Skip to content The UAE's healthcare market is growing rapidly. Registering pharmaceutical products with the Emirates Drug Establishment (EDE) and MOHAP proves your medicines meet UAE standards for safety, effectiveness, and compliance building the trust and credibility essential for success in this competitive, lucrative market.
Excellent
5 Star Ratings
Pharmaceutical product registration is the mandatory approval process by the Emirates Drug Establishment (EDE) and Ministry of Health and Prevention (MOHAP) enabling legal sales in the UAE. It evaluates your product’s safety, quality, effectiveness, manufacturing standards, and international compliance, ensuring only safe, effective medicines reach patients.
The UAE is a strategic gateway to the GCC region, offering access to over 10 million residents and neighboring Gulf countries. Its world-class healthcare infrastructure, advanced medical facilities, and commitment to innovation make it an ideal hub for pharmaceutical companies targeting Middle East and North Africa markets.
The EDE and MOHAP maintain highly efficient pharmaceutical approval systems, with the UAE ranking first or second globally for innovative drug approval speed. This creates a competitive market where registered products gain immediate credibility. Major hospital networks, pharmacy chains, and healthcare providers require proper registration certificates, giving your brand instant trust with doctors, pharmacists, and patients.
Our Team of professional advisors will contact you for a tailored package that suits your requirements
Registration ensures products meet strict safety and quality standards through rigorous evaluation of manufacturing practices, ingredient quality, clinical effectiveness, and labeling, protecting patients from harm.
All pharmaceutical products require EDE registration before import, distribution, sale, or use in UAE. Non-compliance results in seizures, fines, penalties, and legal action.
Only registered products can legally enter UAE healthcare for prescription or sale. Registration provides official recognition, protects IP, and enables distribution across healthcare facilities.
EDE and MOHAP registration builds credibility with doctors, pharmacists, and healthcare institutions, confirming your products meet international standards for confident prescribing and dispensing.
We handle all documents required for EDE and MOHAP registration, ensuring full compliance.
We provide regulatory guidance and quality verification ensuring products meet UAE and international pharmaceutical standards.
Professional labeling services meeting EDE and MOHAP's strict bilingual requirements for all UAE pharmaceutical products.
Expert handling of EDE and MOHAP online 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 formulation, assess EDE and MOHAP requirements, identify the registration pathway, and create a customized strategy.
Complete eCTD dossier compilation including clinical data, stability studies, GMP certificates, CPP documentation, and Arabic translations, meeting EDE and MOHAP standards with attestation.
Professional EDE portal submission via UAE PASS with all attachments, fee processing (AED 100 plus product fees), confirmation, and tracking reference number.
EDE evaluation with active monitoring, query response, and additional documentation submission if needed. Technical committee reviews product safety, efficacy, and quality standards.
Laboratory analysis coordination if needed, including bioequivalence studies, stability testing, pharmacovigilance plan evaluation, and product sample analysis at approved facilities.
Final approval confirmation, 5-year registration certificate issuance, product pricing approval (48 hours to 90 days), and official UAE and GCC market authorization.
98% first-time success through precise eCTD documentation and deep EDE and MOHAP expertise.
Complete end-to-end service: assessment, dossier preparation, submission, translations, attestation, and certificate delivery.
Dedicated regulatory specialists provide real-time updates and guide you through every registration step.
Trusted by international pharmaceutical companies and local distributors with proven complex registration expertise.
Clear timelines, upfront fees, no hidden costs, smooth process from consultation to authorization.
Specialized expertise in EDE regulations, MOHAP compliance, fast-track pathways, and GCC reliance procedures.
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 market entry. Our pharmaceutical registration experts fast-track your products to UAE healthcare with full compliance, transparency, and professional support throughout the process.
Optimized by Seraphinite Accelerator