The Five Most Common Mistakes
When Entering Iraq

Executive Summary

Every year, international pharmaceutical companies invest significant time and resources to enter the Iraqi market. Many succeed. Others experience costly delays or fail to reach their commercial objectives — not because of product quality, but because of avoidable strategic and regulatory mistakes.

Based on ESHNUNNA's experience, the following five are the most common.

Mistake 1 — Ignoring pricing requirements before registration

The most expensive mistake in this market is preparing a complete dossier without first assessing whether the product can obtain a commercially viable official price.

Iraqi pricing regulations may differ significantly from a company's expectations. Manufacturers have completed the entire registration process only to discover that the approved price does not support a sustainable business model — producing financial loss, wasted effort, delayed entry, and in some cases withdrawal before commercialisation.

⭐ ESHNUNNA Insight

Pricing feasibility can be evaluated before committing to full registration costs. Iraq operates a preliminary pricing assessment mechanism for a modest official fee.

Iraqi pricing is referenced rather than set in isolation: the originator price establishes the anchor, and generic pricing follows as a defined proportion of it — with the proportion determined by the country of origin of the manufacturing site. Two manufacturers producing an identical molecule to identical standards can therefore receive materially different Iraqi prices.

Best practice: establish your expected price band and resulting margin before dossier preparation begins.

Mistake 2 — Submitting products that do not meet Iraqi requirements

Some manufacturers begin registration without verifying that their documentation complies with Iraqi requirements: missing bioequivalence studies where required, stability data that does not satisfy Iraq's climatic conditions, incomplete regulatory documentation.

These deficiencies typically surface only after substantial investment.

Recommendation: perform a comprehensive regulatory gap analysis before submitting any dossier.

Mistake 3 — Granting exclusive rights too early

Manufacturers frequently appoint an exclusive scientific bureau before fully understanding the Iraqi registration framework. If only part of the portfolio is successfully commercialised, the remaining products become difficult to reallocate because of the existing contractual structure — limiting flexibility and reducing the commercial potential of the whole portfolio.

Recommendation: develop your registration and distribution strategy before signing long-term exclusive agreements.

Mistake 4 — Choosing a partner without regulatory expertise

Selecting a local representative on reputation or commercial relationships alone can cost years. Several international companies have worked with local partners for years without registering a single product, because the partner lacked specialised regulatory capability.

⭐ ESHNUNNA Insight

A scientific bureau should not only promote products. It should understand regulatory affairs, pricing strategy, market access and commercialisation — four different competencies that are rarely found together, and never assumed.

Mistake 5 — A weak distribution strategy

Successful registration does not guarantee commercial success. Some local partners rely heavily on sub-distributors without effective coordination across Iraq's governorates, producing inconsistent coverage, internal competition, poor sales performance and reputational damage to the manufacturer.

Recommendation: evaluate nationwide distribution capability, field force, reporting systems and performance management before entering.

Lessons Learned

The Iraqi market offers significant opportunity, but success requires far more than registration. Companies that invest time in understanding regulations, pricing, partner selection and commercialisation strategy are the ones that achieve sustainable growth.

CEO Checklist

Before entering the Iraqi pharmaceutical market:

• Have we evaluated Iraq's pricing implications?
• Does our dossier fully comply with Iraqi regulatory requirements?
• Have we selected the right market entry model?
• Are we appointing the right local partner?
• Does our commercialisation strategy cover both the public and private sectors?

Disclaimer

This guide is provided for general informational purposes and does not constitute legal, regulatory or commercial advice. Iraqi regulations are subject to change; confirm current requirements with the competent authorities or through a licensed scientific bureau before acting.