Iraq is two administrations, and in medicines they run in series rather than in parallel. The Kurdistan agency will not register a product until you hold the federal registration decision from Baghdad, so a Kurdistan-only entry is not available for a registered medicine. We establish what each of your products would need, in which order, and which firms can actually carry it through both.
The organising fact about Iraq is that federal Iraq and the Kurdistan Region run separate administrations across much of what matters to an importer. That much is widely known. What is less known, and what changes entry strategy, is that in medicines the two are not alternatives. The Kurdistan agency publishes its own service conditions, and they require the Iraqi Ministry of Health’s preliminary decision letter before preliminary registration and its final certificate before final registration. Manufacturer registration works the same way. Erbil sits downstream of Baghdad.
Federally, registration is of the factory and the product, with the manufacturer named on the file. The route has been considerably faster since a fast-track was introduced in 2019, which on the published account produces temporary registration and an import licence in about a month against roughly a year for the standard route. Recognised regulators — the American, European, British, Swiss, Canadian, Japanese and Australian authorities among them — carry weight, and a manufacturer without one of their certificates can expect a ministry inspection before approval.
Price is set at registration, and the formula is unusually explicit about where you manufacture. On the account published in 2021, a generic was priced as a percentage of the brand that varied by the manufacturer’s location: around 60% for North America, Europe, Australia, South Korea and Japan, around 40% for the Middle East and South America, and around 20% for East and South East Asia. We would treat those as the position as documented five years ago rather than as today’s numbers, but the principle — that your plant’s address is a pricing input — is worth knowing before you choose where to make what you sell here.
It is a market people leave and come back to. GSK withdrew from Iraq and, on the Ministry of Health’s own account of meetings held in August 2026, is in talks to return. That is a fair summary of the opportunity and the difficulty in one sentence.
Most entry plans we see for Iraq treat the Kurdistan Region as an easier door into the same room. The Kurdistan agency’s own published service conditions say otherwise: its preliminary product registration requires a preliminary decision letter from the Iraqi Ministry of Health, and its final registration requires the federal final certificate. Manufacturer registration runs the same way. So Erbil is downstream of Baghdad, the two files have to agree, and you pay for both.
The second thing to settle is who holds what. A commercial agency has to be registered with the Registrar of Companies, and an unregistered agreement is not recognised by Iraqi authorities and is unenforceable by either party, not only by the agent. On the reading of the 2017 law published when it came in, a corporate agent’s capital must be entirely Iraqi-owned. And on the pharmaceutical side the operating licence is the scientific bureau’s, issued to it, reportedly not transferable, and reportedly capped at five companies represented. Appointment decisions here are structural, not commercial.
The private channel runs through the scientific bureau — a licensed entity, not a job title. It is licensed by the pharmacists’ syndicate rather than by the ministry, it imports and sells to drug stores, and on the account of the one Iraqi firm we found addressing it directly it may represent up to five companies and its licence cannot be transferred. We would attribute rather than assert those two limits, because they rest on a single source, but both are the kind of detail that decides whether a candidate can take you on at all, so they are worth asking about in the first conversation.
The public channel is the state drug company, which tenders, imports and distributes to public facilities across all eighteen governorates, Kurdistan included. Its bidding documents are unusually informative about what it expects of a foreign supplier: the scientific bureau must be the exclusive representative of all the company’s products and must be named in the contract; a bidder without a business presence in Iraq must have a qualified local agent for service and warranty if it wins; and while registration is not an absolute precondition to bidding, no payment is made for shipped goods without proof that registration documents have been submitted. Bid security is 1%, and SWIFT guarantees are not accepted.
In the Kurdistan Region there is a third route: local health directorates procure directly from marketing authorisation holders alongside the state company’s distribution. That is worth knowing because it is the one part of this market where a manufacturer deals with a public buyer without a national intermediary — and it still does not remove the requirement to have registered federally first.
Ask for the documents. Iraq rewards this more than most markets, because the gap between what a firm says it can do and what it is licensed to do is wide and the public record is thin.
Several of these are about your own position rather than the candidate’s, because in Iraq the order of operations decides what any partner can do for you.
Work out, product by product, what federal registration would require and what the Kurdistan chain would then require on top. If your plan was to start in Erbil because it looks easier, this is the step that corrects it. The two files have to agree, and the Kurdistan agency asks for a pledge that identical information was filed with both.
A federal registration is revoked automatically if the information is not updated after five years. Ask a candidate to describe how it tracks that across the portfolios it already represents. A firm that has let one lapse will usually say so; a firm that has never thought about it will say it is routine.
Not whether they have an agency agreement — whether it is registered with the Registrar of Companies. Unregistered, it is unenforceable by you as well as by them, which is a worse position than having no agreement at all because it looks like protection and is not.
Since the dollar auction closed, payment runs through commercial banks’ own correspondent relationships. Ask which bank, which correspondent, and whether the bank has had dollar access restricted at any point. Iraq was added to the FATF’s increased-monitoring list in June 2026, which makes those relationships more expensive and more fragile, not less.
