South Africa Launches Plan to Combat Falsified and Substandard Medicines

In September, the South African Health Products Regulatory Authority (SAHPRA) released its Traceability Guideline Implementation Roadmap1 to accompany a broader national action plan to combat falsified and substandard (SF) medicines. The guideline aims to enhance supply chain transparency and regulatory oversight through unique product identification across the health sector.

The roadmap sets out a phased approach to implementation.

• Phase 1 (2025–2029) will introduce batch-level identification, requiring a Global Trade Item Number, expiry date, and batch or lot number.
• Phase 2 (2027–2031) will expand to full unit-level serialisation with unique serial numbers.

Imported products must comply earlier than domestic products, and the requirements apply across all packaging levels: primary, secondary, and tertiary. The use of GS1 Data Matrix and GS1-128 barcodes is mandatory, and by 2030 all logistics units, such as pallets, must also carry Serial Shipping Container Codes.

By 2031, South Africa aims to have a fully operational traceability system aligning with global best practices.