Certificate of Free Sale (CFS)
Dietary supplements, medical foods and foods for special dietary use.
Iraq has not joined the Hague Apostille Convention, so Iraqi ministries will not rely on an apostilled FDA certificate. The document is first authenticated by the U.S. Department of State and then legalized by the Embassy of Iraq in Washington. Send us the digital certificate and we return the legalized original by FedEx in about 14 business days.
Simply upload your FDA digital file, and you will receive your legalized document via FedEx.
FedEx delivery is used to return the completed legalized document after processing.
See expedited options →Health products in Iraq pass through two gates. The Ministry of Health registers foreign suppliers and their products through its registration board, and it issues the import licence for each private-sector consignment. Kimadia, the state-owned company managed by the Ministry, imports and distributes medicines and medical appliances for public hospitals through near-daily tenders. Both gates ask for proof from the country of origin that the manufacturer and product are legitimate, and for U.S. goods that proof is an FDA export certificate.
Registration guides for Iraq are blunt about the paperwork: every document submitted must be properly legalized and stamped under Iraqi law. A certificate that is merely notarized or apostilled will be returned. That is why we route each FDA certificate through the U.S. Department of State for authentication and then to the Embassy of Iraq for legalization, the two signatures an Iraqi reviewer looks for.
Match your product to the Iraqi authority that reviews it and the FDA certificate that authority normally expects.
| Product type | Iraqi authority | FDA certificate |
|---|---|---|
| Medicines | Ministry of Health registration board, with Kimadia for public-sector supply | Certificate of a Pharmaceutical Product (CPP), Certificate of Exportability |
| Medical devices & appliances | Ministry of Health and Kimadia | Certificate to a Foreign Government (CFG), Certificate of Exportability |
| Manufactured food & infant formula | Ministry of Health (health certificates); COSQC for product standards | Certificate to a Foreign Government (CFG), Health Certificate |
| Dietary supplements | Ministry of Health, as a drug or food depending on the claims | Certificate of Free Sale (CFS) |
| Cosmetics & personal care | Ministry of Health and COSQC standards | Certificate for Cosmetics |
Federal Iraq and the Kurdistan Region run separate systems. In Erbil, the KRG Ministry of Health's Directorate of Pharmaceutical Products Quality Control approves medicines and licenses importers. Ask your Iraqi agent or scientific office which authority will review your file before ordering certificates.
Iraq is not a party to the Hague Apostille Convention, so it does not accept apostilles. Your FDA certificate is first authenticated by the U.S. Department of State and then legalized by the Embassy of Iraq.
Send the digital certificate exactly as the FDA issued it and choose Iraq as the destination.
We submit it to the Office of Authentications, which issues the federal authentication certificate in about 9 business days.
We take the authenticated certificate to the Embassy of Iraq for legalization, which takes about 5 business days.
The legalized certificate ships to you, your importer or your agent in Baghdad or anywhere else.
Kimadia publishes tenders almost daily, and a bid is only valid with a complete, legalized document set. Because legalization takes about 14 business days, keep spare legalized FDA certificates on hand rather than ordering them after a tender opens.
Before any product file is reviewed, the foreign manufacturer must be registered with the Ministry of Health. That company file typically includes a legalized registration certificate from the country of origin, a quality certificate such as ISO, the product catalogue and a letter of authorization for the local representative.
Medicines entering through KRG border crossings are approved and laboratory-tested by Erbil's own quality-control directorate, which aims to finish testing within 45 days. If you sell in both Baghdad and Erbil, plan one legalized certificate set for each regulator.
A local representative is not strictly required for tenders, but in practice Kimadia favours suppliers with a scientific office or local agent in Iraq. Arabic is the working language, so budget for a certified Arabic translation made after legalization.
| Item | Amount | Notes |
|---|---|---|
| Our service fee | $120 / doc. | Review, submission, tracking and FedEx dispatch |
| U.S. Department of State fee | $20 / doc. | State Department authentication, about 9 business days |
| Embassy of Iraq fee | $160 / doc. | Embassy legalization, about 5 business days. Paid by us on your behalf |
| Total | $300/ doc. | Standard processing: 14 business days. Expedited options available. |
No. Iraq is not a party to the Hague Apostille Convention. FDA certificates need U.S. Department of State authentication and then legalization by the Embassy of Iraq.
About 14 business days: roughly 9 business days at the State Department and 5 business days at the Embassy of Iraq, plus FedEx shipping to you or your agent.
$300: our $120 service fee, the $20 U.S. Department of State fee and the $160 Embassy of Iraq fee. There are no extra government charges on top.
Kimadia is the state-owned company, managed by Iraq's Ministry of Health, that imports and distributes medicines and medical appliances for the public health system. It buys through tenders, and suppliers must first be registered with the Ministry.
The legalization chain is the same, but the regulator is different. The KRG Ministry of Health in Erbil approves and tests medicines on its own. See our Kurdistan Region page and confirm with your importer which authority needs the certificate.
Usually a CPP for medicines, a CFG for devices and conventional foods, a Certificate of Free Sale for supplements and a Certificate for Cosmetics for cosmetic products. A Certificate of Exportability covers products not marketed in the U.S.
Dietary supplements, medical foods and foods for special dietary use.
Medical devices, conventional foods, food additives and infant formula sold in the U.S.
The WHO-format certificate used to register human drugs.
Products made in the U.S. for export only.
Collagen and gelatin exports (EU health certificate or SRM certificate).
Skincare, makeup, haircare and fragrance products.
Upload your FDA certificate today and receive it legalized by FedEx in 14 business days, for $300per document with State Department and embassy fees included.
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Simply upload your FDA digital file, and you will receive your apostilled document via FedEx.