In Ethiopia, the Ethiopian Food and Drug Authority (EFDA) plays a pivotal role in ensuring the safety, efficacy, and quality of pharmaceuticals. Central to its regulatory framework is the EFDA Traceability Directive, a comprehensive set of requirements designed to bolster the traceability of medicinal products within the pharmaceutical supply chain.
EFDA mandates the serialization of pharmaceutical products, necessitating each unit to carry a unique identifier. This serialization enables precise tracking and tracing, ensuring the authenticity and integrity of pharmaceuticals as they move through the supply chain.
Pharmaceutical manufacturers are required to submit detailed data to EFDA at various stages of the supply chain. This includes information on production, distribution, and sales. The robust data reporting and integration framework empower EFDA to monitor the movement of pharmaceuticals effectively and swiftly respond to any irregularities.
EFDA enforces strict compliance oversight through inspections and audits. Pharmaceutical entities are subject to regular assessments to ensure adherence to serialization and data reporting requirements. Non-compliance may result in penalties, including fines and regulatory actions.
Navigating the intricacies of EFDA's Traceability Directive demands a strategic and experienced approach. Our specialized team provides tailored solutions for pharmaceutical entities seeking to implement and maintain robust traceability systems. From serialization strategies to data integration, we guide organizations toward compliance, fostering a transparent and secure pharmaceutical supply chain in Ethiopia.Speak With a Compliance Expert