Switzerland regulates medical cannabis and psychedelic medicines under an interlocking set of statutes. The starting point is the Federal Act on Narcotics and Psychotropic Substances (NarcA), implemented through four ordinances:

• the Ordinance on the Control of Narcotics (BetmKV);
• the Ordinance on the Addiction to Narcotics (BetmSV);
• the Ordinance on the Register of Narcotics (BetmVV-EDI); and
• the Ordinance on Pilot Trials under the NarcA (BetmPV).

The Federal Act on Medicinal Products and Medical Devices (the Therapeutic Products Act, TPA) and its implementing ordinances govern the placing on the market of ready-to-use products.

Foodstuffs, cosmetics and utility articles fall under the Federal Act on Foodstuffs and Utility Articles (FSA) and the Ordinance on Foodstuffs and Utility Articles (LGV).

Chemical products fall under the Chemicals Act and the Chemicals Ordinance (ChemO).

Plant-based smoking products and e-cigarettes are now regulated under the new Tobacco Products Act (TabPA) and its Ordinance (TabPO), in force since 1 October 2024.

Cannabis with a tetrahydrocannabinol (THC) content of 1% or more is a prohibited narcotic, except for medical use. Since 1 August 2022, the prior Federal Office of Public Health (FOPH) exception permit is no longer required for medical prescribing. Physicians may prescribe medical cannabis directly, while cultivation, manufacture and trade of medical cannabis remain subject to Swissmedic licensing under the TPA. Two ready-to-use products are authorised: Sativex (THC/CBD oromucosal spray, indicated for MS-related spasticity) and Epidyolex (highly purified CBD, indicated for Lennox-Gastaut, Dravet and tuberous sclerosis-related seizures). All other use is by extemporaneous (magistral) preparation in compliance with the Pharmacopoea Helvetica and the Good Manufacturing Practice (GMP) requirements for small-scale manufacture, on the basis of a physician’s prescription. Recreational use of cannabis with a THC content of 1% or more remains prohibited outside the authorised pilot trials.

Cannabis with a THC content of below 1% is not a narcotic and is broadly marketable, subject to the legislation applicable to the relevant product category: chemicals, cosmetics, utility articles, tobacco products or foodstuffs. The same regulatory logic applies to other non-psychotropic cannabinoids (CBG, CBN, CBC and others). The primary practical reference for product classification, applicable law and the competent authority is the cross-agency implementation guide Produkte mit Cannabidiol (CBD) und anderen Cannabinoiden, die nicht dem Betäubungsmittelrecht unterliegen – Überblick und Vollzugshilfe (Version 8.0, 1 May 2025; the Vollzugshilfe), drafted by the Expert Panel for Delimitation Issues representing the FOPH, the FSVO, Swissmedic, the Cantonal Pharmacists’ Association (KAV) and the Association of Swiss Cantonal Chemists (VKCS). Recent EU developments (the 2026 Scientific Committee on Consumer Safety (SCCS) Scientific Advice and the 9 February 2026 EFSA update on cannabidiol (CBD) as a novel food, both addressed in 3.2 Non-Controlled Cannabinoids in Food) have tightened the practical compliance conditions, and an update of the Vollzugshilfe is expected.

Psychedelic substances are split across two regimes in the BetmVV-EDI. Verzeichnis d lists prohibited narcotics such as LSD, psilocybin, MDMA, mescaline, ibogaine and DMT. They may not be cultivated, imported, manufactured or placed on the market without an FOPH exception permit under Article 8(5) NarcA. The exception permit is available for three purposes:

• scientific research;
• development of medicinal products; and
• limited medical use (often referred to as “compassionate use”).

Verzeichnis b lists controlled psychotropic substances that are available as authorised medicinal products under standard narcotic prescription. Ketamine sits in Verzeichnis b. It is widely used in Switzerland as an anaesthetic and analgesic and, through the authorised esketamine product Spravato, as a psychiatric treatment for treatment-resistant depression. The practical consequence of the b/d distinction is significant: Verzeichnis b substances can be prescribed by any authorised physician under a narcotic prescription (Betäubungsmittelrezept) and supplied through any pharmacy with the requisite Swissmedic licence, while Verzeichnis d substances require an individual FOPH exception permit for each named patient, indication and treatment period.

Switzerland has operated a limited medical use programme for psychedelics under Article 8(5) NarcA since 2014. The statute is available in principle for any Verzeichnis d substance. In practice the programme has covered three: LSD and MDMA from 2014, and psilocybin from 2021. The operational mechanics of the programme are addressed in 1.4 Existing Markets. Treatment is delivered through the Geneva University Hospitals (HUG), Bethesda Spital Basel, the University Psychiatric Clinics of Basel and Bern, centres in Fribourg and Zurich, and a network of individual psychiatrists and psychotherapists. The Swiss Society for Psychedelic-Assisted Therapy (SÄPT) is the principal professional society and training body and maintains a public list of practitioners active in the field.

