MOH Product Registration in Dubai, UAE
Pharmaceuticals, cosmetics, herbal, and health products must be registered via MOHAP through approved pathways to meet UAE safety, efficacy, and quality standards. We guide the process from documentation to submission, ensuring legal import, sale, and distribution across the UAE and access to the wider GCC market.
What is MOH Product Registration
MOH product registration is a mandatory compliance process governed by the Ministry of Health and Prevention (MOHAP) and the Emirates Drug Establishment (EDE). It applies to a wide range of health-related products, including pharmaceuticals, medical supplements, cosmetics, herbal preparations, OTC products, and wellness items entering the UAE market. Before any product can be imported, manufactured, advertised, or sold, it must first meet the UAE's strict safety, efficacy, labeling, and quality requirements through MOHAP's online registration system.
This process ensures that every product available in the UAE healthcare and consumer market is safe for public use and meets internationally recognized quality benchmarks. All labels must be provided in Arabic, with English allowed only as an exact match. Products are evaluated and classified based on their category and risk level, which determines the approval path, whether a simplified cosmetic review or a comprehensive pharmaceutical dossier assessment is required. Technical documents, laboratory reports, safety studies, and certificates of free sale are often part of the submission.
Once a product is approved, it receives formal authorization for importation, distribution, and commercial sale across pharmacies, retail outlets, medical distributors, and online channels in the UAE. Beyond compliance, registration adds strong market credibility, enhances consumer trust, and positions your brand for wider expansion across GCC countries. It serves as a gateway to regional growth while ensuring full alignment with UAE and international regulatory standards.
Benefits of MOH Product Registration in Dubai
Registering health products with UAE authorities ensures lawful market entry, builds consumer and healthcare provider trust, and provides regulatory credibility. It supports public safety, streamlines pharmacy and retail distribution, and prepares your brand for wider GCC market expansion.
Legal Market Entry
Secure approval for import, manufacturing, and UAE distribution while avoiding penalties, customs delays, or product seizures.
Brand Credibility & Trust
Build confidence with pharmacies, retailers, hospitals, and consumers; gain access to government healthcare tenders and programs.
Safety & Efficacy Verification
Certify products meet international safety, efficacy, and quality standards through rigorous MOHAP review.
Labeling Compliance Assurance
Meet bilingual Arabic-English labeling, ingredient disclosure, and safety warning requirements; reduce rejection risks.
Regional Export Gateway
Enable trading throughout GCC markets and Middle East regions using UAE as the regulatory and logistical hub.
Fast-Track Approval Options
Access expedited pathways for innovative, orphan drugs, and simple products with faster approval timelines.
Conditions and Requirements for MOH Product Registration
01.Trade License & Company
UAE-registered company with pharmaceutical, cosmetics, or medical trading activity and a valid business license.
02.MOHAP Portal Registration
Register on the MOHAP or EDE portal with authorized signatory details and Marketing Authorization Holder status.
03.Product Classification
Identify category (pharma, OTC, herbal, cosmetic) using MOHAP’s classification tool; determines pathway and timeline.
04.Technical Dossier
Prepare full documentation: composition, manufacturing process, quality standards, efficacy data, and safety assessment.
05.Free Sale Certificate
Origin-country certificate confirming legal sale and approval, legalized by the UAE Embassy.
06.GMP/Quality Certificate
Manufacturing facility’s GMP or ISO certification proving adherence to international quality standards.
07.Product Labels & IFU
Arabic-English labels covering ingredients, usage, warnings, storage, expiry, and instructions for use.
08.Lab Test Reports
Safety, stability, efficacy, and quality testing from accredited labs confirming compliance.
09.Marketing Authorization
Provide evidence of approval from EU, FDA, or other recognized authorities supporting UAE registration.
10.Authorized Representative Agreement
Appoint a UAE-based agent for foreign manufacturers with defined compliance responsibilities.
How We Help Register Your MOH Products
Step 1
We determine product category, approval pathway, and regulatory requirements.
Step 2
We compile technical files, certificates, and compliant label artwork.
Step 3
We register your company as MAH and set up the MOHAP portal with signatory.
Step 4
We upload all documents, submit labels, and handle fee payment and tracking.
Step 5
We respond to MOHAP queries and provide any additional required documentation.
Step 6
We obtain your registration certificate and guide compliance, renewals, and updates.
Special Requirements for Certain MOH Products
- Prescription Pharmaceuticals (Rx): Require clinical trial data, pharmacovigilance, and post-market monitoring.
- OTC Medicines: Must show safe self-use; labels list active ingredients and max daily doses.
- Herbal & Traditional Medicines: Need botanical verification, traditional-use evidence, and safety assessment.
- Cosmetic Products: Require safety report, verified ingredients, and evaluation; therapeutic claims prohibited.
- Novel or Innovative Pharmaceuticals: Qualify for fast-track review with full dossiers and orphan-drug support.
- Imported Foreign Products: Require proof of international approval, clinical data, and UAE-based authorized representative.
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