal

Currently classified as a strictly controlled substance/material under national drug scheduling (the DMT constituent and related psychoactive constituents fall under control), with no authorised medical use or reimbursement outside of approved clinical research. Traditional/ceremonial uses are not a recognized legal exception in San Marino’s publicly available drug‑control framework. # #.

Mescaline

Strictly Illegal

Currently classified as a strictly controlled substance under national scheduling consistent with international conventions, with no authorised medical use or reimbursement in San Marino outside approved clinical research. There is no public evidence of legal religious or medical exemptions in San Marino. # #.

2C-X

Strictly Illegal

Currently classified as a strictly controlled substance (synthetic phenethylamines and novel psychoactive substances are included in San Marino’s updates to controlled lists) with no authorised medical use or reimbursement outside of approved clinical research. San Marino’s legal framework follows UN conventions and periodically updates its controlled lists to include new psychoactive/synthetic compounds. # #.