South Africa

Regulation name

Government Notice No. 988 of 2017 (NDoH) and SAHPRA serialization guidelines (2022–2024)

Serialization status

Tertiary packaging GS1 DataMatrix (GTIN, batch, expiry) required by Dec 30, 2018; secondary packaging same data required by Jun 30, 2020; serial numbers mandatory on both tertiary and secondary by Jun 30, 2022

Country population

~60 million

Alert requirement: Not yet defined in SAHPRA regulation; digital event tracking and alerting expected in upcoming SAHPRA roadmap

Aggregation requirement: Implicit via GS1 SSCC requirement; explicit parent–child aggregation not yet enforced

Track & Trace requirement: Phased implementation—physical serialization in place; digital T&T (ePedigree/EPCIS) under SAHPRA development

Official governing body: South African Health Products Regulatory Authority (SAHPRA), per NDoH notice

Implementation deadline / enforcement date: GTIN + batch + expiry on tertiary by 30 Dec 2018, on secondary by 30 Jun 2020; serial numbers mandatory on both by 30 Jun 2022. In South Africa, although serialization is mandatory, there is currently no centralized national database where MAHs report serialization or traceability data

Serialization type / level: Mandatory on both secondary and tertiary packaging since deadlines above; unit-level (primary) serialization not mandated. Compliance today is demonstrated physically on packaging. Digital submission will be required when SAHPRA finalizes and launches its traceability/serialization upload platform. Primary optional; secondary/tertiary include GTIN, batch, expiry, serial number

South Africa

Alert requirement: Not yet defined in SAHPRA regulation; digital event tracking and alerting expected in upcoming SAHPRA roadmap

Aggregation requirement: Implicit via GS1 SSCC requirement; explicit parent–child aggregation not yet enforced

Track & Trace requirement: Phased implementation—physical serialization in place; digital T&T (ePedigree/EPCIS) under SAHPRA development

Official governing body: South African Health Products Regulatory Authority (SAHPRA), per NDoH notice

MAH / CMO responsibilities: No central digital platform yet; SAHPRA tracking currently physical—digital transmission expected in future phases

Serialized product scope: All human medicines (Rx & OTC); medical devices may be included later

Penalties for non-compliance:

Repackaging rules: Not explicitly defined; best practice would require re-labeling and aggregation when repackaging occurs

Serialization exemption rules: No formal exemptions; all trade-level secondary and tertiary packaging subject to the phased requirements

Market coding requirements:

GS1 DataMatrix on secondary and tertiary packing—(01) GTIN, (10) batch/lot, (17) expiry; serial (21) added June 2022