Product Registration UAE: The Move from MOHAP to EDE Explained
20 October 2026 · Emiracle Advisory
Quick answer: Product registration UAE rules for medicines, health supplements with medical claims and medical devices now sit with the Emirates Drug Establishment (EDE), not MOHAP. You apply through the EDE portal via a licensed local agent, with a manufacturer registration, a certificate of pharmaceutical product or free sale certificate, GMP evidence and compliant labels. Ordinary cosmetics in Dubai still go to Dubai Municipality.
Key takeaways
- The Emirates Drug Establishment is now the federal regulator for medical products. MOHAP has transferred registration, pricing, import permits, pharmacovigilance and advertising approvals to EDE.
- Applications go through the EDE portal at ede.gov.ae. Community and compounding pharmacies remain with MOHAP.
- Only a UAE entity licensed as a medical warehouse (or marketing office for devices) can file, and the manufacturer must be registered before its products.
- Since February 2026, EDE requires more than one agent per medical product, ending exclusive single agent arrangements.
- Ordinary cosmetics and personal care products for Dubai are still registered with Dubai Municipality through Montaji.
- Published service time for the main registration services is 45 working days after a complete file. Real timelines vary.
What is the Emirates Drug Establishment and why did product registration UAE rules change?
The Emirates Drug Establishment is a federal body created by decree in 2023 to take over regulation of medical products that was previously split between the Ministry of Health and Prevention (MOHAP) and other federal entities. Its mandate covers the full product lifecycle: classification, registration, pricing, import and export, pharmacovigilance, advertising, inspection and recalls. It also licenses and inspects factories, medical warehouses and marketing offices.
The substantive rules come from Federal Decree-Law No. 38 of 2024 on medical products, the pharmacy profession and pharmaceutical facilities. EDE cites this law as the basis for its newer mechanisms, and it carries significant penalties for establishments that place unregistered or non-compliant products on the market.
Where things stand in 2026
EDE was formally launched at the World Health Expo in Dubai in February 2026, with a strong focus on local pharmaceutical manufacturing. MOHAP has published a notice confirming that it has transferred a long list of services to EDE and that customers should submit and track requests on the EDE portal. In July 2026, EDE also took enforcement action against 71 violators selling unapproved peptide weight loss products, including licensed facilities and social media promoters. The message is clear: unregistered health products are an active enforcement priority.
Which products now need EDE approval?
According to MOHAP’s service transfer notice, the services moved to EDE cover registration and renewal of the following categories:
- Conventional pharmaceutical products, including biologicals.
- General sale products, which include dietary supplements, medical cosmetics and medical disinfectants with limited medicinal use.
- Pharmaceutical products derived from natural sources, such as herbal medicines.
- Medical equipment and devices, across risk classes.
- Raw materials, controlled and semi-controlled medicines, narcotics, psychotropics and chemical precursors (import and export permits).
What stays with other authorities?
| Product or activity | Main authority | Notes |
|---|---|---|
| Prescription and OTC medicines | EDE | Full dossier, pricing and pharmacovigilance plan |
| Supplements and medical cosmetics with health claims | EDE (general sale) | Classification decides the pathway |
| Medical devices | EDE | Evidence depends on risk class |
| Ordinary cosmetics and personal care (Dubai) | Dubai Municipality | Registered on Montaji |
| Community and compounding pharmacies | MOHAP | Facility licensing stays with the ministry |
| Hospital, clinic and pharmacy licences in Dubai and Abu Dhabi | DHA or DoH | Separate from product approval |
If you also run a clinic or pharmacy, facility licensing is a separate track. See our DHA and DoH health licensing service.
What changed for importers and distributors?
A new portal and a new counterparty
Your licences, product files and permit requests are now handled by EDE. Import permits for medicines, raw materials and devices, product renewals, variations and advertising approvals all run through the EDE portal. Many companies previously used MOHAP accounts, so check that your UAE PASS access, authorised signatories and company profile are correctly set up on the new system.
