Swissmedic tightens Expectations for International Trading and Supply Chains

At the end of 2025, Swissmedic published version 4.0 of its technical interpretation I-SMI.TI.18e, "Legal requirements and mandatory due diligence by Swiss firms wishing to engage in foreign trade with medicinal products or ATMPs from Switzerland, and on supply chain traceability if products are imported for re-export". The revision signals a regulatory shift: supply chain knowledge and verifiable due diligence are no longer treated as general principles, but as concrete, enforceable obligations.

I-SMI.TI.18e V4.0 consolidates existing requirements under the Swiss Therapeutic Products Act (TPA) and the Medicinal Products Licensing Ordinance (MPLO). In practice, it reflects years of supervisory experience and inspection findings in supplier qualification and gaps in supply chain documentation.

Switzerland requires a dedicated establishment licence for "trading abroad". Version 4.0 reinforces that this licence comes with certain responsibilities. Compared with earlier versions, the updated interpretation marks a move away from high-level guidance toward explicit, inspection-relevant expectations covering supply chain traceability for import-and-re-export scenarios.

Key points of the document:

• Swiss companies trading medicinal products abroad without the products entering Switzerland require a Swissmedic establishment licence.
• Import for re-export is considered an import activity and requires appropriate import/export licences and full GDP compliance.
• Companies must guarantee and demonstrate product quality, integrity, and full supply chain traceability throughout the entire distribution chain.
• An effective quality system is mandatory, including complete transactional records (product, batch, dates, suppliers/customers), documented processes, and retention of quality evidence.
• Robust, risk-based qualification and regular re-qualification of suppliers and trading partners is required, including verification of authorisations, GDP/GMP compliance, and, where justified, on-site audits.