Compassionate Use in Austria
Compassionate use is defined as an optional exceptional measure in Article 83 of Regulation 726/2004/EC. It was translated into National Law by amending the Austrian Medicinal Products Act in 2009 and incorporated as §8a.
Compassionate use facilitates the provision of unauthorised medcinal products to patients for whom no adequate treatment modalities exist and who cannot be included in clinical trials. Scientific data on Safety and Efficacy of the medicinal product have to be provided, and the applicant commits to the submission of a marketing authorization in due course. These requirements and the temporary limitation of the compassionate use programm were instated to assure that only promising medicinal products qualify for compassionate use programmes.
Conditions to Compassionate Use
Compassionate use is granted as exceptional and temporary measure for a group of patients, when the medicinal product in question meets the following conditions:
- the medicinal product is intended for the treatment, prevention or diagnosis of a chronically or seriously debilitating disease or a disease which is considered to be life-threatening
- the disease can not be treated satisfactorily by an authorised and available medicinal product
- based on the scientific data provided there is a realistic possibility for a therapeutic benefit
- the medicinal product is either the subject of an application for a centralised marketing authorisation in accordance with Article 6 of Regulation 726/2004/EC or is undergoing clinical trials in the European Union and/or elsewhere.
Verfahren in Österreich/Procedures in Austria
- F I453 Liste CUP in AT 019.pdf241 KGenehmigte CUP Verfahren in Österreich/ Authorised CUP Procedures in Austria
If your questions are not covered by the information in the guide, please contact compassionate-usebasg.gvat
Dr. Corina Spreitzer
Dr. Stefan Strasser
Created: 20.01.2011 | Page last modified: 29.08.2017