Definition

The official prescribing information, package insert, or Summary of Product Characteristics (SmPC) that describes a medicine's approved uses, warnings, and adverse reactions.

Example

Signal evaluation determines that a new serious adverse reaction should be added to the label. A safety variation is submitted to update Section 4.8 (Adverse Reactions) of the SmPC.

Regulatory source

21 CFR 201, EU Directive 2001/83/EC

Common mistakes

Not maintaining current copies of all regional labels, leading to inconsistent expectedness assessments.

Inspector question

How do you maintain current product labeling across regions? How quickly do you update after label changes are approved?

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