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FDA Document Authentication for Kurdistan

FDA Certificates · Kurdistan Region of Iraq

FDA Document Authentication for Kurdistan

The Kurdistan Region is part of Iraq, which is not a party to the Hague Apostille Convention, so U.S. documents headed to Erbil cannot be apostilled. We obtain U.S. Department of State authentication for your FDA certificate, add the certification of the Kurdistan Regional Government's representation in Washington, and return it by FedEx in about 14 business days.

  • Part of Iraqnot in the Hague Convention
  • State Dept + KRG stampdocument route
  • Kurdish and Arabicofficial language
  • 14 daysstandard processing
FDA Digital Certificate Sample

Submit Your FDA Certificate for Kurdistan

Simply upload your FDA digital file, and you will receive your authenticated document via FedEx.

Processing time 14 business days
  • We accept credit card payments.
  • Track your order history and expenses online.
  • U.S. Department of State and KRG Representation fees are already included.
  • Submit the files you received from the FDA electronically.
  • We use the State Department minimum processing time.
  • You may update your own FedEx air waybill or purchase a new one.
  • U.S. Department of State Form DS-4194 is not required; we handle it.
Exp. Service fee$120 / Doc.
U.S. Department of State fee$20 / Doc.
Embassy of Kurdistan fee$10 / Doc.
Total:$150 / Doc.

FedEx return shipping is available for completed documents.

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Legalized FDA certificate sample

Why the Kurdistan Region Asks for an Authenticated FDA Certificate

The Kurdistan Regional Government (KRG) runs its own Ministry of Health, and medicines entering the region through its official border crossings are approved and tested by the ministry's Directorate of Pharmaceutical Products Quality Control in Erbil. The directorate approves medicines, licenses importers and manufacturers, sets prices and inspects the market. According to the KRG, samples from importers are tested in its laboratories against European and American standards, with testing completed within 45 days.

Because the KRG reviews products against U.S. and European benchmarks, an FDA certificate is a natural part of a Kurdistan registration file. This service covers both steps Kurdistan files usually call for: U.S. Department of State authentication of the FDA signature, then certification by the KRG Representation in Washington, with both fees included in one price.

Which FDA Certificate Does Your Kurdistan Region Importer Need?

Match your product to the Kurdistan Region authority that reviews it and the FDA certificate that authority normally expects.

Product typeKurdistan Region authorityFDA certificate
MedicinesKRG Ministry of Health, Directorate of Pharmaceutical Products Quality ControlCertificate of a Pharmaceutical Product (CPP), Certificate of Exportability
Medical devicesKRG Ministry of HealthCertificate to a Foreign Government (CFG), Certificate of Exportability
Food & ingredientsKRG health and trade authoritiesCertificate to a Foreign Government (CFG), Health Certificate
Dietary supplementsKRG Ministry of Health, depending on classificationCertificate of Free Sale (CFS)
CosmeticsKRG Ministry of Health; confirm with your importerCertificate for Cosmetics

The KRG Ministry of Health regulates medicines entering the Kurdistan Region separately from Baghdad. Products sold in both federal Iraq and the Kurdistan Region usually need files with both regulators. Your importer will confirm which documents each requires.

How FDA Document Authentication for the Kurdistan Region Works

The Kurdistan Region is part of Iraq, which is not a party to the Hague Apostille Convention, so an apostille is not available. Your FDA certificate follows a two-step route: U.S. Department of State authentication, then certification by the Kurdistan Regional Government Representation in Washington. If a federal Iraqi authority in Baghdad also needs the document, see our Iraq page for Embassy of Iraq legalization.

  1. Upload your FDA certificate

    Send the digital certificate exactly as the FDA issued it and choose Kurdistan as the destination. We confirm it is complete and signed by an FDA official.

  2. U.S. Department of State authentication

    The Office of Authentications attaches its certificate in about 9 business days.

  3. KRG Representation certification

    We present the authenticated certificate to the Kurdistan Regional Government Representation in Washington, which adds its stamp in about 5 business days.

  4. FedEx delivery

    The finished certificate ships to you, your importer or your agent in Erbil, Sulaymaniyah or Duhok.

Exporting to the Kurdistan Region: What to Prepare

Separate from Baghdad

Medicines imported through KRG border crossings are approved and tested in Erbil rather than by the federal Ministry of Health. If you also sell in federal Iraq, plan a separate file and certificate set for Baghdad. See our Iraq page for that route.

Laboratory testing on entry

The KRG tests samples from importers in its quality control laboratories, with results in up to 45 days. Make sure the product details on your FDA certificate match the samples and paperwork exactly.

Barcoded price stickers

Approved medicines in the Kurdistan Region carry barcoded stickers showing the drug name, supplier and price, and the KRG keeps a list of approved suppliers and essential medicines. Work with an approved importer to get onto the market.

Baghdad needs its own stamp

The KRG Representation stamp is for use in the Kurdistan Region. If the same product is also registered with the federal Ministry of Health in Baghdad, that file usually needs Embassy of Iraq legalization instead, so order a separate set.

FDA Document Authentication Cost for the Kurdistan Region

ItemAmountNotes
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 Kurdistan fee$10 / doc.KRG Representation certification, about 5 business days. Paid by us on your behalf
Total$150/ doc.Standard processing: 14 business days. Expedited options available.

FDA Document Authentication for the Kurdistan Region: FAQs

Can I apostille an FDA certificate for Kurdistan?

No. The Kurdistan Region is part of Iraq, which is not a party to the Hague Apostille Convention, so the U.S. Department of State issues an authentication certificate instead.

What does the KRG Representation stamp add?

After the State Department authenticates the FDA signature, the Kurdistan Regional Government Representation in Washington certifies the document for use in the Kurdistan Region. This service includes both steps.

How long does it take and what does it cost?

About 14 business days and $150per document: our $120 service fee, the $20 U.S. Department of State fee and the $10 KRG Representation fee.

Who regulates medicines in the Kurdistan Region?

The KRG Ministry of Health's Directorate of Pharmaceutical Products Quality Control in Erbil, which approves medicines, licenses importers and tests products entering through KRG border crossings.

Do I need separate documents for Baghdad and Erbil?

Usually yes. The KRG and the federal Iraqi Ministry of Health run separate approval systems, so products sold in both normally need separate files.

Which FDA certificate does the Kurdistan Region need?

KRG files generally use a CPP for medicines, a CFG for devices and foods, a Certificate of Free Sale for supplements and a Certificate for Cosmetics for cosmetic products. A Certificate of Exportability covers products that aren't sold in the U.S.

Health Certificate

Collagen and gelatin exports (EU health certificate or SRM certificate).

Nearby destinations

Get Your FDA Certificate Authenticated for the Kurdistan Region

Upload your FDA certificate today and receive it authenticated by FedEx in 14 business days, for $150per document with State Department and KRG Representation fees included.

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FDA Digital Certificate Sample

Simply upload your FDA digital file, and you will receive your apostilled document via FedEx.

Processing time

14 business days
  • We accept credit card payments.
  • Track your order history and expenses online.
  • The U.S. Department of State fee is already included.
  • Submit the files you received from the FDA electronically.
  • We use the State Department minimum processing time.
  • You may update your own FedEx air waybill or purchase a new one.
  • U.S. Department of State Form DS-4194 is not required; we handle it.

Exp. Service fee

US Dept. of State fee

Embassy of Kurdistan fee

Total:

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