For all pharma companies export or intend to export to #Ethiopia you should read the below
𝐾𝑒𝑦 ℎ𝑖𝑔ℎ𝑙𝑖𝑔ℎ𝑡𝑠:
🔹 Event Reporting
• Reporting applies only to shipments to Ethiopia
• Products not physically shipped to Ethiopia shall not be reported
• Submission is a single consolidated EPCIS file containing:
→ Commissioning (sGTIN & SSCC)
→ Aggregation into higher packaging levels
→ Shipping details
🔹 𝐶𝑜𝑚𝑚𝑖𝑠𝑠𝑖𝑜𝑛 & 𝐴𝑔𝑔𝑟𝑒𝑔𝑎𝑡𝑖𝑜𝑛
• Events must represent only the products inside the shipment
Example: If a batch commissions 5,000 units but only 2,000 are shipped the commission event declares only the 2,000
• Remaining units are commissioned later with a new EPCIS submission
• Must follow GS1 standards and reflect the actual physical aggregation
🔹 𝐶ℎ𝑟𝑜𝑛𝑜𝑙𝑜𝑔𝑖𝑐𝑎𝑙 𝑂𝑟𝑑𝑒𝑟
• Events must be declared in sequence:
Commission → Aggregation → Shipment
• Files with incorrect sequencing will Fail validation and require resubmission
🔹 𝑉𝑎𝑙𝑖𝑑𝑎𝑡𝑖𝑜𝑛 𝑅𝑢𝑙𝑒𝑠
• All GLN / sGLN / GTIN / sGTIN must be approved and registered with EFDA
• readPoint identifiers must reflect the actual processing location
• MAH must list all associated GLNs under Alternate Processing Site (APS)
• If import declaration is made by a non-MAH party (Wholesaler / appointed rep), they go under Source Location
• MAH sGLN is always used under Source Owner without exception
🔹 𝐹𝑎𝑖𝑙𝑢𝑟𝑒𝑠 & 𝑅𝑒𝑠𝑢𝑏𝑚𝑖𝑠𝑠𝑖𝑜𝑛𝑠
• Failures are reported to the Entity's Technical POC
• Resubmissions must be full files representing the entire shipment, no partial files or fragments accepted
🔹 Submission Standards
EPCIS 1.1 → XML
EPCIS 1.2 → XML
EPCIS 2.0 → XML, JSON-LD
𝑆𝑢𝑏𝑚𝑖𝑠𝑠𝑖𝑜𝑛 𝑆𝑡𝑎𝑛𝑑𝑎𝑟𝑑𝑠
• Direct submission via EFDA-MVC Traceability System
• AS2 Connection
• Direct REST API Connection
🔹 𝑆𝑝𝑒𝑐𝑖𝑓𝑖𝑐𝑎𝑡𝑖𝑜𝑛 𝐿𝑖𝑚𝑖𝑡𝑠
• File Size: 100MB
• Max Events per File: 5,000
• Max Serial Numbers per Event: 50,000
• Max Level of Hierarchy: 5
• Min Level of Hierarchy: 2
⚠️ Successfully transmitted EPCIS files to EFDA-MVC shall not be voidable.
🔹 𝑅𝑒𝑞𝑢𝑖𝑟𝑒𝑑 𝐸𝑣𝑒𝑛𝑡𝑠
• Commissioning → All UIDs (SSCC/sGTIN) transmitted to the system
• Aggregation → Final aggregation with all nested levels
• Shipment → Highest level aggregation UID declared
Visit #TraceHub to find more Docuemnts,Guidelines and news about track and trace in #Ethiopia https://lnkd.in/dvCA8i6W
1️⃣ 𝐑𝐞𝐠𝐢𝐬𝐭𝐞𝐫 𝐡𝐞𝐫𝐞 : https://lnkd.in/dqxavMNY
2️⃣ 𝐉𝐨𝐢𝐧 𝐯𝐢𝐚 𝐋𝐢𝐧𝐤𝐞𝐝𝐈𝐧 𝐋𝐢𝐯𝐞: https://lnkd.in/d49ExYHg
To attend Mr.Nathan Seyoum session at 𝐓𝐫𝐚𝐜𝐞𝐇𝐮𝐛 𝐆𝐥𝐨𝐛𝐚𝐥 𝐕𝐢𝐫𝐭𝐮𝐚𝐥 𝐂𝐨𝐦𝐦𝐮𝐧𝐢𝐭𝐲 𝐌𝐞𝐞𝐭𝐢𝐧𝐠 on 6 of June,to know the latest updates regarding the track and trace in #Ethiopia