🇿🇦South Africa Planned

Track & Trace The South African Health Products Regulatory Authority
Official Portal
Technical Specifications

 October 2026

• Industry readiness assessment

 • GS1 membership verification

• System capability evaluation

 

  April 2027

• Pre-implementation testing phase

• Data sharing protocols establishment

 • Trading partner alignment


 October 2027

• Phase 1 compliance for imported products

• Batch-level identification mandatory


  October 2029

• Phase 1 compliance for domestic products

• Phase 2 initiation for imported products


October 2030

  • Aggregation Mandates

 October 2031

• Full serialization compliance for all products

• Complete traceability system operational

Product Scope
  • Prescribed Medicines
Exempt Products
  • Whole blood and blood components
  • Homeopathic medicines and allied substances
  • Extemporaneous preparations
  • Personal use imports
  • Emergency donations
  • Investigational drugs
Official Documents
View All
Guideline
HPA16-202526-Industry-Comms-for-Traceability-Guideline-publication
SAHPRA
Login to Access
Guideline
SAHPGL-INSP-RC-04_v1-Guideline-on-Traceability-of-Health-Products
SAHPRA
Login to Access
Key Deadlines
Phase 1 (Imported Products)
Oct 01, 2027
Batch-level identification mandatory
Phase 2 (Imported Products)
Oct 01, 2029
Unit Level identification mandatory
Phase 1 (Domestic Products)
Oct 01, 2029
Batch-level identification mandatory
Aggregation Phase
Oct 01, 2030
SSCC applied
Phase 2 (Domestic Products)
Oct 01, 2031
Unit Level identification mandatory
Latest News
View All News
SAHPRA announced traceability guildines in South Africa
Oct 10, 2025
Announcement
Quick Links
Analyze EPCIS Files EPC Encoder/Decoder
Last updated: January 09, 2026