Czechia

Medical useeffective

Psilocybin is legal for medical use in Czechia as of 17 Aug 2026.1

1. What the law is

Key legislation

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

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. Pending legislation

Introduced but not yet law. If a bill passes, this record changes with it.

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.

3. History

The laws behind today’s status, when each took effect, and every review since, in order.

  1. Medical use status takes effect.

    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.

    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 entry now cites the adopted regulation rather than the draft that was notified to the EU, and records which specialists may prescribe.

    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.

4. Trials in Czechia

Interventional psilocybin trials with at least one study site in Czechia, drawn from ClinicalTrials.gov, EU CTIS, and ISRCTN. Registry data is reported by sponsors and shown as filed.

1Recruiting
6Active
2Completed
1Closed
10Total

Recruiting, active, completed and closed add up to the 10 trials with a study site in Czechia, as of Aug 2026. Closed covers trials terminated, suspended, withdrawn or left unverified.

From ClinicalTrials.gov, EU CTIS, and ISRCTN, as of Aug 2026. Showing all 10 trials with a study site in Czechia, recruiting trials first. This site makes no medical claims about psilocybin.
NCT06793397 (opens in new tab)A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder (opens in new tab)Sites in Prague and PředměstíPhase Phase 3Sponsor Cybin IRL LimitedStatus RecruitingStarted
NCT06782724 (opens in new tab)Psilocybin Therapy for Psychological Distress in Palliative Patients (opens in new tab)Recruiting at National Institute of Mental Health, PraguePhase Phase 2Sponsor University Medical Center GroningenStatus Not statedStarted
2024-515899-13-00 (opens in new tab)Psilocybin versus ketamine; fast acting antidepressant strategies in treatment-resistant depression (opens in new tab)Phase Not statedSponsor Narodni Ustav Dusevniho ZdraviStatus Not statedStarted
2024-517902-27-00 (opens in new tab)Regression of Atherosclerosis induced by liFe chAnging Experience with psiLocybin (opens in new tab)Phase Not statedSponsor Psyon s.r.o.Status Not statedStarted
2023-505268-12-00 (opens in new tab)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)Phase Not statedSponsor Compass Pathfinder LimitedStatus Not statedStarted
NCT05711940 (opens in new tab)Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With TRD (opens in new tab)Sites in Klecany, Kutná Hora, OstravaPhase Phase 3Sponsor COMPASS PathwaysStatus Active, not recruitingStarted
2024-517747-31-00 (opens in new tab)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)Phase Not statedSponsor Narodni Ustav Dusevniho ZdraviStatus Not statedStarted
NCT05383313 (opens in new tab)Psilocybin Versus Ketamine in Treatment-Resistant Depression (opens in new tab)Recruiting at National Institute of Mental Health, KlecanyPhase Phase 2Sponsor National Institute of Mental Health, Czech RepublicStatus Unknown statusStarted
NCT04519957 (opens in new tab)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, KlecanyPhase Not statedSponsor COMPASS PathwaysStatus CompletedStarted
NCT03775200 (opens in new tab)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, KlecanyPhase Phase 2Sponsor COMPASS PathwaysStatus CompletedStarted

ClinicalTrials.gov data courtesy of the U.S. National Library of Medicine.

5. Common questions

Are magic mushrooms ("shrooms") legal in Czechia?

"Magic mushrooms" and "shrooms" are common names for fungi that contain psilocybin. Psilocybin is legal for medical use in Czechia as of 17 Aug 2026. Some laws control the compound and the fungus separately, so this record states the position for psilocybin in Czechia.

Sources and confidence

Every status line is checked against the primary sources below. How each record is graded for confidence is set out in the methodology.

  1. 1.mzd.gov.cz (opens in new tab) · mzd.gov.cz
  2. 2.e-sbirka.gov.cz (opens in new tab) · e-sbirka.gov.cz

Cited at the review

This information is for educational purposes only and does not constitute legal advice. Laws change frequently, and enforcement practice can differ from the letter of the law. Verify current status with local authorities before relying on this record.

Changes to this record

Every change we have made to this record, dated, corrections included. Nothing changes silently.

  1. Correction

    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.

  2. Correction

    Czechia's entry now cites the adopted regulation rather than the draft that was notified to the EU, and records which specialists may prescribe.

  3. Correction

    Czechia's record drops an unsupported claim to be Europe's first such framework, and now states the three conditions the regulation actually names.

  4. Correction

    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.

Cite this recordCZ-001

Czechia: psilocybin legal status. The Psilocybin Record. Accession CZ-001. Status as of 17 Aug 2026. https://psilocybinlegalization.com/record/czechia

Record 22 of 100 · Last reviewed CZ-001

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