Definition

An adverse event that is described in the Reference Safety Information, meaning it is an expected or known risk of the medicinal product.

Example

The EU SmPC Section 4.8 lists 'headache' as a common adverse reaction. When a patient reports headache, this event is classified as 'listed' for expectedness purposes.

Regulatory source

EU GVP Module VI

Common mistakes

Classifying an event as listed based on class effects without verifying it appears in the specific product's RSI.

Inspector question

How do you maintain current RSI for expectedness assessment? How often do you update when labels change?

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