Labelling: Federal Gap and Kurdistan Warning

1. Key takeaways

At the federal (Baghdad) level, no statutory provision on medical device labelling or advertising was retrieved on this pass: across all 106 articles of Public Health Law No. 89 of 1981, the Arabic words for “advertisement” (إعلان) and “standard” (مواصفة) each hit 0 times. This must not be stated as “Iraq has no device labelling rules”. The Kurdistan Region (KRI) gives two strands: according to a public statement by the KRI Ministry of Health (media-relayed), drugs and medical supplies lacking ministry quality control labels are deemed illicit and contraband, and unregistered medicines on premises are treated as a criminal offense; and article 4 paragraph 2 letter ژ of KRI Instruction No. 1 of 2016 provides that the mandatory packaging and insert information may be written in at least one of Kurdish, Arabic or English, with the COA in English. Multi-source reporting on the federal drug traceability system covers pharmaceuticals only; label counts conflict (billion/million), so no specific quantity is cited.

• Federal: no device labelling or advertising provision retrieved; item 24 is pharmaceutical-specific.
• KRI: the Ministry of Health statement covers drugs and medical supplies; Instruction No. 1 of 2016 accepts one of Kurdish, Arabic or English; pages 8–24 unverified.

2. Legal basis

Five sources are engaged, set out below.

Evidence level: row one [first-hand, verified] (FAOLEX gazette text: https://faolex.fao.org/docs/pdf/irq149622.pdf , marked “نافذ المفعول”, in force); row two [second-hand; must not be cited as law]; row three [media-relayed official statement, no official decision number] (Channel 8: https://channel8.com/english/14074 ); row four [first-hand, verified (rasterised scan, word-by-word)] — a 24-page Sorani Kurdish scan, read with pypdfium2, pages 8–24 unverified; row five [multi-source reports quoting serving ministry officials].

Verbatim extracts of the provisions:

• KRI statement: «Drugs and medical supplies absent of quality control labels from the ministry of health are deemed illicit and contraband».
• KRI statement: «any presence of unregistered medicines will be treated as a criminal offense».
• KRI Instruction No. 1 of 2016, article 4 paragraph 2 letter ژ: «…دەبێ بە لایەنی کەمەوە بە یەکێ لە زمانەکانی کوردی یا عەرەبی یا ئینگلیزی بنووسرێن.»
• Technical documents: «بە زمانی ئینگلیزی».
• Body: «بەڕێوەبەرایەتی کۆنترۆڵی جۆری بۆ دەرمان و پێداویستی و ئامێرە پزیشکییەکان (KMCA) لە وەزارەتی تەندروستیدا» — the KRI Ministry of Health / Directorate of Quality Control for Drugs, Supplies and Medical Appliances (KMCA).
• Federal side (official’s formulation, no official decision number): «Any product that does not pass the required inspection cannot receive the official label».
• Negative search: “advertisement” 0, “standard” 0, “withdrawal/revocation” (سحب) 2 (both licence revocation).

3. Expert insights

Insight 1: start from the comparison table, marking every blank as “no official provision seen”.

*“No official provision seen” means no official original was retrieved in directly accessible channels on this pass (do not state “Iraq has no such rule”). The KRI cells reflect only the verified part of the instruction and must not be taken to assert that it contains no other labelling obligations.

Insight 2: a territorial asymmetry has opened between the federal side and the KRI. Federal statements on traceability name “pharmaceuticals”; the KRI statement writes medical supplies into the same sentence. For the same consumable, no quality control label in Erbil means “contraband plus criminal case”, while the product may fall outside the federal system; nationwide distributors should follow the KRI standard.

Insight 3: falsification check — “Iraq requires device labels and inserts in Arabic” has no official source. No corresponding provision exists in Public Health Law No. 89 of 1981 or the Section D checklist. Practical estimate: Arabic labelling is generally demanded in practice (no official provision found).

Insight 4: never write a blanket Arabic position — the federal and KRI layers must be written separately. Federal: as of 29 October 2026, no official provision mandating Arabic was retrieved in any directly accessible channel (do not state “Iraq does not require Arabic”). KRI: article 4 paragraph 2 letter ژ accepts at least one of Kurdish, Arabic or English, with the COA, finished-product method of analysis and specifications in English (pages 8–24 unverified). The same country gives two answers at two layers, so GRZAN splits it into federal and KRI.

Insight 5: “no express provision” does not mean “no risk exposure”. Article 105 of the Public Health Law authorises the Ministry of Health to issue regulations and instructions (تعليمات), and the penalties of articles 96 and 99 target violations of those documents — a labelling obligation becomes enforceable once it lands in a ministerial instruction, with penalties reaching shutdown and confiscation.

Insight 6: horizontal comparison — Gulf neighbours have express device labelling rules. Saudi Arabia and the UAE carry written requirements on label languages, content items and responsible-party identification; on the Iraqi federal side even “standard” cannot be retrieved. Gulf-standard labels cover this uncertainty.

4. Practical recommendations

• KRI business must carry the quality control label per the KRI Ministry of Health statement.
• Prepare labels and inserts in Arabic plus English (practical estimate: no official provision makes Arabic mandatory, but it avoids on-site disputes).
• For KRI projects, follow Instruction No. 1 of 2016, article 4 paragraph 2 letter ژ: submit English labels plus an English COA directly, without additional translation. The responsible party is the party responsible for the registration documentation; artwork must be finalised and proof samples retained before submission to the KRI Ministry of Health / KMCA. GRZAN keeps an Arabic version ready for federal-side questioning.
• Build a labelling evidence pack: artwork, finalised inserts, language comparison table, batch and expiry marking rules.
• Review the Ministry of Health and Technical Affairs Directorate ministerial instruction sections on a fixed cycle (practical estimate: GRZAN recommendation, no official provision found).
• State in the agency agreement who bears labelling compliance responsibility and remediation costs — a KRI contraband ruling costs far more than the registration fee.

5. Verification checklist

• □ Re-run the negative search on Public Health Law No. 89 of 1981 on FAOLEX/ECOLEX; confirm “advertisement” and “standard” hit 0
• □ Obtain the .gov.iq original and confirm that item 24 is pharmaceutical, not device, in scope
• □ Search moh.gov.krd for the original decision and number behind the quality control label; until obtained, write “according to the public statement”
• □ Continue verifying pages 8–24 of KRI Instruction No. 1 of 2016 (read through page 7): confirm whether device/IVD labelling provisions and effective/publication dates exist; until obtained, no definitive negative statements
• □ Search for the official decision number and effective date of the federal drug traceability system (المنظومة الوطنية للدواء); until obtained, no fixed document number
• □ This article cites no label-affixing quantities (the billion/million conflict remains unresolved)
• □ Re-verify whether the cited official documents have been superseded (verification baseline date: 29 October 2026)

Regulatory information verified as of 29 October 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Iraqi market. Our team prepares registration dossiers and legalisation chains, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com