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Swiss Medic Guidance: Document on Formal requirements

Swissmedic released an updated guidance document on "Formal requirements" yesterday (15 February 2023). By publishing this document, Swissmedic provides transparency regarding how applications should be structured so that they can be processed efficiently.

The requirements of the directory Overview of documents to be submitted HMV4 must be taken into account in addition to these requirements and this guidance document applies to all submissions to Swissmedic

It specifically does not apply to:

  • Requirements related to the content of applications

  • Medical devices

  • Market monitoring cases other than those explicitly mentioned

  • Legal cases

  • Inspections

  • Certificates

  • Clinical trials

  • Notifications for narcotics

  • Submission of laboratory orders

Requirements such as Submission formats, Timelimits, Signatures, Packaging, etc all are detailed elaborately in this guidance and the requirements specific to certain types of applications that are not found in this guidance are described in the relevant guidance documents.


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