Etiopía

Regulation name
Directiva de Trazabilidad de Productos Farmacéuticos Etíopes (No. 43/2019) y Guía de Datos Maestros de Trazabilidad de la EFDA
Serialization status
In progress — Batch traceability (GTIN + batch + expiry) implemented, unit-level serialization (GS1 DataMatrix) rolling out; pilot platforms live, registration ongoing by July 2025
Country population
~120 million

Alert requirement: Not clearly defined yet; EFDA platform intended to support event capture (ship, receive, dispense, recall) with future alerting

Aggregation requirement: Mandatory parent–child aggregation from unit → case → pallet; started in pilot phase

Track & Trace requirement: Yes — system records supply chain events (EPCIS-like) from manufacturer to dispenser

Official governing body: Ethiopian Food, Medicines & Healthcare Administration and Control Authority (EFDA)

Implementation deadline / enforcement date: Directive published 2019/2020; master data guideline effective January 17, 2022; exporters must register by July 25, 2025; full serialization phased over 2022–2026

Serialization type / level: Secondary mandatory; tertiary (aggregation) mandatory; primary optional

MAH / CMO responsibilities: Data captured at manufacturer/CMO; MAH or delegated entity uploads master and event data to EFDA system before shipment

Serialized product scope: Full scope: Rx, OTC, veterinary, herbal, imported and domestic market

Penalties for non-compliance: Civil and criminal penalties described in Directive; EFDA enforcing via audits and inspectons (exact fines TBD)

Repackaging rules: Not explicitly detailed; GS1 best practice implies re-serialization and re-aggregation post-repackaging

Serialization exemption rules: None officially; small primary packaging likely practically exempt, but not formally stated

Market coding requirements:

Secondary packaging: GS1 DataMatrix (GTIN + batch + expiry + SN when phased); tertiary: SSCC (GS1‑128/DataMatrix); GLN for location identifiers

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