Build, upgrade or modernize your pharmaceutical serialization infrastructure with a scalable, GS1-based solution from Jekson Vision.
Jekson Vision provides integrated serialization, aggregation, vision inspection and enterprise traceability solutions for pharmaceutical manufacturers in Egypt, and for manufacturers, CMOs and CDMOs exporting medicines to Egyptian importers.
Whether you are serializing a new packaging line, upgrading an existing system, adding aggregation or preparing line-level data for Egyptian Drug Authority (EDA) reporting, Jekson can help you design an architecture suited to your operation and to Egypt's phased requirements.
Egypt has established a National Unified Electronic Track and Trace System for human pharmaceutical and biological products under the Egyptian Drug Authority's jurisdiction. It applies to locally manufactured and imported products and follows each pack from production or importation through distribution, storage and dispensing, or until export or destruction.
The framework is built on several EDA decrees:
Unified coding using unique-identifier 2D barcodes, replacing the earlier single-GTIN barcode standard.
Establishes the national system and its phased application dates.
The Regulatory Guide setting out obligations for each type of supply-chain entity.
Under Decree 475, the system applies to imported finished human medicines from 1 February 2026 and to locally packaged, filled or produced medicines from 1 August 2026, with application graded by dosage form and therapeutic group. Batches produced or imported before those dates may stay on the market until expiry, but product produced or imported afterwards may not be traded unless it is enrolled in the system. In August 2026 the EDA Chairman described the rollout as beginning with imported medicines and expanding gradually to local products over three to five years. Manufacturers should confirm the phase that applies to their products directly with the EDA.
Jekson Vision does not administer Egypt's track and trace system. Jekson provides the hardware, software, vision inspection and integration capabilities manufacturers use to generate, verify and manage serialized product data within that ecosystem.
The EDA's Technical FAQ for Phase 1 of the Egyptian Track & Trace System (EPTTS) sets out the following:
| Requirement | What the FAQ Says |
|---|---|
| Serial numbers | The EDA does not issue them. Manufacturers generate globally unique, non-reusable serial numbers (AI 21) linked to GTINs registered with the EDA before importation. |
| Serialization level | Mandatory at secondary packaging, defined as the smallest saleable unit dispensed to patients. |
| Code | GS1 DataMatrix ECC 200 encoding GTIN (01), serial number (21), expiry date (17) and batch/lot (10), with FNC1/GS separators after variable-length fields. |
| Expiry format | Encoded as YYYY-MM-DDT, a deliberate EPTTS deviation from the GS1 YYMMDD format. |
| Human-readable text | Mandatory, following GS1 General Specifications, with AI prefixes in parentheses. |
| Reporting accountability | The importing entity is legally accountable for reporting commissioning, aggregation, shipping and receiving events. Manufacturers and CMOs may generate the data, but submission accountability stays with the importer. |
| Submission format | CSV, uploaded manually, in Phase 1 (maximum 50,000 serial numbers per file and 5 batches per commissioning file; any error rejects the whole file). API and XML integration are planned for later phases. |
| Timing | Reports must be completed before the shipment arrives in Egypt. |
| Printing | Barcode printing within Egypt is permitted only at EDA-licensed facilities after batch approval. Distribution centers may not serialize or reprint barcodes. |
Meeting Egypt's traceability requirements is not simply about printing a code. The Regulatory Guide expects manufacturers to verify at commissioning that no GTIN-and-serial combination is duplicated, to aggregate packs to higher packaging units using SSCC, and to report events accurately and promptly. For importers, data defects can stop a shipment, so the data created on the line must be accurate enough to be relied on by every party downstream.
A typical architecture: Product → Serialization → Vision Verification → Aggregation → Site Management → Enterprise Traceability → Supply Chain
Serialization printing, GS1 DataMatrix printing with market-specific encoding, barcode verification, OCR/OCV, reject management and commissioning.
Coordinate serialization across packaging lines, batches and production environments.
REETRAK manages serial numbers, production data and packaging hierarchies.
REESOURCE connects serialized product information across manufacturing, warehouse and distribution, and can prepare data for regulatory reporting.
Connect traceability information across sites, markets and systems, including external regulatory and importer systems where required.
One architecture. Multiple levels. Built to scale as EPTTS moves beyond Phase 1.
Serialization gives each saleable pack a unique identity. Aggregation records how those packs are grouped into higher levels. EPTTS supports hierarchical aggregation from serialized packs (SGTIN) up to SSCC at bundle, carton, pallet and container level. No packing method is mandated, but parent-child hierarchy integrity must be preserved.
Per the EDA's Technical FAQ, aggregation events that affect product traceability must be reported unless demonstrated otherwise. Disaggregation requires the SSCC to be decommissioned, and partial unpack and partial receive events are permitted but must be reported immediately.
Because Egypt's expiry encoding and human-readable rules differ from some other markets, verification matters. Jekson's vision inspection systems verify the machine-readable and human-readable information printed on pharmaceutical packaging, with AI-enabled inspection available across the Jekson vision range.
Depending on the application, inspection can include GS1 DataMatrix verification, GTIN, serial number, batch number, expiry date, human-readable interpretation against the encoded data, OCR/OCV, print quality grading, code readability, label verification, product presence and SSCC verification on cases and pallets.
Print → Inspect → Verify → Accept / Reject → Record
This helps prevent unreadable, incorrect or mismatched codes from leaving your facility, reducing the risk of shipments being queried or held.
The Regulatory Guide places obligations on every entity in the chain. According to published legal analysis of the Guide, distributors and warehouses must register receiving events within 48 hours, pharmacies and hospitals must verify each pack before dispensing, and non-compliance can lead to seizure, suspension of circulation or supply, and financial penalties. The Guide also points to EPCIS as the long-term event standard, and the EDA has said it intends to align future releases with EPCIS 2.0.
A serialization architecture should therefore be ready for both the Phase 1 reality (CSV files) and later phases (API and system-to-system integration). Depending on the project, this can involve:
REETRAK provides line and site-level serialization and aggregation within Jekson's traceability ecosystem, built on GS1 standards, managing serial numbers, product and batch data, packaging hierarchy, exceptions, rework, audit trails and reporting.
REESOURCE provides the enterprise layer, designed to connect serialized product information across manufacturing, warehouse, distribution and enterprise environments, and to prepare it for regulatory and partner reporting.
Can REESOURCE integrate with ERP, MES and WMS systems? Yes. REESOURCE is designed to integrate with existing enterprise systems and packaging-line infrastructure, depending on the project architecture.
For products shipped into Egypt, the importing entity is legally accountable for reporting to EPTTS, but the serialization and aggregation data originates at your packaging site. Foreign manufacturers and CMOs therefore need to hand over clean, complete serialized and aggregated data, in the right format, before the shipment arrives.
Jekson can help you structure line-level data so your importer can report accurately, while keeping the same architecture for your other markets.
Many manufacturers supplying Egypt already serialize for the EU, the USA, Saudi Arabia or India. The gap is often in market-specific encoding, aggregation, reporting formats or aging equipment rather than in the whole system. Jekson can conduct a line study and recommend the right approach: retrofit, replacement, an additional line, or integration with suitable existing equipment. Whether a line can be retrofitted depends on its equipment, configuration and project requirements.
Egypt has one of the region's largest local pharmaceutical industries, and new lines and expansions are being planned now. Designing serialization into cartoning, blister, bottle, vial and labeling lines, case packing, aggregation stations and warehouse operations from the start is far more efficient than adding it later.
