We coordinate product and manufacturing-site registration files for the Iraqi Ministry of Health in Baghdad and the Kurdistan Medicine Control Agency: for European manufacturers entering Iraq, and for Iraqi importers and scientific offices who want a product registered exclusively in their own name. Of the 1,515 formulations listed, 1,050 show their plant's MoH/KMCA status on the product page: 799 from registered plants, 251 open for exclusive registration.
European manufacturers of supplements, medicines and devices who need a manufacturing-site file and product files with the Iraqi MoH or the KMCA. Iraqi importers and scientific offices who want a European product registered in their own name and held exclusively. Brand owners who already sell in Iraq and want the Kurdistan region as a second market, or who are moving a product to a different plant and need the file updated.
Certificate of Analysis, product specifications and stability data, a Free Sale Certificate (or, for medicines, the Certificate of a Pharmaceutical Product where the authority requires it), the plant's GMP certificate and manufacturing licence, the certificate of origin, artwork with Arabic labelling and samples for laboratory testing where requested. Every product page lists the documents available on request: Certificate of Analysis, Certificate of Origin, Certificate of Conformity, Free Sale Certificate and MSDS. Certificates are legalised through the Chamber of Commerce and the Iraqi embassy before submission.
The site comes first: a plant that is not yet registered with the authority is filed before its products. Several network plants in Germany, Italy, Spain and elsewhere already hold MoH or KMCA registration, which is what shortens the product file. We assemble the file with the plant, the applicant of record in Iraq submits it with us, and we follow the authority's queries until the certificate is issued. This is coordination, not legal advice; the authority's current checklist applies.
The Kurdistan Medicine Control Agency runs its own registration, with its own file, review and certificate. A product registered in Baghdad is not automatically cleared for the Kurdistan region, and the reverse is also true: in our catalogue 209 formulations come from plants with KMCA registration only, 236 hold Iraqi MoH only and 354 hold both. We prepare and submit the two files separately, so one market does not wait for the other.
Assembling the file takes weeks when the plant's certificates are current; missing or expired GMP and Free Sale Certificates are the usual delay. Legalisation runs in parallel with production, which is quoted at 3 to 4 months from formula lock and artwork approval to the first pallet. Review time at the authority depends on the category, the queue and the completeness of the file; we state the current expectation when you enquire, never a guaranteed date.
The registration is issued in the applicant's name, not ours and not the plant's, and the exclusivity follows it for as long as it is renewed. For each shipment we prepare the batch documents that customs and the health authority check: batch Certificate of Analysis, certificate of origin and legalised commercial documents. Renewals and variations such as a new pack size or a label change run on the same file.
We confirm whether the plant holds site registration with the MoH and the KMCA and whether the product is registered, open for exclusive registration or already in a queue. The current status of every supplement and medicine is printed on its catalogue page.
CoA, Free Sale Certificate or CPP, GMP certificate, specifications, stability data and Arabic artwork, collected from the plant and legalised through the Chamber of Commerce and the Iraqi embassy while production is running.
We file with the Iraqi MoH and, as a separate file, with the KMCA in the applicant's name, answer the authority's queries and deliver samples for laboratory testing where required.
You receive the registration certificate in your name and the batch documents for the first shipment. Repeat orders, renewals and variations run on the same file.
Yes. The Kurdistan Medicine Control Agency runs its own process with its own file and certificate, independent of the Iraqi MoH in Baghdad. We prepare and submit the KMCA file separately; in our catalogue 209 formulations come from plants registered with the KMCA only and 354 with both authorities.
Typically a Certificate of Analysis, specifications and stability data, a Free Sale Certificate (a CPP for medicines where required), the plant's GMP certificate, the certificate of origin, Arabic labelling and samples, all legalised through the Chamber of Commerce and the Iraqi embassy. The authority's current checklist applies; we coordinate the documents with the plant rather than give legal advice.
Yes. Iraqi importers and scientific offices can register an unregistered formulation in their own name and hold it exclusively; the certificate is issued to the applicant, not to us and not to the plant. 251 formulations in the catalogue are marked as not yet registered in Iraq and open for exclusive registration, 136 of them medicines from a GMP plant in Spain with a minimum order of 10,000 units.
The file itself is assembled in weeks if the plant's certificates are current, and legalisation runs alongside the 3 to 4 months of production. Review time at the authority depends on the product category, the queue and the completeness of the file; we quote the current expectation for your product when you enquire, never a guaranteed date.
Several network plants hold MoH or KMCA registration, and 799 products in the catalogue come from plants already registered with one or both authorities, most of them made in Italy and Germany. Site status is confirmed per plant at the start of each project; a plant that is not yet registered is filed before its products.
A Free Sale Certificate is issued by the competent authority or chamber in the country of manufacture and confirms that the product is sold freely there. It is part of the supplement file for Iraq and the Kurdistan region and is available on request for every product in the catalogue; for medicines the authority may ask for a Certificate of a Pharmaceutical Product as well. We obtain it through the plant and legalise it for submission.
Send us the formulations you picked, your target market and the volume you have in mind. You receive a written quotation, the minimum order quantity per SKU and a realistic production timeline. Prices are shared by custom quote only.