Pharmaceutical serialization requirements are currently being introduced in Ethiopia in phases. According to the EFDA strategic plan, the stated objective is to combat pharmaceutical counterfeiting and enable greater transparency and efficiency throughout the supply chain. According to the WHO, one in ten medicines in low- and middle-income countries such as Ethiopia is either substandard or falsified. In addition, Ethiopia aims to use its traceability system to address supply shortages and lengthy procurement lead times.
Regulation: Food and Medicine Administration Proclamation No. 1112/2019
Platform: EFDA-MVC Traceability Hub
Competent Authority: EFDA
Products: All medicinal products
Code Type: GS1 DataMatrix 2D barcode
Aggregation: Yes, transition period until December 1, 2026 (Source: EFDA)
Timeline: Registration of economic operators until October 30, 2026 (final deadline, previously postponed several times), while the original deadline for implementing the traceability requirements was June 26, 2026
What does the timeline for pharmaceutical serialization in Ethiopia look like?
The EFDA-MVC Traceability Hub (MVC: Medical Value Chain W.L.L.) went live on June 26, 2025. The deadline for registering MAHs/manufacturers in the EFDA-MVC Traceability Hub was most recently extended until October 30, 2026. Officially, the authorities have not communicated any postponement of traceability or serialization data reporting requirements. The Circular contains no information on this matter.
Accordingly, the original deadlines for serialization and aggregation requirements have not officially been suspended or postponed. Since the registration obligation for economic operators has been extended until October 30, 2026, the industry currently assumes that a revised implementation schedule for Ethiopia’s serialization requirements will be announced shortly.
The Pharmaceutical Products Traceability Directive No. 43/2019 explicitly provides that the EFDA will publish product or medicinal product lists and define the respective implementation dates for traceability requirements for those products. However, during the review of publicly available EFDA and EFDA-MVC documentation, no such product list could be identified. Instead, the currently available EFDA-MVC communications primarily focus on the registration of MAHs and manufacturers, technical connectivity to the national EFDA-MVC Traceability Hub, and the submission of traceability data. It is assumed that these lists will become accessible after registration in the EFDA Traceability Hub.
While the original phased implementation plan from 2019 remains the formal legal basis, the actual rollout through the Hub is taking place significantly later and at its own pace.
Current Status Observed in Practice (via the EFDA-MVC Traceability Hub)
| Date | Event |
|---|---|
| June 26, 2025 | EFDA-MVC Traceability Hub goes live |
| November 18, 2025 | First EFDA registration call (“First Call”) for the EFDA-MVC Traceability Hub |
| February 16, 2026 | Second registration call (“Second Call”) |
| July 9, 2026 | Third and final notice announcing a new extended registration deadline |
| October 30, 2026 | Currently valid final registration deadline for manufacturers and MAHs in the EFDA-MVC Traceability Hub |
A timeline published in August 2025 already provided for the reporting of all relevant traceability events as of June 26, 2026. Due to the repeated postponement of the registration obligation for manufacturers/MAHs in the EFDA-MVC Traceability Hub, the original timeline seems to have been superseded. As described above, however, this has not been officially confirmed.
Originally planned (based on Directive No. 43/2019, effective since August 19, 2019, and the EFDA Announcement of August 18, 2025):
| Period After Entry into Force | Calculated Date | Requirement (According to the Directive) |
|---|---|---|
| 2 years | August 19, 2021 | Locally manufactured medicinal products: GTIN on secondary packaging and higher packaging levels; logistics units with SSCC. Imported medicinal products: GTIN + batch number + expiry date on secondary packaging and higher packaging levels; logistics units with SSCC. |
| 3 years | August 19, 2022 | Local manufacturers must include GTIN, batch number, and expiry date on the affected packaging. In addition, product and location master data must be submitted to the authority. |
| 4 years | August 19, 2023 | Manufacturers, wholesalers, and healthcare providers must implement batch traceability for the products listed by the EFDA. |
| 5 years | August 19, 2024 | All actors in the pharmaceutical supply chain must implement batch traceability for listed products. |
| 5.5 years | February 19, 2025 | Full serialization of listed medicinal product packs: GTIN + batch number + expiry date + serial number on secondary packaging and higher packaging levels; logistics units with SSCC. |
| 5.5 years (already extended) | August 25, 2026 | All manufacturers, MAHs, and export distribution companies exporting medicinal products to Ethiopia must be registered in the EFDA-MVC Traceability Hub and must have signed the Participation Agreement. |
| 6.5 years (resulting from extension) | June 26, 2026 | Reporting of all relevant traceability events to the EFDA-MVC Traceability Hub. |
| 7 years | December 1, 2026 | Aggregation of all medicinal products becomes mandatory. |
| 7.5 years | February 19, 2027 | Fully operational national traceability system at product level for the covered medicinal products. |
What are the requirements for the serialization code in Ethiopia?
