Modification of various documents relating to authorisation


The existing application procedures for fast-track (FTP) and temporary (temp.auth.) authorisations were replaced as of 1 April 2021 by the Accelerated Application Hearing (AAA) meeting with the applicant.

Swissmedic has updated the content of the guidance documents based on accumulated experience. To clarify the AAA procedure for the applicant, there is a detailed description of the procedure for an AAA in the annex to the guidance documents.

There have also been some changes to wording and some further explanations have been added regarding the content, but these do not involve any new requirements for the applicant.

Swissmedic has updated the guidance documents Fast-track authorisation procedure HMV4 / Temporary authorisation for human medicinal products HMV4 accordingly.