Facility licences matter more
EDE now licenses factories, medical warehouses, marketing offices, pharmaceutical consulting offices and pharmaceutical laboratories. It also issues Good Distribution and Good Storage certificates. Inspections focus on cold chain, storage conditions and traceability, so a trading licence alone is not enough to import health products.
The end of exclusive single agents
On 24 February 2026, EDE announced a mechanism requiring companies to appoint more than one agent for each medical product in the UAE. The stated aim is to reduce supply disruption and prevent monopolistic control of quantities and timing. For distributors, this means exclusivity clauses in existing agency agreements need review. For foreign brands, it means planning for at least two licensed local partners. Implementation details are still emerging, so confirm the current position before you sign.
Where does Dubai Municipality still handle cosmetics and personal care?
Ordinary cosmetics and personal care items, such as shampoos, skin care, fragrances and make up without medical claims, are registered for the Dubai market with Dubai Municipality through its Montaji platform. Typical requirements include a free sale certificate, a full ingredient list using INCI names, safety assessment or test reports, and an Arabic and English label. Our Dubai Municipality product registration team handles these files.
The dividing line is the claim. A moisturiser that hydrates is a cosmetic. A cream that claims to treat eczema or a serum that claims to regrow hair is a medical cosmetic and moves to the EDE general sale pathway. If you are unsure, apply for product classification before you print labels.
How does product registration UAE work under EDE in 2026?
The sequence below reflects the published service cards and current practice. Exact screens and fee schedules are set by EDE and can change.
- Set up a licensed local entity. The applicant must be a medical warehouse (or a marketing office for devices) holding a valid licence. If you do not yet have one, start with mainland company setup with the right activity.
- Classify the product. Confirm whether it is a conventional medicine, a general sale product, a natural source product, a device or a cosmetic.
- Register the marketing authorisation holder and manufacturer. The company and its manufacturing sites must be registered before individual products.
- Prepare the dossier. Conventional medicines use the eCTD format. General sale products and devices use the document lists set out below.
- Submit on the EDE portal. Log in with UAE PASS, upload documents and pay fees online.
- Technical review and testing. Expect evaluation, possible laboratory analysis of samples and, for medicines, a pricing review.
- Answer queries. Respond promptly. Delays usually come from incomplete answers, not from the regulator.
- Receive the registration certificate. For conventional medicines, the certificate is valid for five years from committee approval.
- Apply for import permits and advertising approval. Registration is a prerequisite for import, and any promotion needs its own approval.
Which documents do you need for product registration UAE applications?
Requirements differ by category. The table summarises the core items from the published service requirements.
| Document | Medicines | General sale (supplements, medical cosmetics) | Medical devices |
|---|---|---|---|
| Certificate of pharmaceutical product (CPP) or free sale certificate, attested | Yes | Yes | Yes (free sale or registration certificate) |
| Manufacturer registration certificate | Yes | Yes | Yes |
| GMP or quality system evidence | Yes | Yes | Yes (for example ISO 13485, CE or FDA evidence by class) |
| Full composition or formulation | Yes (eCTD) | Yes | Description, models and accessories |
| Labels, inner and outer packs, leaflet | Yes | Yes, stamped and signed | Yes, plus manuals |
| Agency contract with local agent | Yes | Yes | Yes |
| Samples and certificate of analysis | Yes | Yes | Yes |
| Halal certificate and declaration of no harmful substances | Where relevant | Yes | Animal origin only |
| Pharmacovigilance plan | Yes | Where relevant | Post market surveillance |
Attestation and translation
Certificates from abroad normally need legalisation, and labels must carry the required Arabic content. Getting the attestation chain right first time saves weeks. Our MOHAP and EDE product registration service covers document collection, attestation and submission.
How long does product registration UAE take?
The published service cards for registration of a conventional medicine, a general sale product and a medical device each list a standard service time of 45 working days. That clock usually starts once the file is complete and accepted. Total elapsed time is often longer because of:
- Manufacturer and site registration, which must come first.
