Country · Middle East
Pharmaceutical exports to the UAE, ready for registration
Progene Pharma supplies importers, distributors, hospital suppliers and tender suppliers in the United Arab Emirates with generic medicines we manufacture in a WHO-GMP certified facility. We prepare the dossier, the COPP and the GMP evidence the federal authorities ask for, pack in Arabic and English, and ship to Jebel Ali.
- Regulators
- EDE and the Ministry of Health
- Labels
- Arabic and English
- Stability
- Zone IVb, 30 °C / 75% RH
- Main ports
- Jebel Ali, Khalifa Port
The Emirati medicines market in brief
The United Arab Emirates is a compact but very open pharmaceutical market and one of the Gulf's main distribution hubs. Dubai in particular is a trading centre for medicines that are re-exported to the rest of the Gulf, Africa and Central Asia, which makes registered products and clean documentation especially valuable.
Demand follows an expatriate and national population with high rates of diabetes, high blood pressure and heart disease, so chronic care medicines sell in large volumes, alongside antibiotics, pain medicines, supplements and personal care products. Quality expectations are high.
Medicines are registered at the federal level, while hospitals and health groups in each emirate, including Dubai and Abu Dhabi, run their own procurement. Distributors, pharmacy chains and hospital groups buy alongside them. The authorities also set the price of registered medicines, so margins are agreed with that in mind.
Medicines we supply to United Arab Emirates
These are the medicines Emirati distributors ask us for most. We make any human formulation to your specification, under your brand. See all human formulations
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Generic medicines for pharmacies
Analgesics, antihistamines, gastric medicines and everyday prescription generics in the strengths and packs pharmacies sell.
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Antibiotics and infections
Amoxicillin, amoxicillin and clavulanic acid, azithromycin, ciprofloxacin, cefixime and ceftriaxone injection, for clinics and hospitals.
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Pain and fever
Paracetamol, ibuprofen and diclofenac in tablets, suspensions and injections.
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Diabetes and heart care
Metformin, glimepiride, amlodipine, losartan and atorvastatin, as long-term conditions become a larger share of prescriptions in Dubai, Abu Dhabi and Sharjah.
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Stomach and allergy
Omeprazole, pantoprazole, cetirizine, montelukast and cough syrups, for everyday pharmacy sale.
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Hospital and tender supplies
IV fluids, injectable antibiotics, anaesthetics and analgesics in hospital packs for tenders.
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Vitamins and supplements
Multivitamins, vitamin D3, omega-3, probiotics and protein products for pharmacies, health stores and online sellers.
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Herbal and personal care
Herbal products, creams, washes, shampoos and soaps under your brand, with the ingredient lists your authority requires.
EDE registration, step by step
A medicine cannot be imported or sold in the UAE until the federal authorities, the Emirates Drug Establishment and the Ministry of Health and Prevention, have registered it. This is the usual route for a finished pharmaceutical product made abroad.
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01
A local company applies
The registration is held through a company in the UAE that is licensed to register and distribute medicines, usually the importer or a scientific office, acting as the local agent of the manufacturer. It applies to the authority.
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02
The manufacturer authorises it
The manufacturer gives the applicant a letter of authorisation that names the product and the company, which we provide.
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03
The dossier goes in
The applicant submits the CTD dossier with Zone IVb stability data, the WHO-format COPP, the GMP certificate, the samples and, for generics, the bioequivalence data the authority asks for. We prepare the manufacturer's documents.
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04
EDE reviews it
The authority assesses the dossier and may ask questions, which we answer with you.
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05
GMP evidence and samples
The authority checks that the manufacturing site complies with GMP, from the documents or an inspection, and may test samples.
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06
Registration and renewal
On approval the authority issues a registration and sets the price. The product is entered in the UAE's medicine tracking system, and the registration is renewed before it expires.
Registration takes from several months to more than a year, and EDE updates its requirements from time to time, so check the current guidelines with EDE or your regulatory agent. Many importers register a few products first and add more as orders grow.
Who does what when you import into United Arab Emirates
A clear split of the paperwork, so nothing falls between the importer and the manufacturer.
Your company handles
- The registration application, as the licensed UAE agent
- The licences your business needs to import and distribute medicines
- Bioequivalence studies for generics, where the authority asks for them
- The import permit and customs declaration, through your clearing agent
- Entry of each product in the national tracking system
Progene Pharma handles
- The CTD dossier, stability data and samples
- The COPP, the GMP certificate and the letter of authorisation
- A Certificate of Analysis for every batch
- Labels and leaflets with your registration details
- Invoice, packing list and certificate of origin
- Answers to EDE's questions during review
Made for Emirati conditions
Heat, humidity, long journeys and several languages: what a medicine needs to stay good from the port to the patient.
