EPTTS

Securing Egypt's Pharmaceutical Supply Chain: The EPTTS Framework

The EPTTS Framework

Egypt has established a comprehensive regulatory framework for pharmaceuticals through the Egyptian Pharmaceutical Track & Trace System (EPTTS), overseen by the Ministry of Health and Population. This pioneering initiative represents Egypt's commitment to safeguarding public health by ensuring the authenticity, safety, and traceability of medicinal products throughout the entire pharmaceutical supply chain.

Key Tenets of Egypt's Pharmaceutical Regulations

GS1-Compliant Serialization

The EPTTS mandates the serialization of pharmaceutical products using GS1 standards, requiring each secondary package to bear a unique 2D DataMatrix barcode. This standardized approach ensures that every pharmaceutical item carries critical identification elements including the Global Trade Item Number (GTIN), batch number, expiration date, and unique serial number, enabling precise tracking throughout the distribution network.

End-to-End Supply Chain Visibility

Egypt's regulatory framework encompasses all participants in the pharmaceutical ecosystem, including manufacturers, contract manufacturing organizations, distributors, wholesalers, pharmacies, and hospitals. This comprehensive approach creates uninterrupted visibility from production to patient, establishing a chain of custody that significantly reduces the risk of counterfeit products entering the legitimate supply chain.

Event-Based Traceability System

The EPTTS monitors 12 distinct EPCIS (Electronic Product Code Information Services) events throughout a product's lifecycle, including commissioning, shipping, receiving, packing, unpacking, dispensing, and recall. This event-based tracking methodology ensures real-time accountability and transparency at each transition point, allowing for swift identification of irregularities and effective recall management when necessary.

Phased Implementation Approach

Egypt has adopted a strategic, phased implementation of the EPTTS, beginning with pilot programs involving key stakeholders. This measured rollout acknowledges the complexity of the system while enabling continuous refinement based on real-world application. Rather than a one-time project, the EPTTS represents an ongoing transformation program designed to align Egypt's pharmaceutical sector with global standards.

Why Choose Our iTS Compliance Solution

Expert Guidance

Our team of compliance experts possesses in-depth knowledge of iTS and Turkish pharmaceutical regulations. From serialization strategies to data reporting, we guide your organization through the intricacies of compliance, ensuring a smooth and informed journey.

Cutting-Edge Technology

Leverage our state-of-the-art compliance solution, designed to integrate seamlessly with iTS requirements. Our technology ensures accuracy, efficiency, and real-time visibility, empowering your organization to meet and exceed compliance expectations.

Future-Ready Operations

Compliance is not just about meeting today's standards; it's about preparing for the future. Our solution is designed to evolve with regulatory changes, ensuring that your organization remains at the forefront of compliance in the dynamic Turkish pharmaceutical landscape.

Transparent Collaboration

We believe in transparent collaboration. Partner with us, and we'll work closely with your team to implement and maintain compliance measures. Our goal is to build a resilient, compliant, and future-ready pharmaceutical supply chain together.

Speak With a Compliance Expert

LSPedia's Expertise in EPTTS Compliance

Navigating Egypt's pharmaceutical regulations requires specialized knowledge and technological capabilities. LSPedia offers comprehensive solutions tailored to the unique requirements of the EPTTS framework. Our platform seamlessly integrates with your existing systems to enable GS1-compliant serialization, streamline EPCIS event reporting, and ensure complete supply chain visibility. With LSPedia's expertise, pharmaceutical companies can not only achieve regulatory compliance but also realize operational efficiencies and enhanced product security throughout the Egyptian market. Our dedicated team provides ongoing support, system updates, and regulatory monitoring to ensure continued compliance as the EPTTS framework evolves.RetryClaude can make mistakes. Please double-check responses.

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We invite you to learn more about how LSPedia can support your compliance and supply chain needs. For more information about our solutions, partnership opportunities, or to speak with one of our experts.

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