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EDA (Egyptian Drug Authority)

The Egyptian Drug Authority is responsible for the regulation of all pharmaceuticals, medical devices, their accessories, and IVDs in the Egyptian market.

For any kind of medicinal substance to enter Egyptian pharmacies, hospitals, and even homes, the EDA must keep track of every single item going in and out.

EDA - Egyptian Drug Authority

Where Does GS1 Fit In?

As the universal language of commerce and trade, our involvement with the EDA allows for reliable traceability throughout the medical device and pharmaceutical lifecycle.

Pharmaceuticals differ from region to region across the world, and with GS1’s GTINs, the EDA can easily follow the same universal standard of drug and device identification. This allows for far smoother and more precise logistical operations throughout the country’s pharmaceutical and medical device infrastructure.

GS1 and Pharmaceuticals

Following decree 29 placed by Minister Dr. Ahmed Emad in 2016,

everyone involved in the drug-making process must include their ingredients and constituents in the GS1 Data Matrix: a 2D barcode which contains the GTIN, batch number, expiry date, and random serial number. As soon as a product is released from production, it receives a GS1 Data Matrix. Each product bears a unique random serial number reported to the EDA. Factory owners dispatch products once serialized, where they then go to aggregation. In this phase, they’re packaged, given a number, and when added to palettes, they have their own batch shipping number

This process ensures that all items going to and from suppliers and manufacturers are efficiently tracked and processed, making dispatches, recalls, and similar services happen much more efficiently.

GS1 Egypt - GS1 and Pharmaceuticals
Decree no 29 for 2016 regarding track & trace project

Decree no 29 for 2016
regarding track & trace project

هيئة الدواء المصرية – توقيع بروتوكول تعاون مع المنظمة العالمية للترقيم لدعم منظومة قواعد بيانات المستحضرات والمستلزمات الطبية باستخدام أحدث المعايير العالمية
(eda egypt.gov.eg)

GS1 and Medical Devices

From cotton to complex medical machinery, IVDs, and even cardiac stents, GS1 is on all of it.

All manufacturers of medical devices and accessories must now bear GS1 standards when serializing any of their products. The EDA has an automation program for companies, both local and global, to register their product with a GTIN.

Medical devices are required to have a Unique Device Identification number or UDI, which is directly linked to, and in keeping with, GS1’s general specifications, standards, and guidelines. With GS1’s grading standard keeping track of all devices coming in and out of the market, manufacturers and providers can easily integrate with the EDA’s requirements for a GS1 GTIN and, in turn, a UDI.

GS1 and Medical Devices
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