In addition to the approval of the clinical trial in accordance with Regulation (EU) 536/2014, an environmental risk assessment must be carried out for the use of genetically modified organisms (GMOs) for therapeutic purposes as part of participation in a clinical trial.

An application in accordance with § 74 GTG (Genetic Engineering Act, Federal Law Gazette No. 510/1994 as amended) must be submitted to the Federal Ministry of Social Affairs, Health, Care and Consumer Protection (BMSGPK) - Department VI/A/2 - Genetic Engineering Competence Center. For further information and details on the official procedure in German and English, please refer to the website for consumer health.

Administrative fees and charges must be paid for the application pursuant to § 74 GTG, the documents submitted and the notice of authorisation, which are based on the corresponding tariffs of the Fees Act 1957 as amended and the Federal Administrative Fees Ordinance 1983 as amended. These costs are to be paid by the applicant organisation in Austria. These fees and charges shall be imposed at the same time as the notification of the decision.

The applicant in this official procedure is not the sponsor of the clinical trial, but the head of the institution/hospital in which the therapeutic application is to take place. This means that a separate application must be submitted for each trial site, which is should contain

• documents on the suitability of the trial center and
• information on the investigational product.

Information on the investigational device may also be written in English.

For accompanying activities during the storage, handling and disposal of GMOs, the requirements of the Systems Ordinance 2002 (Ordinance of the Federal Minister for Social Security and Generations on safety when working with genetically modified organisms in closed systems, Federal Law Gazette II No. 431/2002) must be observed. For study centers according to § 19 GTG, this also requires the registration of work with GMOs in a closed system.

In the context of the use of GMOs for therapeutic purposes, a notification pursuant to § 19 GTG must be submitted at the respective safety level of the work with GMOs.

The application in accordance with § 74 GTG for at least one institution/hospital must be submitted at the latest in parallel with an application for approval of the clinical trial is submitted to the Federal Office for Safety in Health Care (BASG) (see § 31 Medicinal Products Act).

The BMSGPK decides within 90 days of receipt of all necessary documents and enclosures by means of a decision to the applicant. Missing information has a time limiting effect.

In the following situations, no (renewed) environmental impact assessment is required:

• The investigational product is an already authorized medicinal product that is used in accordance with the product information.
• The investigational product has already undergone an environmental risk assessment in the course of another clinical trial in Austria and is used in exactly the same way and at the same study centers as in the previous clinical trial. - However, a submission would be required for new study centers.

Austria has followed the content of the Questions & Answers document and best-practice documents on GMOs, which can be found on the website of the European Commission.

The Federal Office for Safety in Health Care decides on the clinical trials with GMOs with the condition that the clinical trial at a center may only be started after approval has been granted in accordance with § 74 GTG (Genetic Engineering Act, Federal Law Gazette No. 510/1994 as amended).

Proof of approval and thus fulfillment of the requirement should be provided by the sponsor via informal national notification (e-mail) to the Clinical Trials Department.