Iraq Good Pharmacovigilance Practice Guideline for Marketing Authorisation Holders, Version 2.0

1. Key takeaways

The Iraqi Good Pharmacovigilance Practice Guideline for Pharmaceutical Companies, Marketing Authorization Holders and their Representatives in Iraq, V 2.0, is substantively the most complete corporate obligation list: domestic serious and fatal cases must be reported within 15 calendar days (from receipt, day 0); domestic non-serious cases within 90 calendar days, in CIOMS or E2B (R2 or R3) format — line listings are not accepted; even with no cases in the period, a nil report must still be filed every six months (last week of January and last week of July). New registrations and renewals of all pharmaceutical products additionally require a risk management plan (RMP); a Direct Healthcare Professional Communication (DHPC) is submitted with a distribution plan, and the IPC reviews it and proposes changes within 2–7 calendar days of receipt. One evidence limitation: the guideline’s official Ministry of Health URL was not obtained; only a ResearchGate-hosted copy is presently available.

• Serious and fatal domestic cases: 15 calendar days from receipt (day zero).
• Non-serious domestic cases: 90 calendar days, in CIOMS or E2B (R2 or R3), not line listings.
• Nil reporting every six months, in the last week of January and the last week of July.
• RMP required for all new registrations and renewals; DHPC reviewed by the IPC within 2–7 calendar days.

2. Legal basis

Source level: primary source, indirectly verified. — The document is confirmed as issued by the vigilance body of the Ministry of Health and marked V 2.0 on every page, but the official Ministry of Health URL could not be obtained (moh.gov.iq and its storage domain are blocked), and only a third-party-hosted copy was secured. Its content is guide-level obligation, not statute.

Excerpts from the source:

• Reporting timelines (Module VI): all domestic serious and fatal cases shall be reported within 15 (fifteen) calendar days from the date the report is received by the pharmaceutical company, MAH or its representative (day zero); non-serious domestic cases shall be reported within 90 (ninety) calendar days, using CIOMS or E2B (R2 or R3) and not line listing.
• Semi-annual nil reporting (Module VI): if there are no cases, notification shall be given periodically every six months (the last week of January and the last week of July).
• RMP and DHPC: for all new registrations and renewals of all pharmaceutical products, files are accepted in the two formats EU/Core or global, except for biologicals, where the files must be in the EU/RMP format; the IPC shall review and propose the required changes, if any, within 2–7 (two to seven) calendar days from the date of receipt.

3. Expert insights

Insight 1 | The nil-reporting windows are fixed in the text — the most distinctive requirement of this guideline. The guideline does not merely say a report is required even with no cases; it fixes the two windows as the last week of January and the last week of July. This means a pharmaceutical company’s vigilance obligations in Iraq are a permanently running calendar, not an event-triggered reaction. The consequence of missing a nil report is not stated in the guideline, but the obligation itself is explicit. Practical estimate: nil reports are usually submitted as a paper letter or by email (format per the guideline text); how receipt is evidenced — no official provision found.

Insight 2 | Horizontal comparison: in the same system the duty list on the medicines side is written in extreme detail, while the devices side is blank. The medicines side has requirements specified down to days and time windows — 15 days, 90 days, half-yearly nil reporting, RMP coverage of all registrations, DHPC review in 2–7 days; on the devices side, under the same document, the same portal and the same contacts, not one sentence addresses them (limited to this guideline’s full text). The contrast is not that device requirements are pending: V 2.0 is already the second revision and no revision added devices. GRZAN accordingly classifies Iraq as a mature vigilance system not open to devices.

Insight 3 | Falsification check: the two circulating wrong versions are quarterly nil reporting and no submission needed when nothing happens. The first gets the frequency wrong: the original is clearly once every 6 months, that is 2 times a year, in the last weeks of January and July. The second is more common: readers see only the phrasing about if no cases occur in the period and overlook the active notification duty that follows immediately. Putting the two together, the judgement is not hard: nil reporting is an obligation, not an option.

Insight 4 | Two mailboxes run in parallel; confirming submission validity is a real problem. The submission addresses given in the guideline are iqphvc@yahoo.com and iraqiphvc@moh.gov.iq; the latter, on the ministry’s official domain, better serves as evidence of official contact. Companies using E2B must additionally send an XML file. The difficulty is that email submission normally carries no institutionalised receipt. Practical estimate: companies must build their own sending log covering time, address, subject and reference number (no official provision found).

Insight 5 | The official DHPC review period is only 2–7 days, and a unified version may be issued. The guideline provides that the IPC reviews and proposes changes within 2–7 calendar days of receipt, that materials must be translated into Arabic where necessary, and that where several MAHs are involved the IPC leads the issuance of a unified DHPC. In effect, a company cannot fully control the wording and release rhythm of its safety communications in Iraq. With time and language planning, this remains executable; without it, the 2-to-7-day review window is easily missed.

4. Practical recommendations

• Companies holding pharmaceutical registrations in Iraq should write the last week of January and the last week of July into the vigilance SOP calendar and appoint a backup submitter.
• Prefer the official-domain mailbox iraqiphvc@moh.gov.iq and copy iqphvc@yahoo.com; E2B users must send an XML file, and the sending log should be kept for at least 3 years. Practical estimate: the retention period is set by the company (no official provision found).
• Device companies should not apply this guideline directly. GRZAN treats it as a formatting model: keep the internal event ledger with CIOMS fields, so records can be submitted directly if the system expands.
• The RMP requirement covers new registrations and renewals of all medicines, and biologicals must be in EU/RMP format. If a client’s product line includes biologicals, move RMP drafting forward in the registration schedule.
• For safety information involving several companies, align the internal position in advance and confirm with the IPC whether a unified DHPC will be issued.

5. Verification checklist

• □ Attempt to locate the guideline’s original path on storage.moh.gov.iq through a local Iraqi network or a local colleague, to complete the official URL.
• □ Check whether the footer of every page of the hosted copy is uniformly marked V 2.0.
• □ Check the three figures of 15 days, 90 days and 2–7 days, and the wording about the last week of January and the last week of July, item by item.
• □ Confirm whether the two mailboxes iraqiphvc@moh.gov.iq and iqphvc@yahoo.com are both currently valid.
• □ Search whether a V 3.0 or a replacement version has followed this document.
• □ 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