Definition

Standard risk minimization through product labeling, including SmPC, package leaflet, and appropriate pack size.

Example

Routine risk minimization includes: contraindications in Section 4.3, warnings in Section 4.4, adverse reactions in Section 4.8, and appropriate dosing instructions.

Regulatory source

EU GVP Module XVI

Common mistakes

Assuming routine labeling is sufficient for all risks without assessing if additional measures are needed.

Inspector question

How do you assess whether routine risk minimization is adequate?

Related terms