Pharmacovigilance (PV)

Science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. In line with this general definition, underlying objectives of pharmacovigilance in accordance with the applicable EU legislation are:

• preventing harm from adverse reactions in humans arising from the use of authorised medicinal products within or outside the terms of marketing authorisation or from occupational exposure
• promoting the safe and effective use of medicinal products, in particular through providing timely information about the safety of medicinal products to patients, healthcare professionals and the public

Pharmacovigilance is therefore an activity contributing to the protection of patients’ and public health.