The University of Basel (Liechti group, Division of Clinical Pharmacology and Toxicology) and the University of Zurich (Heffter Research Center) are particularly active in clinical research on psychedelics and provide a substantial part of the underlying clinical evidence base. Other Verzeichnis d substances, including DMT, 5-MeO-DMT, mescaline and ibogaine, are present in Switzerland only in scientific research contexts under Article 8(5) authorisations issued for that distinct purpose.

For medical cannabis, no general compassionate use mechanism is needed since the 2022 reform, though reimbursement remains available only on a case-by-case basis under Article 71a/b of the Health Insurance Ordinance (KVV), the so-called “exception reimbursement” pathway for life-threatening or chronic severe conditions where no equivalent treatment exists.

Esketamine (Spravato) was authorised by Swissmedic on 25 February 2020 for adults with treatment-resistant major depressive disorder who have not responded to at least two prior antidepressants, and was admitted to the Spezialitätenliste on 1 October 2025 with a limitation. It is prescription-only and the only psychedelic-class substance with a formal OKP reimbursement pathway in Switzerland, as well as the only ready-to-use psychiatric medicinal product with a psychedelic-class active substance available domestically. The decision to prescribe must be taken by a psychiatrist. Each treatment session requires a minimum two-hour post-administration observation in a setting equipped for resuscitation, with the patient self-administering under direct medical supervision.

The Federal Office of Public Health (FOPH/BAG) issues exception permits for psychedelics and for non-medical cannabis used in scientific research, supervises the cannabis pilot trials, and runs the data collection on medical cannabis prescribing introduced with the 2022 reform.

Swissmedic authorises ready-to-use medicinal products, issues operating licences for the cultivation, manufacture, processing, storage, distribution, importation and exportation of medical cannabis, and inspects against GMP and Good Distribution Practice (GDP) standards. It also handles the special licences for scheduled-substance manufacturing.

The Federal Food Safety and Veterinary Office (FSVO/BLV) is the federal authority on foodstuffs, including the authorisation of novel foods and the assessment of cannabinoid-containing food products.

The cantonal pharmacists’ associations (Kantonsapothekervereinigung, KAV) issue position papers and supervise the cantonal-level dispensing practice for cannabis-based magistral preparations.

The Office of the Attorney General of Switzerland (OAG) has parallel investigative competence in narcotics matters where conduct crosses cantonal or international lines.

The cantonal authorities – such as public prosecutors, cantonal chemists, cantonal pharmacists’ offices and cantonal police – carry out the day-to-day enforcement load for narcotics, foodstuffs, cosmetics and chemicals legislation. The well-known divergence in cantonal practice creates a meaningful compliance variable for operators with national reach.

The Swiss Chemicals Notification Authority (Anmeldestelle Chemikalien) runs the Chemicals Register and issues general rulings affecting CBD-containing scented oils and similar products.

The Expert Panel for Delimitation Issues (formerly the Technische Plattform für Abgrenzungsfragen) is the cross-agency body composed of representatives of the FOPH, the FSVO, Swissmedic, the KAV and the Association of Swiss Cantonal Chemists (VKCS) which authors the Vollzugshilfe and other delimitation guidance papers; it is also the principal co-ordinating body for borderline product questions.

The Swissethics network of cantonal ethics committees, applying the Human Research Act (HFG), reviews clinical trials with cannabis or psychedelics. Trials with controlled substances additionally require notification or authorisation by Swissmedic.

The cannabis sector relies on several industry bodies. IG Hanf Schweiz operates the Swiss Certified Cannabis label, with audited standards on quality, production, packaging, storage, hygiene and labour. The Swiss Society of Cannabis in Medicine (SGCM-SSCM) is an interdisciplinary umbrella body for clinicians, pharmacists, researchers and industry. Medcan advocates on behalf of patients. On the recreational side, IG Hanf Schweiz is the principal co-ordinating body with the FOPH and lawmakers in the legislative process around the Cannabis Products Act.

For psychedelics, the Swiss Society for Psychedelic-Assisted Therapy (SÄPT) has become the principal professional society. It runs an advanced training programme (2023–2028 cohort), issues guidance on indication, setting, dosing and integration, and feeds into the FOPH’s expectations on physician qualifications. The Swiss Society for Psychiatry and Psychotherapy (SGPP/SSPP) published treatment recommendations on psychedelic-assisted therapy in September 2024, positioning psychedelic-assisted therapy (PAT) as an off-label third-line option for treatment-resistant moderate-to-severe mental illness. The Interdisciplinary Group for Psychedelic-Assisted Therapy (IG-PAT) at the SÄPT manages the standardised outcome questionnaire used to report each completed treatment to the FOPH. Clinical trials follow ICH-GCP and the HFG, and GMP standards apply to product manufacture.

Medical Cannabis

Since the 2022 NarcA reform, the system has worked as follows.

