National rules and regulations New
Overview of the national process
The national legislation supplementing Regulation (EU) 536/2014 ("Clinial Trials Regulations", "CTR") are contained in the Austrian Medicines Act (AMG), Federal Law Gazette I No. 8/2022.
The competent authority in terms of the CTR is the Federal Office for Safety in Health Care (BASG).
Ethics Committees acting under the CTR are organised in a national platform and published on the website of the Ministry of Social Affairs, Health, Care and Consumer Protection.
Currently, these are...
- the Ethics Committee of the Medical University of Graz
- the Ethics Committee of the Medical University of Innsbruck
- the Ethics Committee of the Medical Faculty of the Johannes Kepler University Linz
- the Ethics Committee for the Province of Salzburg
- the Ethics Committee of the Medical University of Vienna
The BASG and the platform of Ethics Committees will define the details of their cooperation in an agreement. This agreement will be published shortly.
The application dossier should be submitted in English for multinational clinical trials and in German or English for purely national clinical trials.
The application must be accompanied by a German-language version of the scientific synopsis of the protocol in accordance with point D. line 24 of Annex I of Regulation (EU) No. 536/2014.
The documents intended for the trial subjects shall be submitted also in German. This includes both the information material used prior to inclusion in the trial (Sections K and L of Annex I of Regulation (EU) No 536/2014) and materials used during the clinical trial in connection with endpoints ("patient facing documents" according to Eudralex Vol.10 Q&A 1.24).
Member States may charge fees for the performance of the activities resulting from Regulation (EU) 536/2014. However, Member States should avoid having to make multiple payments in a single Member State to different bodies involved in the assessment of the clinical trial application.
Therefore, fees for activities under Regulation (EU) 536/2014 are collected by the Federal Office for Safety.
In accordance with Article 86 of Regulation (EU) 536/2014, these fees are set according to the principle of cost recovery and published in the fee tariff of the BASG. The fees for the competent ethics committee are already included in this tariff.
The billing is carried out independently of the processing and in most cases in the later course or after completion of the procedure. Proof of payment is not part of the valid submission.
Billing is made to the organization registered as the point of contact for the Union. If other billing roles (e.g., other billing recipient, other payer) are desired, they must be communicated to BASG in a document to be uploaded in the "Proof of Payment of Fee" section of the Clinical Trials Information System (CTIS). This is only an information document and not a confirmation of payment.
According to Regulation (EU) 536/2014, an appeal procedure should be provided by the member state for the refusal of approval of a clinical trial or of substantial modification. For Austria, the appeal procedure is governed by the General Administrative Procedure Act (AVG).
The entire appeal procedure takes place outside of CTIS!
An appeal against a decision of the BASG can be lodged with the Federal Administrative Court (BVwG) within four weeks of service.
The appeal must contain the name of the contested decision, the name of the authority against which the appeal has been lodged, the grounds on which the allegation of illegality is based, the request and the information required to assess whether the appeal has been lodged in time.
The complaint should be made in writing and submitted to the address of BASG, Traisengasse 5 in 1200 Vienna, or by e-mail to the address email@example.com.
The BASG can then either issue a preliminary decision on the complaint itself within 2 months or forward the complaint directly to the Federal Administrative Court (BVwG) for a decision on the complaint.
In its preliminary appeal decision, the BASG may
- revert its decision
- amend its decision (e.g., on the basis of new documents submitted in the appeal)
- reject the complaint either for formal reasons (rejection) or for its legal content (dismissal).
This preliminary appeal decision can, in turn, be challenged by filing a request for referral to the Federal Administrative Court (BVwG).
The final decision is then implemented in CTIS through the "Revert Decision" action (if necessary). This allows a negative decision to be converted into an approval or an approval with conditions. The latter may include the need for the subsequent submission of a substantial modification.