Services
Product registration
We prepare your dossiers for both of Iraq's regulators, submit them in parallel and stay with each file until the marketing authorisation is issued.
Why registration in Iraq takes two files
Iraq has two independent health authorities. The Ministry of Health in Baghdad regulates the fifteen federal governorates, and the Kurdistan Medical Control Agency in Erbil regulates the four governorates of the Kurdistan Region. Approval from one does not allow you to sell in the other.
Our regulatory team works with both authorities every week. We know how each one reads a dossier, which questions they tend to ask and how to prepare a file that answers them before they are raised. That is what shortens timelines.
How we take a product to approval
- 1
Dossier assessment
We review your CTD or eCTD dossier against the specific requirements of the MOH and the KMCA and send you a written list of gaps to close before anything is filed.
- 2
Manufacturing site registration
A product cannot be registered until its manufacturing site is approved. We file the site master file and GMP evidence first so the product dossiers are not held up later.
- 3
Submission
We compile, translate and submit the product dossiers to both authorities, keeping the two files consistent so a change in one does not create a query in the other.
- 4
Committee queries
Technical committees often ask for clarification or extra data. We follow up in person, explain what is being asked and prepare responses with your regulatory team.
- 5
Pricing approval
We prepare the CIF pricing file with reference prices from neighbouring markets and present it to the pricing committee.
- 6
Marketing authorisation
Once the certificate is issued, the product can be imported. We hand over to our distribution team on the same day.
MOH and KMCA at a glance
| Parameter | MOH Baghdad | KMCA Erbil |
|---|---|---|
| Jurisdiction | Federal Iraq, 15 governorates | Kurdistan Region, 4 governorates |
| Dossier format | CTD, eCTD preferred | CTD accepted |
| Pricing | Strict CIF price caps | Independent pricing review |
| Typical timeline | 12 to 18 months | 6 to 9 months |
Timelines are counted from submission of a complete dossier and vary by product class.
Documents you will need
Most delays come from missing or unlegalised certificates. We send this list at the start of every engagement and check each document before it is filed.
- Certificate of Pharmaceutical Product (CPP)
- Good Manufacturing Practice (GMP) certificate
- Free Sale Certificate (FSC)
- Complete CTD dossier, modules 1 to 5
- Stability data for climatic zones IVa and IVb
- Bioequivalence studies, for generics
- Pricing justification with reference prices
- Legalised agency agreement with Jaddaf