Have these adverse drug reactions been described before?
- Expected adverse drug reaction – An adverse reaction, the nature, severity or outcome of which is consistent with the summary of product characteristics
- Unexpected adverse drug reaction – An adverse reaction, the nature, severity or outcome of which is not consistent with the summary of product characteristics
Do these adverse drug reactions are danger to a patient’s life and health?
Serious adverse drug reaction:
- which results in patient’s death or life-threatening;
- which requires inpatient hospitalisation or prolongation of existing hospitalisation;
- which results in persistent or significant disability or incapacity;
- is a congenital anomaly/birth defect;
- information is medically important (asseded by reporter and/or expert)
Non-serious adverse drug reactions – adverse drug reactions that do not follow the criteria of serious adverse drug reaction mentioned above.
Please be informed on January 2013 Cabinet of Ministers Regulation No. 47 „Procedure for Pharmacovigilance”