Non-interventional studies (NIS)

Notification Requirement for NIS

According to the Ordinance of the Federal Minister of Health on the Notification Requirement for Non-Interventional Studies (Verordnung des Bundesministers für Gesundheit über die Meldepflicht von Nicht-interventionellen Studien BGBl. II Nr. 180/2010), NIS studies with patients included on or after 1-Sep-2010 have to be notified to the Austrian Federal Office for Safety in Health Care (Bundesamt für Sicherheit im Gesundheitswesen, BASG).

 

Please find additional information here.

 

OnlineForms
online notification

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NIS Register
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Created: 04.06.2010 | Page last modified: 22.05.2019

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