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Psychedelics in Portugal: what is legal, substance by substance

KETAMED is a medically assisted psychedelic therapy clinic, with assessments in Lisbon and sessions in Sintra. In Portugal, only ketamine, as an anaesthetic, and esketamine, for treatment-resistant depression, are approved medicines. Psilocybin, MDMA, LSD and DMT are not permitted outside authorised research; possession for personal use is an administrative offence, not a crime.

Substance by substance

The status of each substance in Portugal, with the law, clinical trials and sources.

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  • Ketamine

    Approved medicine

    Hospital-use anaesthetic; in depression, off-label use with a psychiatric assessment

    What the law says

    It is authorised in Portugal as an injectable anaesthetic, on restricted prescription for hospital use only [1]. It is not listed in the tables of Decree-Law 15/93 [2]. Its use in depression is off-label, under the prescribing doctor’s responsibility [3].

    Trials in Portugal

    The EU clinical trials register lists no ketamine trials in psychiatry with sites in Portugal [4].

    Learn more about Ketamine

  • Esketamine

    Approved medicine

    Nasal spray, decided by a psychiatrist

    What the law says

    Esketamine nasal spray has been authorised in the European Union since 2019 for adults with treatment-resistant depression, together with an antidepressant [5]. In Portugal, public funding for hospital use was approved in 2025, for a narrower indication [6].

    Trials in Portugal

    One phase 3 trial, now completed, had sites in Portugal [7].

    Learn more about Esketamine

  • Psilocybin

    In clinical trialsNot permitted

    Possession for personal use: administrative offence, not a crime

    What the law says

    It is not an approved medicine. It is listed in Table II-A of Decree-Law 15/93, together with psilocin [2]: producing, selling or supplying it is a crime. Since 2001, possession for personal use has been an administrative offence, not a crime [8] [9].

    Trials in Portugal

    One ongoing phase 2 trial in palliative care, with a site at the Champalimaud Foundation [10]; one phase 2 trial in treatment-resistant depression, now completed, had a site in Portugal [11].

    Learn more about Psilocybin

  • MDMA

    Not permitted

    Possession for personal use: administrative offence, not a crime

    What the law says

    It is not an approved medicine. It is listed in Table II-A of Decree-Law 15/93 [2]: producing, selling or supplying it is a crime; possession for personal use is an administrative offence [8].

    Trials in Portugal

    There are no registered clinical trials with sites in Portugal.

    Learn more about MDMA

  • LSD

    Not permitted

    Possession for personal use: administrative offence, not a crime

    What the law says

    It is not an approved medicine. It is listed in Table II-A of Decree-Law 15/93 [2]: producing, selling or supplying it is a crime; possession for personal use is an administrative offence [8].

    Trials in Portugal

    There are no registered clinical trials with sites in Portugal.

    Learn more about LSD

  • DMT and ayahuasca

    Not permitted

    Possession for personal use: administrative offence, not a crime

    What the law says

    DMT is listed in Table II-A of Decree-Law 15/93 [2]. Ayahuasca is not named in the tables, but a higher court ruled in 2025 that importing ayahuasca is importing DMT [12]. Possession for personal use is an administrative offence [8].

    Trials in Portugal

    There are no registered clinical trials with sites in Portugal.

    Learn more about DMT and ayahuasca

Summary table

SubstanceStatus in PortugalTrials with sites in Portugal
KetamineApproved medicineHospital-use anaesthetic; in depression, off-label use with a psychiatric assessmentThe EU clinical trials register lists no ketamine trials in psychiatry with sites in Portugal [4].
EsketamineApproved medicineNasal spray, decided by a psychiatristOne phase 3 trial, now completed, had sites in Portugal [7].
PsilocybinIn clinical trials · Not permittedPossession for personal use: administrative offence, not a crimeOne ongoing phase 2 trial in palliative care, with a site at the Champalimaud Foundation [10]; one phase 2 trial in treatment-resistant depression, now completed, had a site in Portugal [11].
MDMANot permittedPossession for personal use: administrative offence, not a crimeThere are no registered clinical trials with sites in Portugal.
LSDNot permittedPossession for personal use: administrative offence, not a crimeThere are no registered clinical trials with sites in Portugal.
DMT and ayahuascaNot permittedPossession for personal use: administrative offence, not a crimeThere are no registered clinical trials with sites in Portugal.

