Swissmedic Tightens Due Diligence and Traceability Rules for Foreign Trade in Medicines

At the end of 2025, Swissmedic issued Version 4.0 of its technical interpretation I-SMI.TI.18e, clarifying legal obligations for Swiss companies engaged in foreign trade involving medicinal products or ATMPs. The updated guidance signals a clear regulatory shift: supply chain transparency and documented due diligence are now defined as binding, enforceable requirements rather than general expectations.

Version 4.0 consolidates provisions under the Swiss Therapeutic Products Act (TPA) and the Medicinal Products Licensing Ordinance (MPLO), reflecting inspection experience and recurring deficiencies in supplier qualification and documentation practices.

Swiss firms conducting “trading abroad” must hold a dedicated establishment licence. Importing products for re-export is classified as an import activity and requires appropriate licences and full GDP compliance. Companies must ensure product quality, integrity, and end-to-end traceability, supported by a robust quality system, detailed transaction records, and risk-based qualification and requalification of suppliers and trading partners.

15-02-2026