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The Ordinance on the obligation to report non-interventional studies was repealed on 07.10.2022 by BGBl II No. 374/2022 (RIS - BGBLA_2022_II_374 - Bundesgesetzblatt authentisch ab 2004 (bka.gv.at).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