A physician with a Swiss cantonal practice authorisation writes a narcotic prescription (Betäubungsmittelrezept) directly to the patient. No individual FOPH exception permit is needed. The prescription is filled at a pharmacy with the requisite cantonal narcotic licence, in the form of either one of the two authorised ready-to-use products (Sativex; Epidyolex) or, more typically, as a magistral (extemporaneous) preparation prepared by the pharmacy to the physician’s prescription, in compliance with the Pharmacopoea Helvetica and GMP requirements for small-scale manufacture.

Cultivation, manufacture, processing, storage, distribution, importation and exportation of medical cannabis are subject to Swissmedic operating licences under the TPA. The prescribing physician is required to report defined treatment data to the FOPH for each medical cannabis prescription under the data collection introduced by the 2022 reform, although the absence of penalties for non-reporting has weakened compliance with this obligation. Cantonal pharmacists (Kantonsapotheker), co-ordinated through the KAV, supervise the dispensing of magistral preparations and apply KAV position papers on cannabis-based medicinal products. Reimbursement under the OKP is available only on a case-by-case basis under Article 71a/b KVV (the hardship route), as addressed in 1.5 Challenges Facing Market Participants and 3.1 Access to Medicinal Cannabis and Psychedelic Medicines Today.

The legal medical market is dominated by extracts (roughly an 80/20 split versus flower) and is supplied by a small number of domestic producers and imports (primarily of dronabinol and standardised extracts), with the prescription of flower growing fast from both domestic and imported sources. Patient numbers have grown since the 2022 reform but are still modest. A substantial population continues to self-medicate with illicit cannabis, with the quality and contamination risks that follow. Specialist dispensing pharmacies (Bahnhof Apotheke Langnau, Stauffacher Apotheke and others) play an outsized role given the dominance of magistral preparations.

CBD and Other Non-Controlled Cannabinoids

Switzerland has had a mature CBD market for several years across cosmetics, scented oils, tobacco substitutes and food-adjacent products. The market is in structural transition, driven by the 2026 EU developments described in 3.2 Non-Controlled Cannabinoids in Food.

Pilot Trials for Non-Medical Cannabis

Seven pilot trials are ongoing across Swiss cities and municipalities, testing different regulated sales models. In the first cross-trial overview (data from June 2024), around 7,000 adults were participating. In the subsequent cross-trial overview (data from June 2025), participation had risen to around 10,400 adults. These figures are reported at specific cut-off dates and should be read as a moving baseline rather than a fixed market size indicator. Zurich (Züri Can) illustrates the scale at city level: more than 2,300 participants have purchased around 750 kg across roughly 88,000 transactions, with the city estimating around CHF7.5 million diverted from the illicit market. The first systematic interim report (“Analysis and Results from Cannabis Pilot Trials in Swiss Cities – Part I, 2023 to Mid-2024”) has been published by the FOPH and a second wave of results is expected during 2026.

Psychedelic-Assisted Therapy

The system operates through individual FOPH exception permits issued under Article 8(5) NarcA for the limited medical use of Verzeichnis d substances. Each authorisation is granted to the treating physician for one named patient, one substance and one indication, valid for 12 months and renewable. The physician must demonstrate a treatment-resistant or otherwise indicated patient population, an appropriate clinical setting equipped for prolonged supervised dosing sessions, and informed consent. The substance is supplied through a small number of specialised compounding pharmacies authorised to handle Verzeichnis d substances (Apotheke Dr Hysek being one of the best known). Each treatment is reported to the FOPH through standardised outcome questionnaires.

In 2024 the FOPH issued 723 such authorisations to approximately 100 authorised physicians (245 for MDMA, 130 for LSD and 348 for psilocybin), with approximately 1,660 dosing sessions delivered. Psilocybin has overtaken MDMA and LSD as the most authorised substance.

Treatment is overwhelmingly directed at depressive disorders, post-traumatic stress disorder (PTSD) (including complex PTSD), anxiety disorders and substance use disorder. A typical PAT course covers preparation sessions, one or more supervised dosing sessions, and structured integration sessions, with the entire episode delivered outside the OKP and borne by the patient. Esketamine (Spravato), reimbursed under the OKP via the Spezialitätenliste with a limitation since 1 October 2025, sits commercially adjacent to PAT and represents the only psychedelic-class psychiatric treatment with a genuine population access pathway today. Investor interest in the wider sector is rising in parallel with the global Phase 3 pipeline (Compass Pathways, AtaiBeckley, GH Research, MindMed, Lykos and others).

The structural challenges to medical cannabis access in Switzerland are well known, and their centre of gravity has shifted from regulatory uncertainty to clinical and reimbursement gaps. The 2022 NarcA reform settled the prescribing question: physicians can prescribe medical cannabis directly, without a FOPH exception permit, and the operating-licence regime under Swissmedic is now established. What the reform did not address, and what continues to define the practical environment for patients and operators, sits in the layers above and around the prescribing right.

