Articles 41 and 42: The Legal Basis of the Import Licence

1. Key takeaways

Articles 41 and 42, as replaced by the Third Amendment Law to the Public Health Law, No. 53 of 1986 (1986-05-20), established the prototype of Iraq’s rule that importation, production, or sale is not permitted without a licence issued by the Ministry of Health under instructions it issues for that purpose. The scope of these two provisions, however, is chemicals and preparations: chemicals and preparations used for medical, industrial, or agricultural purposes, dyes, cosmetics, and insecticides. Medical devices are not included. GRZAN’s finding: Article 42 may be cited as the legal prototype of an import licensing system grounded in ministerial instructions, but it cannot be written up as the statutory basis of a medical device import licence; this is the single most over-cited provision in Chinese-language material.

• Articles 41 and 42 replaced by Law No. 53 of 1986 dated 1986-05-20.
• The enumerated scope covers chemicals, preparations, dyes, cosmetics, and insecticides; devices are absent from the list.
• Article 42 is a licence over conduct (import, production, sale), not a product approval.
• Penalties attach through the instruction interface, so ministerial documents on devices can carry statutory teeth indirectly.

2. Legal basis

The provisions relied on in this article are tabulated below.

Source grade. All provisions above are primary, verified (official gazette text reproduced by FAOLEX). The finding on whether Articles 41 and 42 apply to medical devices is a legal interpretation based on the textual scope of the provisions, not a statement of the provisions themselves.

Excerpts:

• Article 41, first paragraph: the mixed and private sectors may not import or produce the chemicals and preparations used for medical, industrial, or agricultural purposes, nor dyes, cosmetics, or insecticides, unless the producing or importing body first provides the competent department of the ministry with a sufficient explanation and obtains its consent.
• Article 42, first paragraph: the items listed in the first paragraph of Article 41 may not be imported, produced, or sold except after obtaining a licence from the ministry in accordance with the instructions it issues for that purpose.
• Article 96, first paragraph: violation of the law or of regulations, instructions, or announcements issued under it carries an on-the-spot fine of up to 250,000 Iraqi dinars, or closure for up to 90 days, or both.

3. Expert insights

Insight 1: the licence under Article 42 is a licence over conduct, not product access. What Article 42 grants is permission over the acts of importing, producing, and selling, not a marketing approval for a given model. In the United States, the FDA’s 510(k) is an access decision on a product, and the EU MDR CE certificate is a conformity conclusion on a product; the Iraqi licence sits at a different level, answering whether this consignment may move, not whether the product has been approved. Confusing the two leads to the mistaken expectation of receiving a product registration certificate.

Insight 2: refutation, citing Article 42 as a device import licensing provision is a mis-citation. The basis is direct: the first paragraph of Article 41 enumerates the regulated items one by one, and medical devices are not in the list. The scope of a provision is fixed by its enumeration, and the appearance of the phrase for medical purposes cannot stretch it over devices. The most common mis-citation GRZAN encounters translates Article 42 as medical devices require an import licence from the Ministry of Health and attaches the statutory citation; that is a substantive misquotation.

Insight 3: the phrase under instructions it issues carries the greatest weight. It externalises the entire substantive rule set into ministerial documents: the law says only that a licence is required, while the concrete requirements, materials, and procedures are all delegated to instructions the Ministry of Health issues separately. This is the operation of the Article 105 empowerment mechanism inside a single provision, and it determines that the real object of Iraqi compliance management is documents, not statutes (expanded in Article 05).

Insight 4: the scope does not reach devices, but the penal provisions can reach them indirectly through the instruction interface. This is the most easily overlooked risk structure. The applicability conditions of Article 96 first paragraph and Article 99 are violation of the law or of regulations, instructions, or announcements issued under it. Once a ministerial instruction does impose requirements on medical devices, breaching it can trigger Article 99: imprisonment from 1 month to 2 years, and for repeat offenders permanent revocation of the health licence. The law itself does not govern devices, but the law supplies the teeth for ministerial documents that do. A company’s real risk in Iraq lies not in the statute but in the instruction it has not read.

4. Practical recommendations

• When citing the Iraqi import licensing system, GRZAN describes Articles 41 and 42 as the legal prototype rather than device provisions, and states their enumerated scope in the same passage to prevent clients or evaluators from reading them as extended to devices.
• For the shipment-by-shipment import licence a client actually obtains, the materials and procedure follow the MOH’s current instructions and notices, never inference from the text of Article 42. Practical estimate: the number and effective date of the current instruction follow what the accepting window publishes (no consolidated public text of the current instruction found).
• Maintain an instruction tracking list: for every action demanded at customs, tendering, or warehousing, trace the number of the corresponding ministerial document; where no number can be found, treat it as administrative practice, document it, and never record it as a statutory duty.
• Where contracts or compliance documents mention penalties, cite Article 96 first paragraph (up to 250,000 dinars or closure up to 90 days) and Article 99 (imprisonment from 1 month to 2 years) as order-of-magnitude references, noting their trigger is breach of instructions issued under the law.
• Where an agent asserts something is required by law, demand the Arabic statutory text and gazette source; failing that, downgrade it to market practice.

5. Verification checklist

• □ In the FAOLEX full text locate Articles 41 and 42 and confirm the current text is the version replaced by the Third Amendment Law No. 53 of 1986.
• □ Verify the item enumeration in Article 41 first paragraph and confirm no medical device terminology appears in it.
• □ Verify the current figures of Article 96 first paragraph (250,000 dinars / 90 days) and Article 99 (1–2 years) and confirm they have not been replaced by later amendment.
• □ Search the current instructions of the Technical Affairs Directorate of the MOH for any dedicated instruction on device import licensing and its number.
• □ Verify with customs and clearing agents the accepting body and required documents for the shipment-by-shipment import licence in practice, and compare against the statutory scope.
• □ 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