Changes to the Guidance Document GMP Compliance by Foreign Manufacturers and the Form Declaration by the Responsible Person for Foreign Manufacturers

1 May 2023 – the Swissmedic published updated guidance documents on clarification of the requirements for the submission of audit reports.

Certain documents must be submitted by the Responsible Person (RP) as proof of the GMP compliance assessment of foreign manufacturers for an application for authorization (new application) or type IA/IAIN variation that can be notified after the event, a minor type IB variation that must be notified in advance or a type II major variation for an authorized human medicinal product, or for a new application or a variation with or without evaluation of an authorized veterinary medicinal product.

Swissmedic has clarified the conditions for the submission of an audit report as proof of the GMP compliance of foreign manufacturers from countries whose GMP control systems are not deemed to be equivalent to that in Switzerland.

These documents are valid as of 01 May 2023.