Traceability Guideline – Implementation Roadmap

Traceability Guideline – Implementation Roadmap

Dear Applicants,

This roadmap outlines the phased implementation of unique product identification requirements for all health products in South Africa, transitioning from batch-level to unit-level serialisation across primary, secondary, and tertiary packaging levels.

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Document Number: HPA16-2025/26
Version: 1
Date Updated: 01/10/2025
File Type: pdf
Category: Communication to industry
Unit: General ECTD & human medicines, HPA, Regulatory Compliance