Importing medicines into the United Arab Emirates

The regulator

The Emirates Drug Establishment (EDE) is the federal regulator for medicines in the UAE. It was set up as a separate federal body in 2023, and Federal Decree-Law No. 38 of 2024 on medical products makes it the authority for marketing authorisations, import and export permits and establishment licences. The new law came into force on 2 January 2025 and replaced Federal Law No. 8 of 2019. On 29 December 2025 the Ministry of Health and Prevention (MOHAP) transferred 44 core services to EDE, while a handful of narcotic services such as prescription books and hospital quotas reportedly stay with MOHAP.

Healthcare delivery is regulated by emirate. The Department of Health Abu Dhabi (DoH) and the Dubai Health Authority (DHA) license hospitals, pharmacies and professionals in their emirates, and the Chambers Life Sciences 2026 UAE chapter notes that they help enforce import rules in coordination with EDE. Federal registration applies in every emirate, and the emirate authority can add its own formulary requirements.

Legal routes for unregistered medicines

No medical product may be circulated in the UAE without EDE approval. A registered medicine is imported by the local agent named in its marketing authorisation under EDE's two-stage import permit: an initial permit in 3 working days, then a shipment clearance permit in 2 working days, with a request fee of AED 100.

Health facility requests

Where no registered product is available, a health facility may apply to procure a non-registered one. The clearest published practice is in Dubai. The DHA Pharmacy Guidelines list four grounds: no registered alternative, discontinued marketing or a proven supply interruption, quality or safety concerns about the registered brand, and emergencies. An authorised distributor then imports against the facility's justification letter and an expected consumption of no more than six months' supply, and the facility keeps the distributor's import permit for audit. The guidelines date from 2021 and name MOHAP, so confirm with EDE how the approval is filed today.

Abu Dhabi formulary

The DoH formulary is reported to include about 4,400 non-registered coded products with special authorisation, alongside more than 16,000 approved products. Abu Dhabi facilities keep a facility formulary drawn from the DoH list, so an Abu Dhabi hospital should check both the DoH authorisation and the federal import approval.

Personal use and controlled medicines

EDE runs a personal-use import permit that lets a resident clear medicines through customs. It is mandatory for narcotic and psychotropic medicines, costs nothing and is listed at one working day. The EDE user guide lets the applicant enter a medicine by active ingredient when it is not in the EDE database. Narcotics are governed by Federal Decree-Law No. 30 of 2021, and EDE lists a separate import authorisation for narcotic drugs and psychotropic substances.

Documents a buyer usually needs

• EDE import permit or non-registered medicine approval, issued to the UAE consignee
• Justification letter from the health facility with the expected consumption
• Prescription and medical report for a named patient
• Proforma invoice and commercial invoice showing origin, batch numbers and manufacture and expiry dates
• Certificate of analysis for each batch, a GMP certificate and proof of registration in the country of origin
• Halal certificate for products containing animal-derived gelatin, an EDE permit condition
• Packing list, air waybill and temperature records

Timeline: a worked example

A hospital in Dubai needs an orphan medicine for a named patient. The medicine has no EDE registration.

Total: roughly 2 to 5 weeks from request to delivery, most of it waiting for the approval. These are planning estimates, not published service times.

Shipping lanes from India

The UAE is one of the best-connected destinations from India by air. Mumbai, Delhi, Bengaluru, Hyderabad, Chennai, Kochi, Ahmedabad and many smaller cities have direct flights to Dubai (DXB), Abu Dhabi (AUH) and Sharjah (SHJ), and several carriers run freighters. Express courier service is usually 2 to 4 days door to door for small, non-controlled parcels. Air cargo is usually 3 to 7 days including EDE inspection and customs.

CIP and DAP are the usual terms, and FCA suits distributors with their own forwarder. DDP is rarely practical because the UAE consignee must hold the permit and clear the goods. Goods moved out of a UAE free zone into the local market need at least 12 months of remaining shelf life under the EDE permit conditions.

Practical tips for buyers

• Identify the emirate first. Dubai, Abu Dhabi and the free zone health regulators each add their own rules on top of the federal EDE approval.
• Keep product name, strength, pack size and quantity identical across the approval, invoice, packing list and air waybill.
• Duty on HS 3004 medicines is 0 percent according to World Bank WITS data for the GCC common tariff.
• VAT is 5 percent, but Cabinet Decision No. 56 of 2017 zero-rates medicines that are registered or imported with the authority's permission. From 1 October 2026, Cabinet Decision No. 149 of 2026 replaces that wording with a single term, medical product, to be defined by a later Cabinet decision, so confirm the treatment with a tax adviser.
• In summer, ask the forwarder to pre-book cool-room space at the arrival airport for cold-chain lots.