Non-Interventional-Studies NIS

Repeal of the Ordinance on the Notification Requirement for Non-Interventional Studies.

The Ordinance on the obligation to report non-interventional studies was repealed on 07.10.2022 by BGBl II No. 374/2022 (RIS - BGBLA_2022_II_374 - Bundesgesetzblatt authentisch ab 2004 (

A reporting obligation for non-interventional studies as defined in Section 2a (3) of the Austrian Medicines Act, Federal Law Gazette I No. 23/2020, or Article 2, paragraph 2 Z4 of Regulation (EU) 536/2014 thus no longer applies.

Implications for notified non-interventional studies

This also means that there is no longer a legal basis for notifications for ongoing or completed non-interventional studies to the BASG.

  • changes to ongoing non-interventional studies
  • end-of-study notifications and
  • final reports

no longer have to be submitted to the BASG.

This general rule is also applicable in each individual case. Therefore no study-specific confirmations need to be issued.

The public registry for non-interventional studies will be discontinued with immediate effect.

Guideline for differentiation from other studies

The BMSGPK and BASG have jointly prepared a guideline on the differentiation of clinical studies - clinical trials and non-interventional studies - from other studies.

Likewise, the guideline contains rules for other studies involving medical devices and in vitro diagnostics (IVDs).

Important topics:

  • Non-interventional studies according to VO (EU) 536/2014 do not require a notification to the BASG.
  • Non-interventional studies according to Regulation (EU) 536/2014 can also be conducted with approved medicinal products whose use falls within normal clinical practice in Austria
  • For non-interventional studies according to MPG, BGBl. I No. 122/2021, § 40 para. 5 MPG, BGBl. No. 657/1996, continues to apply. These studies also do not require a notification to the BASG.
  • Restrospective data evaluations do not count as clinical studies and do not require a notification to the BASG.
  • The linking of non-interventional studies or retrospective data evaluations with evaluations from biobanks is possible.
  • Other relevant regulations, such as the General Data Protection Regulation, the Austrian Research Organization Act and the Declaration of Helsinki, continue to apply to the above-mentioned research projects.

Guideline for differentiation clinical study - non-interventional study - other study


Further inquiry note