If you have been told that UAE product registration goes through MOHAP, that guidance is out of date — and it is still repeated across most consulting websites.
Federal responsibility for medical products has transferred to the Emirates Drug Establishment (EDE). The enabling legislation, Federal Decree-Law No. 38 of 2024, took effect on 2 January 2025, replacing the previous federal law. MOHAP has published its own notice listing the services that moved across, including product registration, import and export permits, facility and warehouse licensing, and GMP certificates. MOHAP retains community and compounding pharmacies.
Raised Pharma supports manufacturers and brand owners preparing for the UAE market: classification, dossier preparation in eCTD format, GMP evidence, stability data and bilingual labelling review.
This is the most common and most expensive misunderstanding about the UAE, so it is worth being blunt about it.
One further correction worth making, because it appears constantly in older guidance: ESMA no longer exists as a standalone authority. It was merged into the Ministry of Industry and Advanced Technology. Standards are now published under the UAE.S designation.
EDE operates two distinct federal routes. One covers drugs and biopharmaceutical products. The other covers healthcare products — preparations for general health care that do not require prescription or direct medical supervision, a category that explicitly includes nutritional supplements, herbal products and cosmetics with a medicinal effect.
Separately, a supplement presented purely as a foodstuff may fall to municipality-level registration instead.
Where the line sits is driven by composition and claim, and there is a commercial consequence most brands do not anticipate: municipal approval covers that emirate only, while federal authorisation covers the whole country. Registering in Dubai does not give you Abu Dhabi.
We will say plainly that published sources disagree on where certain supplement categories land. That is not a gap in our research — it reflects a genuinely live ambiguity, and it is exactly why classification should be confirmed case by case with EDE and the relevant municipality before you build a dossier, not after.
A foreign manufacturer cannot file a UAE product application on its own behalf. EDE restricts applicants to licensed medical warehouses and stores, licensed local manufacturers, and licensed marketing offices.
More importantly, both the manufacturer and the marketing authorisation holder must be registered with EDE before any product application can be submitted. This is a real prerequisite gate, and it is the stage where unprepared projects lose months.
Under the 2024 decree-law, the marketing authorisation holder must also appoint at least two importers and one or more distributors, and designate a single main pharmaceutical establishment responsible for regulatory affairs, pharmacovigilance and quality across the product lifecycle.
eCTD is mandated for drugs and biopharmaceutical products, not optional, and EDE publishes its own eCTD structure guidance.
The healthcare product route uses a lighter document set — typically a WHO-format pharmaceutical certificate or free sale certificate with embassy legalisation, full formula, halal certificate, certificate of analysis, packaging artwork and insert, and a declaration covering hormones, heavy metals, antibiotics, steroids and porcine derivatives.
For a nutraceutical brand this distinction matters commercially: the healthcare product route is meaningfully lighter than a full drug dossier, provided your product genuinely belongs in that category.
A valid GMP certificate is required — from EDE, from the competent authority in the country of origin, or from an EDE-recognised reference body. EDE also conducts GMP compliance inspections at manufacturing sites and issues its own GMP compliance certificates. Which reference bodies are accepted, and what triggers a site inspection, should be confirmed directly with EDE.
Bilingual Arabic and English labelling is required for medical products, alongside GS1-compliant barcodes for traceability. For food-classified products, Arabic labelling is mandatory under the applicable UAE.S standard — product name, ingredients in descending order of weight, allergens, net weight, country of origin and storage conditions. Imported European and North American brands routinely need Arabic artwork added; missing Arabic labelling is grounds for seizure.
We do not publish UAE approval timelines. EDE’s service pages state a procedural target in working days; independent practitioners report considerably longer in practice once entity registration and deficiency rounds are counted. Both can be true — they measure different things. Rather than quote a number that sets a wrong expectation, we will scope your specific product and tell you what actually drives the schedule. Current timelines and fees must be confirmed with EDE.
Tell us the product, the dosage form, the claims you intend to make and where you are in development.
Email: info@raisedpharma.com Phone: +1 (716)-777-4800
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Important: This page is general information about the UAE regulatory environment, not regulatory or legal advice. The UAE regulatory structure changed materially in January 2025 and services transferred in stages, so some published guidance elsewhere is out of date — and this page will require review over time. Nothing here should be relied on for a submission. Classification, dossier content, labelling and claims must be reviewed by a qualified regulatory professional and confirmed with the Emirates Drug Establishment before filing. Last reviewed August 2026.