Table of Contents
Frequently Asked Questions
What is activity code 7010.98 and what does it permit in Dubai
Activity code 7010.98 is the designated classification for a Pharmaceutical Representative Office in Dubai, sitting within ISIC Division 70 — Activities of Head Offices. It provides a defined, compliant route for foreign pharmaceutical companies to establish a licensed mainland presence without operating as a full commercial entity.
Permitted activities include medical detailing to licensed healthcare practitioners, regulatory liaison with MOHAP and DHA, market intelligence gathering, and coordination support for clinical trial submissions. The office can represent the parent company's product portfolio and facilitate regulatory submissions.
Critically, the structure does not permit invoicing, importing, or directly distributing pharmaceutical products. Operating outside this scope — for example, concluding local sales contracts — exposes the entity to regulatory action from both DET and MOHAP.
Which regulatory bodies oversee a Pharmaceutical Representative Office in Dubai
Three distinct authorities govern this structure, and none can be bypassed. Each has a specific and non-overlapping role in the approval and compliance process.
- MOHAP — The Ministry of Health and Prevention governs pharmaceutical product registration and representative office approvals at the federal level.
- DHA — The Dubai Health Authority oversees healthcare marketing and engagement with DHA-licensed practitioners operating within Dubai.
- DET — Dubai Economy and Tourism issues the trade licence under activity code 7010.98 and handles commercial registration for mainland Dubai entities.
If your medical detailing activity targets Dubai-based clinicians specifically, DHA compliance is required in addition to the federal MOHAP registration.
Does a Pharmaceutical Representative Office in Dubai require a local sponsor
No. Under current UAE commercial law, a Pharmaceutical Representative Office established under activity code 7010.98 does not require a local sponsor. 100% foreign ownership is permissible for this structure.
This makes it a particularly attractive low-overhead entry point for international pharmaceutical companies seeking a licensed UAE presence without the cost or complexity of a joint venture or local partnership arrangement.
The foreign parent company is still required to provide notarised and UAE embassy-attested documentation, including a board resolution authorising the establishment, a certificate of incorporation, and recent audited financials.
What is the minimum share capital requirement for this structure
There is no minimum share capital requirement for a Pharmaceutical Representative Office under activity code 7010.98. This is one of the structural advantages of this licence type compared to a full commercial entity in the UAE.
Because the representative office operates as an extension of the foreign parent company rather than as an independent trading entity, the capital requirements that typically apply to standalone commercial companies do not apply here. This significantly reduces the financial barrier to establishing a compliant UAE presence.
What documents does the foreign parent company need to provide for the licence application
The foreign parent company must supply a specific set of corporate documents, all of which must be properly notarised and attested by the UAE embassy in the country of origin before submission.
- A board resolution authorising the establishment of the representative office in the UAE
- An attested certificate of incorporation for the parent company
- Recent audited financial statements for the parent company
Incomplete or improperly attested documentation is cited as the primary cause of delays in the licence setup process. Ensuring all documents meet UAE attestation requirements before submission is essential to avoiding unnecessary setbacks.
What is the size of the Gulf pharmaceutical market and why is Dubai a strategic entry point
The Gulf pharmaceutical market is valued at approximately USD 8.7 billion, making it one of the most significant regional markets for international pharmaceutical companies seeking growth outside established Western markets.
Dubai sits at the centre of this market geographically and commercially, offering access to the broader GCC region alongside a well-developed regulatory infrastructure. The city's position as a regional hub for healthcare, logistics, and professional services makes it a natural base for companies looking to engage with regulators, healthcare practitioners, and distribution partners across the Gulf.
The Pharmaceutical Representative Office structure is specifically designed to provide a low-overhead, compliant entry point for foreign companies that need a licensed presence for promotion and regulatory engagement without committing to the full complexity of a commercial trading entity.
What is the difference between a Pharmaceutical Representative Office and a full commercial licence in Dubai
The distinction is both structural and consequential for compliance. A representative office under activity code 7010.98 operates as an extension of the foreign parent company and is restricted to promotion, regulatory liaison, and market intelligence activities. It cannot invoice clients, import products, or distribute pharmaceuticals directly in the UAE.