Only Epidyolex (a cannabidiol oral solution indicated for severe paediatric epilepsy) is on the Spezialitätenliste, having been admitted on a temporary basis on 1 January 2025. Sativex (THC/CBD oromucosal spray, indicated only for spasticity in multiple sclerosis), magistral preparations and all THC-containing products are not on the list.

Reimbursement under the OKP is therefore available only on a case-by-case basis under the hardship provisions of Article 71a/b of the Health Insurance Ordinance (KVV), and only where treatment is expected to provide a major therapeutic benefit against a life-threatening or chronic severe condition for which no equivalent treatment is available. The 2022 reform did not adjust the reimbursement requirements; the 2021 Health Technology Assessment did not confirm the so-called WZW criteria (Wirksamkeit, Zweckmässigkeit, Wirtschaftlichkeit; efficacy, appropriateness and cost-effectiveness) for chronic pain or MS-related spasticity, the two largest indications. Treatment costs reported by Medcan range from CHF450 to over CHF10,000 per month, which still keeps a large patient population on the illicit market. The substantive picture and the likely paths to change are addressed in 3.1 Access to Medicinal Cannabis and Psychedelic Medicines Today.

Furthermore, only two ready-to-use cannabis-based medicinal products are authorised in Switzerland: Sativex and Epidyolex. Sativex’s authorised indication is materially narrower than the patient population that would clinically benefit from a THC/CBD product, which leaves most legitimate prescribing reliant on magistral preparations dispensed by a small number of specialised pharmacies. The galenic landscape is improving, and metered vaporisers and standardised extract concentrations have advanced consistency at the patient level, but slow-release oral tablets, dry-powder inhalers, transdermal systems and sublingual formats remain underdeveloped.

Moreover, the Swiss clinical evidence base is thin. Domestic clinical trial activity in cannabis-based medicines is limited compared to Germany, the United Kingdom or the Netherlands, with academic groups (notably at the University Hospital Basel and the University of Zurich) carrying most of the research load. The 2021 HTA found the available efficacy data for chronic pain and multiple sclerosis spasticity inconsistent and inconclusive, which was the immediate reason for the WZW criteria not being confirmed. The mandatory FOPH data reporting introduced with the 2022 reform was designed to build a Swiss real-world dataset as a basis for both reimbursement decisions and clinical-practice guidance, but the absence of penalties for non-reporting has weakened the dataset materially. A tightening of the reporting requirement is the most realistic medium-term route to a domestic evidence base capable of supporting a structural reimbursement decision and, indirectly, a broader range of indications and authorised products, along with more investment into drug development.

Physician training and prescribing capacity remain a further constraint: cannabinoid-trained physicians are still a minority of the profession. The 2022 reform did not include a structured continuing-education obligation for prescribers. Patient access in practice depends on proximity to a small number of cannabinoid-experienced practices and dispensing pharmacies, although telemedicine is progressively narrowing the geographic gap, subject to the cantonal rules on remote prescribing of controlled substances. Cantonal divergence in inspection and enforcement practice adds a further variable for both prescribers and operators with national reach.

For low-THC operators adjacent to the medical cannabis market, EU regulatory pressure on CBD has increased materially in 2026 through the SCCS Scientific Advice (SCCS/1685/25) and the EFSA (European Food Safety Authority) novel-food update of 9 February 2026.  In addition, ANSES (Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail, the French food, environment and occupational health agency) proposed in 2025 that CBD be classified as a presumed human reproductive toxicant under the EU CLP (Classification, Labelling and Packaging Regulation, formally Regulation (EC) No 1272/2008) framework, based on available animal data. That proposal was opened for public consultation at EU level in March 2025. If the classification proceeds through the EU process, it would materially tighten labelling, formulation, and supply chain risk allocation for CBD-adjacent products across EU-linked value chains, with predictable spillover into Swiss administrative practice. The Vollzugshilfe predates these developments, and an update is expected.

Reimbursement is the single largest practical obstacle for the field. The classical psychedelic substances are not on the Spezialitätenliste and cannot be reimbursed under the OKP. Patients pay out of pocket. Reported per-session substance costs in institutional programmes range from CHF199 to CHF445 depending on substance and dose, and the full cost of a complete PAT episode (substance, supervised dosing session, preparation and integration sessions) typically runs into the four-figure range per treatment episode borne by the patient.

The supervised dosing session, lasting six to 12 hours for LSD, six to eight for psilocybin and four to six for MDMA, does not map cleanly onto TARDOC (previously TARMED), the Swiss outpatient fee-for-service tariff, which was designed around shorter consultation positions and was not built for prolonged continuous medical supervision of this kind, which can be very expensive. Preparation and integration sessions could in some configurations be billed under the Anordnungsmodell for psychological psychotherapy that has been an OKP benefit since 1 July 2022 (subject to physician referral and an OKP-accredited psychotherapist), but the dosing day itself cannot. The result is a structural reimbursement gap that confines PAT in practice to patients who can fund treatment privately. Esketamine (Spravato) is the structurally distinct counter-example: an authorised medicinal product on the SL with a limitation since 1 October 2025, prescribed within the standard psychiatric framework, with a two-hour post-administration observation that fits TARDOC. This contrast defines the route that the field now needs to travel.

