Pharmaceutical Registration, Product Approval UAE

Overview

Bringing a medicine to market in the UAE

Getting a medicine approved for the UAE can feel daunting, a maze of federal requirements, committees and paperwork. We make it simple. Our regulatory team knows exactly what the authorities expect and guides your product through from day one.

You stay focused on your launch while we handle the heavy lifting, preparing your file, managing the submission and following it through to approval, so your product reaches UAE pharmacies, hospitals and shelves without the guesswork.

What We Cover

Pharmaceuticals we register

From prescription medicines to over-the-counter lines, we cover the full pharmaceutical range.

Prescription medicines Over-the-counter products Generics Biologics & biosimilars Vaccines Veterinary medicines Medical gases Controlled substances

The Process

How registration works, step by step

1

Establish local presence

Register the Marketing Authorisation Holder and all manufacturing sites with the authority, and secure a licensed medical-warehouse operation.

2

Compile the eCTD dossier

Assemble the quality, safety and efficacy modules with every attested certificate in the electronic Common Technical Document format.

3

Submit and pay online

File the application through the MOHAP / EDE e-services portal, authenticated with UAE PASS, and settle the applicable fees.

4

Technical and pricing review

Technical and ministerial committees assess the file, request clarifications, run analysis where required, and approve the product price.

5

Certificate issued

A five-year market authorisation is granted and the product is cleared for legal import and trade in the UAE.

Why Product Registration Matters

Product registration is what makes your product legal to sell in Dubai

Retailers will ask for approval

Major retailers, distributors, pharmacies and online marketplaces often require valid UAE product registration before they agree to list, stock or sell your product.

Customs clearance becomes easier

The right registration, permits, labels and product documents help reduce the risk of shipment holds, rejected imports and costly delays at UAE customs.

Your brand looks more credible

A registered product shows buyers, retailers and distributors that your product has been reviewed for compliance, labeling, safety and market readiness.

You can scale more products

Once your first product is registered, it becomes easier to launch additional SKUs, pack sizes, variants and product lines across Dubai and the wider UAE market.

UAE Product Registration Support

UAE product registration support built for faster market entry

Dubai and UAE product classification

We identify whether your product requires Dubai Municipality registration, MOHAP approval, veterinary registration, cosmetic registration, food registration, supplement registration or another UAE authority pathway.

Registration documents reviewed properly

We check labels, certificates, formulas, ingredients, claims, product images, technical files and manufacturer documents before submission to reduce authority comments and avoid unnecessary delays.

Authority submission and follow-up

We manage the registration process with the relevant Dubai or UAE regulatory authority, including application preparation, submission, clarification responses and approval tracking.

Market entry support after approval

Once approved, we support import clearance, distributor onboarding, retail listing, online marketplace requirements, renewals, variations and additional SKU registrations.

FAQ

Pharmaceutical registration FAQs

Who can register a pharmaceutical product in the UAE?

Only a UAE-licensed Marketing Authorisation Holder operating a licensed medical warehouse. Foreign manufacturers must appoint a local agent to hold the registration and act on their behalf.

How long is a registration valid?

Five years from the date of committee approval. Renewal must be completed before expiry to keep the product on the market.

What dossier format is required?

The internationally recognised electronic Common Technical Document (eCTD), covering the quality, safety and efficacy of the product.

Which authority handles drug registration now?

Pharmaceuticals are regulated federally. From 29 December 2025, registration services transitioned from MOHAP to the Emirates Drug Establishment (EDE).

Is a Halal certificate required?

In most cases yes, products require a Halal certificate together with a declaration covering animal-derived substances, hormones, steroids and any alcohol content.