Safety Data in Label | PharmaBharat Tools

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Safety Data in Label | PharmaBharat Tools

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PV Regulatory ReportingSafety Data in Label

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Global Safety Database Acknowledgment (ACK)

Safety Data in Label

Regulatory Reporting

Definition

Safety information in SmPC/PI (sections 4.3, 4.4, 4.8, etc.); source of RSI.

Example

Section 4.8: adverse reactions.

Regulatory source

SmPC

Related terms