Drug Registration in the UAE: Licensing Rules for Manufacturers, Importers, and Distributors

The Emirates Drug Establishment now controls drug registration in the UAE

Pharmaceutical companies that registered products with MOHAP before 2026 are now dealing with a different authority. Federal Decree-Law No. 38 of 2024, which came into force on 2 January 2025, replaced the previous Federal Law No. 8 of 2019 and established the Emirates Drug Establishment (EDE) as the federal authority responsible for issuing marketing authorisations, licensing pharmaceutical establishments, overseeing pharmacovigilance, and regulating the advertising and import of medical products. No medical product may be circulated, manufactured, or sold in the UAE without prior marketing approval from the EDE.

• The EDE assumed 44 core services from MOHAP effective 29 December 2025, including all marketing authorisations, import and export permits, GMP certification, pharmaceutical facility licensing (for factories, warehouses, medical stores, and marketing offices), and pharmacovigilance oversight.
• MOHAP retains jurisdiction over community pharmacies, compounding pharmacies, and five specific services related to narcotic drug controls (prescription books, custody authorisation, quota management, and hospital approvals).
• The Department of Health Abu Dhabi (DOH) operates a separate drug authorisation system for the Abu Dhabi market, maintaining its own approved drug formulary alongside the federal registration managed by the EDE.
• Entities and individuals subject to the new law have a one-year grace period from 2 January 2025 to comply with its provisions. The executive regulations of the previous law remain in force to the extent they do not contradict the new legislation.

Who this applies to

The new framework applies to international pharmaceutical manufacturers seeking to register products for sale in the UAE, local and foreign companies holding or seeking marketing authorisations, medical warehouses and distributors licensed to import and distribute pharmaceutical products, marketing offices representing international manufacturers, contract research organisations conducting clinical or non-clinical trials, and pharmacies (community and compounding) dispensing registered products.

For companies investing in or acquiring healthcare businesses in the UAE, the regulatory transition adds a layer of due diligence complexity. Our article on healthcare M&A in the UAE covers the legal, financial, and clinical due diligence framework. For healthcare lawyers in the UAE, including pharmaceutical regulatory compliance, licensing disputes, and market access strategy, our team advises manufacturers, distributors, and investors across the sector.

Foreign manufacturers cannot register products directly. They must appoint a UAE-based authorised agent, which must be a licensed pharmaceutical establishment (typically a medical warehouse or marketing office), to submit the registration application and manage post-market obligations on their behalf.

Which authority applies where

The UAE's pharmaceutical regulatory structure involves three overlapping authorities, and determining which one applies depends on the type of activity and the emirate in which the company operates.

The practical consequence of this structure is that a pharmaceutical company must engage with the EDE for product registration and marketing authorisation, and separately with the relevant emirate-level authority (DOH in Abu Dhabi, DHA in Dubai) for healthcare facility licensing, formulary inclusion, and distribution within that emirate's healthcare system. These are parallel processes, not sequential ones.

How drug registration works under Federal Decree-Law No. 38 of 2024

The new law establishes three types of marketing approval, each with different conditions and timelines.

Standard marketing authorisation. This is the primary pathway for conventional and biological pharmaceutical products. The applicant must be a licensed pharmaceutical establishment (marketing office, manufacturer, contracted manufacturing company, or designated medical warehouse). The application must include quality, safety, and efficacy data compliant with EDE guidelines, a valid GMP certificate from the EDE or from the competent authority in the country of origin or an EDE-approved reference body, a Certificate of Pharmaceutical Product (CPP) in accordance with the WHO system or a certificate of free sale from the country of origin, bioequivalence data (for generic products), a pharmacovigilance plan, and bilingual labelling (Arabic and English) compliant with ESMA requirements including GS1-compliant barcodes or QR codes for traceability.

The EDE reviews the dossier and may request additional data, testing, or clarification. Once approved, the registration committee's decision is communicated within 10 working days. The pricing certificate is issued within 48 hours of the ministerial pricing decision. Registration is valid for five years and must be renewed 90 days before expiry.

