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27 Jun

[Blog] New Traceability Rules in Ethiopia: What Pharma Exporters Must Do by 2026

by Milena Atanasova
in Blog, news
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New Traceability Rules in Ethiopia: What Pharma Exporters Must Do by 2026

 

The Ethiopian Food and Drug Authority (EFDA) is taking a major step forward in securing its pharmaceutical supply chain. With the launch of the EFDA-MVC Traceability Hub, Ethiopia is now enforcing traceability requirements for all companies exporting medicinal products into the country.

Whether you’re a Marketing Authorization Holder (MAH), manufacturer, or CMO, these updates require immediate attention. Here’s what you need to know.

 

Step 1: Register with the EFDA-MVC Traceability Hub

 

Deadline: July 25, 2025

 

The first mandatory step is registration with the EFDA-MVC Traceability Hub. Exporting companies must:

 

  • Sign a Participation Agreement with the Ministry of Health (MOH-MVC)
  • Pay the required registration fees

 

 

Registration officially opens on June 26, 2025, and EFDA will hold webinars to support MAHs in navigating the process.

 

 

Step 2: Start Traceability Reporting

 

Deadline: June 3, 2026

 

By this date, all traceability events (e.g., commissioning, shipping, receiving) must be reported to the national traceability hub.

If your company is not yet connected to a partner system capable of automating this data exchange, now is the time to act. Delays could lead to regulatory non-compliance or disrupted market access.

 

 

Step 3: Submit Aggregation Data

 

Grace Period Until: December 1, 2026

 

Recognizing the operational complexity of aggregation, EFDA has granted a grace period for submitting aggregation events (e.g., parent-child packaging relationships). Still, this is not a delay tactic—your systems must be aggregation-ready in advance.

 

 

Step 4: Provide Company Contact Details

 

Deadline: August 4, 2025
EFDA requires all participating companies to submit official contact information by email to EFDA-MVC-support@avc360.com. The email must include:
  • Company name
  • Assigned contact person
  • Communication details
  • Reference to the Letter of Notification_250603_15332

Why This Matters for SoftGroup Clients

 

Ethiopia is rapidly aligning with global pharmaceutical traceability standards. For SoftGroup’s partners and clients, this is more than a compliance task—it’s an opportunity to streamline operations, improve visibility, and ensure uninterrupted market access in a growing economy.
The SATT PLATFORM supports full integration with national hubs like EFDA-MVC, offering:
  • Automated traceability data exchange
  • Aggregation-ready packaging and reporting tools
  • Compliance tracking across multiple markets
Whether you’re managing a global serialization strategy or entering Ethiopia for the first time, we help you stay ahead of regulatory deadlines—without disrupting your production timelines.

 

SoftGroup assists pharmaceutical companies in managing traceability in Ethiopia and worldwide. Let us show you how the SATT PLATFORM simplifies compliance in emerging markets.

 

Book a free demonstration of the SATT PLATFORM

 

 

 

Reference: EFDA – Ethiopian Food and Drug Administration