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The Ordinance on the obligation to report non-interventional studies was repealed on 07.10.2022 by BGBl II No. 374/2022 (RIS - BGBLA_2022_II_374 - Bundesgesetzblatt authentisch ab 2004 (bka.gv.at).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.
This does not affect the obligations to notify the Pharmacovigilance Department that exist for marketing authorisation holders in accordance with Articles 36 to 38 Implementing Regulation (EU) No 520/2012 and GVP Module VIII.C.2.1.
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.