Conditional marketing authorisation. The new law introduces this pathway for products addressing unmet medical needs, life-threatening conditions, or situations where the benefit-risk balance justifies early access before full clinical data is available. The authorisation may be granted subject to post-marketing commitments, including additional safety studies.

Emergency use authorisation. For public health emergencies where no adequate alternatives are available, the EDE may grant time-limited approval based on available safety and efficacy data. This pathway was not formally codified under the previous law.

For companies involved in the clinical trial process that precedes registration, our article on how clinical trial agreements are structured in the UAE covers the regulatory and contractual framework.

The registration fees and timeline

Registration costs under the EDE framework are structured as follows: AED 100 for the application, AED 7,000 for registration of a conventional or biological product, AED 3,500 for product analysis or re-analysis, AED 500 for the pricing certificate after committee approval, and AED 1,000 for pharmacovigilance plan evaluation. Fees vary for other product categories (dietary supplements, medical cosmetics, medical disinfectants) and for fast-track eligibility.

The typical registration timeline is three to six months for a complete and well-prepared dossier. Fast-track registration is available for lifesaving or critical care products. The most common causes of delay are incomplete dossiers (particularly inadequate bioequivalence data or missing stability studies), inconsistent Arabic translations on labelling, delays in pharmacovigilance officer appointment or approval, and incorrect product classification leading to submission under the wrong regulatory track.

Pharmaceutical facility licensing

Before a company can register products, the entity itself must be licensed as a pharmaceutical establishment. Under the new framework, facility licensing for factories, warehouses, medical stores, and marketing offices has transferred to the EDE (jointly with MOHAP for certain administrative functions). Community and compounding pharmacies remain under MOHAP's jurisdiction.

The licensing process involves several stages. The applicant submits a pre-licensing application to the EDE. An initial approval is issued after security clearances and document review, valid for six months (extendable). For manufacturing facilities, detailed engineering drawings must be submitted and approved before construction, demonstrating compliance with material flow, personnel flow, and GMP technical requirements. Staff licensing (pharmacists) is processed in parallel. Initial and final inspections are conducted. Upon approval, the licence fee is paid and the licence is issued electronically.

The applicant must be a UAE-based entity with a valid pharmaceutical trade licence. Foreign companies cannot hold a pharmaceutical facility licence directly; they must establish a local entity or appoint a licensed local agent. The marketing authorisation holder is required under Article 22 of the new law to appoint at least two importers and one or more distributors, a requirement carried over from the 2023 amendments. One designated pharmaceutical establishment must be nominated as the main entity responsible for regulatory affairs, pharmacovigilance, and quality management across the product's entire lifecycle in the UAE.

The distinction between a medical store and a medical warehouse is now codified. Medical stores may engage in logistics, hold title to products, and carry out importation, distribution, or re-export. Medical warehouses are licensed only for storage and cannot distribute or sell. The specific activities permitted under each licence type will be further clarified in the executive regulations.

The Abu Dhabi drug authorisation system

The DOH Abu Dhabi operates its own drug authorisation framework in parallel with the federal registration system. Products must hold an EDE marketing authorisation to be sold in the UAE, but distribution and use within Abu Dhabi's healthcare system requires additional DOH approval.

The DOH maintains an approved drug formulary for the Abu Dhabi market. As of the most recent published data, the Abu Dhabi formulary includes over 16,400 approved coded drug products, plus approximately 4,400 non-registered coded products with special authorisation approval. Healthcare facilities in Abu Dhabi must establish and maintain a facility formulary selected from the DOH-approved list, in accordance with DOH pharmacy standards.

The DOH's drug authorisation process involves reviewing products for inclusion in the Abu Dhabi formulary, granting special authorisation for products not on the formulary where clinical need is demonstrated, and monitoring adverse drug reactions through the DOH pharmacovigilance reporting system. Healthcare facilities are required to report suspected adverse reactions, medication errors, and adverse events following immunisation within stipulated timeframes.

