- GMP Assessment
Switzerland is a PIC/S member and has a bilateral MRA with the EU for GMP. Swissmedic GMP certificates are accepted by EMA and national EU authorities. EU-GMP certificates are accepted by Swissmedic.
- Swiss or foreign manufacturer?
Swiss manufacturers are certified by Swissmedic. Foreign manufacturers need a Swissmedic-recognised certificate.
- Swiss Manufacturer — Swissmedic certified
Swissmedic issues GMP certificates for Swiss manufacturers. These are accepted in the EU under the EU-Switzerland MRA. Swissmedic and EU GMP requirements are fully harmonised.
- Swissmedic manufacturing authorisation
- Cannabis-specific manufacturing scope
- Annual Swissmedic GMP inspection
- Foreign Manufacturer — EU-MRA or recognised cert
Switzerland has GMP MRAs with the EU, UK (MHRA), Australia (TGA), Canada (Health Canada), Japan (PMDA), NZ (Medsafe), and Israel (IMFA). These certificates are accepted by Swissmedic.
- EU-GMP certificate: accepted directly under EU-CH MRA
- MHRA, TGA, Health Canada, IMFA: accepted bilaterally
- Cannabis scope required on certificate
- Swissmedic QP Equivalent
Batches imported to Switzerland must be certified by a person responsible for batch release (verantwortliche Person für die Freigabe) named on the Swiss wholesale authorization.
- Verantwortliche Person named on Swissmedic wholesale auth
- Reviews full batch record and test results
- Certifies compliance with Swiss/EU GMP
- Legally responsible for each released batch
- Batch Released for Swiss Supply ✓
Certified batch available for distribution to cantonal pharmacies. GDP-compliant distribution required throughout Switzerland.