Good morning, let’s take a quick look at the latest updates on pharmaceutical track & trace in Egypt so far… and as agreed for the current phase,

the submission will be based on CSV files. A few days ago, the key technical FAQ was released, and these are the main highlights

Regarding serialization:

= The Egyptian Drug Authority is not responsible for issuing serial numbers… the manufacturer is responsible for generating GS1-compliant serial numbers

= The serial number must be unique and non-reusable, and must be linked to an approved GTIN registered with EDA before import

Human Readable (HRI)

= Human-readable text is mandatory

= AI prefixes must be enclosed in brackets… and Data Titles such as (GTIN / EXPIRY / BATCH) are allowed

Aggregation Model

= The system supports hierarchical aggregation from SGTIN up to SSCC through:

Bundle / Carton / Pallet / Container

= There is no mandated packaging configuration, but maintaining accurate parent-child relationships is required

Aggregation & Disaggregation Events

= Any aggregation activity impacting traceability must be reported

= Disaggregation requires decommissioning of the SSCC

= Partial disaggregation or partial receiving is allowed, but must be recorded in real time

Data Upload in Phase 1

= CSV is the mandatory format

= Upload will be manual initially

= Any error will result in full file rejection (XML and API will be introduced in later phases)

EPCIS Compliance

= The current CSV format is not aligned with EPCIS 2.0

= The roadmap includes alignment with EPCIS 2.0 while maintaining backward compatibility

API & Integration

= No API in Phase 1

= System-to-system integration will be introduced in future phases

Key Operational Constraints

= Reuse of any serial number is strictly prohibited

= Barcode printing inside Egypt is only allowed at EDA-approved sites after batch release

= Distribution centers are not allowed to perform serialization or reprint barcodes

On another note, 9 imported narcotic products have been registered on the platform so far, with expectations to reach 201 products by end of May

It is also worth noting that a guideline was issued at the end of last month explaining how to create the CSV file, including the following rules:

= The file must not exceed 50,000 serial numbers

= The file must not include more than 5 batches

= The production date must be earlier than the event time in the file

= Event times must be logically and sequentially ordered

= Any error in the file will lead to reporting failure

Additionally, one of the key observations is that the production date must be clearly printed in a human-readable format on pharmaceutical packages

Phase 1 will include only two events: Commissioning and Packing.