TRW & Co · Healthcare and life sciences
Pharmaceutical Registration and Distribution in the UAE
Pharmaceutical registration UAE-wide now runs through the Emirates Drug Establishment. Under Federal Decree-Law No. 38 of 2024, medicines need EDE marketing approval before import, manufacture or sale, the holder must designate a main establishment, appoint at least two licensed importers, and have a price set before launch. Here is how the process and supply chain rules work.
Key pointThe 2024 law turns registration into a supply chain decision: the holder must name one main establishment and at least two licensed importers, so exclusive single-distributor models need restructuring before filing, not after approval.
At a glance
New law in force
Federal Decree-Law No. 38 of 2024 replaced the 2019 medical products law and took effect on 2 January 2025, with a one-year grace period for existing businesses.
EDE is the regulator
The Emirates Drug Establishment grants marketing approvals, import and export permits, pricing and advertising approvals, and licenses pharmaceutical establishments across the UAE.
Two importers required
Article 22 requires the marketing authorisation holder to appoint at least two EDE-licensed importers and one or more distributors, unless the Cabinet grants an exemption.
Main establishment
The holder designates one main pharmaceutical establishment to handle regulatory affairs, pharmacovigilance and quality across the product's life cycle in the UAE.
Price before launch
A registered medicine cannot be marketed until a price has been set under rules issued by the EDE's board, informed by a pharmaceutical policy committee.
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Pharmaceutical registration UAE-wide is now handled by one federal body, the Emirates Drug Establishment (EDE). Under Federal Decree-Law No. 38 of 2024, in force since 2 January 2025, no medicine may be imported, manufactured or sold for circulation without EDE marketing approval, and the marketing authorisation holder must organise its UAE supply chain through licensed pharmaceutical establishments.
This guide explains the legal framework, the registration route, the rules on importers, distributors and pricing, how to set up a pharmaceutical company in the UAE, and the mistakes that delay market entry.
Pharmaceutical registration UAE: the short answer
- One federal regulator. The EDE handles marketing approvals, import and export permits, pricing, pharmacovigilance and the licensing of manufacturers, warehouses, medical stores and marketing offices.
- Marketing approval first. Medicines need EDE approval before they are imported, manufactured or sold, and approvals are time-limited and must be renewed.
- A main establishment. The marketing authorisation holder designates one main pharmaceutical establishment to handle regulatory affairs, vigilance and quality across the product's life cycle in the UAE.
- A licensed supply chain. The holder must appoint at least two EDE-licensed importers and one or more distributors, unless the Cabinet grants an exemption.
- A set price. A registered medicine cannot be marketed until its price has been set under the EDE's pricing rules.
Pharmacies and pharmacists remain licensed by MOHAP and the local health authorities, so a full market entry usually involves both federal and emirate-level regulators.
The legal and regulatory framework
Federal Decree-Law No. 38 of 2024
The 2024 medical products law regulates medical products, the pharmacy profession and pharmaceutical establishments. It replaced Federal Law No. 8 of 2019 and took effect on 2 January 2025, with a one-year grace period for existing businesses to comply, extendable by the Cabinet. Existing implementing regulations continue to apply where they do not conflict with the new law.
The law covers medicines, medical devices, health products, biological products, supplements, cosmetics and certain controlled and hazardous substances. It applies in free zones as well as onshore, and it introduces exclusive, conditional and emergency use marketing approvals, a fast track for innovative products and regulatory protection for innovation.
Who regulates what
The EDE was established by Federal Decree-Law No. 28 of 2023 (rendered in the official English translation as the UAE Drug Corporation) as the federal authority for medical products. MOHAP has since transferred most pharmaceutical services to it, including manufacturer registration, pricing, export certificates, approval of pharmacovigilance officers and accreditation of clinical study centres, with some services shared and a small number of narcotics-related services retained.
| Function | Regulator | Notes |
|---|---|---|
| Marketing approval of medicines and devices | Emirates Drug Establishment | Required before import, manufacture or sale for circulation |
| Import and export permits | Emirates Drug Establishment | Issued to licensed establishments such as importers and warehouses |
| Licensing manufacturers, warehouses, medical stores and marketing offices | Emirates Drug Establishment | Applies onshore and in free zones |
| Pricing | Emirates Drug Establishment | Price must be set before a registered medicine is marketed |
| Pharmacies and pharmacists | MOHAP and local health authorities | DHA in Dubai, DOH in Abu Dhabi, MOHAP in the northern emirates |
| Commercial licence and ownership | Economic departments and free zone authorities | Determines the legal entity and permitted activities |
How pharmaceutical registration works: step by step
The EDE publishes its services on its official website and accepts applications through its digital channels. The sequence below reflects the structure of the 2024 law; detailed document lists and fees are set by the EDE and change from time to time.
