Every pharmaceutical, medical device, and API consignment entering the UAE needs an Emirates Drug Establishment import permit. We prepare the application, file it under our own importer licence, and manage it through to issuance, matched exactly to the shipment it covers.
Under the UAE pharmaceutical law in force from 2025, the Emirates Drug Establishment (EDE) is the federal authority for import and export permits, a function that transferred from MOHAP. An EDE import permit is the authorisation that lets a specific consignment of pharmaceuticals, medical devices, or APIs enter the UAE.
The requirement applies to every consignment: commercial stock of registered products, samples for registration and testing, APIs for manufacturing, and named-patient supply. Whether you need a medical device import permit, an API import permit, or a sample import permit, the permit is issued to the licensed importer, generally per consignment, and the shipment paperwork must match it.
We are a licensed partner, not a paperwork consultancy: permits are filed under our own importer licence, not yours. You send the product details, and we handle the authority.
Five permit categories, each with its own file and requirements.
Commercial consignments of registered pharmaceuticals and medical devices, matched to the registration record.
Samples for registration and laboratory testing, brought in before the product is on the market.
Active pharmaceutical ingredients for manufacturing, with a permit obtained per consignment under our importer licence.
Supply of unregistered products for named patients where permitted, assessed case by case.
Consignments entering the UAE for onward re-export, moved under the corresponding permit.
We need three inputs to start: the proforma invoice, the product details, and the quantities. Timelines vary by permit type and are subject to authority response times.
Proforma invoice, product details, and quantities. That is all we need from you to open the file.
We check every line against the registration record, the HS codes, and the MAH authorisation before anything is filed.
The application goes to the EDE under our own importer licence, in the correct permit category.
We track the application and resolve authority queries through to an issued permit.
With the permit issued, the consignment ships, clears customs, and is received into GDP-compliant storage.
Rejections usually trace back to three causes. The first is a registration mismatch: a product name, pack size, or manufacturer on the invoice that does not agree with the registration record. We verify every line against the record before submission, so the application the EDE sees is already consistent.
The second is wrong HS codes on the shipment paperwork, which put the consignment in the wrong regulatory category at the border. We assign and check the codes as part of preparing the file, not after a query arrives.
The third is missing MAH authorisation: the applicant has no documented right to import the product. Because we act as Marketing Authorisation Holder and licensed importer for our clients, that authorisation is already in place before the application is filed.
Full importation under our licence: permits, customs clearance, and GDP storage.
Active pharmaceutical ingredients imported, registered, and stored for UAE manufacturing.
Every EDE service explained: classification, registration, permits, and licensing.
Send us the product details and we will come back with a roadmap, classification opinion, and indicative timeline within 48 hours.
Talk to our regulatory team