Egyptian Track & Trace Regulations for Domestic Manufacturing

Egypt has implemented specific Track and Trace regulations for the pharmaceutical industry to enhance the safety and security of its domestic pharmaceutical supply chain. These regulations are designed to prevent counterfeit drugs from entering the market and ensure that all pharmaceutical products are adequately monitored from production to end consumer. This article provides an overview of the essential Track and Trace requirements in Egypt for domestic manufacturing.

Key Regulations for Track & Trace in Egypt

Serialization Requirements

All pharmaceutical products manufactured in Egypt must have unique serial numbers. This serialization is a critical component in ensuring traceability across the supply chain. Each unit of the product must be serialized with a Global Trade Item Number (GTIN), a unique product identifier, and a serial number, which helps in distinguishing each unit from another.

• GTIN: A unique identifier for trade items.
• Serial Number: Unique for each unit of the product.

Aggregation

The regulations mandate aggregation, where a parent-child relationship between the packaging levels (e.g., cartons, cases, pallets) is established. This requirement allows easier tracking and tracing of products through various packaging stages and improves inventory management.

Reporting to the Egyptian Drug Authority (EDA)

Manufacturers must report all serialized products to the Egyptian Drug Authority (EDA). This includes details on production, shipment, and any changes in product status. The reporting is done through an electronic system, which facilitates real-time monitoring of the pharmaceutical products throughout the supply chain.

• Reporting Frequency: Continuous, as products move through the supply chain.

Data Management and Retention

Companies are required to maintain a comprehensive database that includes all serialized data for a minimum of five years. This database should be accessible to the EDA upon request to verify product information and supply chain integrity.

Compliance Deadlines

The regulations set specific deadlines for compliance, with penalties for non-compliance. Manufacturers must ensure that all processes related to serialization, aggregation, and reporting are fully compliant within the set timelines.

Authentication and Verification

Pharmacies and distributors are required to verify the authenticity of pharmaceutical products before dispensing them to consumers. This process involves scanning the product’s barcode and verifying its information against the data reported to the EDA.

Recall Management

The Track and Trace system also supports effective recall management by allowing for the rapid identification and removal of products from the supply chain if they are found to be counterfeit, expired, or otherwise non-compliant.

Overview of Requirements

Serialization

Requirement: Unique serial numbers for each product unit

Details: GTIN + Serial Number

Aggregation

Requirement: Parent-child relationship between packaging levels

Details: Required for inventory and tracking

Reporting to EDA

Requirement: Continuous reporting of product data

Details: Real-time updates required

Data Management

Requirement: Maintain serialized data for at least five years

Details: Database must be accessible to EDA

Compliance Deadlines

Requirement: Specific deadlines for implementing serialization and aggregation

Details: Non-compliance may result in penalties

Authentication and Verification

Requirement: Verification of product authenticity by pharmacies and distributors

Details: Required before dispensing to consumers

Recall Management

Requirement: Supports effective recall processes

Details: Rapid identification and removal of non-compliant products

Conclusion

The Egyptian Track & Trace regulations for domestic manufacturing are comprehensive and designed to secure the pharmaceutical supply chain against counterfeit drugs. These regulations emphasize serialization, aggregation, reporting, data management, and compliance to ensure that only authentic and safe products reach consumers. Companies operating in Egypt’s pharmaceutical industry must ensure they meet these requirements to avoid penalties and maintain market access.

To comply with these regulations, manufacturers and stakeholders in the pharmaceutical industry can consider solutions that offer robust serialization and aggregation capabilities, real-time data management, and seamless integration with the EDA’s reporting system. For more information on how to meet these regulatory requirements efficiently, consider consulting with industry experts who specialize in serialization and track and trace solutions.