Overview

The regulation of all medicinal products is based on risk management. It is an accepted principle that no medicinal product is entirely without risk – the use and regulation of medicines is therefore calibrated on the concept of benefit versus risk; that is, the degree to which the benefit that the product brings to the patient outweighs the risk to the health of the patient.

The safety and wellbeing of the patient is the paramount concern of all healthcare stakeholders. Those given the task of developing public health policy and establishing regulatory obligations have a duty to minimise patient exposure to the variety of risks associated with medicinal products.

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