Egypt Track and Trace Regulations: Strengthening Pharmaceutical Supply Chain Integrity

Egypt Track and Trace Regulations: Strengthening Pharmaceutical Supply Chain Integrity

Egypt has taken significant steps towards securing its pharmaceutical supply chain by implementing track and trace regulations. These measures, driven by the Egyptian Drug Authority (EDA), aim to protect consumers from counterfeit drugs, improve the transparency of the healthcare industry, and enhance public health. In this blog, we delve into Egypt’s track and trace system, its implementation timeline, and how it compares with global standards.

Key Highlights of Egypt Track and Trace Regulations

The Egyptian Drug Authority (EDA) has mandated Egypt Track and Trace Regulations to ensure end-to-end visibility of pharmaceutical products. The core components of Egypt’s Track and Trace Regulations include:

  1. Serialization: Each pharmaceutical product is required to have a unique identifier, which includes a GS1-compliant Data Matrix code containing the GTIN (Global Trade Item Number), batch number, expiration date, and serial number.
  2. Aggregation: The regulation extends serialization to secondary and tertiary packaging levels, ensuring hierarchical traceability across the supply chain.
  3. Data Reporting: All serialization and aggregation data must be reported to a centralized platform overseen by the EDA.
  4. Verification: Pharmacies, hospitals, and other stakeholders can verify product authenticity through real-time data access, reducing the risk of counterfeit products reaching consumers.
Egypt Track And Trace Regulations 1

Implementation Timeline

The EDA has adopted a phased approach to allow smooth adaptation by all supply chain stakeholders. The timeline includes:

  • 2024: Pilot projects begin, focusing on serialization for high-risk products such as vaccines and essential medicines.
  • 2025: Serialization becomes mandatory for all prescription drugs.
  • 2026: Aggregation requirements are extended to include over-the-counter (OTC) drugs.

Comparing Egypt and Turkey’s Track and Trace Systems

Egypt’s approach to pharmaceutical traceability, governed by Egypt Track and Trace Regulations, is inspired by Turkey’s successful İlaç Takip Sistemi (ITS). Both systems share several similarities while addressing specific national requirements.

Barcode Requirements

Like Turkey, Egypt has adopted GS1 Data Matrix codes as the standard for serialization. These codes are preferred for their high data capacity, resistance to tampering, and ability to provide accurate information even when damaged.

Comparing Egypt And Turkey’s Track And Trace Systems?

The Journey of a Serialized Product in Egypt

The serialized pharmaceutical products follow a secure and traceable journey across the supply chain:

  1. Manufacturers/Importers: Generate serialization data and report it to the EDA’s centralized platform.
  2. Distributors: Maintain the aggregation hierarchy and report data updates to the EDA.
  3. Pharmacies/Hospitals: Verify product authenticity and report sales or consumption data.
  4. Consumers: Can verify product authenticity through digital tools provided by the EDA.

VISIOTT-TPS Solutions for Egypt Track and Trace Requirements

VISIOTT-TPS offers tailored solutions to help pharmaceutical companies comply with Egypt track and trace regulations. Our solutions include:

  • Serialization Stations: High-speed systems for vials, cartons, and bottles, enabling accurate application of Data Matrix codes.
  • Aggregation Solutions: Seamlessly integrated tools to maintain hierarchical traceability at all packaging levels.
  • Software Integration: Platforms to manage serialization, aggregation, and data reporting aligned with the EDA’s requirements.

Achieving Compliance with Egypt Track and Trace Regulations

Compliance with Egypt track and trace regulations is crucial for protecting public health and building trust within the pharmaceutical industry. VISIOTT-TPS innovative solutions ensure seamless compliance, offering robust hardware, scalable software, and 24/7 technical support.

Contact our experts today to learn how our serialization and aggregation solutions can help you meet Egypt’s regulatory requirements efficiently and effectively!

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