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South Africa Regulatory

Regulatory For

South Africa

South Africa Regulatory Requirements

Regulatory Agency South African Health Products Regulatory Authority (SAHPRA) Under the National Department of Health.
Regulation Name
  • Medicines and Related Substances Act, 1965 (Act 101 of 1965)
  • SAHPRA Labeling & Packaging Guidelines
  • No standalone national pharmaceutical serialization regulation
    currently enacted.
Compliance Dates


Key Implementation Timeline (SAHPRA Guidelines):

Phase 1: Batch-Level Identification (2025–2029):

  • 1 October 2027: Mandatory GTIN, expiry date, and batch/lot number (2D DataMatrix) on secondary packaging.

Phase 2: Unit-Level Serialization (2027–2031):

  • 1 October 2029: Mandatory serialization (unique serial number added) for all unit-level pharmaceutical products.
  • 1 October 2031: Full, mandatory unit-level serialization compliance.
Applies to
  • All registered human medicines must comply with SAHPRA labeling requirements.
  • No mandatory serialization requirement for prescription or OTC
    medicines at present.

Secondary Packaging

Barcode Symbology 2D DataMatrix code (specifically GS1 DataMatrix) is mandated for unit-level serialization.
Barcode Content
  • GTIN (AI 01)
  • Serial Number (AI 21)
  • Expiry Date (AI 17)
  • Batch/Lot (AI 10)
Serial Number Randomization Yes – unique and randomized
Serial Number Reuse Not permitted
Human Readable Expiry Date Format Typically MM/YYYY or DD/MM/YYYY consistent with labeling
Barcode Data Encoding GS1 Application Identifiers (01, 17, 10, 21)
Product Code Notes NA
Free Samples must be marked? Yes – must comply with labeling and serialization if distributed within supply chain

Tertiary Packaging

Barcode SymbologyGS1-128 (SSCC – AI 00)
Barcode ContentsSSCC (Serial Shipping Container Code)

Aggregation Data Capture

Parent-Child Mapping Aggregation Capture?
 Yes

Data Exchange

Send Unit Data to Government Repository? Not Specified
Send Unit Data to Third-Party Repository? Not Specified
Send Unit Data to Trading Partner? Not Specified
Send Aggregation Data to Government Repository? Not Specified
Send Aggregation Data to Third-Party Repository? Not Specified
Send Aggregation Data to Trading Partner? Not Specified

Authentication

Who Offers Data Repository for Authentication? NA
Manufacturers Must Register Shipments in Repository? Not Specified
Downstream Trading Partners Must Authenticate on Receipt? As applicable
Downstream Trading Partners Must Authenticate on Shipment? As applicable

Government Reporting

Manufacturer Activity Reported? As applicable
Downstream Trading Partner Activity Reported? Not specified
Source and Credit: This information is fully or partly based on the GS1 master document (all rights reserved). As GS1 does not control the content of the information, GS1 shall not be held liable, under any circumstance, if it differs from the master document.

Disclaimer

This information is being provided ‘As Is’ with no claims of suitability for a particular purpose. It represents just a possible interpretation of information available in the public domain and that interpretation is subject to change. This information does not constitute legal advice.

About Kevision Systems

Kevision Systems, a part of the Kevin Group, is a leading solutions provider for complete end to end inspection of products & services for the inspection of pharmaceutical products like tablets, capsules and more. In addition to the inspection systems, Kevision’s Track & Trace Software & related equipment provide a fully integrated solution to the traceability of pharmaceutical products & Supply Chain Integrity.

Built on the cornerstone of strong quality focus, we deliver excellent solutions with very high quality & reliability.

Kevision Systems is dedicated and driven to provide the finest & the most optimum solutions for the Supply Chain Integrity as well as Optical Inspection Systems. We stand strong on the pillars of integrity, professionalism, innovation and expertise and have earned the credibility to work with any size of projects. We strive to excel in terms of quality and technology and be a preferred partner for our valued clientele.

For Further Information, please contact our Compliance Team at info@kevision.in

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