Public Health Law No. 89 of 1981, Article 3: Medical Supplies

1. Key takeaways

Article 3, item 11 of Public Health Law No. 89 of 1981 places the supply of various medical supplies among the statutory duties of the Ministry of Health, and item 12 requires work toward developing the pharmaceutical and medical supplies industries. These are the two passages closest to device clauses anywhere in current Iraqi law. Yet both are duty-empowerment clauses: item 11 answers who is responsible for supplying such goods to Iraq, item 12 answers whether policy supports a domestic industry; neither creates a definition, classification, technical review, or marketing authorisation procedure. GRZAN therefore draws a hard line: Article 3 item 12 is a policy direction only and creates no priority at the level of registration or market access. At the level of government procurement, however, a primary provision does exist: Article 37 of the Instructions on the Execution of Public (Government) Contracts No. 1 of 2025 grants domestic products preferential treatment over competing foreign products where value added is not less than 30 percent and quality specifications are met. Registration is one line, tendering is another, and the two must not be conflated; merging them is the most common error in Chinese-language material.

• Article 3 items 11 and 12 are duty clauses and create no registration or access procedure.
• No priority for localised production exists at the registration level; none is verifiable in the Public Health Law.
• A local-product preference does exist in government procurement: Article 37 of the Public Contracts Instructions No. 1 of 2025, threshold 30 percent value added.

2. Legal basis

The instruments and the disputed claim examined in this article are set out below.

Source grade. Public Health Law No. 89 of 1981: primary, verified. The Public Contracts Instructions No. 1 of 2025: primary, verified from the gazette original hosted on the Ministry of Planning’s own domain mop.gov.iq; publication date 2025-11-17, gazette issue 4849. The official PDF is a facsimile and the provisions were read page by page from the layout, so Arabic quotations should be proofread against the original pages before formal publication; cite Article 37 only, without deeper paragraph numbers. The Registration Department Drug Registration Regulations: secondary reprint / official publication index level, source unreachable.

Excerpts:

• Article 3, item 11: provision of drugs, sera, vaccines, injection solutions, and various medical supplies.
• Article 3, item 12: work toward the development of advanced pharmaceutical and medical supplies industries.
• Registration Department document A/3: products that are required to be registered are any pharmaceutical products, vaccines and sera with a therapeutic effect; the per-product registration scope covers drugs, vaccines, and sera and does not include medical devices.

3. Expert insights

Insight 1: duty clauses and access clauses are two different legislative techniques. Article 3 belongs to the genre of enumerating ministry duties; the legislator’s concern is who bears the supply responsibility, not what is reviewed before a product reaches the market. In China, the Regulation on the Supervision and Administration of Medical Devices (State Council Decree No. 739) defines medical devices in Article 6 and applies Class I/II/III management under Article 4; the EU MDR (EU) 2017/745 sets 22 classification rules in Annex VIII. Iraq is blank at the corresponding position. This is not loose drafting but a different legislative choice: for Iraq, devices have long been a procurement and supply question, not a product review question.

Insight 2: refutation of the claim that localised production enjoys registration or tender priority. No provision of the Public Health Law supports this; Article 3 item 12 is a statement of policy direction only. The accurate formulation has two layers: at the registration and access level, no priority provision exists; at the government procurement level, Article 37 of the Public Contracts Instructions No. 1 of 2025 contains a local product preference, with a threshold of value added not below 30 percent and conformity with the set quality specifications. The mechanism of the error is precisely the merging of the two layers into one sentence about local companies receiving benefits.

Insight 3: medical supplies has a duty clause but no definition, so its scope is indeterminate. The law neither defines the term nor enumerates what it includes. A company cannot determine from the statutory text whether its product falls within the ministry’s scope, and in practice each product must be confirmed with the Registration Department individually. The question GRZAN meets most often in client consultations is exactly this one, whether a given product is regulated at all; the law gives no answer.

Insight 4: the legislative context of item 12 fixes its reach. The provision is built around the development of the pharmaceutical and medical supplies industries; its target is availability and sufficiency, not safety. This explains why Iraq’s policy attention to devices has stayed on availability and price rather than technical review and post-market oversight, and why the documents that actually bind companies later are instructions and notices in the procurement and import stages.

4. Practical recommendations

• GRZAN requires clients never to cite Article 3 item 12 in business plans or tender documents as a legal basis; it may serve as market background description, not as a claim of right.
• Where local treatment is claimed in a bid, cite only Article 37 of the Public Contracts Instructions No. 1 of 2025, and before filing proofread the provision number and the 30 percent threshold wording against the gazette facsimile.
• Build a provision scope table: mark each product intended for export as covered by a clearly identified statutory regulator, scope unclear, or clearly outside coverage; products with unclear scope go through written confirmation.
• For products with unclear scope, submit a written enquiry to the Registration Department of the Technical Affairs Directorate and retain the receipt as supporting material for later tendering and customs stages.
• Do not build pricing or bid strategy on assumed localisation bonuses. Practical estimate: the magnitude of any evaluation advantage from localisation has no official quantified provision (no official provision found).

5. Verification checklist

• □ In the FAOLEX full text (irq149622.pdf) locate Article 3 and verify the Arabic wording of items 11 and 12 verbatim.
• □ Search the amendment laws (No. 53/1986, No. 71/1988, No. 54/2001, No. 20/2021) and confirm Article 3 has not been replaced.
• □ Download the gazette original of the Public Contracts Instructions No. 1 of 2025 from the Ministry of Planning website and check page by page the number of the local product preference provision and the 30 percent threshold.
• □ Verify the date of Iraqi Gazette issue 4849 (2025-11-17) and the 90-day entry-into-force date computed under Article 42 (2026-02-15).
• □ Confirm with the Registration Department the current scope of products requiring listing or registration, and whether medical devices remain excluded from per-product registration.
• □ Recheck whether the official documents cited here have been superseded by later instructions or decisions (verification date for this article: 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 manages KMOC (Kurdistan) and federal MOH registration procedures, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com