1. What the law is
In force is not the same as operating. Czechia's scheme took effect on 1 Jan 2026 under Act 270/2025 Sb. and government regulation 552/2025 Sb., and it lets physicians prescribe individually prepared psilocybin medicinal products.
The regulation names three indications: clinically severe depressive disorder without psychotic symptoms; depressive disorder associated with oncological disease; and acute worsening of another serious neuropsychiatric disorder. Failure or documented intolerance of authorized medicines is a separate precondition, not an indication. Only a physician holding specialist competence in psychiatry, or special competence in the medical psychotherapy subspecialty, may prescribe or administer the preparation, and only in accordance with the clinical recommended procedure for psilocybin-assisted psychotherapy.
The building matters as much as the prescriber. Section 3(3) of the Act on Addictive Substances confines treatment to psychiatric institutions and psychiatric hospital units under the direct authority of the Ministry of Health, and any other healthcare facility needs a permit. No SUKL publication has been located confirming that the scheme is yet running, so a route open in law should not be read here as a route open in practice.
2. Trials in Czechia
Interventional psilocybin trials with at least one site in Czechia, as their sponsors filed them with ClinicalTrials.gov, EU CTIS and ISRCTN. Each row links to the registry record, which sets out who may take part.
Recruiting or opening counts trials recruiting now, not yet recruiting, or enrolling by invitation. Closed counts trials terminated, suspended, withdrawn or left unverified by their sponsors.
| Registry ID | Trial | Phase | Sponsor | Status | Start date |
|---|---|---|---|---|---|
| NCT06793397 | A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder (opens in new tab)Sites in Prague and Předměstí | Phase Phase 3 | Sponsor Cybin IRL Limited | Status Recruiting | Start date |
| NCT06782724 | Psilocybin Therapy for Psychological Distress in Palliative Patients (opens in new tab)Recruiting at National Institute of Mental Health, Prague | Phase Phase 2 | Sponsor University Medical Center Groningen | Status Authorised | Start date |
| 2024-515899-13-00 | Psilocybin versus ketamine; fast acting antidepressant strategies in treatment-resistant depression (opens in new tab)Site at Narodni Ustav Dusevniho Zdravi, Klecany | Phase Not stated | Sponsor Narodni Ustav Dusevniho Zdravi | Status Authorised | Start date |
| 2024-517902-27-00 | Regression of Atherosclerosis induced by liFe chAnging Experience with psiLocybin (opens in new tab)Sites in Prague and Praha 2 | Phase Not stated | Sponsor Psyon s.r.o. | Status Authorised | Start date |
| 2023-505268-12-00 | A Phase III, multicentre, randomised, double-blind, controlled study to investigate the efficacy, safety, and tolerability of two initial administrations of COMP360 in participants with treatment-resistant depression (opens in new tab)Sites in Klecany, Plzen 3, Poruba | Phase Not stated | Sponsor Compass Pathfinder Limited | Status Authorised | Start date |
| NCT05711940 | Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With TRD (opens in new tab)Sites in Klecany, Kutná Hora, Ostrava | Phase Phase 3 | Sponsor COMPASS Pathways | Status Active, not recruiting | Start date |
| 2024-517747-31-00 | Psilocybin - a strategy of rapid antidepressant response in depression comorbid with cancer,a randomized double-blind study with the possibility of entering open extension (opens in new tab)Sites in Brno-Stred and Klecany | Phase Not stated | Sponsor Narodni Ustav Dusevniho Zdravi | Status Authorised | Start date |
| NCT05383313 | Psilocybin Versus Ketamine in Treatment-Resistant Depression (opens in new tab)Recruiting at National Institute of Mental Health, Klecany | Phase Phase 2 | Sponsor National Institute of Mental Health, Czech Republic | Status Unknown status | Start date |
| NCT04519957 | Long Term Follow Up Study to COMP 001 And COMP 003 Trials (P-TRD LTFU) (opens in new tab)Site at National Institute of Mental Health Czech Republic, Klecany | Phase Not stated | Sponsor COMPASS Pathways | Status Completed | Start date |
| NCT03775200 | The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression (opens in new tab)Site at National Institute of Mental Health Czech Republic, Klecany | Phase Phase 2 | Sponsor COMPASS Pathways | Status Completed | Start date |
ClinicalTrials.gov data courtesy of the U.S. National Library of Medicine.
3. History
The legal events behind this entry, dated and oldest first. Our own reviews and corrections are listed under Changes to this record.
Medical use status takes effect.
4. Proposed laws
Proposals that are not yet law and would change this entry if adopted.
Reimbursement and funding rules under public insurance are still being finalized. The National Institute of Mental Health (NUDZ) expects the first treatments in the second half of 2026.
5. Common questions
Is psilocybin legal in Czechia?
Psilocybin is legal for medical use in Czechia.
Are magic mushrooms ("shrooms") legal in Czechia?
"Magic mushrooms" and "shrooms" are common names for fungi that contain psilocybin, and this entry states the law on psilocybin itself, which some laws treat separately from the fungus. Psilocybin is legal for medical use in Czechia.
Read the law
Act 270/2025 Sb. amends the Criminal Code (40/2009 Sb.), the Criminal Procedure Code (141/1961 Sb.), the Act on Pharmaceuticals (378/2007 Sb., new section 79a) and the Act on Addictive Substances (167/1998 Sb., new section 33l) to permit prescribing, dispensing and use of individually prepared psilocybin medicinal products. Government regulation 552/2025 Sb. sets the indications, dose limits and supervision conditions. Both take effect January 1, 2026. The operative consolidated text is the Act on Addictive Substances 167/1998 Sb. as effective 1 January 2026, published by the Ministry of Health: Head VIII governs medical psilocybin, section 33l sets the conditions for psilocybin for medical use, and section 3(3) confines its use to psychiatric institutions and psychiatric hospital units under the direct authority of the Ministry of Health, with any other healthcare facility requiring a permit.1
Sources
This entry's status is checked against the primary sources below, and the methodology explains how each entry is graded for confidence.
- 1.mzd.gov.cz (opens in new tab) · mzd.gov.cz
- 2.e-sbirka.gov.cz (opens in new tab) · e-sbirka.gov.cz
This entry is for information only and is not legal or medical advice. Laws change, and enforcement can differ from the letter of the law, so check the current position against the primary sources above before relying on it.
Changes to this record
4 changes on file, the latest on . Show allHide
Every change we have made to this record, dated, corrections included. Nothing changes silently.
Czechia's entry now cites a version of the law that can be read and checked, and records a limit it had missed: treatment is confined to psychiatric hospitals run directly by the Ministry of Health, and any other facility needs a permit.
Czechia's entry now cites the adopted regulation rather than the draft that was notified to the EU, and records which specialists may prescribe.
Czechia's record drops an unsupported claim to be Europe's first such framework, and now states the three conditions the regulation actually names.
Czechia's prescribing scheme was confirmed in force from 1 Jan 2026, and the entry now cites the act and the December 2025 decree that create it. The first treatments were expected in the second half of 2026.
Psilocybin Media Group. "Czechia: psilocybin legal status." The Psilocybin Record, accession CZ-001, version of 23 Aug 2026. https://psilocybinlegalization.com/record/czechia