- Map the product and the pathway. Confirm the product category and whether a standard, conditional, emergency use or fast-track route fits, and whether any controlled substance rules apply.
- Register the manufacturer. Register each manufacturing site with the EDE, with evidence of good manufacturing practice, before product applications proceed.
- Appoint the UAE establishments. Designate the main pharmaceutical establishment, appoint at least two licensed importers and one or more distributors, and identify the qualified person resident in the UAE.
- File the marketing approval application. Submit the product dossier, covering quality, safety and efficacy, labelling and a pharmacovigilance system, through the main establishment.
- Respond to questions and testing. Answer EDE queries and provide samples or additional data if requested.
- Obtain approval and a price. Once approved, the product is recorded in the national database and a price must be set before marketing.
- Import, distribute and monitor. Obtain import permits, distribute through licensed channels, run pharmacovigilance and renew the approval before it expires.
Choose the main establishment and importers before you file, not after approval. Under the 2024 law, one designated establishment handles regulatory affairs, vigilance and quality for the product's whole life cycle, and the supply chain must include at least two licensed importers. Changing these partners later can be slow and commercially sensitive, so negotiate the contracts alongside the dossier.
What the dossier needs to show
A pharmaceutical registration UAE dossier must satisfy the conditions in Article 6 of the 2024 law, which include quality assurance, a pharmacovigilance system and evidence of good manufacturing practice. In practice, applicants assemble material along the following lines, adapted to the EDE's current checklists:
- Administrative documents: applicant and manufacturer details, the authorisation letter for the UAE establishment and evidence of approval status in other countries.
- Quality data: composition, manufacturing process, specifications, stability data and good manufacturing practice certification for each site.
- Non-clinical and clinical data supporting safety and efficacy, or bioequivalence data for generics.
- Labelling, package leaflets and artwork meeting UAE language requirements; a 2025 resolution introduced language requirements for package inserts.
- A pharmacovigilance system description and the details of the responsible pharmacovigilance officer.
Gaps in good manufacturing practice evidence, inconsistent labelling and incomplete stability data are the usual causes of questions. Treat the pharmaceutical registration UAE file as a living record: the main establishment will need to keep it updated through variations, renewals and safety reports.
What changed from the MOHAP era
Before the EDE took over, registration sat with MOHAP's drug department. According to an official announcement reported by WAM, 44 services were fully transferred to the EDE, 13 were partially transferred and 5, mostly concerning narcotics custody and quotas, stayed with MOHAP. Businesses with legacy files should confirm which authority now holds each record.
Types of marketing approval
The 2024 law broadens the routes to market. Each route has its own conditions, and the EDE's executive rules fill in the detail.
- Standard approval. The default route, granted for a fixed term and renewable on application before expiry.
- Conditional approval. For products such as orphan drugs, treatments for rare diseases or products unavailable in the UAE that hold approval in a recognised reference country, valid for a short renewable period and tied to a commitment to seek standard approval.
- Emergency use authorisation. For urgent public health needs, such as pandemics.
- Fast track. A simplified route for innovative products of therapeutic importance.
- Exclusive approval. Allowing a single entity to market specific products to specific UAE entities.
Importers, distributors and agency questions
For many businesses, the supply chain is the hardest part of pharmaceutical registration UAE planning. The supply chain rules in Article 22 of the 2024 law are central to commercial planning. The marketing authorisation holder must appoint at least two EDE-licensed importers and one or more distributors, and a Cabinet decision may exempt a holder on the EDE's proposal. Further conditions are left to executive regulations.
The requirement has a commercial edge: it reduces dependence on a single local partner and supports continuity of supply. Foreign manufacturers that have historically used one exclusive agent should review their arrangements, including any registered commercial agency. Our guides to the commercial agency law and distribution agreements in the UAE explain the contractual side.