- Laboratory analysis of samples.
- Pricing committee review for medicines.
- Query rounds and resubmissions.
- Attestation of overseas documents before you even file.
We do not quote fixed timelines because they genuinely vary. A realistic plan treats the 45 working day figure as the regulator’s step, not your total project.
Why are product registration UAE applications rejected?
Wrong pathway
Filing a supplement with medical claims as a cosmetic, or a device as a general sale product, leads to refusal or a restart. Classify first.
Document gaps and attestation errors
Expired CPPs, free sale certificates that do not match the brand name or formulation, missing site details or unattested documents are the most common problems.
Label and claim issues
Unsupported claims such as “100 per cent natural” or “cures”, missing Arabic text, and inconsistent ingredient lists between label and formula trigger queries or rejection.
Prohibited or undeclared ingredients
Hormones, steroids, undeclared pharmaceutical actives or ingredients of porcine origin are red flags, particularly for weight loss and sports supplements.
Licensing gaps
An applicant without a valid medical warehouse or marketing office licence, or an unregistered manufacturer, cannot proceed regardless of how good the file is.
How Emiracle helps with health product registration
Emiracle Advisory supports manufacturers, importers and distributors from licensing to market entry. From our office at Level 9, Boulevard Plaza Tower 1, Downtown Dubai, we:
- Set up or adapt your UAE entity with the correct medical warehouse or marketing office activity, as an authorised channel partner across 45+ UAE free zones and with mainland options.
- Classify products and map each SKU to EDE or Dubai Municipality.
- Prepare, attest and translate dossiers and labels.
- Submit, track and respond to regulator queries.
- Review agency agreements in light of the multiple agent mechanism.
- Protect your brand with trademark registration before launch.
Ready to register your products? Contact Emiracle Advisory, call or WhatsApp +971 52 185 3005, or email info@emiracle.ae for a document checklist tailored to your range.
Frequently asked questions
Is MOHAP still responsible for product registration in the UAE?
For medicines, general sale products and medical devices, no. MOHAP has announced that these services have moved to the Emirates Drug Establishment, which now receives and decides applications through the EDE portal. MOHAP keeps responsibility for community and compounding pharmacies, and some controlled substance permits are issued jointly.
Do I need to re-register products that MOHAP already approved?
EDE has not announced a blanket requirement to re-register valid approvals. Existing registrations generally continue until expiry, after which renewal is handled by EDE. Confirm the position for your specific product numbers, especially if you plan amendments or a change of agent.
Are dietary supplements registered with EDE or Dubai Municipality?
It depends on the product and its claims. Supplements with therapeutic or medicinal claims are usually handled as general sale health products by EDE, while some food supplements without medical claims can be approved locally. A product classification request removes the guesswork before you file.
Who registers cosmetics in Dubai?
Ordinary cosmetics and personal care products for the Dubai market are registered with Dubai Municipality through its Montaji platform. Cosmetics making medical or therapeutic claims, sometimes called medical cosmetics, fall under the general sale pathway with EDE.
Can a foreign manufacturer apply directly?
Not on its own. Applications are filed by a UAE entity licensed as a medical warehouse or, for devices, a marketing office, acting as local agent. The manufacturer and its sites must also be registered before individual products can be submitted.
How long does health product registration take?
Published service cards for the main registration services show a standard service time of 45 working days once a complete file is accepted. In practice the total time varies with product type, laboratory testing, pricing review and how quickly queries are answered.
What is the multiple agent rule announced by EDE?
In February 2026 EDE activated a mechanism under Federal Decree-Law No. 38 of 2024 requiring companies to appoint more than one agent for each medical product in the UAE. EDE has not published every implementation detail yet, so check current guidance before signing or renewing agency agreements.
Last reviewed: 20 October 2026. Rules change; confirm current requirements with an Emiracle advisor before you apply.
