Clinical trials with medicinal products - DIR 2001/20/EC New
General information for submission and conduct
Directive 2001/20/EC and the Austrian Medicines Act, Federal Law Gazette I No. 23/2020, only apply to clinical trials submitted to the BASG before 31 January 2023. As of 31 January 2023, initial applications for approval of clinical trials of medicinal products must be submitted in accordance with Regulation (EU) 536/2014.
The cut-off date for the end of the transition period is the date of submission to the Federal Office (date of receipt of the e-mail or electronic transmission or postmark).
For further information on...
- Obligations during the clinical trial and
- Obligations after completion of the clinical trial
please refer to the document "Guidelines for the submission of clinical trials according to AMG".
Information related to initial applications in this guidance that is still based on Directive 2001/20/EC is irrelevant.
In addition, the general requirements for application of clinical trials with medicinal products of the European Commission (CT-1 Guidance Document, Euralex Vol.10) apply.
The document "Classification of Amendments" describes which changes are subject to approval or reporting by the authority or the Ethics Committee.
Information on the Ethics Commissions in Austria can be found at the Forum of the Austrian Ethics Commissions.
Further information on pharmacovigilance in clinical trials (SUSAR and DSUR) can be found here.
The current fees for clinical trials can be found in the BASG ordinance on fees.
Changes to the EudraCT database
No EudraCT functionality will be modified. There will be only additional pages with questions to sponsors / NCAs, in order to confirm that after January 30th, 2023:
- no new EudraCT number is created for a trial conducted in EU/EEA: sponsors will need to confirm that they ask a new EudraCT number for a trial conducted exclusively in a third country that is part of a PIP/Art 46 of the paediatric regulation
- no new CTA is created for a trial conducted in EU/EEA: sponsors will be still be allowed to create a new EU/EEA CTA, but only in case a CTA for the same trial was already submitted in the same member state. If the sponsor declares that the CTA is for a new EU/EEA trial, or for an additional member state to be added on an existing trial, the sponsor is taken to CTIS homepage or to module 23 on transition trials, respectively.
- the load CTA function is allowed to sponsors only for EudraCT CTAs submitted before January 31st, 2023. If the sponsor needs to create a CTA for the same trial but for a different NCA, the sponsor will need to transition the trial to CTIS, first.
- the load CTA functionis allowed to NCAs only to upload EudraCT CTA amendments of CTAs that were submitted before January 31st, 2023.
The creation and loading of third country files for PIP/Art 46 trials conducted exclusively in third countries will still be allowed as it is now.
EU/EEA Forms for Amendments and End-of-Trial Notification
The EU/EEA harmonised forms for
- the application for approval of a substantial amendment (Annex 2)
- the notification of the national or global end of the clinical trial (Annex 3)
can be found in the "Eudralex Volume10: Clinical trials guidelines".
Guidelines and documents