Pharmaceutical registration UAE strategy is as much about choosing partners as about compiling a dossier.
Setting up a pharmaceutical company
The entity you need depends on the activity. The 2024 law recognises several types of pharmaceutical establishment, each licensed by the EDE or the health authority:
- Marketing offices, which can apply for marketing approval and promote products scientifically.
- Medical warehouses, which can import, store and distribute.
- Medical stores, which provide storage and logistics only, without trading or distributing.
- Manufacturers, for local production.
- Pharmaceutical consulting offices, for regulatory and technical advice.
- Pharmacies, licensed by MOHAP or the local health authority.
Each needs a commercial licence from an economic department or free zone authority that matches the health activity. Ownership rules for some activities differ between onshore and free zone entities and between emirates, so confirm them with the licensing authority before choosing a structure. Our guide to healthcare licensing in the UAE covers facility licensing more broadly.
After approval: pricing, advertising and vigilance
Pricing. Article 20 of the 2024 law requires a price to be set before a registered product is marketed, and a Pharmaceutical Policy Committee proposes pricing policy. The EDE issued a series of pricing resolutions in 2025, so check the current rules before launch and before any price change.
Advertising. Promotion of medicines requires EDE approval, must be truthful and must disclose risks; public advertising of controlled and hazardous substances is prohibited. See our guide to healthcare advertising rules.
Pharmacovigilance and withdrawals. The holder must monitor and report safety information and follow withdrawal procedures when a product or batch is defective. The law also creates a national tracking and coding system for medical products. Penalties for breaches include administrative sanctions and fines that can reach AED 1 million for establishments.
An illustrative scenario
This scenario is illustrative only and does not describe a real matter.
A mid-sized European manufacturer has sold one product in the UAE for years through a single exclusive distributor, which also handled registration. Following the 2024 law, it wants to launch two new medicines and renew the existing approval.
The manufacturer would need to designate a main establishment for each product, which may or may not be its existing distributor, and appoint at least two licensed importers. That raises questions about the exclusivity clause, any registered commercial agency and who holds the regulatory files. A sensible approach is to map the regulatory roles first, then renegotiate the distribution contract to match, with clear transfer provisions if the relationship ends.
Risks and common mistakes
Letting the distributor control the registration
Historically, many foreign manufacturers allowed their local distributor to file and hold registrations. If the relationship breaks down, transferring the files can be slow and contentious. Under the 2024 law, the main establishment manages the product's life cycle, so its identity matters. Contracts should state who controls regulatory files, require cooperation on transfer and give the manufacturer access to all correspondence with the EDE.
Ignoring the two-importer requirement
Exclusive single-importer models are common in the region, but the 2024 law requires at least two licensed importers unless the Cabinet grants an exemption. Exclusivity clauses, minimum purchase commitments and territory definitions need to be reviewed. Where a commercial agency is registered, the interaction with the agency law needs specific advice before appointing additional importers.
Assuming the grace period still applies
The 2024 law gave existing businesses one year from 2 January 2025 to comply, unless the Cabinet extended the period. As of October 2026, businesses should assume the new rules apply in full unless they have confirmation of an extension that covers them. Existing approvals, establishment licences and supply arrangements should be checked against the new requirements.
Marketing before the price is set
Approval alone does not allow a product to be sold. A price must first be set under the EDE's pricing rules. Launch plans that schedule tenders, promotional campaigns or hospital listings straight after approval can slip if the pricing step is not built into the timetable. Pricing resolutions also change, so check the current rules before any reprice.
Promoting without approval
Scientific events, social media posts and patient materials can all amount to promotion requiring EDE approval. Approvals are time-limited and can be cancelled. Marketing teams should route all external materials through regulatory review, and avoid any public promotion of prescription-only or controlled products.
Cross-border angle
Manufacturers in India, Bangladesh, China, Europe and the UK commonly reach the UAE through a mix of local partners and regional hubs. The UAE also re-exports to the wider GCC and Africa, so EDE export certificates and free zone warehousing often feature in the plan. Each importing country applies its own registration rules, and approval in the UAE does not carry over automatically.
