Non-Interventional Studies (NIS)
To align with the European terminology, the term “Anwendungsbeobachtung” was replaced by the term “Non-interventional Study” through the Amendment BGBl. I Nr. 63/2009 to the Austrian Medicinal Product Act (AMG). The requirement to plan and conduct these studies according to the scientific state-of-the-art was additionally introduced, with a view to the foreseen reporting obligation.
The power to issue a reporting obligation and to establish a public registry for Non-interventional Studies was introduced to the Austrian Medicinal Product Act in § 48 para 3 through Amendment BGBl. I Nr. 153/2005.
The power of authority of the Secretary of Health to issue reporting rules for Clinical Trials and Non-interventional Studies with respect to drug safety is outlined in § 48. It is further elaborated in paragraph 3 empowering the Secretary of Health, with a view to drug safety and international scientific standards, to issue ordinance on the reporting obligations for Non-interventional Trials, including a registry for these studies with partial accessible by the public.
These reporting rules were issued in the „National Regulation for the Reporting Obligations for Non-interventional Studies“ on June 17th 2010, (Verordnung des Bundesministers für Gesundheit über die Meldepflicht von Nicht-interventionellen Studien), BGBL. II Nr. 180/2010. Any Non-interventional study initiated after September 1st 2010 has to be registered with the BASG.
Non-interventional studies fall under the reporting obligation, if the inclusion of the first patient occured on or after September 1st 2010. The regulation is not applicable to Non-interventional studies where the first patient was included prior to this date.
Notice: The registration portal for Non-interventional Studies and the public registry are accessible via the BASG / AGES -e-Service-Portal
Should our guidance documents or the information on this page not answer your questions, please contact nisagesat.
Dr. Stefan Strasser
Dr. Ilona Reischl
Created: 06.05.2010 | Page last modified: 02.12.2014