Companies and individuals operate in a multi-layered web of interrelated and constantly changing rules. The practical risk map looks broadly as follows (non-exhaustive).

Unauthorised cultivation, manufacture, possession, importation or exportation of cannabis above 1% THC or of psychedelics in Verzeichnis d is criminal. Penalties range from monetary fines and custodial sentences of up to three years in standard cases to up to 20 years for aggravated trafficking. 

The TPA prohibits placing unauthorised medicinal products on the market and prohibits health-related advertising or promotional claims for unauthorised products. The risk is most widespread in the borderline space between supplements, foodstuffs and medicinal products. Promotional language suggesting therapeutic indications, dosage recommendations linked to a medical condition, or even soft positioning (eg, “supports sleep”, “helps with pain”) will draw the medicinal-product classification and trigger the requirement for Swissmedic authorisation. Breach is criminal under Article 86 et seq TPA, with custodial penalties and significant fines.

Medical cannabis with a THC content of 1% or more is a prescription-only narcotic medicinal product. Specialist advertising (Fachwerbung) to healthcare professionals is permitted under defined conditions while advertising to the general public (Publikumswerbung) is not, under the Ordinance on Advertising of Pharmaceuticals (AWV) read with the TPA. Swissmedic confirmed in March 2026 that it was investigating two advertisements run by a Swiss platform offering medical cannabis prescriptions, with promotional headlines such as “Cannabis auf Rezept” (cannabis per prescription) and “Kostenlos” (free), and indicated that fines of up to CHF50,000 may follow if the unlawful state is not remedied. The case is the cleanest illustration of an enforcement direction that operators in this space need to assume will accelerate as the patient market grows. Telemedicine platforms should build a compliance baseline that addresses the following:

• no active substance name and indication in public-facing communications;
• no price or “free” framing in respect of the prescription;
• clear separation between the platform’s marketing and the physician’s clinical decision;
• compliance with the cantonal rules on remote prescribing of controlled substances (which vary); and
• demonstrable independence of the prescribing physician’s judgement from the platform’s customer-acquisition strategy.

Beyond criminal exposure, recent enforcement has included shutdowns of CBD retailer websites for unlawful health claims and marketing bans for specific CBD oils.

On psychedelics, operating outside an FOPH permit, including offering “guided” sessions, importing psychedelics for personal or non-medical use, or exporting Swiss-made material to foreign clinical or therapeutic settings, exposes the operator and the prescribing physician to NarcA criminal liability. The advertising perimeter for the limited medical use programme is narrower still: PAT services and the substances themselves cannot be publicly advertised, and any online presence by individual physicians needs to remain within the bounds of professional information rather than promotional positioning.

The risk profile in 2026 has shifted from product-classification disputes, which the Vollzugshilfe has materially clarified, to advertising and prescribing conduct. Operators in the medical cannabis space should treat their public-facing content (websites, social media, search advertising, paid placements, partner referral channels) as the most active enforcement exposure.

Enforcement is split across federal and cantonal authorities. Operators typically face oversight from several channels at once, and one fact pattern can generate parallel proceedings.

Swissmedic

Swissmedic is the central federal enforcement authority for therapeutic products. Its toolkit covers operating licences (cultivation, manufacture, processing, storage, distribution, importation and exportation of medical cannabis and of controlled-substance medicinal products), GMP and GDP inspections, post-market surveillance, batch recalls, marketing prohibitions, vigilance reporting and enforcement of the AWV.

Penal powers under Article 86 et seq TPA include monetary penalties and custodial sentences of up to three years, scaling to ten years for aggravated cases involving danger to health. In practice, Swissmedic’s most frequent interventions in this sector are GMP inspection findings, refusals or conditions on operating licences, and administrative orders to cease unauthorised marketing or unlawful advertising. Inspection findings carry forward into licence renewal cycles and into the operator’s broader regulatory standing.

FOPH/BAG

The Federal Office of Public Health (FOPH/BAG) runs the enforcement layer specific to the NarcA. It issues, refuses, conditions, suspends and revokes Article 8(5) exception permits for psychedelics and for non-medical scientific use of cannabis. It supervises the pilot trials under Article 8a NarcA and the BetmPV, and it administers the data reporting obligation introduced with the 2022 medical cannabis reform. The mandatory data reporting is currently weakened by the absence of penalties for non-reporting. A tightening of that requirement is widely expected and would convert reporting from a soft obligation into a real enforcement vector. NarcA criminal penalties run from monetary penalties and custodial sentences of up to three years for standard offences to up to 20 years for aggravated cases (large quantities, organised conduct, professional dealings).