A full commercial licence, by contrast, establishes an independent trading entity capable of conducting sales transactions, importing goods, and engaging in distribution. It typically carries higher setup costs, more complex regulatory requirements, and — depending on the structure — may involve additional ownership or sponsorship considerations.
Choosing the wrong structure creates compliance risk. Operating a representative office outside its permitted scope exposes the entity to regulatory action from both DET and MOHAP. Understanding the boundary before setup is, as the regulatory framework makes clear, not optional.
What role does MOHAP registration play specifically for a Pharmaceutical Representative Office
MOHAP — the Ministry of Health and Prevention — is the federal authority responsible for pharmaceutical product registration and representative office approvals across the UAE. Its role is distinct from DET's commercial licensing function.
Any engagement in product promotion or facilitation of regulatory submissions requires a separate MOHAP representative office registration, in addition to the DET trade licence. This is not an optional step — it is a prerequisite for the core activities the structure is designed to support.
Current fee schedules and application requirements are published directly by MOHAP at mohap.gov.ae. Given that fee structures and documentation requirements can be updated, consulting the official source before initiating the application is strongly recommended.
Pharmaceutical Representative Office Setup in Dubai
Dubai sits at the centre of a Gulf pharma market worth billions. A representative office is the lightest structure that lets a foreign drug maker operate here legally. It costs less than a full trading entity and keeps your compliance footprint small.
This guide covers the license code, the approvals you need, and how to choose between mainland and free zone setup.
What This License Covers
A pharmaceutical representative office is a promotional structure. It lets your team meet doctors, brief hospitals, and build brand presence. It does not let you invoice customers or hold stock in the UAE.
The permitted scope is narrow by design. You promote products on behalf of a foreign parent company. All sales still run through the parent or a licensed distributor. The Ministry of Health and Prevention, known as MOHAP, runs a parallel approval track for the products you promote. You need both the trade license and MOHAP registration before you start any activity.
Key Stats at a Glance
| Activity code | To be confirmed with DET or Meydan Free Zone at setup |
|---|---|
| Permitted activity | Promoting pharmaceutical products – no selling, no invoicing |
| Key regulator | MOHAP (Ministry of Health and Prevention) |
| Secondary regulator | Dubai Health Authority (DHA) for Dubai-specific facilities |
| Foreign ownership | 100% permitted in a free zone |
| Minimum capital | Confirm with chosen jurisdiction at time of application |
| Stock holding | Not permitted under this structure |
A rep office cannot generate UAE revenue. If you need to sell directly, you need a different license. Many foreign pharma firms start with a rep office and upgrade later once the market is proven.
Who You Will Work With
Your main contacts are hospitals, clinics, and pharmacies. In Dubai, most large facilities are either government-run or DHA-regulated. Getting onto their approved vendor lists takes time. Start that process early.
Government hospitals run formal procurement rounds. They do not buy on a phone call. You need to be registered with the relevant health authority before your reps can present products. The Dubai Health Authority controls which products can be promoted to Dubai health facilities. DHA approval is a separate step from your MOHAP file.
Private hospital groups also have their own approval steps. Each group keeps its own formulary. Getting a product listed on a formulary can take 6 to 12 months. Plan your market entry timeline around that reality, not around your license issue date.
Your clients in this structure are not end patients. They are prescribers, procurement officers, and pharmacy buyers. Your reps need to speak their language and hold the right credentials.
Mainland or Free Zone
This is the biggest choice you will make at setup. Let your client base decide it.
| Factor | Mainland (DET) | Free Zone (Meydan Free Zone) |
|---|---|---|
| Client access | Direct access to UAE government hospitals and health bodies | Mainly international parent company link – local access needs a local agent |
| Office need | Physical office required | Flexi-desk options available |
| Cost | Higher setup and running costs | Lower cost, leaner structure |
| MOHAP filing | Filed as a mainland entity | Filed as a free zone entity – same MOHAP process |
| Foreign ownership | 100% permitted – Invest in Dubai | 100% permitted |
| Best for | Rep offices targeting government health procurement | Rep offices supporting a foreign parent with a lean Dubai presence |
A mainland license from DET lets you work directly with UAE government bodies. If your parent company's main target is Ministry of Health tenders or government hospital contracts, mainland is the right call.
