Urgent Safety Restriction (USR) | PharmaBharat Tools

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Urgent Safety Restriction (USR) | PharmaBharat Tools

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PV Risk ManagementUrgent Safety Restriction

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Risk Management System Safety Concern Assessment

Urgent Safety Restriction(USR)

Risk Management

Definition

Temporary restriction imposed by authority for safety; MAH must comply.

Example

USR: suspend use in pregnancy until review.

Regulatory source

EU Regulation

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