For companies licensing healthcare facilities in Abu Dhabi specifically, our article on healthcare facility licensing in the UAE explains the DOH and MOHAP requirements.

Pharmacovigilance and post-market obligations

The new law significantly strengthens pharmacovigilance requirements. Marketing authorisation holders must implement a quality assurance and product traceability system, a pharmacovigilance system, and post-marketing follow-up throughout the product's lifecycle. The EDE must approve the company's pharmacovigilance officer, who must be a UAE-resident professional with appropriate credentials. The pharmacovigilance plan must be submitted as part of the registration dossier and approved before the marketing authorisation is issued.

Any changes in formulation, source, packaging, or safety data after registration require fresh EDE approval. The EDE conducts regular audits and GMP compliance inspections at manufacturing sites, and non-compliance may result in fines, product bans, marketing authorisation suspension or revocation, or facility licence cancellation.

The Tatmeen system, developed by MOHAP in partnership with EVOTEQ, provides a national track-and-trace platform for monitoring individual events in the drug supply chain and confirming product authenticity. Under Article 66 of the new law, the EDE is required to establish and manage a national system for the circulation, tracking, and coding of medical products from the factory to the end user. All designated pharmaceutical establishments must participate in this system.

Intellectual property protections for pharmaceutical products

The new law includes enhanced protections for pharmaceutical intellectual property. Marketing authorisation for a generic (similar) product may only be granted once the legal protection period for the innovator product has expired. The applicant for a generic product must demonstrate bioequivalence with the reference product and provide evidence of compliance with applicable intellectual property and trademark legislation.

The EDE may grant marketing authorisation to the first generic product that applies (a "pioneer generic"), which receives a distinct regulatory status. This creates a first-mover advantage for generic manufacturers that are ready to file when the innovator's protection period ends.

Data exclusivity provisions require that the EDE not rely on the innovator's clinical data to approve a generic application during the exclusivity period, unless the generic applicant provides its own independent data or the innovator consents. The specific exclusivity periods and conditions will be further defined in the executive regulations.

Penalties for non-compliance

The new law imposes substantially harsher penalties than the 2019 legislation. Fines may reach up to AED 1 million (approximately USD 270,000), and imprisonment terms have been increased for serious violations. The EDE has enforcement powers to conduct inspections without prior notice, seize non-compliant products, temporarily suspend or permanently cancel licences, and shut down establishments that violate the law.

Specific violations that attract penalties include circulating unregistered products, manufacturing without a valid GMP certificate, falsifying or plagiarising research used in marketing or product approvals, advertising without EDE approval, and failure to maintain required pharmacovigilance systems. Advertising of controlled substances to the public is prohibited outright.

What companies should do next

For pharmaceutical companies currently operating in the UAE, the immediate priorities are confirming that all applications, renewals, and communications are now directed to the EDE portal (www.ede.gov.ae) rather than MOHAP for transferred services, reviewing existing marketing authorisations to ensure they comply with the new law's requirements within the one-year grace period (expiring 2 January 2026), and appointing or confirming a UAE-resident pharmacovigilance officer with EDE approval.

For international manufacturers entering the UAE market for the first time, the critical preliminary step is appointing a licensed UAE-based authorised agent (a medical warehouse or marketing office) that will submit the registration application and manage all post-market regulatory obligations. The Certificate of Pharmaceutical Product from the country of origin must be attested by the UAE Embassy before submission.

For companies involved in healthcare M&A, the transfer of a marketing authorisation to a new owner requires EDE approval under Article 22 of the new law. Due diligence should verify that the target's marketing authorisations, facility licences, and pharmacovigilance arrangements are current and compliant with the new framework. Our article on certificates of free sale for UAE medical device registration covers the parallel requirements for medical devices, which are also now regulated by the EDE under the same law.

Legal advice may be required to assess how the transition from MOHAP to the EDE affects existing distribution agreements, facility licences, and marketing authorisation ownership arrangements, particularly where contracts reference the former regulatory authority by name.

‍