Customs and trade compliance also matter: our guide to customs and trade compliance covers import controls. Data and safety reports moving between the UAE and a global safety database should be mapped against UAE health data rules.
Checklist: what to do next
- Confirm the product category and the marketing approval route.
- Register each manufacturing site with the EDE.
- Choose the main establishment, two or more importers and distributors, and the resident qualified person.
- Align distribution and agency contracts with the regulatory roles.
- Prepare the dossier, labelling and pharmacovigilance system.
- Build pricing approval and advertising review into the launch timetable.
- Diary renewal dates and monitor EDE resolutions for changes.
- Review existing approvals against the pharmaceutical registration UAE rules now in force.
- Confirm which authority now holds each legacy file transferred from MOHAP.
TRW & Co advises manufacturers, distributors and investors on market entry, structuring, distribution and agency contracts and regulatory engagement, as part of our healthcare regulation practice. Related guides cover medical devices and clinical trials. To discuss a launch, contact us at info@trw.co or +971 58 942 1012.
Frequently asked questions
01Who registers medicines in the UAE?
The Emirates Drug Establishment, a federal body established in 2023, is the regulator for medical products. Under Federal Decree-Law No. 38 of 2024 it grants marketing approvals, import and export permits, pricing and advertising approvals, and licenses manufacturers, warehouses, medical stores and marketing offices. MOHAP transferred most pharmaceutical services to it. Pharmacies and pharmacists are still licensed by MOHAP and the local health authorities.
02Does a foreign manufacturer need a UAE company to register a medicine?
The application is made through licensed UAE establishments. The 2024 law requires the marketing authorisation holder to designate a main pharmaceutical establishment for regulatory affairs, vigilance and quality, to appoint at least two licensed importers and one or more distributors, and to have a qualified person resident in the UAE. A foreign manufacturer can use licensed partners or set up its own marketing office, warehouse or other establishment.
03How long is a UAE marketing approval valid?
A standard marketing approval is granted for a fixed term and must be renewed by application before it expires. Conditional approvals for products such as orphan drugs are granted for a shorter renewable period and require a commitment to seek standard approval, and emergency use authorisations last for the emergency. Check the EDE's current rules for renewal timing and documents, diary renewal dates well in advance, and make sure the main establishment is ready to file the renewal.
04Can I sell a medicine as soon as it is approved?
Not immediately. Article 20 of the 2024 law requires a price to be set before a registered product is marketed, under rules issued by the EDE's board. You also need import permits, a licensed distribution chain and, for any promotion, EDE advertising approval. Build the pricing step into the launch timetable so tenders and listings are not scheduled before the product can lawfully be sold.
05What are the penalties under the UAE medical products law?
The 2024 law provides administrative sanctions including licence suspension, precautionary closure and cancellation, and the EDE can inspect, seize non-compliant products and withdraw approvals. Reported fines reach AED 1 million for establishments and AED 500,000 for practitioners, and the law also carries criminal penalties for serious breaches. Penalties can affect both the establishment and the individuals responsible, so compliance should be owned at board level.
06Does the medical products law apply in free zones?
Yes. Federal Decree-Law No. 38 of 2024 applies to pharmaceutical establishments operating in free zones, and its pharmacy profession provisions also extend to free zones. A free zone warehouse or marketing office therefore needs EDE licensing and must comply with the same marketing approval, import, pricing and vigilance rules as an onshore business, in addition to its free zone commercial licence.
Sources and official materials
- Federal Decree-Law No. 38 of 2024 on medical products, the pharmacy profession and pharmaceutical establishments — Marketing approval, establishments, pricing, advertising and penalties
- Federal Decree-Law No. 28 of 2023 establishing the federal drug regulator — Creation and mandate of the Emirates Drug Establishment
- Emirates Drug Establishment — Federal regulator for medical products and its services
- WAM: MOHAP transfers key services to the EDE — Services transferred, shared and retained
- Ministry of Health and Prevention — Pharmacy and pharmacist licensing in the northern emirates
General information only, current as at 27 October 2026. It is not legal advice and does not create a lawyer–client relationship. UAE law differs between the onshore jurisdiction, the DIFC, ADGM and the free zones, and changes frequently; check current official sources and take advice on the facts of your matter.
