Understanding the Swissmedic’s license

From prohibition to a controlled pharmaceutical framework

Switzerland entered a new regulatory phase for medical cannabis on 1 August 2022, when cannabis containing 1.0% THC or more was moved from Table d to Table a of the Ordinance on Narcotics Tables (OTStup-DFI). This reclassification brought medical cannabis under the same comprehensive control regime applied to all Table A substances, such as morphine, meaning that its cultivation, distribution and use must follow strict narcotics legislation and oversight mechanisms.

The reform simultaneously removed the previous requirement for exceptional authorisations from the Federal Office of Public Health for medical use, replacing it with a structured system under the supervision of Swissmedic, which now acts as the national Cannabis Agency in accordance with the UN Single Convention on Narcotic Drugs (1961).

The Convention emphasises the high risk of diversion during cultivation and requires each member state to operate an agency capable of monitoring production, preventing surplus and ensuring that the entire harvest is taken over by authorised operators. Swissmedic’s mandate therefore spans licensing, inspections, reporting, security, and coordination with the International Narcotics Control Board (INCB), creating a coherent system designed to guarantee pharmaceutical-grade control.

Licensing and compliance: a two-step system for cultivation

The centrepiece of the Swiss framework is a two-step licensing process that regulates every cultivation cycle. The first step is the cultivation operating licence, which a company must obtain before any cannabis can be grown. To receive it, the applicant must be registered in the commercial register, implement storage conditions that meet Article 54 OCStup, demonstrate adequate anti-theft and diversion-prevention measures, and appoint a Responsible Person (RP) with academic training in a relevant scientific or agronomic field. The RP must exercise the role under their own professional responsibility and ensure that the entire operation aligns with narcotics legislation. Once the documentation has been reviewed and the cantonal inspection completed, Swissmedic may issue the licence for a maximum period of five years.

With this authorisation in place, the operator may apply for an individual cultivation authorisation, which is tied to a specific crop cycle. Swissmedic requires detailed information about the intended cultivation, including the site location, surface area, growing method, varieties used, expected THC levels and projected yield. A written supply contract must also be submitted, obliging the licensed buyer to take over the entire harvest. Once authorised, the operator must notify Swissmedic of the start of cultivation, significant incidents, partial or full harvests, quantities delivered and any destruction, each within ten working days. This approach ensures continuous traceability from the earliest stages of the crop to the moment it leaves the cultivation facility.

Crucially, cultivators may only perform minimal post-harvest activities, such as soft drying that does not induce decarboxylation and the removal of excess plant material. Any processing that affects pharmaceutical quality—final drying, extraction, distillation, purification or other GMP-relevant steps—requires a separate Swissmedic establishment licence under the Therapeutic Products Act (LPTh). This separation prevents cultivators from performing unauthorised manufacturing and preserves a clear regulatory chain between agricultural production and pharmaceutical transformation.

Pharmaceutical use, downstream operators and restrictions on promotion

Once the harvest is handed over, responsibility shifts to the licensed buyers—typically manufacturers, wholesalers or pharmacies operating within the LPTh and OCStup licensing framework. These companies must hold both a narcotics authorisation for the use of Table A substances and an LPTh establishment licence suitable for producing APIs, intermediates or magistral preparations. Swissmedic emphasises that pharmacies cannot purchase cannabis directly from cultivators to produce magistral medicines unless an authorised GMP-compliant manufacturer has first released the material as an API according to Article 7 OAMéd. This requirement ensures the pharmaceutical quality of any preparation reaching patients.

Communication and promotion are also strictly regulated. Public advertising for cannabis-based medicinal substances is prohibited, and even professionals may only receive promotional information about products formally authorised by Swissmedic, such as Sativex®. Magistral preparations, although legal, cannot be marketed with references to active ingredients, therapeutic indications or dosages; only general information about available galenic forms is permitted. These restrictions reflect Switzerland’s commitment to preventing commercial pressure in a domain where medical oversight must remain paramount.

Annual reporting, international coordination and cross-border controls

All operators involved in cultivation must submit a yearly account (JARE), providing a full overview of stocks, harvest volumes, cultivated area, deliveries and losses. This report must be transmitted to Swissmedic by 31 January of the following year and is essential for both national surveillance and the preparation of Switzerland’s annual data submission to the INCB.

For the 2024 reporting year, Swissmedic introduced a transitional system that limits reporting to three THC categories—1.0–5.9%, 6.0–15.9%, and 16.0–30.0%—and excludes seeds, seedlings and mother plants due to ongoing technical optimisations of the NDS-Web platform. Despite the reduced dataset, companies must still ensure that the declared opening and closing stocks correspond exactly to the physical stock on site, and Swissmedic reserves the right to impose administrative fees or trigger inspections in case of inconsistencies or delays.

Cross-border activities are equally tightly regulated. The import or export of medical cannabis requires a Single Permit issued by Swissmedic, often complemented by authorisations from the destination country. Each transaction must be reported within ten working days, and permits are valid only for a short period, generally four months. These mechanisms ensure that Switzerland remains aligned with international control standards and maintains full oversight of all flows of Table A substances across its borders