Patient safety and pharmacovigilance

Medicines may affect the body in unintended, harmful ways. These effects, called side effects, adverse events or adverse reactions, represent risks of medicines. It is important to identify, as quickly as possible, new risks or changes to the known risks associated with the use of medicines.

Actions must be taken to minimise the risks, maximise the benefits and promote safe and effective use of medicines by patients. These activities are known as pharmacovigilance.

This document contains information regarding the safety of medicines and pharmacovigilance.