Cantonal Chemists

The cantonal chemists (Kantonschemiker), co-ordinated through the VKCS, are the primary day-to-day enforcement layer for foodstuffs, utility articles, cosmetics and chemicals, and are increasingly active on the borderline between cannabinoid products and medicinal products. Their toolkit ranges from sampling and laboratory analysis through to administrative orders, marketing bans, recalls and notifications to the cantonal prosecutor where criminal liability under the FSA, the LGV or the ChemA is engaged. The cantonal chemists apply the cross-agency Vollzugshilfe. Their delimitation calls, particularly between foodstuffs, cosmetics and medicinal products, are typically the first formal regulatory contact that a borderline operator experiences.

Cantonal Pharmacists’ Offices

The cantonal pharmacists’ offices (Kantonsapotheker), co-ordinated through the KAV, supervise pharmacy operations and the dispensing of medical cannabis as magistral preparations. They issue and enforce cantonal pharmacy operating licences, run inspections, impose conditions, marketing bans and licence revocations, and refer matters to the cantonal prosecutor where appropriate. For the medical cannabis supply chain, which is heavily reliant on a small but rapidly growing number of specialised dispensing pharmacies, cantonal pharmacist supervision is a direct and recurring touchpoint. The KAV’s published position papers on cannabis-based medicinal products and on magistral preparations set the practical compliance baseline.

Cantonal Medical Societies

The cantonal medical societies open and run formal proceedings against FMH-member physicians on the basis of complaints. Sanctions range from reprimands to fines, suspension and exclusion from the FMH. These are professional disciplinary proceedings, not criminal proceedings, but the reputational and licensing consequences are material. Cantonal medical practice authorisations can be conditional on professional standing.

The Swiss Chemicals Notification Authority

The Swiss Chemicals Notification Authority (Anmeldestelle Chemikalien) runs the Chemicals Register and enforces the ChemA framework, including the general ruling regime for CBD-containing products positioned as scented oils.

Cantonal Prosecutors and Police

The cantonal prosecutors and police have the criminal-law lead for NarcA, TPA, FSA, LGV and ChemA offences. The Office of the Attorney General of Switzerland (OAG) has parallel competence in cross-cantonal and international cases. Federal customs supervises the borders and is the first practical filter for unauthorised importation or exportation of cannabis above 1% THC, of psychedelics in Verzeichnis d, or of medicinal products without the relevant Swissmedic authorisations.

The enforcement record across these authorities reflects two clear patterns. First, the cantonal chemists in Zurich, Bern, Basel and Geneva are materially more active than their counterparts elsewhere, and an operator with national reach should plan around the practice of the most active office rather than the average. Second, multi-authority alignment on a single fact pattern is the rule rather than the exception: a single problematic public-facing campaign by a telemedicine platform can generate, in parallel, a Swissmedic AWV/TPA proceeding, a cantonal chemist or cantonal pharmacist administrative measure, an FMH professional standing procedure against the prescribing physician, and a cantonal prosecutor file. Operators should map their compliance posture against this concurrency from the outset.

Switzerland sits outside the EU but is closely exposed to EU regulatory spillovers in the cannabinoid and psychedelic space through practical market access mechanics and parallel legal structures. Four cross-jurisdictional issues are most relevant for medicinal cannabis and psychedelic medicines.

First, since 1 August 2022, Switzerland permits the commercial exportation of medical cannabis within the Swiss authorisation and control system. In practice, cross-border supply is only feasible where the exporter holds the required Swiss authorisations, and where the importing jurisdiction issues the necessary import permits and treats the specific product category as lawful and marketable. Cross-border treatment depends on the destination country’s classification, scheduling and customs practice for the relevant product type, which is challenging for operators to navigate.

Second, for prohibited narcotics in Verzeichnis d, the pathway is structurally different from post-2022 medical cannabis. The Federal Office of Public Health can grant exception permits under Article 8(5) of the Narcotics Act for cultivation, importation, manufacture and placing on the market only if the purpose is scientific research, drug development or limited medical use, and only where no international agreement prevents it. The framework also makes clear that trade in prohibited narcotics for a general, unrestricted medical use abroad does not correspond to any Article 8(5) exception purpose and therefore cannot be authorised. Any cross-border movement remains subject to Swiss narcotics import and export controls under the Narcotics Control Ordinance, including the relevant permits checked at the border.

