Key Takeaways
- Established through Proclamation No. 1112/2019, the Ethiopian Food and Drug Authority (EFDA) is responsible for controlling the importation, registration, and distribution of all medications in Ethiopia.
- All medications need a valid marketing authorisation (product registration) from EFDA in order to be imported and distributed in Ethiopia.
- Each importer, wholesaler and distributor needs an additional certificate of competence (business license) from EFDA.
- i-Register and i-License are the online platforms used by EFDA to regulate the process of registering medications and applying for business licenses.
- Before releasing goods from the port of entry, each shipment of imported products should have a valid purchase order and a port clearance permit.
- One of the ports of entry in Addis Ababa, Ethiopia, is Bole International Airport, which is used for importing air freight shipments of pharmaceuticals.
The pharmaceutical market in Ethiopia is among the most rapidly expanding in the East African region due to increased demand for healthcare services and dependence on imported medicines to cater to the demand. However, for any firm considering importing pharmaceutical products into the country, understanding of the regulatory system put in place by the Ethiopian Food and Drugs Authority (EFDA) is important.
The Regulatory Authority: EFDA
The Ethiopian Food and Drug Authority (EFDA) is the federal regulatory agency that oversees the safety, quality, and efficacy of medicines, medical devices, food, and cosmetics within Ethiopia. The establishment of EFDA is provided for in Proclamation No. 1263/2021, with its organisational responsibilities specified in the Council of Ministers Regulation No. 531/2023, whereas the basic regulatory framework concerning medicines, medical devices, and cosmetics regulation is provided for in Proclamation No. 1112/2019.
Regulatory achievements of EFDA over the recent years have included attaining WHO Maturity Level 3 (ML3) in medicine regulation, which is an international measure demonstrating the stability, sustainability, and integration of the regulatory system.
The Two Core Authorisations Required
The framework of drug imports in Ethiopia is based on two types of authorisations that are frequently misunderstood and perform different functions:
1. Product Registration (Marketing Authorisation)
No medication can be imported and supplied in Ethiopia without a proper marketing authorisation granted to the respective product by EFDA. The authorisation at the manufacturer level requires the review of a dossier concerning all aspects, including quality issues, production details, as well as GMP certification in case the product was produced abroad. The process of registering drugs in Ethiopia is conducted through the i-Register website of EFDA.
2. Business Licensing (Certificate of Competence)
Besides product registration, any business that wishes to import, export, wholesale, or manufacture medications in Ethiopia must have a Certificate of Competence from EFDA. Such a certificate gives a business the right to conduct operations in pharmaceutical logistics and is obtained via the i-License system of EFDA.
Step-by-Step Process to Import Drugs into Ethiopia
- Apply for a certificate of competence from EFDA as an importer or distributor
- Register the specified drug/medical device with EFDA using the i-Register program
- Get EFDA approval for the order of products you intend to import
- Arrange shipment and see to it that all documents accompany the shipment
- Apply for a port clearance permit from EFDA to clear the goods from the port
- Clear the goods from customs at the Ethiopian Customs Commission
Documentation Required for Pharmaceutical Consignments
As per EFDA’s Proclamation No. 1112/2019, the regulatory guidelines, and standards set by WHO on regulatory control of medicinal products, all pharmaceuticals exported to Ethiopia should have the following documents:
- Valid EFDA product registration certificate for all items in the consignment
- Certificate of analysis (COA) for the specific batch to be imported
- Certificate of origin (COO); the importer is liable for the authenticity and adherence to the requirements of the COO
- Approved purchase order in correlation to the consignment information
- Commercial invoice and pack list correlated to the product particulars
- Labelling should be bilingual or according to EFDA’s requirement
An important consideration on compliance is that all consignment documents – labelling, pack size and manufacturing site – should correlate to the particulars of the product registered. Non-correlation between the consignment particulars and product particulars is one of the main reasons for consignment retention in the port.
