Importing medicines into Ethiopia

The regulator

The Ethiopian Food and Drug Authority (EFDA) regulates the registration, import and quality of medicines under the Food and Medicine Administration Proclamation No. 1112/2019. EFDA inspectors clear pharmaceutical consignments at designated ports of entry, mainly Bole International Airport in Addis Ababa and the Modjo and Kality dry ports, and documents are filed through the national Electronic Single Window. The procedure is set out in EFDA's Guideline for medicine and medicine raw material port clearance, version 001 (August 2025). According to the US commercial guide for Ethiopia, importers use EFDA's i-Register system for registration and registration exceptions and i-Import for import permits, and the Ethiopian Pharmaceutical Supply Service (EPSS) is the public procurement agency.

Legal routes for unregistered medicines

The proclamation requires medicines to be registered before they are marketed, and Article 20 sets out two exceptions that matter here. It exempts a medicine imported for use by a particular patient on the prescription of an authorised medical professional. It also lets EFDA, in compelling circumstances, grant a permit for the import or use of an unregistered medicine.

Special import authorisation

The 2025 port clearance guideline says commercial imports must be registered with EFDA or hold a special import authorisation before clearance, and products without a valid EFDA pre-authorisation are rejected at the port. EFDA does not publish a step-by-step procedure for a named patient or a hospital. Addis Fortune reports that a 2025 EFDA directive allows special approvals for unregistered and emergency medicines, such as cancer treatments, ICU sedatives and rare drugs, based on Ministry of Health requests and backed by quality and origin certificates. In practice the request goes through an EFDA-licensed importer working with the hospital, and the route should be confirmed with EFDA first.

Donations, emergencies and personal use

Government, humanitarian and donor imports for non-commercial use, such as donations or emergency supplies, need prior EFDA approval. For personal use, a patient can ask EFDA to clear prescription medicines up to a 90-day supply, or up to six months with full medical documentation. Import by post or hand carry is prohibited without prior EFDA authorisation.

Controlled medicines

Under EFDA's Directive No. 1121 on narcotic and psychotropic medicines, these products need a special import permit, granted only for medical treatment, clinical trials or scientific research. Consignments also need the exporting country's export certificate.

Documents a buyer usually needs

• EFDA special import authorisation or pre-import permit for an unregistered product
• Import licence of the Ethiopian importer
• Prescription, hospital request or Ministry of Health request letter
• Commercial invoice and packing list with batch numbers, dosage forms and quantities
• Certificate of analysis for each batch, which EFDA requires for biologicals and other specified products
• Certificate of origin
• Air waybill
• Importer's declaration through the Electronic Single Window
• For controlled medicines, the special pre-import certificate and the Indian export authorisation

Timeline: a worked example

A referral hospital in Addis Ababa needs an unregistered oncology medicine for a small number of patients.

Total: roughly 5 to 12 weeks from request to delivery, most of it waiting for the authorisation. These are planning estimates, not published service times.

Shipping lanes from India

Ethiopian Airlines serves six Indian cities, Delhi, Mumbai, Bengaluru, Chennai, Ahmedabad and Hyderabad, with more than 50 weekly passenger and cargo flights reported in June 2025. That makes Addis Ababa (ADD) one of the best connected African destinations from India. Express courier service is usually 4 to 7 days door to door, but medicines must still enter through an EFDA designated port with the right permits. Air cargo is usually 5 to 10 days including EFDA inspection.

CIP and CPT to Addis Ababa are the usual terms, and FCA suits importers with their own forwarder. DDP is rarely practical because the Ethiopian importer holds the licence and permits and clears the goods.

Practical tips for buyers

• Check remaining shelf life before dispatch. EFDA requires at least 30 months left for products with 49 to 60 months total shelf life, 24 months for 37 to 48, 15 months for 25 to 36 and 12 months for 24 months or less, unless EFDA approves an exception before shipment.
• Ship only through Bole, Modjo, Kality or another EFDA designated port. Consignments through other channels are treated as unauthorised and are not cleared.
• EFDA notifies rejections of non-compliant consignments through the Electronic Single Window within three working days, so keep documents complete and consistent.
• Prescription medicines are reported to be VAT exempt under the 2024 VAT proclamation, and WITS data for 2021 shows 5 percent duty on HS 300490 lines. Confirm other import charges with a customs agent.
• Foreign exchange availability has been a reported challenge for private importers, so agree payment terms early.