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Swissmedic: Amendment to the guidance document on GMP compliance by foreign manufacturers

28 May 2025

Swissmedic: Amendment to the guidance document on GMP compliance by foreign manufacturers

For applications concerning the authorization or modification of human or veterinary medicinal products in Switzerland, applicants must submit evidence of GMP compliance for foreign manufacturers, typically via certificates or reports from authorities with GMP systems deemed equivalent by Switzerland. If such certificates are unavailable, an audit report—meeting Swissmedic’s specified requirements—may be submitted, provided it is current (no older than three years), covers the relevant product, and is sufficiently detailed. Redacted documents are acceptable only if they do not hinder GMP assessment, and re-audit reports with reduced scope are allowed if missing information is supplemented. For veterinary products under the notification procedure, a single GMP certificate per foreign manufacturer suffices, or, if unavailable, a risk assessment by the Responsible Person (RP) may be submitted following Swissmedic’s guidelines. The revised guidance is effective since 1 May 2025.

For more information, see here.

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