Egypt Serialization and Traceability Compliance

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Global Regulations

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Labelling

Products are required to display information in writing.

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Lot Level Traceability

Products are traceable as part of uniquely identified lots.

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Unit Level Traceability

Sellable units are uniquely identified enabling a more granular traceability.

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Aggregation

The packaging hierarchy of products is required to be identified and documented.

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Central repository

The traceability documentation is required to be centralized in a unique system.

Summary

Egypt has implemented a national pharmaceutical traceability framework to improve medicine supply chain transparency and combat counterfeit products. The system is managed through the Egyptian Drug Authority (EDA) under the Ministry of Health.

Egypt’s traceability framework is built around the Egyptian Drug Tracking System (EDTS), which requires pharmaceutical products to carry GS1 compliant DataMatrix barcodes with serialized identifiers. The system enables tracking of medicines from manufacturers and importers through distribution to pharmacies.

The EDTS platform supports digital verification of medicines and helps regulators monitor product movement across the pharmaceutical supply chain. Serialization and traceability requirements apply primarily to human prescription medicines, with implementation occurring in phases.

Labelling Requirements 

Pharmaceutical products distributed in Egypt must include a 2D DataMatrix barcode on the secondary packaging.

The barcode must follow GS1 standards and include the following elements:

  • GTIN
  • Serial Number
  • Batch Number
  • Expiry Date

These data elements allow unique identification of each medicine package and support verification through the national tracking system.

Human readable information printed on the packaging must correspond to the encoded barcode data.

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Regulatory Timeline 

2017
Egypt began developing a national pharmaceutical track and trace strategy to combat counterfeit medicines.

2019
The Egyptian Drug Authority introduced initial serialization and traceability requirements.

2020 onward
Implementation of the Egyptian Drug Tracking System (EDTS) began, enabling serialized identification and verification of medicines.

Current Status
Serialization and traceability requirements are actively being implemented across the pharmaceutical supply chain.

Reporting Requirements 

Operation
Data to Report
When to Report
Commission
GTIN, Serial Number, Batch, Expiry
During packaging before product release
Import Reporting
Shipment details and serialized product information
Before product distribution in Egypt
Distribution
Sender and receiver information with serialized identifiers
When product is transferred between supply chain participants
Receiving
Confirmation of serialized product receipt
At warehouse or distributor receipt
Dispensing
Serialized pack information supplied to pharmacies or patients
At supply stage
Decommission
Serial numbers and reason for removal
When product is destroyed or withdrawn

Supply chain actors are responsible for ensuring that serialization data is accurately recorded and reported through the EDTS system.

OperationData to ReportWhen to Report

Commission 
Aggregation 
Shipping 

GTIN, Serial, Batch, Expiry  
Parent SSCC, Child Serials  
Sender GLN, Receiver GLN, SSCC or Serial List
During packaging before shipment 
When creating cases or pallets 
Before dispatch 
ReceivingImport Clearance
Supply to Pharmacy
GTIN, Serial, Batch, Expiry  
Parent SSCC, Child Serials  
Sender GLN, Receiver GLN, SSCC or Serial List
During packaging before shipment 
When creating cases or pallets 
Before dispatch 
Returns 
Decommission 
Serial status and reference 
Reason and serials 
When return is approved 
When product is destroyed or removed 

Operational Timelines for Industry 

  • Configure packaging lines to generate serialized DataMatrix barcodes compliant with GS1 standards.
  • Print serialized identifiers on secondary packaging during manufacturing.
  • Register serialization data within the EDTS system.
  • Report shipment and distribution events as products move through the supply chain.
  • Maintain traceability records and support regulatory inspections conducted by the Egyptian Drug Authority.

Reporting Hub

Traceability reporting in Egypt is conducted through the Egyptian Drug Tracking System (EDTS) operated by the Egyptian Drug Authority.

The system allows pharmaceutical supply chain participants to submit serialization data and track product movement through electronic reporting mechanisms.

Participants interacting with the system include:

  • Manufacturers
  • Importers
  • Distributors
  • Pharmacies

The EDTS platform supports:

  • Serialization data management
  • Product verification
  • Supply chain transaction reporting
  • Regulatory monitoring

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Aggregation Requirements 

Egypt’s traceability system focuses primarily on unit level serialization using DataMatrix barcodes.

Aggregation at case or pallet level is not currently mandated in publicly available regulatory guidance. However, many manufacturers implement internal aggregation processes to support logistics operations and facilitate distribution reporting.

Common Errors to Avoid 

  • Incorrect configuration of DataMatrix barcode data elements.
  • Mismatch between printed serial numbers and reported serialization records.
  • Failure to report distribution transactions within the traceability system.
  • Using incorrect product identifiers or GTIN assignments.
  • Inadequate verification of serialized data during packaging operations.

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