Third, the European environment around patient access programmes has shifted materially in 2025 and 2026, creating both policy pressure and practical cross-border questions. Germany approved a compassionate use programme for psilocybin in adults with treatment-resistant depression in July 2025. The Czech Republic adopted legislative changes effective 1 January 2026 that formally allow therapeutic psilocybin in specialised facilities, while noting that practical roll-out depends on follow-up steps such as reimbursement conditions. At EU level, the European Medicines Agency (EMA) convened a multi-stakeholder workshop in April 2024 focused on defining safe and effective use and clarifying regulatory challenges for psychedelic medicines, and subsequent EMA-facing commentary has discussed how the EU regulatory framework applies to the clinical use and marketing authorisation assessment of psychedelics. If a psilocybin- or MDMA-containing medicinal product were to obtain marketing authorisation for a specific indication, that authorised product would sit within the standard medicinal-product framework for that indication. Switzerland would then have a parallel Swissmedic route for an authorised product, while case-by-case regimes can remain relevant for non-authorised uses.

Fourth, EU regulatory developments affecting the cannabinoid value chain strongly influence Swiss administrative practice even though Switzerland is not formally bound. Developments at EU bodies that shape safety expectations, novel-food positions, and chemical classification debates can tighten compliance measures for Swiss operators, in particular in foodstuffs and cosmetics regulation. This creates cross-jurisdictional risk for product portfolio planning, labelling and claims strategy, and contractual allocation of regulatory change risk across supply chains.

Swiss access is influenced by developments in other jurisdictions, but the mechanism differs by topic. EU and neighbouring-market developments affect Swiss practice in a relatively direct, de facto way through product compliance expectations and market access frictions. US developments do not change Swiss law but can shape the international evidence base, product development trajectories and the reference environment that Swiss regulators and payers look to over time.

On 23 April 2026, the US Department of Justice and the Drug Enforcement Administration (DEA) announced a final order rescheduling two narrow categories of cannabis from Schedule I to Schedule III: FDA-approved drug products containing marijuana, and marijuana covered by a qualifying state-issued medical marijuana licence. Adult-use marijuana and synthetic THC are not included. A separate DEA administrative hearing on broader rescheduling begins on 29 June 2026. For Switzerland, this changes nothing in the short term. Its longer-term relevance is that the lifting of Schedule I research and supply-chain barriers in the USA is likely to expand US regulated research and increase the volume and quality of clinical data that will later be relevant in Swissmedic evaluations and payer discussions.

On 18 April 2026, the White House published a Presidential Executive Order on accelerating medical treatments for serious mental illness. The order accelerates the US regulatory pathway for psychedelic medicines through faster FDA review, USD50 million in matching funds for state-level investments, expanded Right to Try access (including for ibogaine compounds) and scheduling reviews on successful Phase 3 completion. It does not itself approve or reschedule any psychedelic substance. Switzerland’s Article 8(5) limited medical use pathway is unchanged. As with the Schedule III order, the relevance for Switzerland is indirect and longer-term, primarily through the international evidence base and the eventual availability of well-characterised products that Swiss stakeholders may seek to reference.

Switzerland’s domestic narcotics legislation also operates within the UN drug control treaty system. That framework sets the outer boundary for a fully liberalised adult-use model and shapes how tightly the exceptions for controlled psychedelics and cannabis must be drawn around medical and scientific purposes.

Access to medical cannabis improved meaningfully with the 2022 NarcA reform, which removed the FOPH exception permit requirement and shifted cultivation, manufacture and trade to the Swissmedic licensing regime. The binding constraint, as set out in 1.5 Challenges Facing Market Participants, is reimbursement: no THC-containing medical cannabis product is on the Spezialitätenliste. Epidyolex has been temporarily listed since 1 January 2025 for severe paediatric epilepsy, but Sativex and magistral preparations remain outside, the 2021 HTA did not confirm the WZW criteria for chronic pain or multiple sclerosis-related spasticity, and OKP coverage for the broader range of indications remains limited to case-by-case decisions under the hardship provisions of Article 71a/b KVV. The mandatory FOPH data reporting introduced with the reform should, in time, generate the evidentiary base needed for a structural reimbursement decision; however, the absence of penalties for non-reporting weakens the dataset, and a tightening of that requirement is widely expected. Further policy changes in the medical cannabis sphere are not currently planned.

Access to psychedelic medicines runs through the Article 8(5) NarcA limited medical use pathway as described in 1.1 Primary Laws and Regulations and 1.4 Existing Markets, with reimbursement as the binding constraint addressed in 1.5 Challenges Facing Market Participants. Esketamine (Spravato) is, as mentioned previously, the structural counter-example: an authorised medicinal product, prescribed within the standard psychiatric framework, OKP-reimbursed since 1 October 2025. Three independent regulatory developments would close the gap for classical PAT, only the third of which is fully under Swiss control:

• Swissmedic authorisation of a psychedelic ready-to-use product (eg, psilocybin for treatment-resistant depression or MDMA for PTSD), opening the SL listing pathway along the esketamine model and delivering narrow but reimbursable access for the specific authorised indication;
• a tariff position adapted for prolonged supervised psychiatric administration sessions under TARDOC; and
• a NarcA amendment along the lines of the 2022 cannabis reform, which would open the magistral preparation route under physician therapeutic freedom for broader access across indications and clinical protocols, as detailed in 3.3 Legislative Routes to Wider Access. The Trump Executive Order of 18 April 2026 (addressed in 2.2 How Access Is Impacted by Foreign Law and Regulation) and the maturing global Phase 3 pipeline make the first route increasingly likely in the medium term.

