Ethiopia

v. 19 – Q3 2021

Market Executive Summary Roadmap announced and Traceability Pilot underway: Food and Medicine Administration Proclamation 1112/2019

Codified as Directive “Pharmaceutical Products Traceability Directive No.43/2019”, published 19 August 2019

Scope is defined as “1. All pharmaceutical products registered in Ethiopia which are intended for human use” as well as “prescribed medicines, program medicines and medicines easily exposed to counterfeiting.”

September 2021: timelines revised, and next milestone confirmed (19 August 2021): Data Standard Compliance (focus imported medicines)

  • GS1 GTIN application and registration
  • Master data to be shared with authorities (see Note 2)
  • Barcode with Product Identifier on secondary packs and higher levels of packaging
  • Locally manufactured items only need a GTIN
  • For imported products batch number and Expiry date are also mandated
Key Dates Proposed timeline: Phased implementation over 7 years (to 2026), starting with master data guidance, then batch coding leading to serialisation. Roll-out for each phase will start with pilot and be expanded stepwise for different product groups.

The phasing has now been confirmed:

  • August 19, 2023: Stage 1 – Data Standard Compliance (focus imported medicines)
  • August 19, 2022: Stage 2 – Batch/Lot
  • August 19, 2023: Stage 3 – Batch/Lot
  • February 19, 2024: Stage 3 – Serialization (all listed medicines)
  • August 19, 2024: Stage 2 – Batch/Lot
  • February 19, 2027: Stage 4 – Traceability

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