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UAE supplement registration: EDE approval and Montaji filings

Two portals show up in most brand conversations. Which one you need depends on how the product is classified. Both want a real dossier.

This guide summarises primary UAE sources as read on 28 Oct 2026. It is orientation for brand managers, not legal advice. Rules change. Confirm on the live EDE and Dubai Municipality portals before you file.

Emirates Drug Establishment (EDE)

MOHAP transferred many medicine and healthcare-product services to the Emirates Drug Establishment. EDE publishes a service for marketing approval of healthcare products. The Arabic service page states that the scope includes food supplements, herbal products, disinfectants, and cosmetics with a medical effect, for products that are not meant to diagnose, treat, cure, or prevent disease and that do not need a prescription.

Stated on that EDE service page (read 28 Oct 2026):

  • Processing time: 45 working days
  • Fees: AED 5,000 for registration of a pharmaceutical product for general sale, plus AED 100 application fee
  • Approval validity: five years from committee approval
  • Precondition: marketing-rights holder and manufacturing companies must be registered with EDE before product registration

Document themes on the service page and the related "Registration of Pharmaceutical Product for General Sale" materials include composition, artwork, free-sale or WHO pharmaceutical product certificate legalised as required, local-agent authorisation, manufacturer registration evidence, Halal certificate where applicable, and safety declarations (for example freedom from hormones, heavy metals, antibiotics, steroids, and pig derivatives as stated in those materials).

Federal Decree-Law No. 38 of 2024 defines food supplements and requires EDE marketing approval before in-scope medical products are circulated in the State.

Sources: EDE portal on www.ede.gov.ae; MOHAP transfer notices on mohap.gov.ae; Decree-Law text on uaelegislation.gov.ae. Full URLs sit in the handoff facts file.

Dubai Municipality Montaji

Montaji is Dubai Municipality's consumer-products platform (https://montaji.dm.gov.ae). Guideline DM-HSD-GU18-ECOM2 covers e-commerce consumer products and lists Health Supplements as a product group. For that group, the guideline lists product artwork, a conformity certificate or ingredient report, a test report from a Dubai Municipality approved laboratory, and other documents where needed such as a Halal certificate.

The same guideline states a processing fee of AED 10 per consumer product (and variant) for registration, and that consumer products placed on the market must be registered (with a noted free-zone exception when not intended for the local market).

What brands get wrong

  • Treating Amazon.ae onboarding as product registration
  • Printing English-only labels and hoping a sticker appears later
  • Filing the same SKU under the wrong authority
  • Changing formula or pack size without a new filing

How we help

WellnessLine Trading L.L.C supports dossier readiness, portal follow-up, and distribution once the product can move. Send the SKU list through the enquiry form.