Under Article 15 LGV, foodstuffs not consumed in Switzerland or in any EU member state to a significant extent before 15 May 1997 are novel foods and require FSVO authorisation. Cannabinoids, including CBD extracts and CBD-enriched hemp products, fall within this definition; hemp seeds, hemp seed oil, defatted hemp seeds and hemp seed flour do not, and hemp herbal teas are a special case where an operator can rely on the pre-1997 history of consumption. The Ordinance on Maximum Levels of Contaminants (VHK) regulates THC limits in foodstuffs and has historically set those limits higher than the EU equivalents, which has made Switzerland the more permissive jurisdiction for hemp foodstuffs.

Foods authorised in the EU as novel foods are automatically marketable in Switzerland. Foods classified as novel and not authorised in the EU require a separate FSVO authorisation here, which is very challenging to obtain. The principal cross-agency reference for the practical classification of CBD products and other non-narcotic cannabinoids, addressed at a high level in 1.1 Primary Laws and Regulations and 1.5 Challenges Facing Market Participants, is the Vollzugshilfe.

The Vollzugshilfe predates the 2026 EU developments addressed in 2.2 How Access Is Impacted by Foreign Law and Regulation, and an update reflecting them is expected. For Swiss operators, the practical consequences are that:

• any CBD product marketed for ingestion or for exportation into the EU must be reviewed against the EFSA assessment;
• label and website claims must align with pack-level dosing;
• production must reflect the SCCS 2.5 ppm THC impurity ceiling; and
• cosmetics positioned above the SCCS 0.19% CBD level (broadly accepted in Switzerland under cantonal practice up to roughly 12% on the basis of a complete product information file) should be reviewed for reformulation.

The next Vollzugshilfe revision should align Swiss practice with the new EU positions.

For cannabis, the principal legislative route is the draft Cannabis Products Act (CanPG), addressed in 3.4 Adult-Use Markets and Decriminalisation. The preliminary draft was adopted by the SGK-N on 14 February 2025 in implementation of the parliamentary initiative Siegenthaler. The public consultation closed on 1 December 2025 with more than 150 submissions.

Following its analysis of the consultation results, the SGK-N referred the draft back to its Subcommission “Cannabis Regulation” in May 2026 for revision. The revised bill will return to the SGK-N and then to the National Council together with a parallel Federal Council opinion. The parliamentary process in both chambers is likely to run through the October 2027 national elections, with a referendum, if triggered, falling in 2028 or later. The pilot trial framework under Article 8a NarcA and the BetmPV remains in force until 14 May 2031 and is being progressively extended on cantonal request, most recently with Zurich’s application to extend Züri Can to 2028.

For psychedelics, no comprehensive legislative reform is currently on the agenda. Two regulatory developments would, in principle, expand access. The first is Swissmedic authorisation of a psychedelic ready-to-use product (most plausibly psilocybin for treatment-resistant depression or MDMA for PTSD) under existing law, via the Article 8(5) NarcA drug development exception and the Article 8(7) NarcA carve-out for Swissmedic-authorised medicinal products. The second is a NarcA amendment along the lines of the 2022 medical cannabis reform, which would remove the individual Article 8(5) FOPH exception permit requirement, open the magistral (extemporaneous) preparation route under physician therapeutic freedom, and shift cultivation, manufacture and trade out of the Article 8(5) FOPH system into ordinary Swissmedic licensing. The two are independent of each other rather than sequential. The political case for either route is addressed in the Trends and Developments article accompanying this submission.

The likelihood of an adult-use cannabis market in Switzerland has increased materially over the last two years, though the procedural timeline was extended. The CanPG draft cleared an initial SGK-N adoption and a comprehensive public consultation. Following the consultation analysis, the SGK-N referred the draft back to its Subcommission for revision in May 2026. The pilot trial data provides the evidentiary backbone: positive safety signals, no public order issues, modest shifts towards lower-risk consumption methods, and material redirection from the illicit market. The proposed model and the consultation criticisms of its design are addressed in detail in the Trends and Developments article accompanying this submission.

For psychedelics, an adult-use market is not on the legislative agenda, and is unlikely to materialise in the foreseeable future. Swiss policy continues to draw a sharp line between medical and non-medical use of Verzeichnis d substances.

The author’s realistic central estimate is that a tightly designed adult-use cannabis market is unlikely to enter into force before 2029 or 2030, given the May 2026 referral back to the Subcommission, the parliamentary timetable across two chambers, the October 2027 national elections and the near certainty of a popular referendum. Collectively, these developments make 2026 a year in which the central questions facing the field come into sharper focus, even if none of them is resolved yet.