The UAE pharmaceutical law in force from 2025 moved the core federal regulation of medical products to the Emirates Drug Establishment (EDE). MOHAP has not disappeared: it keeps specific functions, and other authorities still own their own territory. This explainer maps who regulates what, so your file lands with the right authority the first time.
What moved to the EDE
Under the 2025 law, the EDE is the federal authority for the regulatory functions that surround a medicine, a medical device, or the facilities that make, store, and move them. These functions transferred from the Ministry of Health and Prevention (MOHAP), and they cover most of what a manufacturer or importer will ever need.
What the EDE owns today
- Pharmaceutical facility licensing, including medical warehouses and drug stores
- Product classification
- Product registration and marketing authorisation
- Manufacturing site registration
- Import and export permits
- GMP, GDP, and GSP oversight
The practical test is simple. If your question involves a product, a manufacturing site, an import or export permit, or a facility that handles medicines, the EDE is the counterpart. Site registration and product registration certificates issued under this framework are each valid 5 years.
For a first-time foreign manufacturer, the working sequence under this framework is fixed: manufacturer site registration as a one-off step per site, product classification first where the category is unclear, then product registration for each product. Every one of those decisions now sits with the EDE, which is why the market has reorganised its filing habits around the new authority.
What MOHAP still controls
MOHAP retains community and compounding pharmacy licensing and certain narcotics controls. A retail pharmacy serving the public, or a compounding pharmacy preparing medicines for individual patients, is still licensed by the ministry rather than the EDE.
This split matters in practice. A pharmacy group can hold MOHAP licences for its branches while the medicines on its shelves were registered, permitted, and imported under EDE processes. The two systems meet constantly, so knowing which authority owns which decision saves weeks of misdirected correspondence.
The wider authority map
Two federal authorities do not cover everything. Health services and consumer products sit with their own regulators, and Dubai runs its own facility licensing.
- The DHA licenses Dubai health facilities, telehealth, and home healthcare through the Sheryan portal. NABIDH is the DHA health information exchange, DESC certification applies to local health data hosting, and TDRA approval applies to video consultation tools.
- Dubai Municipality registers cosmetics and consumer products in Dubai through the Montaji portal.
- Food products go through the food import and registration system (FIRS).
- MOIAT covers certain product categories in the other emirates.
None of these authorities compete with the EDE. Each regulates a different object: the EDE regulates medical products and the facilities behind them, the DHA regulates care delivery in Dubai, and the municipal and federal consumer systems regulate what sits outside the pharmacy channel. Confusion usually starts when one approval is assumed to cover another territory.
What this means in practice
Route the file correctly on day one. A foreign manufacturer registering a medicine deals with the EDE through a UAE licensed local representative. A telehealth operator in Dubai deals with the DHA. A cosmetics brand deals with Dubai Municipality. A compounding pharmacy deals with MOHAP. Each authority has its own portal, its own document standards, and its own response rhythm.
Two constants hold wherever the file lands. Dossiers, labels, and leaflets for registered products must be available in English and Arabic, and timeline planning should treat every estimate as approximate and subject to authority response times.
We work with the EDE daily as a licensed facility, medical warehouse, and importer, and we act as Local Representative and Marketing Authorisation Holder for foreign manufacturers. For a service by service breakdown of the new authority, see our guide to the Emirates Drug Establishment. It covers classification, site registration, product registration, permits, and facility licensing in one place.
Frequently asked questions
Is MOHAP still involved in product registration?
Who licenses pharmacies in the UAE now?
Who issues import permits for medicines in the UAE?
Read our full Emirates Drug Establishment guide
This explainer is general information, not regulatory or legal advice. Responsibilities can continue to evolve under the 2025 law, so confirm current rules with the relevant authority or contact our team before acting on it.