Importing medicines into Egypt

The regulator

The Egyptian Drug Authority (EDA) was set up by Law No. 151 of 2019 and regulates the registration, import and customs release of medicines in Egypt. The same law created the Egyptian Authority for Unified Procurement, Medical Supply and Technology Management (UPA), which procures medicines and supplies for public hospitals. EDA's General Administration of Importation and Customs Release applies the guideline on import and medical customs release, version 5 (April 2026) and works with customs through the NAFEZA single window.

Legal routes for unregistered medicines

The starting rule, in EDA Decree No. 444 of 2023, is that medicines must be registered or under registration to be imported. The same decree allows unregistered medical and biological products when entities or individuals request them and no similar registered product is marketed in Egypt, or local quantities are insufficient. Imports should come from a reference country, and a non-reference source is allowed only when the entity cannot obtain a similar product from one.

Special requests from hospitals and other entities

A licensed Egyptian importing company applies on behalf of the requesting entity, which states its need for up to six months of treatment. For a product registered and marketed in one of EDA's reference countries, the file includes a CPP or evidence of WHO prequalification, and the approval is valid six months. India is not on the reference list published in 2026, so a product marketed only in India follows the stricter route: a prior technical assessment, a three-month approval, a risk management plan and testing of imported batches in EDA laboratories before final release. The product must be used inside the requesting entity and cannot pass to another entity without EDA's agreement.

Individual requests for a named patient

For a product registered and marketed in a reference country, the importing company files the treating physician's medical report with the patient's name, condition, dose and treatment period, capped at six months, plus the physician's undertaking to supervise use. The approval is valid six months. The guideline describes this individual route only for reference-country products, so discuss any other source with EDA first.

Public procurement, donations and personal use

When the buyer is a government entity covered by Law No. 151 of 2019, the import application must include UPA approval. Donations follow the Prime Minister's decrees on grants and donations and need approval from the head of the receiving entity. EDA representatives at ports can also release medicines for personal use, up to three months of treatment or six months for chronic conditions, against a prescription or medical report. Narcotic drugs are excluded and follow EDA's import authorisation and withdrawal permit system.

Documents a buyer usually needs

• EDA import approval, issued before the goods ship
• Letter of need from the requesting entity, or the physician's medical report and undertaking for a named patient
• Certificate of pharmaceutical product showing registration and marketing in a reference country, or WHO prequalification evidence
• Importers register licence, agency agreement or authorisation letter naming the foreign company
• Proforma invoice, commercial invoice, packing list and air waybill
• Certificate of analysis for each batch
• Technical assessment result for biological or non-reference products
• UPA approval for supply to government entities

Timeline: a worked example

A university hospital in Cairo needs an orphan medicine for one patient. The product is not registered in Egypt but is registered and marketed in a reference country.

Total: roughly 4 to 8 weeks from request to delivery. These are planning estimates, not published service times.

Shipping lanes from India

EgyptAir flies nonstop between Cairo (CAI) and both Delhi and Mumbai, with three to five weekly flights on each route in 2026, and Gulf carriers connect through Dubai, Doha or Abu Dhabi. Express courier service is usually 3 to 6 days door to door, but even a small parcel of an unregistered medicine needs the EDA import approval first. Air cargo is usually 5 to 10 days including customs release.

CIP and DAP to the Egyptian importer are the usual terms, and FCA suits importers with their own forwarder. DDP is rarely practical because the Egyptian importer holds the approval and clears the goods.

Practical tips for buyers

• Do not ship before the import approval is issued. The guideline says EDA is not responsible for losses on shipments sent without one, and penalties can apply.
• Check early whether the product is registered and marketed in a reference country. That decides the route, how long the approval is valid and whether EDA tests the batches.
• EDA Chairman's Decree No. 39 of 2025 bars importing finished products with less than two-thirds of their shelf life left on arrival, except in emergencies. Confirm whether EDA applies it to special and individual requests.
• Medicines are exempt from VAT based on an EDA decision, according to a 2024 tax adviser summary. WITS data for 2019 shows duty of 0 to 5 percent across HS 300490 lines, and EDA issues a therapeutic benefit letter that importers present to customs to exempt a product from a tariff item set by Presidential Decree No. 69 of 2015.
• Keep names, strengths and quantities identical across the approval, invoice, packing list and air waybill.