Country · Middle East
Pharmaceutical exports to Iraq, ready for ministry registration
Progene Pharma supplies Iraqi importers, scientific offices, hospital suppliers and tender suppliers with generic medicines we manufacture in a WHO-GMP certified facility. We prepare the dossier, the COPP and the samples the Ministry of Health asks for, label in Arabic, and ship to Umm Qasr and Basra.
- Regulator
- Ministry of Health
- Labels
- Arabic and English
- Stability
- Zone IVb, 30 °C / 75% RH
- Main port
- Umm Qasr
The Iraqi medicines market in brief
Iraq has a large, young population and one of the largest pharmaceutical import markets in the Middle East. Most medicines are imported, and the government has been rebuilding its health system and encouraging local production, so demand for registered imports remains strong.
Chronic care medicines for diabetes, high blood pressure and heart disease sell in large volumes, alongside antibiotics, pain medicines, gastric products and, in the public system, medicines for cancer and kidney disease. Vitamins and supplements sell widely through pharmacies.
The state buys a very large share of medicines for public hospitals through its central marketing company, Kimadia, and its tenders, while private pharmacies, clinics and distributors buy alongside it. Foreign manufacturers normally work through a registered scientific office, and the Kurdistan Region has its own health ministry and registration process.
Medicines we supply to Iraq
These are the medicines Iraqi distributors ask us for most. We make any human formulation to your specification, under your brand. See all human formulations
-
Generic medicines for pharmacies
Analgesics, antihistamines, gastric medicines and everyday prescription generics in the strengths and packs pharmacies sell.
-
Antibiotics and infections
Amoxicillin, amoxicillin and clavulanic acid, azithromycin, ciprofloxacin, cefixime and ceftriaxone injection, for clinics and hospitals.
-
Pain and fever
Paracetamol, ibuprofen and diclofenac in tablets, suspensions and injections.
-
Diabetes and heart care
Metformin, glimepiride, amlodipine, losartan and atorvastatin, as long-term conditions become a larger share of prescriptions in Baghdad, Basra, Erbil and Mosul.
-
Stomach and allergy
Omeprazole, pantoprazole, cetirizine, montelukast and cough syrups, for everyday pharmacy sale.
-
Hospital and tender supplies
IV fluids, injectable antibiotics, anaesthetics and analgesics in hospital packs for tenders.
-
Vitamins and supplements
Multivitamins, vitamin D3, omega-3, probiotics and protein products for pharmacies, health stores and online sellers.
-
Herbal and personal care
Herbal products, creams, washes, shampoos and soaps under your brand, with the ingredient lists your authority requires.
MoH registration, step by step
A medicine cannot be imported or sold in Iraq until the Ministry of Health has registered it, through its drug registration department. This is the usual route for a finished pharmaceutical product made abroad.
-
01
A local company applies
The registration is held through a company in Iraq, usually a registered scientific office or the importer, acting as the local agent of the manufacturer. It applies to the ministry.
-
02
The manufacturer authorises it
The manufacturer gives the applicant a letter of authorisation that names the product and the company, which we provide.
-
03
The dossier goes in
The applicant submits the CTD dossier with Zone IVb stability data, the WHO-format COPP, the GMP certificate and the samples, with documents legalised where required. We prepare the manufacturer's documents.
-
04
MoH reviews it
The ministry assesses the dossier and may ask questions, which we answer with you.
-
05
Samples and inspection
The samples are tested in the national laboratory, and the ministry may inspect the manufacturing site or rely on its GMP certification.
-
06
Registration and renewal
On approval the ministry issues a registration and a registration number, which goes on every pack. The registration is valid for a fixed period and is renewed before it expires.
Registration takes from several months to more than a year, and MoH updates its requirements from time to time, so check the current guidelines with MoH or your regulatory agent. Many importers register a few products first and add more as orders grow.
Who does what when you import into Iraq
A clear split of the paperwork, so nothing falls between the importer and the manufacturer.
