Zambia

Regulation name

Zambia Pharmaceutical Traceability Guideline 2023 (ZAMRA)

Serialization status

In progress — final traceability guideline published August 2023; implementation phases now beginning

Country population

~20.5 million

Alert requirement: Not yet defined; event capture and alerting anticipated within national traceability ecosystem (ZAMRA & GS1 GDSN integration)

Aggregation requirement: Mandatory parent–child aggregation from unit → case → pallet, via GS1‑128/DataMatrix codes on tertiary units

Track & Trace requirement: Yes — end-to-end T&T planned via EPCIS-capable system; traceability to dispenser level is envisioned

Official governing body: Zambia Medicines Regulatory Authority (ZAMRA), supported by Ministry of Health and GS1 Zambia

Implementation deadline / enforcement date: As defined in August 2023 guideline: Imported medicines: must carry GTIN, expiry, and batch from August 2025; serial number added by August 2028 Domestically manufactured products: labeling from August 2026; serialization (including serial number) from August 2028

Serialization type / level: Mandatory on secondary packaging, with tertiary aggregation mandatory Secondary: GTIN, SN, EXP, LOT Tertiary: SSCC (no NTIN or country-specific code specified)

MAH / CMO responsibilities: MAHs or appointed partners (e.g., CMOs, 3PLs) must ensure data (master data and event data) is submitted to ZAMRA, likely via GS1 GDSN integration ahead of product release

Serialized product scope: Rx and OTC medicines — both imported and locally produced — are within scope

Penalties for non-compliance: Exact penalties not specified in guideline; non-compliant products risk being blocked from importation or market release. ZAMRA will likely issue enforcement details closer to rollout phases.

Repackaging rules: Not explicitly defined. Global GS1 best practices imply any repackaged product must be re-serialized and re-aggregated accordingly.

Serialization exemption rules: None officially specified. Only tertiary logistics units and secondary units are in scope; primary packaging isn't mentioned and may not require serialization due to size constraints.

Market coding requirements:

Secondary (saleable unit): GS1 DataMatrix with GTIN, expiry date, batch/lot, and serial number Tertiary/logistics units: GS1‑128 SSCC

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