October 2022: What’s New on Austrian BASG (NIS)

The below update was posted on October 11, 2022, on the What’s new section of the Austrian Federal Office of Safety and Healthcare (BASG), Non-Interventional studies (NIS):

On October 7, 2022, the ordinance on the obligation to report non-interventional studies was repealed as per the Federal Gazette for the Republic of Austria 374/2022. A notice about the same is available in German here.

Submission of the ongoing or completed non-interventional studies including changes to ongoing non-interventional studies, end-of-study notifications and final reports is no longer an obligation. Moreover, the public registry for non-interventional studies has been discontinued with immediate effect.

Currently, there is no notification about channeling existing studies to EU PAS or EU CTIS.

More information can be found here.