A free zone setup through Meydan Free Zone costs less and needs less office space. It suits a rep office that is mainly a liaison point for a foreign parent. The MOHAP approval process is the same either way. The license structure does not change what MOHAP needs from you.
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Calculate NowHow to Set Up: Step by Step
The process runs on 2 parallel tracks: the trade license and the MOHAP approval. Start both at the same time. Waiting for one before starting the other adds months.
- Step 1, book your trade name: Use the DET portal for mainland or the Meydan Free Zone portal for a free zone setup.
- Step 2, pick your activity code: Confirm the code covers pharmaceutical promotion before you file.
- Step 3, submit parent company papers: You need audited accounts, a board resolution, and your home-country registration certificate.
- Step 4, file with your chosen authority: DET for mainland, Meydan Free Zone for free zone. Get your trade license issued.
- Step 5, apply to MOHAP: Each product needs its own file. Submit product dossiers, labelling, and the parent company's manufacturing approvals.
- Step 6, get DHA approval: If you are promoting to Dubai health facilities, file with the Dubai Health Authority as a separate step.
- Step 7, open your bank account: Use your trade license and parent company documents. Free zone companies may find this easier with business banking support.
- Step 8, hire your reps: Medical reps must hold MOHAP-recognised credentials. File their details with MOHRE before they start work.
The MOHAP product file is the longest part. Budget 3 to 6 months for each product. Your license can be issued while MOHAP reviews the files, but your reps cannot promote until both approvals are in place.
Rules You Must Follow
Running a pharma rep office in Dubai means staying on top of 2 sets of rules at once. The trade license has its own renewal cycle. MOHAP approval has its own cycle. Missing either one stops your reps from working legally.
Here are the main compliance duties:
**MOHAP product registration** Each drug or medical product needs its own file with MOHAP. You cannot promote a product until MOHAP has approved it. Registration is not a one-time step. Products need renewal on MOHAP's schedule. **Promotion rules** Off-label claims are not allowed. You cannot promote a product for uses MOHAP has not approved. Direct-to-patient advertising is banned for prescription drugs. All promotional materials need to match the approved product information exactly. **Staff credentials** Medical reps need MOHAP-recognised qualifications. This usually means a pharmacy or life sciences degree. Check the current MOHAP list before you hire. Using unqualified reps is a serious breach. **Annual renewals** Both your trade license and your MOHAP approval need annual renewal. Set reminders 3 months before each deadline. Late renewal means your reps cannot legally call on clients until the file is back in order. **DHA rules for Dubai** If your reps visit Dubai health facilities, DHA has its own code of conduct for pharma promotion. Gifts, hospitality, and samples are all tightly controlled. Read the DHA rules before your reps make their first visit.Breaking these rules can mean fines, suspension of your MOHAP approval, or removal from hospital approved-vendor lists. None of those are quick to fix. Build compliance into your operating model from day one.
The Market Opportunity
The Gulf pharma market is growing. The UAE sits at the top of the region for healthcare spending per capita. Dubai is the main entry point for most foreign pharma firms looking at the wider Gulf.
Government investment in healthcare infrastructure is driving demand for new products. The Ministry of Health and Prevention has been expanding its approved product list. Private hospital groups are also growing fast. Both channels need active rep coverage to stay informed about new products.
A rep office lets you build those relationships without committing to a full trading entity. Once you have market data and a proven prescriber base, converting to a full trading license is straightforward. Many firms use the rep office as a 2 to 3 year market-building phase before they scale.
You can also start a business remotely if your team is not yet based in the UAE. Meydan Free Zone supports remote company formation, so you can get the license in place while your reps relocate.
Conclusion
A pharma rep office in Dubai is a lean, compliant way to build market presence. It runs on 2 parallel approval tracks: the trade license and MOHAP registration. Get both right from the start and the structure works well.
The choice between mainland and free zone comes down to your client base. Government hospital contracts point to mainland. A leaner liaison office points to Meydan Free Zone. Either way, the MOHAP process is the same.
Plan for 3 to 6 months from first filing to having reps in the field with full approval. Use that time to build your hospital contacts and get onto approved vendor lists.
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