The Scientific Bureau as Local Representative in Iraq

1. Key takeaways

According to multiple legal commentaries and prevailing industry practice, imports of medicines and medical devices through private channels in Iraq generally must be handled through scientific offices registered with the Ministry of Health, with the exception of direct imports that the State Company for Marketing Drugs and Medical Appliances (KIMADIA) deems necessary. Secondary sources further state that paragraph 2 of Article 9 of the same law requires a licence for pharmaceutical factories or warehouses to be held with at least 51 percent Iraqi ownership, that a scientific office may represent up to five companies, and that its practice licence is non-transferable. All of these points are consistent citations from secondary sources whose official originals were not obtained (attempts via moj.gov.iq, moh.gov.iq, parliament.iq and gjpi.org all failed), so they must not be presented as citations of statutory text. The characterization must be precise: this is administrative practice, not a statutory obligation — a full-text search of the 106 articles of Public Health Law No. 89 of 1981 found no such provision. The corroboration is nevertheless solid: official KIMADIA circulars are addressed to companies and scientific offices, showing that these actors do operate daily.

• Import through private channels generally runs through scientific offices registered with the Ministry of Health; the exception is direct import deemed necessary by KIMADIA.
• Secondary sources cite a 51 percent Iraqi ownership threshold for licences of pharmaceutical factories or warehouses, a five-company cap per scientific office, and non-transferable practice licences — all resting on secondary sources whose official originals were not obtained, not quotable as statutory text.
• KIMADIA circulars addressed to companies and scientific offices are primary corroboration that the system operates.

2. Legal basis

The table below lists the sources cited in this article together with their document numbers, publication dates and the provisions relied upon.

Source grading: the first two items are graded secondary and must not be cited as a legal provision (consistently cited by sources such as Al Tamimi and Co., Muayad and Associates, and Salt Legal; moj.gov.iq was unreachable and the gazette originals were not obtained). The Country Profile 2020 is graded primary, indirectly verified (content obtained through indexed snippets). The KIMADIA circulars are graded primary and verified (hosted on kimadia.gov.iq), but their content is procedural notice, not the founding basis of the scientific office system.

Excerpts of the original provisions:

• KIMADIA notice of June 2026: addressed to all companies and scientific offices, it urges them to study carefully the Instructions on the Execution of Public Contracts No. 1 of 2025 and the annexed controls — primary corroboration of the scientific office as an official addressee.
• Country Profile 2020 Section 6.5: «Any scientific bureau or pharmaceutical company fail to send updated information after five years of the registration, their registration will be cancelled automatically» — scientific offices bear the five-year information submission duty.
• Country Profile 2020 Section 6.10: «applicants (scientific bureaus and national companies) can appeal against Registration Department and the NCDS decisions» — scientific offices have the right to appeal against Registration Department decisions.
• The original of Article 9 paragraph 2 was not obtained this round and must not be cited in the form that Iraqi law provides that such and such must be done.

3. Expert insights

Insight 1 | Characterizing this relationship as administrative practice rather than legal obligation is the most valuable step in this article. There is no such gate at the level of Iraqi federal law: article 01 of this series searched the 106 articles of Public Health Law No. 89 of 1981 word by word and found no concept of the scientific office, so strong formulations such as Iraqi law requires appointing a local representative must always be downgraded to generally, reportedly, or in practice. Yet the gate is real in the process: the window recognizes only this actor, and whoever files and follows up holds the relationship.

Insight 2 | Cross-border comparison: local representative mechanisms are strict everywhere; the difference lies in who owns the certificate. Article 11 of the EU MDR (EU) 2017/745 requires non-EU manufacturers to appoint an authorised representative; China’s device supervision regulations require overseas registrants to designate a Chinese enterprise legal person as their agent. The Iraqi scientific office belongs to the strictest tier: it is both the import channel and the de facto holder of the registration relationship.

Insight 3 | Debunking: overstating the strength of sources is the most common accident in articles of this kind. The common formulation is that under paragraph 2 of Article 9 of the Iraqi Practicing Pharmacy Profession Law No. 40 such and such is mandatory. The problem is that not a single page of the law’s original text could be obtained this round, so neither the clause number nor the wording can be checked, nor whether the Instructions No. 4 of 1998 remain in force. GRZAN uniformly writes consistently cited by secondary sources, official originals not obtained.

Insight 4 | The real risk is not whether one can enter but who holds the relationship. First, attachment of the registration relationship: when a scientific office is the registration subject, the Chinese side often cannot recover the files or the relationship on termination. Second, the cap of five companies makes the representative a scarce resource with asymmetric bargaining power. Third, the practice licence is non-transferable, ruling out buying a scientific office. Switching representatives is therefore extremely costly and the leverage lies on the Iraqi side. GRZAN’s answer is to have its own entity in the target country act as the licence holder, keeping ownership of the registration relationship with the manufacturer.

Insight 5 | The actual meaning of the 51 percent ownership threshold must be read precisely. Secondary sources phrase it as requiring at least 51 percent Iraqi ownership for licences of pharmaceutical factories or warehouses. Its reach is the licence, not every scientific office; before designing a shareholding structure one must confirm which category the intended entity falls into.

4. Practical recommendations

• Before selection, run three due-diligence checks: how many companies the representative already serves (cap of five), the status of the practice licence, and any cancellation records in the past three years. Practical estimate: this can be done through written enquiries by local counsel (no official provision found).
• Write four clauses into the agency agreement: ownership and return of the registration relationship, the information submission duty and receipts, handover of files on termination, and compensation for breach.
• Prefer representatives who provide written quarterly status reports plus scanned submission receipts; others do not enter the shortlist.
• Route funds and goods payments so as not to pass through the representative, limiting the spillover of its financial risk.
• For local entities and shareholding structures, including the 51 percent threshold, obtain a written opinion from local counsel.

5. Verification checklist

• □ Obtain the gazette original of the Practicing Pharmacy Profession Law No. 40 of 1970 (from the moj.gov.iq gazette library or a paper gazette) and check Article 9 paragraph 2.
• □ Obtain the original of Instructions No. 4 of 1998 and check the import-through-scientific-office requirement and the KIMADIA direct-import exception.
• □ Retrieve the originals of Sections 6.5 and 6.10 of the Country Profile 2020 and confirm the duties and appeal rights of scientific offices.
• □ Have local counsel verify the validity of the prospective partner’s practice licence and the number of companies already represented.
• □ Check whether the agency agreement contains clauses on the return of the registration relationship and on information submission receipts.
• □ Re-verify whether the official documents cited in this article have been replaced by subsequent instructions or resolutions (verification baseline date of this article: October 29, 2026).

Regulatory information verified as of October 29, 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 federal and Kurdistan registration applications, prepares reference-country dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com