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Iraq Supplement Registration
Essential compliance guidance for registering food supplements in Iraq.
Iraq Food Supplement Registration & Ministry of Health Approval Guide
Brand objective: Build Marley & Mae packaging for international use, with consumer-facing label information designed to be readable in English, Arabic, and French, subject to approval of the final translations and mandatory wording in each market.
Regulatory caution: The three-language format is a Marley & Mae international packaging strategy, not a statement that Iraq requires French. Iraq-specific mandatory language and wording should be confirmed before printing. Public U.S. trade guidance for Iraq emphasizes clear country-of-origin marking and identifies Arabic/English requirements for some regulated categories; therefore final supplement artwork should receive Iraqi regulatory review.
1. Approval Sequence
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Confirm each SKU's Iraqi classification as a food/dietary supplement, herbal supplement, or other regulated category.
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Confirm foreign manufacturer/GMP and local applicant/importer eligibility.
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Send soft-copy dossier and proposed trilingual artwork for pre-review before legalization or commercial printing.
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Correct formula, claims, warnings, translations, manufacturer/brand details, shelf life and specifications.
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Legalize/authenticate only the originals specifically required by the Iraqi filing authority.
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Submit master company/manufacturer documents and an individual technical dossier for each SKU.
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Complete committee/technical review, sample or laboratory testing, and label/artwork review.
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Obtain written product registration/marketing authorization before commercial sale.
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Complete shipment/import release requirements for each commercial shipment as applicable.
2. Core BNSR / Product Dossier Documents
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Authorization Letter (LOA).
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Free Sale Certificate (FSC).
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Method of Analysis (MOA).
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Accelerated stability studies covering 3 batches (per supplied BNSR list).
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Finished Product Specifications.
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Complete quantitative formula/composition (COC).
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Final packaging artwork.
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2 product samples (confirm whether more are required for testing).
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Price Certificate showing CIF Iraq price.
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Finished Product COA.
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DEG/EG, pork, TSE/BSE declarations as applicable.
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Raw Material Specifications.
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Raw Material COAs.
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Method of Manufacture.
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Formal Request to Register Product.
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Packaging Material Specifications.
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PV Declaration using authority-approved wording where applicable.
3. Additional Ministry of Health / Regulatory Confirmations
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Foreign manufacturer/site registration, recognition, GMP acceptance or inspection requirements.
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Current GMP certificate and manufacturing license.
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Authorized Iraqi scientific bureau/importer/local representative licensing requirements.
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Review by the competent MOH body/committee responsible for herbal medicines and food supplements.
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MOH laboratory testing, quality-control clearance, reference standards and additional sample requirements.
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Ingredient and dosage restrictions, especially botanicals, caffeine/stimulants, high-dose nutrients, children's products and combination formulas.
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Acceptance of product claims and avoidance of wording that could cause pharmaceutical classification.
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Final shelf life and storage-condition approval based on stability evidence.
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Import permit, customs/health release and shipment-level documentation.
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Registration validity, renewals, post-approval variations, safety reporting, complaints and recalls.
4. Marley & Mae Trilingual Label Standard — English • Arabic • French
Marley & Mae's preferred international design standard is to create packaging that can be understood across English-, Arabic-, and French-speaking markets. The three languages should be planned into the artwork from the beginning rather than added later as crowded stickers.
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Front panel: Marley & Mae brand, product name, supplement identity/category, strength where appropriate, capsule/gummy/count or net quantity. Keep the premium product name consistent while providing clear Arabic and French equivalents/descriptors where approved.
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Directions: Provide equivalent directions for use in English, Arabic and French.
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Warnings: Translate all mandatory warnings and safety statements accurately into all three languages where the market permits/requires them.
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Ingredients: Provide ingredient information in a layout that remains readable; technical/scientific ingredient names must remain consistent across translations.
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Storage: Translate storage instructions.
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Manufacturer / distributor / country of origin: Present the legally required company and origin information without translation creating a different legal entity name.
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Lot / MFG / EXP: Design permanent fields that are easy to identify regardless of language.
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Arabic: Use professionally reviewed Modern Standard Arabic suitable for regulatory/product labeling; account for right-to-left typography and punctuation.
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French: Use professional regulatory-quality French rather than literal machine translation.
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English: Preserve the U.S. label elements required for products marketed in the United States, including the appropriate Supplement Facts and identity statements.
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Translation control: Create one approved translation glossary for recurring Marley & Mae terms so product names, warnings, directions, dosage forms and brand terminology remain consistent across every SKU.
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Readability: Do not shrink required information simply to fit three languages. If the bottle is too small, use a larger wrap label, carton, peel-back/extended-content label, or market-specific packaging after regulatory confirmation.
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Approval: Submit the complete trilingual artwork—not just English artwork—to the Iraqi regulatory reviewer before final printing.
5. Trilingual Artwork Approval Checklist
| Label element | English | Arabic | French |
| Product identity/name | ■ | ■ | ■ |
| Strength / serving | ■ | ■ | ■ |
| Directions | ■ | ■ | ■ |
| Warnings | ■ | ■ | ■ |
| Ingredients | ■ | ■ | ■ |
| Storage | ■ | ■ | ■ |
| Net quantity/count | ■ | ■ | ■ |
| Country of origin | ■ | ■ | ■ |
| Manufacturer/distributor | ■ | ■ | ■ |
| Lot / MFG / EXP fields | ■ | ■ | ■ |
| Claims/disclaimers | ■ | ■ | ■ |
| Regulatory review complete | ■ | ■ | ■ |
6. Master Company File vs. Individual SKU File
Master file: Marley & Mae company/brand documents; manufacturer agreement/LOA; manufacturer legal identity/address; GMP certificate; manufacturing license; facility information; quality/testing credentials; authorized-representative documentation; reusable declarations accepted by the authority.
Each SKU: exact product name; dosage form; strength; count/net quantity; quantitative formula; ingredient/source details; specifications; MOA; COA; raw-material documentation; stability; manufacturing method; trilingual artwork; FSC coverage; CIF price; declarations; samples; and final registration number/approval dates.
7. Final STOP CHECK Before Printing / Legalization
Do not print commercial quantities or legalize documents until the Iraqi filing channel confirms: classification, exact required language(s), Arabic wording, whether French may appear alongside mandatory text, certificate wording, legalization chain, originals/copies, validity periods, manufacturer/site status, ingredient limits, sample quantities, label claims, and the final approved artwork.
For U.S. sale, FDA dietary-supplement labeling rules still apply to the U.S. version. FDA requires core label statements such as product identity, net quantity, nutrition/Supplement Facts information, ingredient list, and manufacturer/packer/distributor information. A global trilingual design should therefore preserve all mandatory U.S. information rather than replacing it.