All companies importing any medicine into Ethiopia would have to hire a registered Ethiopian Importer, register each product with the Ethiopian Food and Drugs Administration (EFDA) on the e-RIS portal, obtain an import license from i-Import, and then carry out the clearance process at any EFDA-approved port. As of the fiscal year (2025/2026), all pharmaceutical products are required to submit their serialised track-and-trace report to the EFDA-MVC traceability hub. Product Registration is valid for five years and requires renewal before its expiry.
Why Ethiopia’s Drug Import Rules Matter?
Currently, around two-thirds to three-quarters of the pharmaceuticals supplied to Ethiopia are imported (primarily from the Netherlands, Belgium and India). As the country’s projected total market value rises to USD 1.7billion with a USD 700 million supply shortfall by 2025, Ethiopia is actively seeking investment and foreign suppliers to fill in these deficits – while raising the compliance bar due to years of stockouts, smuggled product penetration, and chronic forex shortages.
With the Ethiopian Food and Drug Authority’s (EFDA), the WHO attained a maturity Level 3 rating in 2025. Ethiopia’s pharmaceutical regulatory regime is now rising to international standards and regulations. For companies not prioritising this, they can expect product detentions at customs, fines and outright destruction. However, companies that can navigate and adhere to these regulations benefit from efficient customs clearing and thus have a competitive edge.
The Regulatory Body: EFDA
The Ethiopian Food and Drug Authority (EFDA) is the central national drug regulatory agency of Ethiopia. It is responsible for all import, registration, licensing, and inspections of human and veterinary drugs, medical devices, traditional and modern health services, cosmetics, and associated commodities. It functions according to the Council of Ministers Regulation Number 531/2023, and its mission is to protect and enhance the health of the public through ensuring quality, safety and efficacy of regulatory commodities through inspections, laboratory tests and sample-based testing of products, registration, licensure of firms, products and inspections in the course of post-marketing activities.
The EFDA has most of their operations online across three interconnecting systems;
- I-Register: It provides an online application and processing of a medicine registration certificate for the import of products into the Ethiopian market by importers.
- I-Import: It allows for the application of a medicine import permit online by importers.
- I-License: It allows for the application of an import, export, wholesale or manufacturing competence certificate by importers, exporters, wholesalers and manufacturers.
All of these three are steps required for a legal importation.
Step-by-Step: How the Import Process Works
1. Engage a Licensed Local Agent
EFDA prohibits direct sales by foreign entities. Overseas manufacturers need a local agency/agreement with an Ethiopia-licensed importer/distributor who has an active certificate of competence from the Authority. This local partner will handle the registration, port clearances, and the supplier’s post-marketing duties.
2. Submit the Product Registration via eRIS
Applicants need to be equipped with the necessary administrative documents, quality information, and data on the product’s non-clinical and clinical assessments, along with any supportive documentation and product labels, and submitted via the eRIS of EFDA in the CTD. All the documents will need to be submitted in English. If any documents are submitted in any other language, a certified translation will need to be provided.
In addition to the above, the following are some of the key document requirements:
- Certificate of Pharmaceutical Product and a Certificate of Origin
- A CTD in the Modules 1-5 describing the administrative, quality, non-clinical, clinical, and labelling requirements
- Product barcode that meets EFDA traceability and national barcoding requirements
- A Patient Information Leaflet in English and in Amharic for all products that are on the essential medicines list or that have significant market presence in Ethiopia
Once registered, product registration is valid for five years, after which manufacturers will need to submit an application for product re-registration. Any variation to a registered product will require a submission and approval.
3. Obtain an Import Permit
Purchase orders for products to be imported will need to be approved by the Authority in advance of shipment, and such orders will need to be processed via the i-Import system.
4. Clear the Goods at an Approved Port of Entry
Based on EFDA’s 2025 port clearance guideline, importation is only allowed through Points of Entry POEs that are approved by EFDA, together with the Ethiopian Customs Commission (for example, Djibouti Port, Modjo Dry Port, and Kality Dry Port). If it’s coming in via post, hand carry, or any other not designated channel, that is strictly prohibited unless EFDA gives prior authorisation, which most people forget until it’s too late.
At the port, importers are expected to:
- Check that the product registration exists with EFDA, or secure special import authorisation before anything else
- Confirm that the importing entity actually has a valid EFDA import license
- Submit all the clearance documents through the Electronic Single Window ESW system right away upon arrival
After that, EFDA inspectors will do a risk-based physical inspection of the consignment, and they will also verify quality, labelling, and shelf-life compliance before release.
5. Avoid the Usual Rejection Triggers
A consignment may be delayed, seized, or even destroyed if:
- The product is counterfeit, falsified, misbranded, or adulterated
- The product is not registered in Ethiopia, and it also lacks a valid EFDA pre-authorisation
- The product is linked to an international or national safety alert
- It entered through an unauthorised port of entry
- It is a donation or sample, brought in without EFDA authorisation, even if it seems small or informal
Mandatory Traceability (EFDA-MVC Hub)in 2025–2026:
Ethiopia is rolling out this national serialisation and track-and-trace mandate. Under the EFDA-MVC Traceability Hub, exporting companies, plus the Marketing Authorisation Holders (MAHs), have to sign a Participation Agreement with the Ministry of Health MOH-MVC and then register before they can keep shipping into the country. The registration started on June 26, 2025, and from that point, every traceability event — commissioning, shipping, and receiving — needs to be reported to the national traceability hub. So suppliers that rely on global serialisation platforms should really check that their system can integrate with the hub properly, well before the next shipment comes out.
Special Cases: Samples, Donations and Personal Imports
- Registration Samples: Importers need prior EFDA authorisation first, and only the quantities that are necessary for lab testing or dossier assessment are allowed; these samples can not ever be sold or commercially distributed.
- Donations/Humanitarian Imports: Prior EFDA approval is required for government, humanitarian, or donor imports.
- Personal-use Imports: These are allowed only within strict limits. Non-prescription products may be imported up to a 90-day supply, and prescription medicines also up to a 90-day supply, with a valid prescription plus a copy of the patient’s ID card or passport.
Practical Checklist for International Suppliers
- Identify and formally contract a licensed Ethiopian importer/agent
- Prepare a complete CTD dossier with CPP, CoO, and bilingual labelling
- Submit registration through eRIS and track status online
- Apply for the import permit through i-Import once registration is granted
- Register with the EFDA-MVC traceability hub and align your serialisation data
- Ship only through EFDA-approved ports of entry
- Calendar the 5-year re-registration deadline immediately after approval
Frequently Asked Questions
How long does EFDA drug registration take?
Processing time varies by product risk category and dossier completeness; EFDA evaluates applications on a first-in-first-out basis through eRIS, and incomplete CTD submissions are the leading cause of delay.
Can a foreign manufacturer import directly without a local partner?
No. Ethiopian regulation requires a local agency agreement with a licensed importer who holds an EFDA certificate of competence.
Is product registration permanent once approved?
No registration is valid for five years and must be renewed before expiry, with any product changes reported to EFDA.
What happens if a shipment isn’t registered or pre-authorised?
It can be withheld and is subject to secure detention and supervised destruction under EFDA’s port-clearance procedures.
