The UAE's healthcare market is growing fast, and getting your pharmaceutical products registered is the key to entering this lucrative market. Registration with the Emirates Drug Establishment (EDE) and MOHAP proves your medicines are safe, effective, and fully compliant with UAE standards. This gives you the trust and credibility you need to succeed in a competitive market where quality and speed matter.
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Pharmaceutical product registration is the mandatory approval process by the Emirates Drug Establishment (EDE) and Ministry of Health and Prevention (MOHAP) that allows your medicines to be legally sold in the UAE. This process evaluates your product’s safety, quality, effectiveness, manufacturing standards, and compliance with international guidelines, ensuring only safe and effective medicines reach patients.
The UAE serves as a strategic gateway to the entire GCC region, with a population of over 10 million and access to neighboring Gulf countries. The country’s world-class healthcare infrastructure, advanced medical facilities, and commitment to innovation make it an ideal hub for pharmaceutical companies targeting the Middle East and North Africa markets.
The EDE and MOHAP maintain some of the world’s most efficient pharmaceutical approval systems, creating a competitive market where registered products gain immediate credibility with healthcare providers. The UAE now ranks first or second globally for approval speed of innovative drugs. Major hospital networks, pharmacy chains, and healthcare providers require proper registration certificates for product distribution, giving your brand immediate trust with doctors, pharmacists, and patients alike.
Our Team of professional advisors will contact you for a tailored package that suits your requirements
Registration ensures that pharmaceutical products meet strict safety and quality standards, protecting patients from harmful or substandard medicines. The process verifies manufacturing practices, ingredient quality, clinical effectiveness, and proper labeling through rigorous evaluation and documentation.
All pharmaceutical products must be registered with the Emirates Drug Establishment (EDE) before import, distribution, sale, or use in the UAE. Non-compliance can lead to product seizures, heavy fines, business penalties, and legal action against manufacturers and distributors.
Only registered products can legally enter the UAE healthcare system and be prescribed by doctors or sold in pharmacies. Registration provides official recognition, protects your intellectual property, and enables smooth distribution across hospitals, clinics, and retail pharmacies throughout the region.
Registration with EDE and MOHAP gives your pharmaceutical brand credibility and trust with doctors, pharmacists, and healthcare institutions. It confirms your products meet international standards, ensuring healthcare professionals can confidently prescribe and dispense your medicines to patients.
We handle every document required for successful registration with EDE and MOHAP, ensuring full compliance and accuracy throughout the entire process.
Comprehensive regulatory guidance and quality verification to ensure your products meet all UAE pharmaceutical standards and international requirements.
Professional labeling services that meet EDE and MOHAP's strict bilingual requirements for all pharmaceutical products sold in the UAE.
Expert handling of EDE and MOHAP online registration systems for seamless digital application submission and tracking.
Pharmaceutical products registered and market-ready in as little as 45 working days
Standard registration: 45 days
Fast-track innovative/orphan drugs: 25 days
Comprehensive product review and compliance evaluation. We analyze your pharmaceutical formulation, assess EDE and MOHAP regulatory requirements, identify the appropriate registration pathway (standard or fast-track), and create a customized registration strategy.
Complete dossier compilation in eCTD format including clinical data, stability studies, GMP certificates, CPP documentation, and Arabic label translations. All documents prepared to meet Emirates Drug Establishment and MOHAP standards with proper attestation.
Professional submission through the EDE portal using UAE PASS authentication with all required attachments, fee processing (AED 100 application + product-specific fees), and submission confirmation with tracking reference number.
Emirates Drug Establishment evaluation period with active monitoring, query response management, and additional documentation submission if required. Technical committee reviews product safety, efficacy, and quality standards.
Laboratory analysis coordination if needed, including bioequivalence studies, stability testing verification, pharmacovigilance plan evaluation, and product sample analysis at approved facilities.
Final approval confirmation, registration certificate issuance valid for 5 years, product pricing approval (48 hours to 90 days), and official market authorization to distribute throughout UAE and GCC region.
98% first-time success rate through precise eCTD documentation, comprehensive compliance checks, and deep understanding of EDE and MOHAP requirements.
From initial product assessment and dossier preparation to EDE portal submission, Arabic translations, GMP attestation, and final certificate delivery—we handle everything.
Dedicated pharmaceutical regulatory specialists provide real-time updates, answer all your queries, and guide you through every step of the registration process.
Trusted by international pharmaceutical companies and local distributors expanding into the UAE and GCC markets with proven expertise in complex registrations.
Clear timelines, upfront fee disclosure, no hidden costs, and a smooth process from initial consultation to final market authorization.
Specialized expertise in EDE regulations, MOHAP compliance, fast-track pathways, and GCC reliance procedures for seamless market entry.
The UAE pharmaceutical market is experiencing rapid growth, with healthcare spending projected to reach $20 billion by 2026. Whether you’re a multinational pharmaceutical company or a regional distributor, proper registration with the Emirates Drug Establishment (EDE) is your gateway to one of the fastest-growing healthcare markets in the world.
Medical product registration in the UAE is the official process that allows a medical product to be legally marketed and sold in the country. This ensures safety, quality, and compliance with health regulations.
Only marketing authorization holder companies have to be registered with the Ministry of Health and Prevention (MOHAP). They can file applications to register their products through a licensed local agent.
The process covers human medical products, biological or other human pharmaceutical formulations, as well as products that have been approved for registration in other countries.
Required documents may include details of the medical product, a free sale certificate, manufacturing licenses, product composition, and health and safety test results.
A CCP confirms that the product is free from harmful substances, complies with international standards, and has been issued by the competent authorities for global recognition.
Product registration certificates are valid for five years in most cases. However, certain temporary certificates, such as those valid for one year, may be issued depending on the conditions and requirements.
Yes, both imported and locally manufactured medical products must go through the drug registration process to ensure compliance before sale in the UAE market.
Relevant technical and ministerial committees examine applications, deliberate on health and safety compliance, and decide whether products should be approved for registration.
If products fail to meet the registration to ensure safety standards, it may lead to product confiscation, rejection of the application, or denial of certificates of registration of products.
Yes, product registration consultants in the pharmaceutical industry can guide companies through the process to register, ensuring all conditions are met for successful registration in the United Arab Emirates.
We’re here to help. If you didn’t find the answer you were looking for, feel free to reach out to our team. We’ll make sure you get the clarity you need to move forward with confidence.
Don't let regulatory complexity delay your market entry. Our pharmaceutical registration experts are ready to fast-track your products to the UAE healthcare market with full compliance, transparency, and professional support every step of the way.
