Under the UAE pharmaceutical law in force from 2025, the Emirates Drug Establishment (EDE) is the federal authority for pharmaceutical facilities, products, classification, and import permits. This guide maps every EDE service, what changed from MOHAP, and how we run each pathway daily as a licensed facility holder.
The Emirates Drug Establishment is the product of the UAE pharmaceutical law in force from 2025. Under it, the EDE is the federal authority for pharmaceutical facility licensing, including medical warehouses and drug stores, for product classification, product registration and marketing authorisation, and for manufacturing site registration, import and export permits, and GMP, GDP, and GSP oversight. These functions transferred from the Ministry of Health and Prevention (MOHAP).
EDE vs MOHAP is the question we are asked most, and the split is clean. The EDE regulates products, manufacturing sites, facilities, and the import and export of pharmaceuticals at federal level. MOHAP retains community and compounding pharmacy licensing and certain narcotics controls.
For a foreign manufacturer the consequence is consolidation: classification, site registration, product registration, and import permits now sit with a single authority. Files that are sequenced correctly move; files that are not wait at the first mismatch. We plan the sequence before anything is submitted.
Where your product, site, and facility each sit after the 2025 transfer.
The federal authority for pharmaceutical facility licensing, product classification, registration and marketing authorisation, manufacturing site registration, import and export permits, and GMP, GDP, and GSP oversight.
Retains community and compounding pharmacy licensing and certain narcotics controls. The registration functions it once ran have transferred to the EDE.
Licenses Dubai health facilities, telehealth, and home healthcare through the Sheryan portal. Facility projects in Dubai meet the DHA alongside the federal file.
Registers cosmetics and consumer products in Dubai through the Montaji portal. Food products go through the food import and registration system (FIRS).
Each card links to the page where we explain how we deliver it.
Classification is the first step where a category is unclear. A first-time foreign manufacturer then needs manufacturer site registration, one-off per site, and product registration per product, through to marketing authorisation.
Pharmaceutical product registrationDevices follow their own risk-based EDE registration route. Registration takes approximately 4 to 6 weeks from complete submission, subject to authority response times.
Medical device registrationEvery pharmaceutical, medical device, and API consignment needs an EDE import permit, generally issued per consignment. We prepare and obtain permits under our own importer licence.
EDE import permitsOnly entities holding a UAE pharmaceutical facility or medical warehouse licence with the corresponding EDE import permit may import pharmaceuticals, medical devices, and APIs. We import under our own licence, so clients do not need one.
Pharmaceutical importationNew licences, renewals, and variations for warehouses, scientific offices, and pharmacies, plus pharmacist licensing and inspection readiness before EDE visits.
Facility licensing & renewalsEDE medical warehouse licensing as a turnkey project: application, engineering layout approval, inspections, and GDP compliance under EDE oversight. Or skip the build and use our licensed warehouse.
Pharmaceutical warehouse setupThe sequence we run daily as a licensed facility holder, from first decision to stock in the market.
Where the category is unclear, we obtain the EDE classification decision first. It sets the entire route.
EDE site registration for the manufacturing site, a one-off step per site, valid for 5 years.
CTD dossier prepared and submitted, with dossiers, labels, and leaflets available in English and Arabic.
EDE import permits issued under our importer licence, generally one per consignment.
Stock received into GDP storage under our licences and released to the market, with renewals tracked.
Approximate figures, always subject to authority response times.
Pharmareg holds its own licensed pharmaceutical facility, medical warehouse, and importer credentials, and acts as Local Representative and Marketing Authorization Holder (MAH). We are a licensed partner, not a paperwork consultancy: the EDE processes on this page are the ones our own facility operates under every week.
That changes what an engagement looks like. We can import and hold your stock under our own licence before your structure exists, file EDE import permits as the importer of record, and hold your registration as MAH while you appoint or change distributors.
It also changes the quality of the advice. When the EDE updates a process, we see it in our own filings first, and your roadmap reflects what the authority is doing now, not what it did last year.
Classification, CTD dossiers, and technical committee submissions through to certificate issuance.
Risk classification, device dossiers, and registration through to certificate.
Import permits for pharmaceuticals, devices, APIs, and samples, issued under our own licence.
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