The half of the job that starts when production finishes.
The production time, from formula lock and approved artwork to the first pallet, is set in our offer for each product. The registration file and the legalisation are built during production, not after it. Baghdad and the Kurdistan region are two separate files.
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Product registration with the MoH in Baghdad
The file has to carry a Certificate of Analysis, product specifications, stability data, a Free Sale Certificate and the production site’s GMP certificate. We gather those and submit in the applicant’s name. Where our production site already holds MoH registration, the product file is shorter. 753 formulations in the catalogue are made at sites registered with the MoH, the KMCA or both.
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The KMCA file for the Kurdistan region
A certificate issued in Baghdad does not open the Kurdistan region, and the reverse holds too. The Kurdistan Medicine Control Agency keeps its own file, its own review and its own certificate. We prepare and submit it separately, so one market never waits on the other. In the catalogue, 180 formulations are made at sites registered with the KMCA alone and 360 at sites registered with both.
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Document legalisation
Free Sale Certificate, certificate of origin, Certificate of Analysis, and for medicines a Certificate of a Pharmaceutical Product where the authority asks for one. Each one is legalised through the Chamber of Commerce and then the Iraqi embassy. A GMP or Free Sale Certificate that has expired is the usual reason a file stalls, so we check the dates before anything is submitted. Legalisation runs while production runs.
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Freight to Iraq
Goods leave our site EXW, or we arrange the delivery onward from there. We coordinate the export from our site and hand the documents over. Routing and mode are set per shipment. Rates are not published.
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Customs clearance
The importer holds the import licence for the shipment. We prepare the batch documents that customs and the health authority actually check: the batch Certificate of Analysis, the certificate of origin and the legalised commercial documents. They are drawn from the same file that went to the authority.
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Local representation
Iraqi importers and scientific offices can apply in their own name. Where a certificate is issued, it is issued to the applicant, not to us, and the exclusivity travels with it for as long as it is renewed. The catalogue marks 837 formulations as open for an exclusive application in your name.
Scope and fees are agreed per project. Review time at the authority depends on the category, the queue and how complete the file is. We state the current expectation when you enquire. We do not give a guaranteed date and we do not promise an outcome.
Start with your list of products.
Choose in the library, send your list, and our written offer comes back. No account, no obligation to buy.