IMEA
IRAQ MARKET ENTRY AUTHORITY
IRAQ MARKET ENTRY AUTHORITY · BAGHDAD

Iraq market entry, assessed before it is attempted.

IMEA is the market-entry practice of Eshnunna Scientific Bureau, a licensed Iraqi scientific bureau in Baghdad. We establish whether a product can register in Iraq, on which pathway, and at what documentary cost, before a manufacturer commits to the file.

Request an assessment Knowledge Center

The register, read directly

The register, read directly.

Two channels, different rules

Two channels.

Compliant pathways only

Compliant pathways only.

WHO WE ARE

A licensed bureau files. Everything else follows from that.

In Iraq, a product registration file is submitted by a licensed scientific bureau.

Eshnunna Scientific Bureau holds that licence.

WHAT WE DO

Three pathways.

01

Regulatory assessment

  • Classification determination
  • Documentary gap analysis
  • Pathway and feasibility opinion
  • Pricing exposure assessed before the dossier
02

Registration

  • Dossier preparation
  • Submission to the Registration Department
  • Bioequivalence requirement handling
  • Renewal management
03

Post-registration compliance

  • Local Safety Representative
  • Adverse event reporting
  • Periodic safety reporting
  • Import authorisation documentation
THE MARKET

What Iraq requires of an entrant.

Iraq is an import-dependent healthcare market.

For an international manufacturer the question is therefore not whether the market accepts imported product.

Two channels, two sets of rules

Two channels.

Registration is not one pathway

Registration is not one pathway.

Where entrants actually fail

Where entrants actually fail.

HOW IT WORKS

Four stages.

01

Intake

Intake

02

Determination

Determination

03

Preparation and submission

Preparation and submission

04

Maintenance

Maintenance

REGULATORY UPDATE

Iraq has discontinued the preliminary registration mechanism for foreign pharmaceutical products.

Effective 30 June 2025.

Source
KNOWLEDGE CENTER

Every guide states its regulatory basis and its verification date.

In this market, information without a source is a liability.

PILLAR GUIDE

The complete guide to pharmaceutical product registration in Iraq

The full pathway.

Read the guide MARKET CONTEXT

The structure of the Iraqi healthcare market

Import dependence.

Read the guide MARKET ENTRY

Five structural failures in Iraqi market entry

Five structural failures.

Read the guide
ASSESSMENT

Before you commit a dossier.

If you are evaluating Iraq.

Baghdad, Iraq
info@eshnunna-iq.com
We acknowledge within one business day.