Switzerland

Medical cannabis is legal in Switzerland via two pathways: full Swissmedic Marketing Authorisation (MA) or cantonal exceptional authorizations (Ausnahmebewilligungen) under the Swiss Narcotics Act (BetmG). Only Epidyolex (CBD for epilepsy) holds a full Swiss MA. All other cannabis products require cantonal exceptional authorization.

Switzerland's 26 cantons each have their own health authority and exceptional authorization procedure. This means a product authorized in Zurich is NOT automatically authorized in Geneva or Basel. Suppliers entering the Swiss market must secure separate cantonal authorizations for each target canton — a significant administrative burden.

Like Australia, Switzerland requires two separate federal authorizations: Swissmedic (wholesale dealer authorization, product authorization) and fedpol (annual narcotic handling license + per-shipment import permit). Both must be current. fedpol is separate from Swissmedic — do not conflate them.

Swissmedic is a PIC/S member with a full bilateral MRA with the EU. EU-GMP certificates are accepted by Swissmedic without re-inspection. Swissmedic GMP certificates are accepted in the EU. This makes Switzerland one of the easiest non-EU markets for EU-GMP certified manufacturers to enter.

Switzerland has four national languages — German, French, Italian, and Romansh. Product labeling must be in German, French, and Italian (all three) for national supply. Canton-specific labeling in just the local language may be accepted for cantonal exceptional authorizations — confirm with each cantonal authority.

Swiss parliament passed the second reading of a cannabis reform bill in October 2025 that would expand medical access and streamline the cantonal exceptional authorization process. Implementation expected 2027. Monitor closely — this could significantly simplify Swiss market entry.

Per-shipment narcotic import permit from the Federal Office of Police under BetmG Art. 4. Processing: approximately 2 weeks for complete applications. Application includes product details, exporting country authorization, Swiss importer details, and storage information.

Cantonal exceptional authorization (Ausnahmebewilligung) required for unregistered products. Apply to the cantonal health authority of the canton where the product will be dispensed. Different cantons have different procedures and timelines (2–8 weeks). Full Swissmedic MA required only for commercially registered products.

fedpol import permit (original), Swissmedic wholesale authorization of importer, Cantonal exceptional authorization, Exporting country export authorization, Certificate of Analysis (QP signed), Swissmedic-recognised GMP certificate, GACP certificate, Airway bill, Commercial invoice.

Basel EuroAirport, Zurich ZRH, and Geneva GVA are the primary entry points. Basel is the main land border crossing for pharmaceutical imports from Germany and France. Swiss customs narcotic declaration filed under BetmG at entry point.

Swiss manufacturers may export. fedpol export permit required per shipment. Destination country import authorization must be obtained first. Swissmedic GMP certificates accepted in EU, UK (MHRA), Australia (TGA), Canada, and other MRA partners.

Switzerland and the EU have a comprehensive Mutual Recognition Agreement (MRA) for GMP inspections. EU-GMP certificates from any EEA competent authority are accepted by Swissmedic directly. Swissmedic GMP certificates are accepted by EMA and all EU member state authorities. No additional inspection required for either direction.

EU-GMP Part I (any EEA authority), MHRA UK, TGA Australia, Health Canada, PMDA Japan, Medsafe NZ, and IMFA Israel are all accepted by Swissmedic under bilateral arrangements. This broad recognition makes Switzerland accessible for most internationally certified manufacturers.

All batches imported to Switzerland must be certified by a verantwortliche Person für die Freigabe (person responsible for batch release) named on the Swiss wholesale authorization. This role is equivalent to an EU QP. They are legally responsible under Swiss HMG for each released batch.

For products with Swissmedic MA, full documentation in German, French, and Italian is required. For cantonal exceptional authorizations, cantonal language may be accepted. Batch certificates and COAs should be provided in English — accepted by Swissmedic and cantonal authorities.

Swissmedic accepts EU GACP (EMEA/HMPC/246816/2006) and WHO GACP 2003. Certification by ISO 17065-accredited third-party body required. Self-certification not accepted. Identical requirement to EU member states.

Swiss domestic cannabis cultivation requires a fedpol cultivation license. Domestic cultivators must comply with GACP as a license condition. Third-party GACP certification is required for Swiss cultivators supplying imported product market (not for purely domestic supply).

Swissmedic requires a current GACP certificate for fedpol import permit applications and Swissmedic product authorization applications. No grace period. 1–3 year certificate validity typical.

Cantonal health authorities generally accept GACP certificates that meet EU or WHO standards. Some cantons may request additional documentation — check with the specific cantonal authority for requirements. Zurich and Basel are generally straightforward.

For cantonal exceptional authorization supply, chain of custody from cultivation (GACP certificate) through manufacturing (GMP certificate) to dispensing pharmacy must be documented and available to the cantonal health authority on request.