Pharma
| Regulatory Agency |
Egyptian Drug Authority (EDA) |
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| Regulation Name |
Unified Track & Trace Decree (Decree No. 475 of 2025, published August 2025) |
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| Compliance Dates |
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| Applies to |
All human pharmaceutical and biological products manufactured or imported into Egypt. |
| Free Samples must be marked? | No |
(A carton containing one or more primary packs and includes a “mono carton” containing one primary pack)
| Barcode Symbology | GS1-compliant 2D DataMatrix code |
| Barcode Content |
Hierarchy: Serialization applies to secondary packaging and tertiary |
| Serial Number Randomization | NA |
| Serial Number Reuse | No |
| Human Readable Expiry Date Format | YYMMDD |
| Barcode Data Encoding | GS1 Standard |
| Product Code Notes | NA |
| Free Samples must be marked? | No |
Parent-Child Mapping Aggregation Capture? | Parent-child relationships must be captured between primary, secondary, and tertiary packaging levels. |
| Send Unit Data to Government Repository? | EDA |
| Send Unit Data to Third-Party Repository? | As Applicable |
| Send Unit Data to Trading Partner? | As Applicable |
| Send Aggregation Data to Government Repository? | No |
| Send Aggregation Data to Third-Party Repository? | As Applicable |
| Send Aggregation Data to Trading Partner? | As Applicable |
| Who Offers Data Repository for Authentication? | EDA |
| Manufacturers Must Register Shipments in Repository? | No |
| Downstream Trading Partners Must Authenticate on Receipt? | Downstream participants (distributors, pharmacies) are expected to authenticate product data on receipt through electronic scans linked to the EDA database. |
| Downstream Trading Partners Must Authenticate on Shipment? | Downstream participants (distributors, pharmacies) are expected to authenticate product data on shipment through electronic scans linked to the EDA database. |
| Manufacturer Activity Reported? | Companies must report unit and aggregation events (production, packaging, shipment, receipt, etc.) to the Electronic Track & Trace System. Reporting may be done through API connectivity or direct platform submission; real-time reporting is expected for key event types. |
| Downstream Trading Partner Activity Reported? | Yes |
Kevision Systems, a part of the Kevin Group, is a leading solutions provider for complete end to end inspection of products & services for the inspection of pharmaceutical products like tablets, capsules and more. In addition to the inspection systems, Kevision’s Track & Trace Software & related equipment provide a fully integrated solution to the traceability of pharmaceutical products & Supply Chain Integrity.
Built on the cornerstone of strong quality focus, we deliver excellent solutions with very high quality & reliability.
Kevision Systems is dedicated and driven to provide the finest & the most optimum solutions for the Supply Chain Integrity as well as Optical Inspection Systems. We stand strong on the pillars of integrity, professionalism, innovation and expertise and have earned the credibility to work with any size of projects. We strive to excel in terms of quality and technology and be a preferred partner for our valued clientele.
For Further Information, please contact our Compliance Team at info@kevision.in
