Germany
Psilocybin is legal for medical use in Germany as of 17 Aug 2026.1
- Checked against 2 cited sources at this review.
1. What the law is
Compassionate use program (Haertefallprogramm) notified under section 21(2) no. 3 of the Medicines Act (AMG) and the compassionate use regulation (AMHV). The sponsor files a notification which the Federal Institute for Drugs and Medical Devices confirms under section 4 AMHV; this is a confirmed notification and not an approval. Section 1(2) AMHV excludes single-patient use, so the route is cohort-only, and section 5 AMHV caps a confirmation at one year. The regulator's table of notified programs lists one psilocybin program: Psilocybin bei therapieresistenter Depression, notified 18 June 2026 to 17 June 2027, responsible person Prof. Dr. med. Gerhard Gruender, Zentralinstitut fuer Seelische Gesundheit, Mannheim. General use remains illegal under BtMG Schedule I.1
Germany's psilocybin route is one program at one institute, renewed annually. It supplies psilocybin for treatment-resistant depression outside both a clinical trial and an ordinary prescription, and it reaches only patients enrolled at a participating center. That program runs from 18 June 2026 to 17 June 2027 at the Zentralinstitut fuer Seelische Gesundheit in Mannheim. It is not a national scheme any prescriber can use. The route is set by section 21(2) no. 3 of the Medicines Act and the compassionate use regulation made under it. Nothing here is approved. The sponsor notifies the Federal Institute for Drugs and Medical Devices, which confirms the notification and keeps a right to object, including after the program has started. A confirmation runs one year and then has to be renewed. Possession outside the program remains an offense under the Narcotics Act.
2. Pending legislation
No bill is on file in Germany that would change this record, as of the 17 Aug 2026 review.
3. History
The laws behind today’s status, when each took effect, and every review since, in order.
Medical use status takes effect.
Germany's compassionate use program was confirmed active and unchanged, though the regulator's psilocybin-specific listing could not be read directly at this review.
Germany's entry now describes how its compassionate use programme actually works. A sponsor notifies the regulator, which confirms the notification rather than granting an approval, and the confirmation has to be renewed each year.
Germany's entry was a year out of date. The regulator lists one psilocybin programme, running from 18 June 2026 to 17 June 2027 at a single institute in Mannheim for treatment-resistant depression, and the entry now says that instead of describing a national scheme.
4. Trials in Germany
Interventional psilocybin trials with at least one study site in Germany, drawn from ClinicalTrials.gov, EU CTIS, and ISRCTN. Registry data is reported by sponsors and shown as filed.
Recruiting, active, completed and closed add up to the 5 trials with a study site in Germany, as of Aug 2026. Closed covers trials terminated, suspended, withdrawn or left unverified.
| Registry ID | Trial | Phase | Sponsor | Status | Started |
|---|---|---|---|---|---|
| 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 Berlin, Frankfurt am Main, Homburg | Phase Phase 3 | Sponsor Cybin IRL Limited | Status Recruiting | Started |
| 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 stated | Sponsor Compass Pathfinder Limited | Status Not stated | Started |
| NCT05711940 (opens in new tab) | Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With TRD (opens in new tab)Sites in Berlin, Frankfurt, Lübeck | Phase Phase 3 | Sponsor COMPASS Pathways | Status Active, not recruiting | Started |
| NCT04670081 (opens in new tab) | Efficacy and Safety of Psilocybin in Treatment-Resistant Major Depression (opens in new tab)Sites in Berlin and Mannheim | Phase Phase 2 | Sponsor Central Institute of Mental Health, Mannheim | Status Completed | Started |
| NCT03775200 (opens in new tab) | The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression (opens in new tab)Site at Charité - Universitätsmedizin Berlin, Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin, Berlin | Phase Phase 2 | Sponsor COMPASS Pathways | Status Completed | Started |
ClinicalTrials.gov data courtesy of the U.S. National Library of Medicine.
5. Common questions
Is psilocybin legal in Germany?
Psilocybin is legal for medical use in Germany as of 17 Aug 2026.
Are magic mushrooms ("shrooms") legal in Germany?
"Magic mushrooms" and "shrooms" are common names for fungi that contain psilocybin. Psilocybin is legal for medical use in Germany as of 17 Aug 2026. Some laws control the compound and the fungus separately, so this record states the position for psilocybin in Germany.
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.bfarm.de (opens in new tab) · bfarm.de
- 2.zi-mannheim.de (opens in new tab) · zi-mannheim.de
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.
Germany's entry was a year out of date. The regulator lists one psilocybin programme, running from 18 June 2026 to 17 June 2027 at a single institute in Mannheim for treatment-resistant depression, and the entry now says that instead of describing a national scheme.
Germany's entry now describes how its compassionate use programme actually works. A sponsor notifies the regulator, which confirms the notification rather than granting an approval, and the confirmation has to be renewed each year.
Germany's compassionate use program was confirmed active and unchanged, though the regulator's psilocybin-specific listing could not be read directly at this review.
Germany: psilocybin legal status. The Psilocybin Record. Accession DE-001. Status as of 17 Aug 2026. https://psilocybinlegalization.com/record/germany
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