The World Health Organization (WHO) defines pharmacovigilance as the science and activities concerned with the detection, assessment, understanding and prevention of adverse effects or any other problems associated with medicines.
According to this general definition, the main objectives of applicable pharmacovigilance legislation are: to prevent harm from adverse reactions in humans arising from the use of authorised medicines during or beyond the conditions of marketing authorisation or from occupational exposure;
Pharmacovigilance is therefore an activity that contributes to the protection of patient and public health.