Your company handles
- The ministry application, through a registered scientific office or importer
- The licences your business needs to import and distribute medicines
- The import approval for each consignment
- The customs declaration, through your clearing agent
- Payment terms, usually a letter of credit
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 number
- Invoice, packing list and certificate of origin
- Answers to MoH's questions during review
Made for Iraqi conditions
Heat, humidity, long journeys and several languages: what a medicine needs to stay good from the port to the patient.
-
Arabic labels
Cartons and patient leaflets in Arabic, with English where wanted, and the registration number, batch number, expiry date and storage conditions the ministry requires, and an approved proof before printing.
-
Tested for heat
Stability studies at 30 °C and 75% relative humidity (Zone IVb), the condition regional authorities ask for, with moisture-resistant blisters and bottles, so the shelf life holds up in Iraqi summers.
-
Packs for every channel
Pharmacy packs, hospital packs and tender packs in the quantities Kimadia, hospitals and pharmacies buy.
-
Documents that suit legalisation
Certificates and documents prepared so they can be legalised by the chamber of commerce and the embassy where Iraq requires it.
Shipping to Iraq
Orders leave from Nhava Sheva (JNPT) near Mumbai by sea, or by air when they are urgent, with the documents your clearing agent needs.
-
Umm Qasr
Iraq's main seaport, the usual route for medicines, with road freight to Basra and Baghdad
-
Aqaba
An alternative route through Jordan, by sea and then by road to Baghdad
-
Baghdad, Basra and Erbil
By air to the international airports for urgent orders and samples
-
Terms and documents
FOB, CFR or CIF, with invoice, packing list, certificate of origin and COA, legalised documents where required, and the import approval and customs declaration from your side
Where Iraqi distributors sell
The same registered product moves through several channels, and each needs its own pack.
-
State purchasing
Kimadia and the health ministry buy for public hospitals through tenders, and ask for the full document set.
-
Private pharmacies
Pharmacies in Baghdad, Basra and the other cities sell branded packs of everyday generics and supplements.
-
Hospitals and clinics
Private hospitals and clinics buy in hospital packs, often through distributors.
-
The Kurdistan Region
Distributors in Erbil and Sulaymaniyah supply the region, which has its own health ministry and registration process.
Questions about supplying Iraq
Something else? Email [email protected].
Do you export medicines to Iraq?
Yes. Progene Pharma manufactures generic medicines in a WHO-GMP certified facility and supplies them to importers, wholesalers, hospital suppliers and tender suppliers in Iraq.
Can you help us register products with MoH?
Yes. Progene Pharma prepares the documents MoH registration needs: a CTD dossier with Zone IVb stability data, the WHO-format COPP, the GMP certificate, the letter of authorisation and samples for testing. Your Iraqi company submits the application, and we answer MoH's questions with you.
Do I need a local company to register and import?
Yes. Iraq registers a medicine through a company in the country, usually a registered scientific office or the importer. Check the current requirements with the Ministry of Health.
How long does MoH 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 MoH's questions helps. Many importers register a few products first and add more as orders grow.
Which documents does MoH ask for?
The usual set is a CTD dossier, a COPP, a GMP certificate, stability data, a letter of authorisation, product samples and artwork. MoH updates its requirements from time to time, so confirm the current list with MoH or your regulatory agent. We tell you what we can provide with your quotation.
What is a scientific office in Iraq?
It is a company registered with the Ministry of Health to represent foreign manufacturers, register their products and promote them. A foreign manufacturer normally works through one. Check the current requirements with the ministry.
Does the Kurdistan Region have a separate registration?
The Kurdistan Region has its own health ministry and may require its own approval. Tell us whether you supply federal Iraq, the Kurdistan Region or both and we will confirm what to prepare.
Can you supply Kimadia tenders?
Yes. Progene Pharma supplies tender packs and the product documents state tenders usually ask for. Tell us the tender requirements and we will confirm what we can provide.
What must the packs carry for Iraq?
Arabic text, with English where wanted, the registration number, batch number, manufacture and expiry dates, storage conditions and the other details the ministry requires. 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, humid conditions.
Can you supply tenders in Iraq?
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 Iraq?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Umm Qasr, with onward road freight to Basra and Baghdad, or by air to Baghdad or Basra 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.
Related pages
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