Mandatory VigiFlow eReporting in 2026 and Voluntary Device Compliance

1. Key takeaways

According to industry circulation of a 2026 Ministry of Health circular, the VigiFlow Industry eReporting Tool has been established as the mandatory electronic submission channel for ICSRs and their follow-ups; a company may hold only one submission account no matter how many Scientific Bureaus it has in Iraq, with a single responsible entity designated per the SDEA; companies must also submit the status of their pharmacovigilance representatives for 2026 (Global/Regional QPPV, QPPV Backup, LSR, LSR Backup) through the pharmacovigilance window of the electronic registration portal, and annually thereafter; companies that have not yet obtained a product registration certificate may enter the portal only after the registration procedures are completed and the registration decision is issued (before marketing); LSR/LQPPV training data must be entered into the portal with the certificate attached as PDF or image, to be completed before end-2026; the PSMF, PSSF and SDEA fields require only a yes or no mark, no file upload. It must be expressly flagged: the original URL of the Ministry of Health notice was not obtained, and this item carries medium evidence strength.

• One company, one submission account, regardless of the number of Scientific Bureaus; the responsible entity designated per the SDEA.
• Annual filing of representative status through the pharmacovigilance window of the e-registration portal, starting with 2026.
• Portal entry is conditional on a product registration decision (before marketing).
• Training data with certificates attached before the end of 2026; PSMF, PSSF and SDEA as yes/no fields only.

2. Legal basis

Source level: secondary source, must not be cited as statute (internal rating of this series: medium evidence strength) — moh.gov.iq and the Ministry of Health storage domain are blocked, and the original URL of the notice was not obtained; what exists is one industry-intelligence item reproducing the circular verbatim and one practitioner’s annual review corroborating it, plus a temporally consistent 2024-05-25 forecast.

Excerpts from the sources:

• Annual representative status: companies are to provide the status of their pharmacovigilance representatives for the year 2026 for each company, through the pharmacovigilance window in the electronic registration portal; after this requirement is uploaded, the procedure will continue to be conducted annually.
• Companies without a registration certificate: where they do not yet hold a product registration certificate, they may enter the products in the portal after completion of the product registration procedures and issuance of the registration decision (before marketing of the product in Iraq).
• Training data: the LSR/LQPPV actual training data must be entered in the above-mentioned portal, with the training certificate attached in PDF format or as an image; regarding the fields Global PSMF with Annexes, PSSF and SDEA, it is sufficient to mark yes or no.

3. Expert insights

Insight 1 | When an official URL cannot be given, the strongest honest argument is temporal consistency. The verification could not open moh.gov.iq, so the circular is not written as based on Ministry of Health notice No. such-and-such. But one independent corroboration deserves mention: the VigiServe Foundation entry on Iraq, dated 2024-05-25, already forecast a transition to mandatory electronic submissions required in 2026. That forecast matches the direction of what was actually communicated in 2026, forming temporal self-consistency. GRZAN states the evidence grading clearly and lets readers judge; this is more persuasive than pretending to a first-hand source.

Insight 2 | Horizontal comparison: the medicines side is closing up digitally, while the devices side does not even have an entrance. Reading articles 46 to 49 of this series together with this one, Iraq’s pharmacovigilance system has completed a triple jump: joining the WHO International Drug Monitoring Programme in 2010, issuing the second version of the healthcare-professionals guideline on 2024-03-05, and consolidating ICSR submission into the single VigiFlow channel in 2026. On the same timeline, no vigilance rules or recall system for devices was found as of the verification date, and portal entry eligibility is bound to a product registration certificate — which most device companies cannot obtain. This is not one step behind; it is a different track entirely.

Insight 3 | The one-company-one-account rule imposes hard requirements on corporate structure. The circular requires that, no matter how many Scientific Bureaus the company has registered in Iraq, the system establishes only 1 account, with a single responsible entity designated under the SDEA. For groups declaring through several agents or subsidiaries, an internal consolidation of declaring entities must come first, otherwise submission-right disputes arise. Practical estimate: consolidation should follow the SDEA text and be fixed in the internal letter of authorisation (no official provision found).

Insight 4 | Device companies face a dilemma: not reporting is not clearly a breach, while reporting registers a record about themselves. Not reporting, because no device adverse event reporting duty was found as of the verification date (see article 47, same source-site limitation); reporting proactively may amount to voluntarily entering the regulatory record without any duty, and who would receive it, in what format — nothing found on that either. More practically, portal entry eligibility presupposes a product registration certificate, a precondition most device companies cannot meet.

Insight 5 | Falsification check: the claim that from 2026 all medical devices must be reported through VigiFlow does not hold. The addressees in the original circular are all national and foreign pharmaceutical companies and the scientific bureaus representing them, and the subject matter throughout is the ICSR, the individual case safety report. Medical devices appear nowhere, nor do device vigilance or FSCA concepts. Reading this as a device obligation mistakes the commercial reality that pharmaceutical companies’ representatives also sell devices for the legal scope.

4. Practical recommendations

• The workable path for device companies runs on three parallel tracks: build an internal event ledger, keep records with the CIOMS fields of the medicines side, and communicate through the existing Scientific Bureau channel. GRZAN does not recommend device companies apply to the IPvC for an account themselves.
• Where a group already has a registered medicines business, complete the entity consolidation first, ensuring 1 company corresponds to 1 VigiFlow submission account, and retain the SDEA designation documents.
• Companies that have not yet obtained a product registration certificate should write the window of registration decision issued before marketing into the project plan, so as not to miss the portal entry period.
• Practical estimate: prepare LSR/LQPPV training certificates in advance in both PDF and image versions for contingency (no official provision found).
• Set up an annual re-check: each January, re-search storage.moh.gov.iq for the original notice text; once obtained, replace this article’s evidence with the primary source.

5. Verification checklist

• □ Attempt to open moh.gov.iq and the storage domain with a local Iraqi exit IP or through a local colleague, and search for the original 2026 pharmacovigilance notice.
• □ Re-check whether the wording on mandatory electronic submissions required in 2026 in the VigiServe Foundation entry of 2024-05-25 is still in place.
• □ Check the actual fields of the pharmacovigilance window of the portal: Global/Regional QPPV, QPPV Backup, LSR, LSR Backup.
• □ Verify whether the single-account rule applies to companies also dealing in herbals and dietary supplements.
• □ Confirm that PSMF, PSSF and SDEA are indeed tick-box fields requiring no file upload.
• □ Where a client’s account differs from this article, require the Arabic original or a screenshot before updating the judgement.
• □ 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