Etiopia

Titolo del regolamento

Direttiva etiope sulla tracciabilità dei prodotti farmaceutici (n. 43/2019) e Linee guida dell'EFDA sui dati anagrafici per la tracciabilità

Stato della serializzazione

In progress — Batch traceability (GTIN + batch + expiry) implemented, unit-level serialization (GS1 DataMatrix) rolling out; pilot platforms live, registration ongoing by July 2025

Popolazione del Paese

~120 million

Requisiti per l'avviso: Not clearly defined yet; EFDA platform intended to support event capture (ship, receive, dispense, recall) with future alerting

Requisiti di aggregazione: Mandatory parent–child aggregation from unit → case → pallet; started in pilot phase

Requisiti di tracciabilità: Yes — system records supply chain events (EPCIS-like) from manufacturer to dispenser

Organismo ufficiale di riferimento: Ethiopian Food, Medicines & Healthcare Administration and Control Authority (EFDA)

Termine di attuazione / data di entrata in vigore: Directive published 2019/2020; master data guideline effective January 17, 2022; exporters must register by July 25, 2025; full serialization phased over 2022–2026

Tipo/livello di serializzazione: Secondary mandatory; tertiary (aggregation) mandatory; primary optional

Responsabilità del responsabile del marketing e delle operazioni (MAH) / Direttore marketing (CMO): Data captured at manufacturer/CMO; MAH or delegated entity uploads master and event data to EFDA system before shipment

Etiopia

Requisiti per l'avviso: Not clearly defined yet; EFDA platform intended to support event capture (ship, receive, dispense, recall) with future alerting

Requisiti di aggregazione: Mandatory parent–child aggregation from unit → case → pallet; started in pilot phase

Requisiti di tracciabilità: Yes — system records supply chain events (EPCIS-like) from manufacturer to dispenser

Organismo ufficiale di riferimento: Ethiopian Food, Medicines & Healthcare Administration and Control Authority (EFDA)

Termine di attuazione / data di entrata in vigore: Directive published 2019/2020; master data guideline effective January 17, 2022; exporters must register by July 25, 2025; full serialization phased over 2022–2026

Tipo/livello di serializzazione: Secondary mandatory; tertiary (aggregation) mandatory; primary optional

Responsabilità del responsabile del marketing e delle operazioni (MAH) / Direttore marketing (CMO): Data captured at manufacturer/CMO; MAH or delegated entity uploads master and event data to EFDA system before shipment

Ambito di applicazione dei prodotti serializzati: Full scope: Rx, OTC, veterinary, herbal, imported and domestic market

Sanzioni in caso di inadempienza: Civil and criminal penalties described in Directive; EFDA enforcing via audits and inspectons (exact fines TBD)

Norme relative al reimballaggio: Not explicitly detailed; GS1 best practice implies re-serialization and re-aggregation post-repackaging

Norme relative alle esenzioni dalla serializzazione: None officially; small primary packaging likely practically exempt, but not formally stated

Requisiti di codifica di mercato:

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