Article 99 Imprisonment and Permanent Revocation of the Health Licence

1. Key takeaways

Post-market liability in Iraq can reach natural persons as actual imprisonment. Article 99 and the duplicated Article 99 of Public Health Law No. 89 of 1981 (as amended by Law No. 54 of 2001) provide that whoever violates this law or the regulations, instructions or announcements issued under it is punished with imprisonment for a term of not less than 1 month and not exceeding 2 years; in case of repeated violation, the offender is punished with imprisonment and the permanent revocation of the health licence; ownership of confiscated items vests in the Ministry of Health. Article 100 provides that where pollution in the environment is established as threatening the safety and health of citizens, the Minister is entitled to revoke the health licence and close the premises immediately. One distinction must be made: the health licence here means a premises operating licence, not a product registration certificate.

• First offence: imprisonment of not less than 1 month and not more than 2 years.
• Repeat offence: imprisonment plus permanent revocation of the health licence; confiscated property vests in the Ministry of Health.
• Article 100 allows immediate revocation and closure where environmental pollution threatens citizens’ safety and health.
• The licence at stake is the premises licence, not a product registration certificate.

2. Legal basis

Source level: primary source, verified. — https://faolex.fao.org/docs/pdf/irq149622.pdf

Excerpts of the provisions:

• Article 99: whoever violates the provisions of this law or the regulations, instructions or announcements issued under it is punished with imprisonment for a term of not less than one month and not more than two years; in case of repetition of the violation, the offender is punished with imprisonment and the permanent cancellation of the health licence.
• Article 99, first paragraph (first item): ownership of confiscated property passes to the Ministry of Health.
• Article 100: the Minister of Health has the right to cancel the health licence and close the public premises immediately once pollution in the environment threatening the safety and health of citizens is established.

3. Expert insights

Insight 1 | Horizontal comparison: China has a dedicated device offence; Iraq has only one general clause. Article 145 of China’s Criminal Law specifically establishes the offence of producing or selling medical equipment that fails to meet standards, supported by the administrative penalty system of the Regulation on the Supervision and Administration of Medical Devices (State Council Decree No. 739), with product categories and offences matched one to one. On the Iraq side, as of the verification date of 2026-10-29, no independent device offence was found in any legally reachable official channel: Article 99 strikes at the generalised act of violating this law and its subordinate documents — the offence is general and the scope broad. GRZAN sees this as the other face of what this series has argued repeatedly: because Iraqi federal law does not list medical devices as an independent regulatory object, there is naturally no dedicated device offence or penalty.

Insight 2 | What is revoked is the premises licence, not the product registration certificate. The health licence in Article 99 is cognate with the licences in Articles 41 and 42 of the parent law, and points to the health licence an operator obtains for a particular premises, not to the market-access credential of a product model. This must be stated clearly: the product permanently banned from the market that companies fear, and the premises licence permanently revoked that the law actually provides, are two different things. The latter means the operator concerned cannot reopen business at that premises; the consequences fall on the partner and can also transmit to the supplier through the agency relationship.

Insight 3 | Administrative and criminal penalties are structurally parallel. Article 96 provides fines, closure and confiscation; Article 99 provides imprisonment and permanent revocation. The law does not state that the two are mutually exclusive, so in theory the same violation could first trigger an administrative penalty and then enter criminal procedure. This is why an Iraqi project cannot treat the modest fine level as evidence that risk is under control — the 250,000-dinar cap covers only the administrative fines of item (a), not the deprivation of liberty.

Insight 4 | Article 100 carries harder procedural force than Article 96. Under Article 96, closure is capped at 90 days and the fine at a fixed amount; Article 100 sets no time limit at all and uses the word immediately. Once pollution threatening the safety and health of citizens is established, the Minister may revoke the licence and close the premises directly, and the text shows no procedural prerequisites such as a prior hearing or a prior opportunity to rectify. For projects involving chemicals, disinfectants, sterilisation residues, radiation sources and medical waste, the practical reach of this article exceeds that of Article 96.

Insight 5 | Falsification check: the judgement that Iraq only fines a little does not hold. The circulating story is that Iraqi enforcement is fine-based, of limited magnitude, and that paying settles the matter. On the text, the minimum penalty under Article 99 is 1 month of imprisonment, and the law nowhere states that a fine may substitute for imprisonment. What actually determines application is whether investigation and prosecution are initiated and the state of the evidence — a case-by-case judgement; the risk cannot be deemed controlled by reasoning backwards from the modest fine level.

4. Practical recommendations

• GRZAN writes an express confirmation into Iraqi project contracts that the partner warrants its premises licences remain valid and will give written notice within 3 working days if any is revoked. Practical estimate: the notice period is a contractual term; no official provision found.
• Define the range of natural persons who could be held accountable: the head of a Scientific Bureau, the warehouse manager and the import declarant can all be identified as violators. Before secondment or hiring, complete local regulatory training and keep records.
• For projects involving sterilisation, disinfection chemicals, radiation sources and medical waste, list Article 100 as a dedicated risk and prepare environmental handling statements and third-party test reports in advance.
• Retain the Arabic originals of all correspondence with the authorities; GRZAN recommends a separate project file so that later questions about whether a repeat offence has been found can be verified.
• If an alleged violation occurs, do not settle orally with inspectors. Article 99 involves criminal liability; the handling path should start with a legal assessment.

5. Verification checklist

• □ Check the Arabic wording of Article 99 and the duplicated Article 99 in the gazette full text, confirming one month, two years and permanently.
• □ Check the wording of pollution and immediately in Article 100.
• □ Confirm how the eighth amendment law No. 54 (2001) treats the first paragraph of Article 99.
• □ Confirm with local Iraqi counsel whether the administrative penalties of Article 96 and the criminal practice of Article 99 apply in parallel.
• □ Check the classes and validity periods of the partner’s premises licences and assess whether a repeat-offence finding could arise.
• □ 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