Online reporting of side effects human
Details of the reporting person (Step 1/6)
The reporting person must provide his/her personal data and at least a telephone number or Email adress, as it may be necessary to contact him/her for possible further questions.
This report will be forwarded to the Austrian Federal Office for Safety in Health Care (BASG). Reported adverse events are reviewed by the personnel immediately upon receipt. We as the national regulatory authority, evaluate whether a causal relationship between drug intake and adverse event is possible and whether this event is already known, i.e., it´s type and extent are stated in the product information.
In accordance with the applicable European laws and guidelines, adverse event reports occurring in Austria are forwarded to the database of the European Medicines Agency (EMA) and are thus available to all European countries.