Multiple authorised agents for medical products in the UAE

In brief

• The Emirates Drug Establishment activated a mechanism on 24 February 2026 requiring more than one authorised agent for each medical product marketed in the UAE.
• The requirement runs into the exclusivity that a registered commercial agency gives the agent under UAE law.
• The EDE has not published detailed guidance on scope, timing or how many agents each product needs.
• Removing or diluting a registered agent can expose the principal to a compensation claim before the Commercial Agencies Committee.

What the EDE announced and under which law

On 24 February 2026 the Emirates Drug Establishment announced that it had activated a new mechanism. Companies must now appoint more than one authorised agent for each medical product they market in the UAE. The EDE implements the mechanism under Federal Decree-Law No. 38 of 2024, which came into force on 2 January 2025 and replaced Federal Law No. 8 of 2019. The regulator gave its reasons as pharmaceutical security, supply continuity during emergencies, and competition among distributors. Our commercial lawyers in Dubai advise principals and agents on how existing contracts survive the change.

Two dates set the context. The EDE was established in September 2023. It then took over 44 core regulatory services from the Ministry of Health and Prevention at the end of December 2025. Marketing approvals, import and export permits, GMP certification, establishment licensing and pharmacovigilance now belong to a single federal authority. Our guide to pharmaceutical licensing and drug registration covers that transfer in detail, and the same authority handles medical device registration.

The announcement described the requirement in terms of medical products, which under Decree-Law No. 38 of 2024 is a broad category. The EDE has not yet issued a circular on the detail. Three questions remain open. How many agents does a product need, which product categories fall inside the mechanism, and what happens at renewal for products that currently have one agent. Companies should ask the EDE for written confirmation for their own portfolio rather than assume the answer.

Two registrations, two regulators, two sets of rights

Companies use the word agent for three different arrangements in the UAE, and the differences decide who can be replaced and at what cost.

The distinction matters because an unregistered agency has no standing before the Commercial Agencies Committee or the UAE courts. A principal who appoints a second EDE agent alongside an unregistered distributor faces a contract claim. A principal who does the same alongside a registered agent faces a statutory one.

Where the exclusivity conflict arises

Federal Law No. 3 of 2022 replaced the 1981 commercial agencies law and came into force on 15 June 2023. It kept the central protection. Unless the parties agree otherwise, the goods or services covered by a registered commercial agency are exclusive to the agent within the agency territory. The agent may appoint distributors in one or more emirates, but the principal may not appoint a second agent for the same products.

That is the conflict. The EDE now expects more than one authorised agent per product. The Ministry of Economy register may show a single agent holding exclusivity over the whole country for those same products. A principal who complies with the first requirement without dealing with the second gives the existing agent a breach claim.

The route out depends on the register, not on the wording of the contract. Where no registered agency exists, the principal reviews the exclusivity clause and negotiates. Where a registered agency exists, the principal works within Law No. 3 of 2022 and the Commercial Agencies Committee procedure.

Adding a second agent to a registered commercial agency

Three routes exist, and they carry different costs.

The cheapest is consent. The agent agrees to vary the registration so that exclusivity covers part of the territory or part of the product range. Agents rarely give that away for nothing, so expect to pay through improved margins, longer notice periods or an agreed exit sum.

The second route is expiry. Law No. 3 of 2022 allows a fixed-term agency to end at its term without renewal, subject to the transitional rules. Those rules protect older relationships. For agencies already in force when the law was issued on 13 December 2022, the termination and expiry provisions applied only from 15 June 2025. A longer protection covers two cases. The provisions apply only from 15 June 2033 where the same agent has held the registration for more than ten years, or where the agent's investment exceeds AED 100 million. Many pharmaceutical agencies fall into that second category.

The third route is termination, and it is the expensive one. The agent may claim compensation on two proofs. It must show that its work brought visible and significant success to the principal's products, and that termination deprived it of the benefit. The law also provides for the old agent's stock and equipment to pass to the principal or the new agent at fair value, on defined conditions. During a dispute, the Ministry of Economy may allow goods into the country on a temporary basis. That prevents a total supply freeze without resolving the claim. We set out the mechanics in our guide to terminating a commercial agency in the UAE.

What the change gives an existing agent

Agents holding registered exclusivity should read the mechanism as a negotiation event rather than a threat. The principal needs something from the agent, and the agent decides the price.

Useful asks include a longer fixed term in exchange for consent, a territory split by emirate rather than by product, and first refusal on hospital tenders. Others are minimum purchase obligations that bind the second agent, and a stock buyout at invoice value rather than fair value. Agents should also check that their registration covers the exact product codes named in the EDE file. A mismatch weakens the exclusivity argument before the Committee.

Obligations that do not divide neatly between agents

Appointing several agents splits the commercial channel. It does not split regulatory responsibility in the same way.

The marketing approval holder remains answerable to the EDE for the product. Pharmacovigilance reporting, safety updates, field safety corrective actions and recalls all trace back to that holder, whichever agent imported the batch. Three agents importing the same product create three sets of import permits, three storage chains and three sets of batch records. The holder has to reconcile all of them. Renewal adds a further deadline, since an application to renew a marketing approval goes in ninety days before expiry.

Product liability follows a similar pattern. A patient claim names the parties in the chain, and the manufacturer cannot point to a distribution split as an answer. Supply agreements should therefore set out which agent handles which channel, how each reports adverse events to the holder, and who funds a recall. Our note on supply chain contract disputes covers the allocation questions in more general terms.

The competition angle

Exclusive distribution has a second regulator. Federal Decree-Law No. 36 of 2023 prohibits agreements whose object or effect restricts competition. Territorial restrictions, customer allocation and resale price terms all fall to be assessed under it. A principal renegotiating exclusivity to satisfy the EDE should test the new arrangement against the competition rules at the same time. Fixing one problem should not create another. Our guide to competition compliance for UAE businesses explains the framework.

What manufacturers and agents should do now

• Pull the Ministry of Economy register entry for every UAE agency covering medical products, and check the registered product scope against the EDE file.
• Identify which agencies benefit from the transitional protection running to 15 June 2033.
• Ask the EDE in writing how the mechanism applies to your product categories and at which renewal.
• Model the compensation exposure before opening any conversation about a second agent.
• Redraft pharmacovigilance, recall and reporting obligations so they bind every agent to the marketing approval holder.
• Review revised exclusivity terms against the competition rules before signing.

The EDE has not yet published implementing guidance for the mechanism. The Commercial Agencies Committee has not yet tested how the two regimes interact. Companies should review this position again once the EDE issues a circular, and before any agency contract comes up for renewal. Legal advice may be required to assess how the two regimes apply to a particular product portfolio.

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