SwissMedic Guidance on Fast-Track Authorisation, Temporary Authorisation and Variations & Extensions

Last week Swissmedic, the Swiss Agency for Therapeutic Products updated and released 3 Important guidances and forms.

1. Guidance on Variations and Extensions

This guidance document explains the requirements pertaining to variations and extensions for human medicinal products.

Download the most recent form for Variations and extensions by clicking this LINK.

2. Guidance on Temporary Authorization for Human Medicinal Products

Temporary authorizations are granted under exceptional circumstances when there is an urgent medical need, such as during public health emergencies or when no alternative treatments are available.

This guidance describes the conditions that must be met before a request for temp.auth or temp.AI can be approved, as well as the detailed procedures for the meeting with applicants (AAA) during which the request will be processed and evaluated.

3. Guidance on Fast-Track Authorisation Procedure

This guide provides information about how to apply for a fast-track procedure (FTP) and explains the requirements that must be met for an FTP application to be approved and outlines the detailed procedure for a meeting with the applicant called the Accelerated Application Hearing (AAA), which is scheduled to process the application.

Click this LINK to download the recent "Decision Minutes Accelerated Application Hearing" application.