The required serialization code in Ethiopia is the GS1 DataMatrix as a 2D barcode. The GTIN is assigned by the manufacturer or marketing authorization holder. However, it cannot currently be obtained from GS1 Ethiopia, as there is no Ethiopian GS1 member organization at present. Instead, GTINs can be requested from other GS1 organizations. Recommended examples include GS1 Kenya, Nigeria, Egypt, and South Africa.
The individual data elements must be encoded as follows:
• GTIN (14 digits)
• Batch/Lot number (up to 20 characters)
• Expiry date (YYMMDD format)
• Serial number (up to 20 characters)
The reporting format follows the internationally established standard. As in the United States and the European Union, traceability event reporting is performed via the EPCIS standard (Electronic Product Code Information Services). No unusual aggregation requirements are currently known.
Are there any special serialization requirements in Ethiopia?
No. With GS1 DataMatrix, aggregation, and its focus on pharmaceuticals, Ethiopia follows the industry’s international standards. However, there are several aspects behind the scenes that differ from the typical setup.
• Broad stakeholder involvement from the outset: The Steering Committee, which includes the Ministry, PFSA (Pharmaceutical Fund and Supply Agency), manufacturers, importers, and industry associations, has been set up in a highly collaborative manner, unlike purely top-down systems.
• Relatively short timeframe from launch to full operation: Approximately 16 months pass between the portal go-live (June 2025) and the final registration deadline (October 2026), significantly shorter than the multi-year transition periods seen in the EU or the United States. The actual serialization and aggregation obligations follow afterward. Furthermore, Directive No. 43/2019 only entered into force on August 19, 2019. Also, the period from adoption to implementation is comparatively short.
• A private technology partner (EFDA-MVC) operates the platform on behalf of the authority: This is a model not commonly seen in other markets where portals are operated entirely by government agencies.
What should manufacturers/MAHs do now?
For manufacturers and Marketing Authorization Holders (MAHs) supplying medicinal products to Ethiopia, the most important compliance measure at present is to prepare organizationally and technically for connection to the national traceability system. The EFDA explicitly calls on all MAHs and manufacturers exporting medicinal products to Ethiopia to register with the EFDA-MVC Traceability Hub. The originally established registration deadlines have been extended several times; the currently applicable deadline, described as the “final” deadline, expires on October 30, 2026.
Regardless of the remaining open questions concerning the final rollout of individual traceability and reporting obligations, companies should already ensure that the required GS1 identifiers and master data are available. This includes, in particular, the assignment of GTINs for the affected medicinal products and the allocation of the required Global Location Numbers (GLNs). The Pharmaceutical Products Traceability Directive No. 43/2019 refers to GTINs as part of product identification and requires supply chain participants to use GS1 identifiers. At the same time, according to the published FAQs, the registration and onboarding process for the EFDA-MVC Traceability Hub requires the availability of GLN, GCP, and GTIN data.
In addition, it is advisable to establish the technical prerequisites for future traceability data submissions as early as possible. The currently available EFDA-MVC materials refer to connectivity with the national hub, submission of standardized data, and future requirements for event and aggregation reporting. Companies should therefore prepare their serialization, EPCIS, and aggregation processes conceptually and begin evaluating suitable serialization partners now.
Ask the EFDA to clarify open questions
Since the Pharmaceutical Products Traceability Directive No. 43/2019 provides that the EFDA will define affected medicinal products and implementation dates through separately published product lists, and since no such publicly accessible product list could currently be identified, companies should continuously monitor publications from both the EFDA and the EFDA-MVC portal and clarify any open interpretive questions directly with the authority where necessary.
This approach enables manufacturers and MAHs to address key compliance requirements today without having to make regulatory assumptions regarding detailed deadlines that have not yet been officially confirmed.
mytracekey PHARMA is designed as a flexible serialization platform for numerous markets (including EU-FMD and US-DSCSA) and therefore already supports the exact standards on which the Ethiopian requirements are based (GS1 coding, EPCIS reporting, aggregation). Contact us to discuss how this can be applied in Ethiopia. In addition, you are welcome to schedule a non-binding software demo appointment with us.
Further Regulatory Updates
Pharmaceutical Serialization in Canada: Objectives, timeline, requirements, and assessment
Pharmaceutical Serialization in Bahrain: Timeline and serialization code requirements
Pharmaceutical Serialization in the MENA Region: Overview of Egypt, Qatar, Kuwait, and Libya
Pharmaceutical Serialization in Ukraine: Code requirements, timeline, and connection to the Russian track-and-trace system.
Disclaimer
The information provided here represents only one possible interpretation of the applicable regulations. Regulatory requirements are continuously evolving, which means that the information in this article may be incomplete or no longer fully up to date. This article does not constitute legal advice. Please refer to the official regulatory documents before making any business decisions. (Information status: September 2026)