Bringing a medicine to market in the United Arab Emirates means navigating a federal registration process that is rigorous, document heavy, and (as of 2026) in the middle of a major regulatory transition. This guide explains how pharmaceutical product registration works in the UAE today, who can apply, what you need, and how long it takes.
Who regulates drug registration in the UAE now
Historically, pharmaceutical product registration was handled by the Ministry of Health and Prevention (MOHAP). That is changing. Under Federal Decree-Law No. 38 of 2024, the UAE established the Emirates Drug Establishment (EDE) as the federal authority responsible for regulating medical products. Through late 2025 and into 2026, the EDE has been assuming the core registration services previously run by MOHAP, with submissions moving to the EDE platform.
In practice this means manufacturers should confirm the current submission route before starting. Some pathways still reference MOHAP, while newer submissions go through the EDE. Working with a local regulatory partner is the simplest way to stay aligned with the live requirements during the transition.
Your UAE local representative
Here is how registration works in practice for an international manufacturer: your product is registered through a UAE-licensed Local Authorised Representative (LAR), who also acts as the Marketing Authorisation Holder (MAH). This entity is a licensed pharmaceutical establishment, typically a medical warehouse or marketing office, and it submits the application and carries the ongoing regulatory responsibility for your product, so you can reach the UAE market without setting up your own company. The local representative registers and manages the product on your behalf, but ownership of the registration stays with you, the manufacturer, and it can be transferred to another representative if you choose.
The marketing authorisation holder also appoints importers and distributors to move the product through the supply chain. Choosing the right local representative is therefore not an administrative afterthought. It determines who legally holds your market authorisation in the UAE.
The registration process, step by step
Register the company and manufacturing site
Before any product can be submitted, the marketing authorisation holder and the manufacturing site must themselves be registered with the authority. This establishes the legal entities behind the application.
Classify the product
Products are classified by category (for example conventional pharmaceutical, controlled, biological, or general sale). Classification drives the documentation requirements and the review pathway, so getting it right early avoids costly rework.
Prepare and submit the dossier
The full technical dossier is compiled and submitted through the authority's portal, with fees paid at submission. The dossier covers the product's composition, manufacturing process, quality, safety and efficacy.
Technical committee review
Technical committees review the application and forward recommendations for approval. Queries raised during review are common, and a fast, well-documented response is what keeps a file moving toward a registration certificate.
Documents you'll typically need
- Certificate of Pharmaceutical Product (CPP) legalised by the UAE Embassy in the country of origin
- GMP or ISO certification for the manufacturing facility
- Full composition and manufacturing process details
- Stability, safety, efficacy and quality testing from accredited laboratories
- Bilingual English and Arabic labelling, leaflet (PIL) and artwork
- Appointment documents for the UAE local representative and MAH
How long it takes, and how long it lasts
On average, pharmaceutical product registration in the UAE takes 6 to 12 months, depending on the completeness of the dossier and the product category. Once granted, an imported product's registration is typically valid for five years (often one year for locally manufactured products) and must be renewed before expiry to keep the product on the market.
The biggest controllable factor is documentation quality. Incomplete or inconsistent files are the most common cause of delay, which is why most foreign manufacturers work with a specialist regulatory affairs partner rather than managing the dossier in-house.
Frequently asked questions
Can a foreign manufacturer register a pharmaceutical product directly in the UAE?
Who regulates pharmaceutical registration in the UAE in 2026?
How long does registration take?
How long is a UAE pharmaceutical registration valid?
What documents are needed to register a medicine?
This guide is general information, not regulatory or legal advice. UAE requirements are actively changing during the MOHAP to EDE transition; confirm current rules with the relevant authority or your regulatory partner before acting.