Malta

Last updated 18 August 2026

Psychedelic Therapy Legal Landscape

Esketamine (Spravato)

EMA-approved — practice limited

Esketamine is formally approved for Malta through the EMA’s centralized authorization(Dec 2019); no evidence of an established national Spravato practice yet — ask via psychiatric services.

Ketamine Therapy

Private KAP (Gozo)

Ketamine-assisted psychotherapy runs at HIVE BIO on Gozo (San Lawrenz): a structured 3-1-3 programme (3 weeks online preparation, 1 week residential, 3 weeks integration), with a licensed anaesthetist as medical lead and a warranted psychotherapist — a real, medically-staffed KAP practice inside the EU.

Psilocybin

Trials only

No medical route.

MDMA

Trials only

No medical route.

Clinical Trials

Open route

No registered recruiting psychedelic trials found. Participation is free; screening is strict; never pay for “trial access”.

Frequently asked questions — Malta

Is ketamine therapy legal in Malta?
Private KAP (Gozo). Ketamine-assisted psychotherapy runs at HIVE BIO on Gozo (San Lawrenz): a structured 3-1-3 programme (3 weeks online preparation, 1 week residential, 3 weeks integration), with a licensed anaesthetist as medical lead and a warranted psychotherapist — a real, medically-staffed KAP practice inside the EU.
Is psilocybin legal in Malta?
Trials only. No medical route.
Is MDMA therapy legal in Malta?
Trials only. No medical route.
Can I join a psychedelic clinical trial in Malta?
No registered recruiting psychedelic trials found. Participation is free; screening is strict; never pay for "trial access".