How Portuguese law works

Controlled substances are listed in the tables annexed to Decree-Law 15/93, last updated in May 2026 [2]. Psilocybin, psilocin, MDMA, LSD and DMT are in Table II-A.

Since 1 July 2001, possession for personal use has been an administrative offence rather than a crime; the case goes to a dissuasion committee [8]. Since 2023, holding more than ten days’ quantity is only an indication, not proof, that possession is not for personal use [9]. This does not make the substances permitted: producing, selling or supplying them remains a crime.

Clinical trials of medicines can only start after authorisation by INFARMED, with ethical review by the Clinical Research Ethics Committee [13].

Using a medicine outside its approved indications, such as ketamine for depression, is the prescribing doctor’s responsibility and requires an individual assessment and informed consent [3].

And in the rest of the world?

The situation in other countries, with approvals, special access, regulated programmes and clinical trials, is on its own page, with an interactive map.

Psychedelics worldwide: approvals and laws

Frequently asked questions

Is psilocybin legal in Portugal?

No. Psilocybin is listed in Table II-A of Decree-Law 15/93: producing, selling or supplying it is a crime. Since 2001, possession for personal use has been an administrative offence rather than a crime, but that does not make it permitted. One phase 2 clinical trial of psilocybin is authorised in Portugal.

Is psilocybin a medicine?

Not yet. No psilocybin medicine is approved in the European Union or in Portugal. In the United States, the first marketing application was submitted to the FDA in November 2026.

Are DMT and ayahuasca legal in Portugal?

No. DMT is listed in Table II-A of Decree-Law 15/93. Ayahuasca is not named in the tables, but a higher court ruled in 2025 that importing ayahuasca is importing DMT.

Is MDMA legal in Portugal?

No. MDMA is listed in Table II-A of Decree-Law 15/93 and is not an approved medicine. There are no MDMA clinical trials with sites in Portugal.

Is ketamine legal in Portugal?

Ketamine is a medicine authorised in Portugal as an anaesthetic, for hospital use. Its use in depression is off-label and always requires a psychiatric assessment. Esketamine nasal spray is authorised for treatment-resistant depression.

Are there clinical trials of psychedelics in Portugal?

Yes, a few. A phase 2 trial of psilocybin in palliative care is ongoing, with a site at the Champalimaud Foundation. A phase 2 trial of psilocybin in treatment-resistant depression, now completed, also had a site in Portugal.

This information is educational and the sources are verified. It is not legal advice, a treatment recommendation or advertising of medicines.