Designated Ports of Entry
Pharmaceutical goods that are imported into Ethiopia can only enter through specified ports of entry where the EFDA inspects and clears them. One of the ports of entry used for air cargo imports of pharmaceutical products in Ethiopia is the Bole International Airport in Addis Ababa, among other approved land and sea ports of entry approved by the Ethiopian Customs Commission. Importing pharmaceuticals from unauthorised ports of entry is prohibited.
Personal Importation of Medicines
The other issue concerning the regulation of pharmaceutical imports in Ethiopia is the importation of medicines personally (for non-commercial purposes). For medicines that are not prescription medicines, the importer may usually import these medicines even without the prescription, provided he/she is importing a 90-day personal use supply. On the other hand, when it comes to importing prescription medicines, then a valid prescription issued by a licensed medical practitioner should accompany the prescription medicines.
Distribution Requirements Following Import
The movement of medicines after clearance from customs must occur via the licensed distribution chain. The wholesale distribution operation itself needs EFDA authorisation, with the premises, staff, and storage facilities all meeting the requirements set out under the EFDA 2025 Guide to Good Storage, Distribution, and Dispensing Practices Inspection Manual. These include continuous temperature control, sanitary controls, and cold-chain products requiring specialised cold storage facilities and power back-up systems.
Local Agent and Representative Requirements
Foreign companies will usually require the assistance of a locally licensed importer, distributor, or authorised representative when registering and importing the medicines, since direct dealings with EFDA are only possible with an existing local presence or association. The local representative will usually be responsible for submitting dossiers and maintaining the Certificate of Competence.
Key Compliance Considerations for Importers
- Allow adequate time during planning for imports to cover the permit processing, as this is not done immediately
- Make sure that all shipping documents reflect the product’s registered details accurately, including labelling and packaging
- Be well aware of the cold chain infrastructure needs at an early stage for temperature-sensitive products
- Be informed about EFDA directive changes, as this regulatory structure – with the 2025 Inspection Manual included – is constantly changing
- Allow for possible foreign exchange allocations, which may delay your imports without being affected by regulations
Common Challenges Importers Face
- Lag in allocation of foreign currency even if there is a letter of credit
- Discrepancies in the shipping documents and the product details on record resulting in port detention
- Long durations in the process of product registration via dossier submission
- Dealing with product registration and business license separately
Frequently Asked Questions on Drug Import Regulations in Ethiopia
Who controls the entry of drugs into Ethiopia?
The Ethiopian Food and Drug Authority (EFDA) oversees the registration, importation, and distribution of medicines in Ethiopia through Proclamation No. 1112/2019 and other directives.
Is a company able to import medicines into Ethiopia if they have no local registration?
No. Medicines need to have marketing authorisation from EFDA for importation and sale, and the importer company must have an EFDA Certificate of Competence.
How do discrepancies in shipment documentation affect shipment entry?
Discrepancies in shipment documentation (labelling, pack sizes, etc.) when compared with product particulars registered with EFDA are the most frequent cause of shipment being kept at the port.
Is there any limit on personal medication importation into Ethiopia?
Personal medication importation is limited to a 90-day supply of the medication; prescription medicines require a valid prescription; importation above the maximum amount requires EFDA authorisation.
What is the EFDA WHO Maturity Level 3, and how does it impact the importer?
WHO Maturity Level 3 means that EFDA is a stable and well-operated regulatory authority according to international standards due to the increasing registration, inspection, and enforcement activities importers will encounter.
Conclusion
The importation rules of drugs in Ethiopia consist of two sets of rules that run concurrently; that is, product registration and business licensing, which are both managed by the EFDA, in addition to shipment-based regulations including approved purchase orders, port clearance permits, and port of entry. As the regulatory regime of EFDA becomes increasingly mature with the adoption of Good Storage and Distribution Practices rules in 2025, importers that put in efforts to familiarise themselves with the regulations will be better equipped for smooth product movement.
