Swissmedic: Amendment to GMP Compliance by Foreign Manufacturers

Swissmedic has updated its guidance on Good Manufacturing Practice (GMP) compliance for foreign manufacturers, clarifying documentation requirements for various application types (e.g., new authorizations, type IA/IB/II changes for human and veterinary medicines).

To prove GMP compliance, documents must be provided by the Responsible Person (RP). Preferably, these should be certificates from authorities with GMP systems recognized as equivalent to Switzerland’s. If such certificates are unavailable, audit reports may be accepted under specific conditions.

Key Clarifications on Audit Reports:

• The approved audit report should be submitted with the application. Manufacturer approval depends on this report.
• Re-audit reports with reduced scope are accepted if missing details are addressed through an RP assessment or a RP summary based on the original complete audit covering the missing points.
• Redacted documents (report/CAPA plan) are allowed if the assessment is not compromised.
• Audit reports must be no older than three years and must cover the relevant product.

Inspection Reports:

Reports from recognized authorities are accepted if:

• Not older than three years,
• The inspection was conducted on-site, 
• Relevant to the product in question.

Veterinary Medicines:

For notifications under Art. 39 VAZV, one copy of the GMP certificate or manufacturing authorization per foreign manufacturer is sufficient. If unavailable, an RP-prepared risk assessment may be submitted instead. Swissmedic provides guidance on the required content to ensure it proves GMP compliance.

The updated guidance took effect on 1 May 2025.

Source:

Swissmedic: General communications