References

13
  1. INFARMED, Infomed (base de dados de medicamentos): medicamentos com cetamina autorizados em Portugal, solução injectável, indicação anestésica, receita médica restrita de uso exclusivo hospitalar; escetamina em spray nasal (registo 5788518). Pesquisa por substância activa «cetamina» e «escetamina». (INFARMED, Infomed (medicines database): ketamine medicines authorised in Portugal, solution for injection, anaesthetic indication, restricted prescription for hospital use only; esketamine nasal spray (registration 5788518). Search by active substance “cetamina” and “escetamina”.) extranet.infarmed.ptRegulatory source
  2. Lei n.º 19-F/2026, de 8 de Maio: altera o Decreto-Lei n.º 15/93 e republica as Tabelas I-A, II-A, IV e V. A Tabela II-A inclui a psilocibina, a psilocina, a MDMA, o LSD e a DMT; a cetamina e a escetamina não constam. (Law 19-F/2026 of 8 May: amends Decree-Law 15/93 and republishes Tables I-A, II-A, IV and V. Table II-A includes psilocybin, psilocin, MDMA, LSD and DMT; ketamine and esketamine are not listed.) diariodarepublica.pt (PDF)Legislation
  3. INFARMED (Autoridade Nacional do Medicamento e Produtos de Saúde), Comissão Nacional de Farmácia e Terapêutica. Utilização de medicamentos em regime off-label (orientação aprovada em Março de 2025). Cita a Circular Informativa n.º 184/CD, de 12 de Novembro de 2010: a utilização fora das indicações aprovadas «é da inteira responsabilidade do médico prescritor». (INFARMED (Portugal’s medicines authority), National Pharmacy and Therapeutics Committee. Guidance on off-label use of medicines (approved March 2025). It cites INFARMED Circular 184/CD of 12 November 2010: use outside the approved indications is the full responsibility of the prescribing physician.) infarmed.pt (PDF)Guidance
  4. Clinical Trials Information System (CTIS, União Europeia): pesquisa por substância e país (12 de Novembro de 2026). (Clinical Trials Information System (CTIS, European Union): search by substance and country (12 November 2026).) euclinicaltrials.euClinical trial
  5. European Medicines Agency. European public assessment report (EPAR) and product information for esketamine nasal spray; marketing authorisation in the EU since 18 December 2019. ema.europa.euRegulatory source
  6. INFARMED. Public funding assessment report for esketamine nasal spray in treatment-resistant depression (approved for hospital use on 7 May 2025, for a narrower population than the marketing authorisation). infarmed.pt (PDF)Regulatory source
  7. ClinicalTrials.gov NCT04338321: escetamina em spray nasal na depressão resistente, fase 3, concluído, com centros em Portugal. (ClinicalTrials.gov NCT04338321: esketamine nasal spray in treatment-resistant depression, phase 3, completed, with sites in Portugal.) clinicaltrials.govClinical trial
  8. Lei n.º 30/2000, de 29 de Novembro: regime jurídico aplicável ao consumo de estupefacientes (descriminalização do consumo; não legaliza as substâncias). (Law 30/2000 of 29 November: the legal regime for drug use in Portugal (decriminalises personal use; does not legalise the substances).) diariodarepublica.pt (PDF)Legislation
  9. Lei n.º 55/2023, de 8 de Setembro: altera o Decreto-Lei n.º 15/93 e a Lei n.º 30/2000; exceder a quantidade de consumo médio individual de 10 dias passa a ser indício, e não presunção, de que o propósito pode não ser o consumo (em vigor desde 1 de Outubro de 2023). (Law 55/2023 of 8 September: amends Decree-Law 15/93 and Law 30/2000; holding more than 10 days of average individual use becomes an indication, not a presumption, that the purpose may not be personal use (in force since 1 October 2023).) diariodarepublica.pt (PDF)Legislation
  10. CTIS (UE), ensaio 2023-510488-36-01 (PsyPal; ClinicalTrials.gov NCT06782724): psilocibina no sofrimento psicológico em cuidados paliativos, fase 2, autorizado em Portugal a 25 de Novembro de 2024, com centro na Fundação Champalimaud. (CTIS (EU), trial 2023-510488-36-01 (PsyPal; ClinicalTrials.gov NCT06782724): psilocybin for psychological distress in palliative care, phase 2, authorised in Portugal on 25 November 2024, with a site at the Champalimaud Foundation.) clinicaltrials.govClinical trial
  11. ClinicalTrials.gov NCT03775200: psilocibina (COMP360) na depressão resistente, fase 2, concluído, com centro em Portugal (Centro Clínico Champalimaud). (ClinicalTrials.gov NCT03775200: psilocybin (COMP360) in treatment-resistant depression, phase 2, completed, with a site in Portugal (Champalimaud Clinical Centre).) clinicaltrials.govClinical trial
  12. Tribunal da Relação do Porto, acórdão de 30 de Abril de 2025, processo 1582/24.7JAPRT.P1: a importação de ayahuasca é importação de DMT (Tabela II-A), ainda que a ayahuasca não esteja nomeada nas tabelas. (Porto Court of Appeal, judgment of 30 April 2025, case 1582/24.7JAPRT.P1: importing ayahuasca is importing DMT (Table II-A), even though ayahuasca is not named in the tables.) dgsi.ptLegislation
  13. Lei n.º 9/2026, de 6 de Março: regula os ensaios clínicos de medicamentos para uso humano, em aplicação do Regulamento (UE) n.º 536/2014; os ensaios exigem autorização prévia do INFARMED, com avaliação ética pela CEIC. (Law 9/2026 of 6 March: regulates clinical trials of medicines for human use, implementing Regulation (EU) 536/2014; trials require prior INFARMED authorisation, with ethical review by CEIC.) diariodarepublica.pt (PDF)Legislation

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