Adverse Event & Pharmacovigilance SOP

This SOP defines procedures for identifying, reporting, and managing adverse events
related to prescribed medicines.

1. Definition of Adverse Events
   Any unintended or harmful reaction suspected to be related to a medicine.

2. Practitioner Responsibilities

• Identify and document adverse events.
• Inform the patient promptly.
• Report events in accordance with SAHPRA requirements.

3. Reporting Process

• Serious adverse events must be reported without delay.
• Section 21-related events must be escalated to SAHPRA.

4. Record Retention
   All adverse event records must be securely retained and available for audit.