Off-Label Use

The BASG, the ÖGARI and the Austrian Patient Ombudsman have agreed on the following wording on the subject of off-label use.

“Off-label use" refers to the use of a drug in the context of a medical treatment outside the information given in the Summary of Product Characteristics (SmPC). A legally binding definition is not determined by Austrian law.

Off-label use is generally not prohibited, but requires increased duties of care and special patient information, advice and consent. From the point of view of the Federal Office for Safety in Health Care, the responsibility for this lies with the attending physician. The physician has the medical and therapeutic obligation to justify each individual case according to the best medical knowledge taking into account the available scientific evidence.


Further inquiry note