The customs authority has stated plainly that tariff classification is its exclusive jurisdiction and that a health ministry clearance does not make a product a medicine for assessment. The difference between 0.5% and 10% is decided there. Get the classification settled before you build a price list.
The state buyer requires the scientific bureau to be the exclusive representative of all your products and to be named in the contract. That one condition can be incompatible with a multi-distributor plan, and it is better discovered now than after you have appointed two firms.
Independent research has documented substantial informal payments at port and on internal checkpoints, in estimates attributed to officials rather than to records. We would not put a number on it. We would ask a candidate how its goods move from the port to the warehouse, who handles clearance, and what that costs — and listen carefully to how readily the question is answered.
Federal customs moved to a new electronic system at the start of 2026 and companies registered only in the Kurdistan Region have reported difficulty shipping into federal Iraq since. A mechanism to recognise them exists but is reported to be complex and widely avoided. If your plan assumes one partner serving the whole country, test that assumption explicitly.
A brand owner starts in Erbil because the paperwork looks lighter, then finds the Kurdistan agency will not issue a registration without the federal decision it does not have. The time lost is the whole federal route, and it is spent after the launch date was promised rather than before.
Five years pass, the file is not updated, and the registration is revoked. There is no dispute to have and nobody to blame but the arrangement. This is the single cleanest documented way to lose market access in Iraq and it is entirely preventable.
Parties sign, trade for two years, then fall out — and discover the agreement is not recognised by Iraqi authorities and cannot be enforced by either of them. Registration is not an administrative afterthought here; it is what makes the contract exist.
The federal law says a principal may not terminate or refuse to renew except for good cause. What good cause means has not been tested in any decision we could find. Separately, there is no statutory compensation formula — unlike the Gulf agency regimes people often assume Iraq resembles — so a claim would run on general civil code damages. Iraq is neither as protective nor as predictable as either extreme.
Goods ship, the distributor sells, and the payment does not arrive because its bank has no working correspondent relationship. The central bank’s own account of the system is that traders are unlikely to have problems unless their funds sit at a bank without one, which is precisely why the question belongs in due diligence.
The official pharmacovigilance bulletin recorded thirty-six falsified and forty substandard medicine alerts in 2024, and the peer-reviewed account of this market records that a large majority of private-sector medicines were, as of 2021, neither registered nor quality-tested. A tracking and labelling programme is now running in the private sector, which is a genuine improvement, but whose name sits beside yours in that channel matters more here than in most places.
No, not for a registered medicine. The Kurdistan agency’s published conditions require the Iraqi Ministry of Health’s preliminary decision letter before it will grant preliminary registration, and the federal final certificate before final registration. Manufacturer registration is conditioned the same way. Erbil is a second registration, not an alternative one, and it carries its own fees.
We would be careful with how that question is usually answered. There is no simple rule that says a foreign company cannot import. What is documented is narrower and firmer: private pharmaceutical importation runs through a licensed scientific bureau; the state buyer requires a named scientific bureau as exclusive representative and a local agent for service and warranty where the bidder has no Iraqi presence; and a commercial agency is unenforceable unless registered. In practice you will have a local partner. The question is what it holds and how the relationship is papered.
No. This surprises people who assume Iraq follows the Gulf agency model. The 2017 law requires good cause to terminate or refuse renewal, but it contains no compensation formula, so a claim would be assessed under general civil code principles — actual loss and foreseeable lost profit, with courts able to reduce excessive agreed damages. The good-cause provision was described as untested when it came in and we found nothing since to suggest it has been tested.
Contested, and we will not pretend otherwise. The Region is reported still to apply the older 2000 law, which covers only true agency and is said to allow a principal to terminate at will, leaving distributorship unregulated. That rests on secondary sources, the most specific of which is undated, and a 2023 academic study recommended the Kurdistan parliament enact its own law — which implies there was none. Treat the difference as real and the detail as needing current local advice.
Through your distributor’s bank and its correspondent relationships. The central bank closed its dollar auction platform on 2 January 2025 and moved international transactions onto commercial banks’ own correspondent networks, with the central bank supervising and replenishing balances. The practical consequence is that the identity and standing of your partner’s bank is a commercial term. Iraq’s addition to the FATF increased-monitoring list in June 2026 makes that more acute.
This is the weakest-documented part of the market, and saying so is better than inventing structure. Devices are registered through the same ministry route and the state buyer requires bidders to register the supplies they offer, but we could find no Iraqi device statute, instruction number or classification scheme in any primary source. The class schemes and validity periods published online trace to consultancy marketing. For a device, we would establish the position directly with the registration department rather than rely on any published summary, including ours.
Two registrations in series, an agency that has to be registered to be enforceable at all, and payment that depends on your partner’s correspondent bank. None of that is visible from a company profile.
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