Article 26 Pre-Clearance Testing Under Iraq’s Public Health Law No. 89

1. Key takeaways

Under Iraqi law, the starting point of health-product regulation is not the post-market phase but the pre-clearance phase. Article 26 of Public Health Law No. 89 of 1981 (as replaced by Article 2 of Law No. 54 of 2001) requires the Central Public Health Laboratory to perform biological, chemical and physical examinations of food, water, beverages, medicines and medical preparations, cosmetics, and their ingredients and containers, and the examination must be completed before the goods are released from customs or leave the factory. Consignments that pass receive a health certificate; those that fail are destroyed on the spot with the costs borne by the owner, or may be returned to the supplier outside Iraq. This is the only complete pre-clearance testing plus nonconforming-goods disposal loop written anywhere in Iraqi legislation. One qualification must be stated first: the article expressly names medicines and medical preparations. As of the verification date of 2026-10-29, no official text extending the provision to medical devices was found in any legally reachable official channel or officially hosted repository; because the Ministry of Health website, the Ministry of Justice website and the official legal databases were unreachable during this check, this statement must not be restated as a claim that Iraq has no port-level inspection of devices.

• Testing must be completed before release from customs or from the factory.
• Goods that pass receive a health certificate; goods that fail are destroyed at the owner’s expense or re-exported to the foreign supplier.
• The named objects are food, water, beverages, medicines and medical preparations, and cosmetics.
• No official extension of this pre-clearance testing regime to medical devices was found as of 2026-10-29.

2. Legal basis

Source level: primary source, verified. The article text was checked against the official gazette full text hosted by FAOLEX (https://faolex.fao.org/docs/pdf/irq149622.pdf); the index record appears in ECOLEX at https://www.ecolex.org/details/legislation/public-health-law-no-89-of-1981-lex-faoc149622/.

Excerpts of the provision:

• Article 26 requires the necessary biological, chemical and physical examinations of foodstuffs, water, beverages, medicines and medical preparations, and cosmetics before they leave the customs or the laboratory, to determine their fitness for consumption or human use.
• The second part of the same article provides that where the goods are fit, the laboratory issues the interested parties a health certificate; where they are not fit, they are destroyed and the interested party bears the cost of destruction, or re-export to the supplier outside Iraq is permitted.

3. Expert insights

Insight 1 | The regulatory gate sits at customs, not at hospital procurement. In the architectures commonly used in China, the European Union and the United States, import clearance and post-market surveillance belong to two separate operations: the port checks documents, and quality problems found after marketing are handled through sampling, recall and vigilance procedures. Article 26 compresses both into a single act — test first, then release; goods that fail the test never reach circulation in law. Iraqi projects therefore cannot be scheduled on an enter-first, complete-the-paperwork-later basis.

Insight 2 | Costs borne by the owner are written into the statute, which is uncommon in comparable legislation. Most jurisdictions handle the storage, return and destruction costs of nonconforming goods in departmental rules or customs operating procedures; Iraq wrote them into the body of Article 26. The practical effect is that once a nonconforming finding issues, a company has no room to negotiate rectification at its own cost followed by release, because the law offers only two exits — destruction and return — and the return is limited to the foreign supplier.

Insight 3 | The article sets no deadline for the laboratory, so the time risk falls on the owner. Article 26 requires completion before release but does not fix a working-day limit for the conclusion, nor define at what point submitted documents are deemed accepted. This gap means the completeness of the dossier directly determines the number of days a consignment stays at the port. GRZAN’s observation is that demurrage and warehousing costs often exceed any fine that could arise.

Insight 4 | Falsification check: reading Article 26 as port-by-port batch testing of medical devices in Iraq is an over-reading. It is wrong on two counts. First, the Arabic objects of the provision are medicines and medical preparations, placed alongside water, beverages, food and cosmetics under a single purpose — fitness for human consumption or human use; the legislative target is the hygienic fitness of ingested consumer goods, not the technical compliance of devices. Second, across the whole law the Arabic word for apparatus or devices appears 17 times, all in the senses of bodies or agencies, hearing aids, operating-theatre fixtures and equipment, swimming-pool filtration installations and water-testing instruments (see the word-by-word search in article 01 of this series); not one occurrence is a medical device in the regulatory sense. Claims that CE certificates, ISO 13485 certificates or manufacturer test reports serve as clearance documents under this article find no textual basis. Whether ports actually sample devices is a practical estimate; no official provision was found.

Insight 5 | Medicines and devices are not on an equal footing under this article; the workable response is thicker documentation. Medicines are the named objects of Article 26, with a legal parent provision, an allocation of costs and two statutory exits. Devices are not among the named objects and, when goods are detained, they lack citable procedural safeguards — no written testing deadline and no right to a retest. GRZAN’s recommendation is to do more than the medicines side, because where procedural protection is absent, the only thing a company can rely on is the persuasiveness of its application file.

4. Practical recommendations

• When GRZAN takes on an Iraqi order, it writes the possibility of pre-release detention for testing into the project schedule and does not promise delivery dates based on ordinary air-freight lead times.
• Practical estimate: reserve a buffer of 2–4 weeks for sterile consumables and in vitro diagnostic (IVD) reagents involving cold-chain steps (no official provision found).
• Contracts should state expressly who bears the destruction costs once goods are found nonconforming under Article 26. The article’s default responsible party is the interested party; where the import declaration is led by the Scientific Bureau, the identity of the responsible party in practice must be fixed in the contract.
• Do not build contingency plans on the assumption of one retest or release after on-site rectification. Article 26 offers only destruction and return, and the return is limited to the foreign supplier.

5. Verification checklist

• □ Download irq149622.pdf from FAOLEX, check the Arabic full text of Article 26 and confirm that the phrase on testing before leaving the customs remains in the current text.
• □ Verify that Article 2 of the eighth amendment law No. 54 (2001) was indeed used to replace the second paragraph of Article 26.
• □ Re-check the Official Gazette issue of 1981-08-17 and calculate the effective date of 60 days after publication under Article 106.
• □ Search in Arabic for the terms for apparatus and accessories within Article 26 and re-confirm the judgement that no regulatory-sense medical device is covered.
• □ Obtain written confirmation from the customs broker on actual port practice: which authority performs testing under this article and at which step, and archive the reply.
• □ Re-check whether the official documents cited in this article have been replaced by later directives or resolutions (verification baseline of this article: 29 October 2026).

Regulatory information verified to 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 manages adverse event reporting and recall coordination, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com