Poland

Poland is a restrictive but increasingly relevant European research market. Classical psychedelics such as psilocybin, psilocin, DMT, 5-MeO-DMT, LSD, MDMA and mescaline remain in Group I-P and are research-only under the national drug-control framework.

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Key Insights

A concise read of the policy, research, and stakeholder signals shaping psychedelic medicine in Poland.

1
Poland has publicly funded access to esketamine through B.147, not broad medical access to classical psychedelics.
2
Group I-P compounds are research-only; ketamine is Group II-P and has a separate medical-use basis.
3
Off-label psychiatric ketamine exists, but reviewed sources did not establish a national public reimbursement pathway for antidepressant ketamine.
4
Gdansk is the strongest verified domestic research node, especially through Medical University of Gdansk ketamine and mood-disorder work.
5
Poland is now visible in multinational Phase III psilocybin and LSD programmes and in 5-MeO-DMT-linked GH001 research, but these remain trial routes.
6
Any future EMA approval for a classical psychedelic would still need Polish pricing, HTA, reimbursement and service-delivery decisions before patient access becomes real.

Research Snapshot

Blossom currently tracks 20 psychedelic clinical trials connected to Poland, including 4 active studies.

Active trials: 4
Total trials: 20
Stakeholders: 3
Events: 2

Top Compounds

Esketamine(10)
Ketamine(4)
5-MeO-DMT(1)
LSD(1)
Psilocybin(1)

Active Trial Preview

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Medical Access Snapshot

Poland remains restrictive for classical psychedelics, which are generally research-only under Group I-P controls. The clearest patient-access route is EU-authorised esketamine through NFZ drug programme B.147 for treatment-resistant depression. Ketamine is legally available as a medical anaesthetic and appears in off-label psychiatric research and practice, but no routine public reimbursement route for antidepressant ketamine was identified.

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Regulatory Status

Poland remains restrictive for classical psychedelics. Psilocybin, psilocin, DMT, 5-MeO-DMT, LSD, MDMA and mescaline are treated as Group I-P psychotropic substances, which means research-only use under the drug-control framework. Ketamine is different: it sits in Group II-P, where medical, industrial and research use are possible. Routine care is therefore not a classical-psychedelic access story. The clearest public route is esketamine through NFZ drug programme B.147 for treatment-resistant depression, while antidepressant ketamine use remains off-label and no national reimbursement route for psychiatric ketamine was identified. Possession remains criminal, though Article 62a allows discontinuation in some low-quantity personal-use cases; that is discretion, not decriminalisation.

History of Research in Poland

Poland's modern policy framework starts with the 2005 Act on Counteracting Drug Addiction and the ministerial schedules that classify narcotic and psychotropic substances. For this topic, the key distinction is between Group I-P substances, which are research-only, and Group II-P substances such as ketamine, which can be used medically. # #

The country has not followed a decriminalisation or ceremonial-exemption route. Possession remains a criminal offence, although Article 62a allows proceedings to be discontinued in some low-quantity own-use cases where punishment would be pointless because of the circumstances and social harm. # #

The first meaningful modern clinical foothold came through ketamine and then esketamine. Gdansk-based researchers built a visible ketamine and mood-disorder publication stream, while EU authorisation of Spravato and Polish B.147 reimbursement created a supervised public pathway for esketamine in treatment-resistant depression. # # # #

By 2024-2026, Poland was more visible in multinational psychedelic development. Polish sites appear in Phase III COMP360 and MM120 trial records, and Medical University of Gdansk authorship appears on the 2026 GH001 mebufotenin publication. That shows research integration without wider legal opening. # # # #

Gdansk and Warsaw

Gdansk is the clearest Polish research node. The Medical University of Gdansk appears in ketamine registry work, ketamine publications and the author network around the GH001 mebufotenin paper. That makes it the strongest verified domestic signal in the reviewed sources. # # #

Warsaw matters for a different reason: reimbursement and regulatory decisions are centralised. The Ministry of Health, NFZ, URPL and bioethics bodies determine schedules, market authorisation, public payment and trial approvals. # # # #

Bydgoszcz and Lodz are relevant trial locations rather than broad policy nodes. Promente Bydgoszcz publicly describes COMP006 participation, and ClinicalTrials.gov lists Lodz and Gdansk locations in the MM120 Panorama trial. # #

The national system therefore looks split: research capacity is visible in a few clinical centres, but route-to-market and route-to-payment decisions remain central. That is why Poland can be scientifically relevant while still being restrictive for patient access. # # #

Research Focus

Ketamine and esketamine-adjacent psychiatry are the clearest domestic research strengths. ClinicalTrials.gov lists the Medical University of Gdansk-sponsored KetGD registry on ketamine safety and tolerability in psychiatric inpatient care, and Polish publications from that network cover ketamine treatment in mood disorders. # #

Poland also has a credible 5-MeO-DMT-linked research signal. The GH001 mebufotenin Phase IIb paper was published in JAMA Psychiatry in March 2026, with Medical University of Gdansk authorship visible in the indexed record. # #

The broader classical-psychedelic pipeline is mainly multinational. CTIS-derived and registry sources show Poland in Phase III COMP360 for treatment-resistant depression and in Phase III MM120 for generalised anxiety disorder. Those records indicate trial participation, not routine care. # # # #

I did not identify equally strong verified Poland-specific clinical programmes for MDMA, ayahuasca, ibogaine, mescaline or non-5-MeO DMT by 13 May 2026. That is a source boundary rather than proof that no activity exists anywhere. # #

Key Milestones

29 Jul 2005

Poland enacts the Act on Counteracting Drug Addiction, which remains the core legal framework for controlled substances.

2018

The modern ministerial scheduling regulation consolidates lists of psychotropic substances, narcotics and new psychoactive substances.

18 Dec 2019

Spravato receives EU marketing authorisation, creating the legal basis for standard medicines access to esketamine in Poland.

1 Jul 2023

Public procurement and reimbursement notices later identify esketamine as reimbursed in Polish drug programme B.147 for treatment-resistant depression.

17 Sep 2024

The Phase III COMP006 psilocybin trial records Poland as a participating member state with Polish recruitment starting in early 2025.

7 Feb 2025

CTIS-derived COMP006 data list the start of recruitment in Poland for the COMP360 treatment-resistant depression trial.

25 Mar 2026

JAMA Psychiatry publishes the GH001 mebufotenin randomised trial, with Medical University of Gdansk authorship.

April 2026

The Ministry of Health reimbursement notice page remains the live official source for current Polish reimbursement lists.

13 May 2026

Current review confirms Poland as a research-integrated but access-restricted jurisdiction, with public access centred on esketamine.

Future Outlook

The next 12-24 months are more likely to bring research and sponsor-readout changes than domestic legal liberalisation. Poland is connected to multinational Phase III psilocybin and LSD trials and to a 5-MeO-DMT publication stream, but none of that alters routine care by itself. # # #

For patients, the main access question is downstream of approval. If a classical psychedelic medicine gains EMA approval, Poland would still need pricing, HTA, reimbursement and delivery decisions. The B.147 esketamine route suggests access would probably be programme-based and supervised rather than open private-market prescribing. # # #

Site capability may improve through trial participation. Gdansk, Bydgoszcz and Lodz appear in current or recent trial signals, which could deepen local screening, monitored administration and follow-up experience. Without authorisation and payer decisions, that capability will remain research infrastructure rather than broad patient access. # # # #