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Arabic and English labels
Cartons and patient leaflets in Arabic and English, with the registration details, batch number, expiry date and storage conditions the authority requires, and an approved proof before printing.
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Track-and-trace codes
Space on the pack for the 2D barcode the UAE requires for tracking each medicine through the supply chain, applied to match its system.
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Tested for heat
Stability studies at 30 °C and 75% relative humidity (Zone IVb), the condition the Gulf authorities ask for, so the shelf life holds up in summer temperatures.
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Packs for re-export
Packs and documents that suit a distributor re-exporting to other Gulf, African and Central Asian markets.
Shipping to United Arab Emirates
Orders leave from Nhava Sheva (JNPT) near Mumbai by sea, or by air when they are urgent, with the documents your clearing agent needs.
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Jebel Ali
Dubai's main port and the largest in the region, the route for most medicines, with a free zone for re-export
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Khalifa Port
Abu Dhabi's container port
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Dubai and Abu Dhabi
By air to Dubai International, Al Maktoum or Abu Dhabi airports for urgent orders and samples
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Terms and documents
FOB, CFR or CIF, with invoice, packing list, certificate of origin and COA, legalised documents where required, and the import permit from your side
Where Emirati distributors sell
The same registered product moves through several channels, and each needs its own pack.
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Hospitals and health groups
Government and private hospital groups in each emirate buy in hospital packs, often through group contracts.
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Pharmacies and chains
Large pharmacy chains and independent pharmacies want branded packs of everyday generics and supplements.
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Distributors and re-exporters
Licensed distributors in Dubai supply the UAE and re-export to neighbouring markets, and need clean documents.
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Online and specialty retail
E-commerce and specialty retailers buy supplements and personal care products under their own brands.
Questions about supplying United Arab Emirates
Something else? Email [email protected].
Do you export medicines to United Arab Emirates?
Yes. Progene Pharma manufactures generic medicines in a WHO-GMP certified facility and supplies them to importers, wholesalers, hospital suppliers and tender suppliers in United Arab Emirates.
Can you help us register products with EDE?
Yes. Progene Pharma prepares the documents EDE registration needs: a CTD dossier with stability data, the WHO-format COPP, the GMP certificate, the letter of authorisation and samples for testing. Your UAE company submits the application, and we answer EDE's questions with you.
Do I need a local company to register and import?
Yes. The UAE registers a medicine through a licensed company in the country, which then imports and distributes it. Check the current requirements with the authority.
How long does EDE registration take?
It varies by product and by how complete the dossier is, from several months to more than a year. A complete dossier with clear stability data and prompt answers to EDE's questions helps. Many importers register a few products first and add more as orders grow.
Which documents does EDE ask for?
The usual set is a CTD dossier, a COPP, a GMP certificate, stability data, a letter of authorisation, product samples and artwork. EDE updates its requirements from time to time, so confirm the current list with EDE or your regulatory agent. We tell you what we can provide with your quotation.
Who registers medicines in the UAE?
Medicines are registered at the federal level by the Emirates Drug Establishment and the Ministry of Health and Prevention, while health authorities in each emirate, such as those in Dubai and Abu Dhabi, regulate hospitals and pharmacies. Check the current process with the authority.
Can you supply products for re-export from Dubai?
Yes. Progene Pharma supplies registered products and clean documentation that distributors can use to re-export to other Gulf, African and Central Asian markets, subject to each destination's rules.
Does the UAE set the price?
Yes. The authorities set the price of each registered medicine as part of registration, so the distributor's price and margin are agreed with that in mind.
What must the packs carry for United Arab Emirates?
Arabic and English text, the registration details, batch number, manufacture and expiry dates, storage conditions, and the 2D barcode for the UAE's tracking system. We prepare the artwork to match your registration and you approve a proof before printing.
Are your medicines suitable for the climate?
Yes. Products for this market are tested at 30 °C and 75% relative humidity (Zone IVb) and packed in moisture-resistant blisters or bottles, so the shelf life stays valid in hot conditions.
Can you supply tenders in United Arab Emirates?
Yes. Progene Pharma supplies tender packs and the product documents tenders usually ask for, such as the COPP, GMP certificate and COA. Tell us the tender requirements and we will confirm what we can provide.
How are orders shipped to United Arab Emirates?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Jebel Ali or Khalifa Port, or by air to Dubai or Abu Dhabi for urgent orders, on FOB, CFR or CIF terms. We confirm the schedule with your quotation.
What is the minimum order quantity?
It depends on the product, the dosage form and the packaging. We work with large importers and tender suppliers as well as smaller distributors, and confirm the minimum quantity with your quotation.
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Request a quote
Send us your product requirements and target country. Our team will reply with a quotation and next steps.
- [email protected]
- Phone
- +91 22 49793146
- +91 90829 70494