Swissmedic Updates GMP Compliance for Foreign Manufacturers

Swissmedic revised its Good Manufacturing Practice (GMP) guidelines for foreign manufacturers, detailing documentation needed for new authorizations and changes related to human and veterinary medicines.

The Responsible Person (RP) must submit proof of GMP compliance, preferably certificates from authorities recognized as equivalent to Switzerland. If unavailable, audit reports are accepted under conditions: they must be under three years old, relevant to the product, and included with the application. Reduced-scope re-audits are allowed if gaps are covered by an RP assessment or summary. Redacted reports and CAPA plans are permitted if they don’t affect evaluation.

Inspection reports from recognized authorities are accepted if recent, on-site, and product-specific.

For veterinary medicines under Art. 39 VAZV, a single GMP certificate or manufacturing license per foreign manufacturer suffices, or an RP risk assessment may be submitted.

These updates took effect on May 1, 2025.

04-06-2025