Switzerland – Swissmedic : New requirements and changes to authorisation practice as of May 2021

Changeover to parallel submissions on 1 May 2021

Please note that as of 1.5.2021 submissions (including any subsequent submissions) must be sent on the same day both to Swissmedic and to the responsible cantonal ethics committee. As of 26.5.2021, Swissmedic will only authorise trials if the ethics committee has granted approval of the same version of the trial documentation.

New forms and extended folder structure for submissions as of 1 May 2021

As up to now, applications are still to be submitted to Swissmedic via the eMessage portal and those to the ethics committee via BASEC. The forms and the eDok submission format are being adjusted. By 1.5.2021, Swissmedic expects to publish revised forms and an extended folder structure for submission of the files. From then on, please only use the new forms and the new folder structure…