Swissmedic licenses for cannabis

TL;DR

• Swissmedic is the authority for narcotics licenses (NarcA Art. 4).
• Separate licenses for cultivation, manufacture, trade, import/export, research.
• Costs: CHF 500–5 000 in fees + annual inspections.
• Processing time: typically 3–6 months.

Which license do I need?

• Exceptional license Art. 8 NarcA — for THC (research, medical use).
• Controlled-substances license — for manufacture/trade.
• No Swissmedic needed for: CBD <1 % THC (industrial hemp regime), cosmetics, textiles.
• Pilot projects Art. 8a — separate FOPH license in addition to Swissmedic.

The permit landscape: who authorises what – Swissmedic, FOPH, canton and FOCBS

The most common founding error is assuming there is a single cannabis licence. Responsibilities are split: Swissmedic issues narcotics permits for cultivation, manufacture, trade and export of cannabis above 1 % THC, plus establishment licences under the Therapeutic Products Act. The FOPH authorises scientific pilot trials under Art. 8a NarcA. The canton handles trade, building and food-safety supervision and inspects points of sale. The FOCBS levies tobacco tax on CBD products intended for smoking.

In practice: a CBD business under 1 % THC needs no Swissmedic permit, but depending on the product category it needs a notification to the cantonal food inspectorate, a tobacco-tax registration with the FOCBS and – for orally consumed extracts – clarification of Novel Food status. Anyone working above 1 % THC falls under narcotics law and must hold a Swissmedic permit with a qualified responsible person, secured premises and complete batch-level records.

• Above 1 % THC = narcotics law = Swissmedic permit, no exceptions.
• Below 1 % THC = food, chemicals or tobacco-tax law depending on product form.
• Tobacco tax on smokable CBD is levied on the retail price – budget for it early.
• Cantonal requirements (retail, youth protection, advertising) differ widely – check before choosing a location.

Security requirements for the premises

To obtain a Swissmedic licence for cannabis with a THC content of over 1%, the physical premises must meet strict security requirements. The authority requires a comprehensive security concept that physically and electronically prevents unauthorised access by third parties. This includes certified intruder alarm systems, mechanical barriers such as reinforced doors and windows, and continuous video surveillance of all sensitive areas. The requirements depend on the type of activity and the quantities stored, with the hurdles for storage and processing being set particularly high.

In addition to physical security, companies must establish detailed standard operating procedures (SOPs) for all processes. Every movement of material containing narcotics must be fully documented and traceable. Swissmedic conducts on-site inspections before granting the licence to verify the implementation of these measures. Even after approval, regular, sometimes unannounced inspections take place to ensure ongoing compliance with security standards during operations.

• Mechanical securing of all access points using certified security doors and grille structures.
• Continuous video surveillance of storage and processing rooms with secure data recording.
• Direct connection of the intruder alarm system to a certified alarm receiving centre.
• Establishment of a detailed zoning and access concept for operating personnel.

The role of and requirements for the responsible person

A central element of the Swissmedic licensing procedure is the designation of a responsible person, also referred to as the person making technical decisions (fachentscheidende Person). This person bears personal and legal responsibility for ensuring that all narcotics regulations are complied with within the company. They must possess the necessary professional qualifications, which is typically demonstrated by a degree in pharmacy, chemistry, or a related natural science, along with relevant professional experience.

The responsible person acts as the direct contact for Swissmedic and is responsible for batch release as well as reporting. In the event of personnel changes in this key position, the licence must be amended immediately, as the establishment licence loses its validity without a qualified responsible person. In addition to professional qualifications, Swissmedic thoroughly examines the personal integrity and reputation of the proposed person.

• Proof of an academic degree in pharmacy, chemistry, or biology.
• Evidence of relevant professional experience in pharmaceutical quality control.
• Submission of a current, clean extract from the central criminal register.
• Personal liability for compliance with statutory reporting obligations to the authorities.

Swiss export licences for medicinal cannabis

Since the liberalisation in August 2022, the export of medical cannabis from Switzerland for commercial purposes has been permitted under strict conditions. Swiss companies wishing to export medicinal cannabis require a specific export licence from Swissmedic for each individual shipment. A prerequisite for the granting of this export licence is the existence of a corresponding import licence from the destination country, thereby ensuring the legal nature of international trade.

The regulation is closely aligned with the requirements of the International Narcotics Control Board. This means that exports may only take place within the framework of the globally established country quotas. Swiss exporters must also prove that the products were manufactured in compliance with Good Manufacturing Practice guidelines. Transport must take place via secure logistics chains in order to rule out diversion into the illegal market along the entire transport route.

• Mandatory submission of a valid import licence from the competent authority of the recipient country.
• Compliance with international narcotics quotas in accordance with United Nations specifications.
• Proof of manufacture in accordance with the Good Manufacturing Practice (GMP) guidelines.
• Seamless documentation of the transport chain from the Swiss warehouse to the recipient.

Delineation between Swissmedic licences and cantonal enforcement

Although Swissmedic is the central federal authority for issuing operating licences for narcotics, the cantonal authorities play a key role in enforcement. While Swissmedic regulates the general handling of substances with more than 1% THC, the cantons are responsible for monitoring the local market, business licences, and the protection of minors. This federal division means that, in addition to the federal licence, businesses must also meet cantonal requirements.

This delineation becomes particularly clear in the case of scientific pilot trials under Article 8b of the Narcotics Act. These time-limited projects are primarily approved by the Federal Office of Public Health (BAG), but often require Swissmedic-licensed suppliers for the procurement and processing of cannabis. Companies must therefore precisely analyse the interfaces between federal law, cantonal health law, and local building and zoning regulations to avoid legal conflicts.

• Swissmedic issues the federal operating licences for handling narcotics.
• Cantonal therapeutic products inspectorates monitor compliance with the requirements on-site at the facility.
• The Federal Office of Public Health (BAG) is responsible for authorising scientific pilot trials.
• Local authorities regulate the building law and commercial requirements for operating premises.

FAQ