Iraqi Pharmacovigilance Guidelines for Healthcare Professionals, Version 2.0 (2024)

1. Key takeaways

Version 2 of the Iraqi Pharmacovigilance Guidelines for Healthcare Professionals was issued on 2024-03-05 (evidenced by the URL path on the Ministry of Health storage domain); version 1 was issued in 2012. Its key points: serious cases should be reported on an accelerated basis, as soon as possible and no later than 15 calendar days; non-serious cases are encouraged to be reported within 3 months of occurrence; for serious ADRs the IPvC should be called as fast as possible while filing the form; every hospital has a dedicated pharmacovigilance pharmacist, and the ADR form is incorporated in the admission file of every admitted patient; reports may follow the chain of hospital pharmacist — provincial health directorate — VigiFlow — IPvC, or be sent directly to iqphvc@yahoo.com or delivered by hand. The four elements of a valid report are an identifiable patient, an identifiable reporter, a suspected medicine and a suspected ADR. The evidence method must be stated: moh.gov.iq is blocked by Cloudflare, and the text was obtained through a search cache.

• Serious cases: expedited reporting, as soon as possible and no later than 15 calendar days.
• Non-serious cases: reporting within 3 months of occurrence is encouraged.
• Each hospital has a designated pharmacovigilance pharmacist; the ADR form is part of every admission file.
• Valid reports need four elements: identifiable patient, identifiable reporter, suspected medicine, suspected ADR.

2. Legal basis

Source level: primary source, indirectly verified. — The document is an official publication of the IPvC of the Iraqi Ministry of Health, prepared by Ban Abdulameer Al Shimran and supervised by Dr Manal Mohammed Younus (head of the IPvC); because the official domain is blocked by Cloudflare, the text was extracted through a search-engine cache and could not be downloaded for direct verification.

Excerpts from the source:

• Timelines: serious reports should be submitted in an expedited manner, that is, as soon as possible and no later than 15 calendar days; non-serious reports are encouraged to be reported within 3 months of their occurrence; in case of serious ADRs, call the IPvC as fast as possible while reporting the ADR form.
• Admission file: in each hospital there is a designated pharmacovigilance responsible pharmacist, and for every single patient admitted the ADR form is also incorporated within their admission file.
• Four elements and reportable items: identifiable patient, identifiable reporter, suspected medicine(s) and suspected ADR; batch number, especially for vaccines and biological products; medication errors, regardless of whether they caused an ADR; quality defects, even if they did not lead to an ADR.

3. Expert insights

Insight 1 | Placing the ADR form inside the admission file converts passive reporting into active screening. The practice in most countries is to distribute reporting forms and wait for healthcare professionals to complete them voluntarily, and under-reporting therefore stays high for years. Iraq makes the form a component of the admission file, which amounts to one forced identification opportunity at the admission of every patient. GRZAN has not seen a second example of this in the Middle East; it is the most distinctive design feature of this guideline, and a pragmatic means of raising capture rates in a resource-limited environment.

Insight 2 | Falsification check: writing 15 calendar days as 15 working days is a common transmission error. The original text reads 15 calendar days; the difference between calendar days and working days is enough to cause an overdue report in projects that involve cross-department circulation. This error most likely arose in circulation from mixing the identical timeline of the MAH Good Pharmacovigilance Practices guideline with domestic deadlines. GRZAN requires its teams to write 15 calendar days in every Iraq deliverable.

Insight 3 | Horizontal comparison: the 15-calendar-day requirement matches the accelerated reporting standard for serious cases in ICH and CIOMS. The guideline states that its reporting concepts follow the guidance of ICH, CIOMS, EMA and FDA, together with Iraq’s first ADR reporting guideline and the MAH vigilance guideline. It shows that Iraqi pharmacovigilance rules are not idiosyncratic but deliberately aligned with the mainstream international harmonisation standard. This in turn confirms the reverse: the investment in rule-building on the medicines side is substantial, which makes the blank on the devices side look all the more stark.

Insight 4 | The three extensions in the reportable-items list are valuable models for device companies’ internal ledgers. Lack of efficacy (especially in life-threatening situations), medication errors (whether or not they caused an ADR) and quality defects (even if they did not lead to an ADR) are all listed as reportable items, and none of the three requires a prior finding that harm has occurred. Device companies, for whom no mandatory reporting duty was found, can still log these event classes on the same basis; if the system expands in future, the records can be submitted directly, and in a dispute they evidence that the company exercised due care.

Insight 5 | The reliability of the three submission routes differs sharply. Route one is hospital pharmacist — provincial health directorate — entry into VigiFlow — forwarding to the IPvC, the institutional main route; route two is direct email to iqphvc@yahoo.com; route three is hand delivery. The latter two share the problem that receipt cannot be verified. Where a company has a genuinely urgent matter and must leave the main route, it should retain its own sending records and the reply records of the contact person.

4. Practical recommendations

• In projects involving Iraq that touch medicines or drug-device combinations, GRZAN writes 15 calendar days and marks the starting point as the day the company or its representative receives the report (day 0).
• Within one vigilance system serving both medicines and devices, GRZAN recommends keeping device events in a separate table with fields copied from the four elements, so that device and medicines data cannot be mixed into an indistinguishable scope.
• Practical estimate: assign the Iraqi market a vigilance contact who can communicate in Arabic and English, with a serious-event telephone line matched to that contact’s working hours (no official provision found).
• For submissions by email, copy an internal backup mailbox and retain the sending timestamp; where necessary, ask the recipient to confirm receipt in writing.
• For safety information that needs proactive communication, prefer the Scientific Bureau channel and keep written records, rather than submitting to the IPvC directly as a foreign entity.

5. Verification checklist

• □ Attempt to download the PDF at the storage.moh.gov.iq path using a local Iraqi exit IP or a local colleague, to complete direct verification.
• □ Check whether the URL path 2024/03/05 and the publication month recorded on ResearchGate agree.
• □ Re-check the version history: the first version dates from 2012 and the current one is the second version.
• □ Check the English wording of the four elements and the reportable-items list item by item.
• □ Confirm whether iqphvc@yahoo.com is still a valid contact address and, if necessary, switch to iraqiphvc@moh.gov.iq.
• □ Search whether a third version appeared in 2025–2026.
• □ 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