The CPP Three-Step Legalisation Chain

1. Key takeaways

Section E item 2 of the Iraqi Drug Registration Regulations provides that the pharmaceutical CPP must be issued by the health authority of the country of origin, state the registration number and date, indicate that the product is freely sold in the country of origin, follow the WHO format, and then pass the three-tier legalisation of Ministry of Health → Ministry of Foreign Affairs → Iraqi embassy in the country of origin. This is the only first-hand textual basis for the “three-step legalisation chain”, and it applies to pharmaceuticals only. The device side has no corresponding provision anywhere in that instrument: the six-document checklist of Section D does not contain a CPP. Because the Ministry of Health site and official legal repositories were unreachable on this pass, the situation must not be stated as “Iraq imposes no CPP requirement on devices”; the wording here is limited to “not retrieved”. The circulating claim that all device documents need three-tier legalisation most likely comes from mixing these two provisions up.

• The three-tier chain — Ministry of Health, Ministry of Foreign Affairs, Iraqi embassy in the country of origin — appears only in the pharmaceutical CPP provision.
• The CPP must state the registration number and date, the free-sale statement, and follow the WHO format.
• The Section D items 1–6 device checklist contains neither a CPP nor a certificate of free sale.
• No WHO-format document exists for devices internationally, which is why the provision cannot be transplanted.
• GRZAN’s advice: device companies must not manufacture or submit a CPP — Iraq has no receiving slot for it.

2. Legal basis

The provision sits in the Drug Registration Regulations, issued by the Republic of Iraq, Ministry of Health, Technical Affairs Directorate, Registration Department, bearing no number and no publication date in the copy reviewed. The operative provision is Section E item 2; the Section D items 1–6 checklist is used to disprove the extension of the CPP to devices.

Evidence level: [second-hand source; must not be cited as law]. The original was not obtained (moh.gov.iq is blocked site-wide by Cloudflare); the surviving text is the Pharmexcil reposted PDF: https://pharmexcil.com/uploadfile/ufiles/380351111_drug_regpdf.pdf . This is the only traceable textual source of the “three-step legalisation chain”, but it is itself a second-hand repost; citations must read “according to a document published by the Registration Department of the Technical Affairs Directorate of the Iraqi Ministry of Health”.

Verbatim extracts of the provisions:

• Section E item 2: «CPP issued by the health authority of the country of origin of the manufacturer legalized officially: from Ministry of Health, Ministry of Foreign affairs and Iraqi Embassy in the country of origin of the manufacturer (including the number and date of registration and that the product is freely sold in the country of origin). e.g.: according to WHO form.»
• Rendering: the CPP is issued by the health authority of the country of origin, legalised by the Ministry of Health, the Ministry of Foreign Affairs and the Iraqi embassy in the country of origin; it must state the registration number and date and the free sale in the country of origin statement, in the WHO format.

3. Expert insights

Insight 1: the national attribution of the three authorities must be inferred from the wording. Only the third authority carries a country label (the Iraqi Embassy in the country of origin of the manufacturer); the first two carry none. GRZAN reads the first two as the country-of-origin Ministry of Health and Ministry of Foreign Affairs, with only the third being the Iraqi embassy abroad — otherwise the qualifier “in the country of origin” has nowhere to attach. This is a textual inference; confirmation from the Registration Department should be obtained before formal citation.

Insight 2: the WHO format is the technical core of the chain. WHO maintains a unified CPP format for international pharmaceutical commerce (the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce), and by citing it Iraq builds its review on an international template. No corresponding WHO-format document exists for devices — the structural reason the provision cannot be transplanted, not an Iraqi omission.

Insight 3: falsification check — here is the source of the device-side three-tier legalisation claim. The most widely circulated version online is that every device document must pass notarisation, foreign ministry and Iraqi embassy. Comparison shows the three-tier chain appears only in the Section E pharmaceutical CPP provision; the only device item carrying “legalized” is Section D item 3, and it names no tiers. Applying Section E’s density to Section D is exactly how the misreading was generated.

Insight 4: horizontal comparison — the Gulf states use the CFS, not the CPP. Markets such as Saudi Arabia and the UAE typically require devices to be supported by a certificate of free sale (CFS) issued by the competent authority of the country of origin and legalised, without a WHO format. Iraq goes further — the Section D checklist lacks even a CFS. For multi-market companies, the CFS is the generic document and the CPP is pharmaceutical-specific; neither substitutes for the other.

Insight 5: what device companies should actually submit. Under Section D, a devices business submits the company registration form (Appendix 4), the quality assurance system certificate, the officially legalized country-of-origin manufacturer registration certificate, the product catalogue, the certificate regarding the Israel boycott, and the company registration fee. GRZAN cautions clients never to self-draft a “device-version CPP” — it has no receiving slot and only adds explanation cost.

4. Practical recommendations

• Device companies must not prepare or submit a CPP: the Section D checklist does not include it, and filing a document with no receiving slot slows the whole package.
• If a client runs both pharmaceutical and device lines, keep the two sets in separate files: pharmaceuticals follow Section E item 2 with WHO format and three-tier legalisation; devices follow Section D company registration. Do not share one legalisation approach.
• For the pharmaceutical CPP, execute the sequence strictly in the three tiers and archive each tier’s seal copy; if a tier is missing, the Registration Department typically requires redoing, not remedying. Practical estimate: no official provision on remediation methods.
• The CPP must state the registration number and date with the “freely sold in the country of origin” formulation; missing either fails the formal requirements of Section E item 2.
• GRZAN fixes the HS classification at project launch before choosing the pharmaceutical or device channel — a wrong choice here means the whole package must be redone.

5. Verification checklist

• □ Obtain the .gov.iq original and verify word for word the three authorities and WHO format requirement of Section E item 2
• □ Confirm with the Registration Department the national attribution of the “Ministry of Health” and “Ministry of Foreign Affairs” (country-of-origin authorities, or Iraqi authorities)
• □ Check the Section D items 1–6 checklist and confirm it contains no CPP and no CFS
• □ Search whether the Ministry of Health has an instruction extending the CPP to medical devices; until obtained, do not write it as a device obligation
• □ Obtain the current WHO CPP template and verify the “registration number and date” and “free sale” items are present
• □ If a client is asked for a device-version CPP, request the Arabic document title and gazette issue number; absent these, treat the requirement as nonexistent
• □ Re-verify whether the cited official documents have been superseded (verification baseline date: 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 prepares registration dossiers and legalisation chains, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com