Iraq is an emerging market in the Middle East with significant potential demand for pharmaceuticals, medical devices, and essential health products, driven by ongoing healthcare reconstruction and population needs.
The Iraqi Ministry of Health (MoH – وزارة الصحة), through the Directorate of Drug Registration and Control (or equivalent drug control units), is the primary regulatory authority responsible for the registration, importation, distribution, quality control, and post-market oversight of medicines, medical devices, and related health products in Iraq. The MoH requires product registration, import permits, quality certificates (e.g., CPP, GMP), local agent representation, and alignment with WHO guidelines and regional standards. Foreign manufacturers face procedural complexities, documentation requirements, and import licensing processes. MedWisdom LifeScience provides expert regulatory affairs support to help global companies navigate Iraq’s requirements, prepare compliant dossiers, secure MoH approvals and import authorizations, and achieve successful market entry and compliance in this strategically important regional market.
Get Iraq Compliance Support
Preparation of regulatory dossiers, supporting documents (stability, preclinical/clinical data, GMP/CPP certificates), and quality review for MoH submissions.
End-to-end support for MoH registration of medicines, medical devices, and health products in Iraq.
Assistance with MoH import/export authorizations, batch release certificates, customs documentation, and special import permits.
Guidance on GMP documentation, quality assurance requirements, certificate support, and preparation for MoH quality inspections.
Setup of pharmacovigilance systems, adverse event reporting to MoH, periodic safety reporting, and basic risk management in Iraq.
Support for post-market monitoring, vigilance reporting, field safety corrective actions, and compliance with MoH post-registration requirements.
Arabic labelling review, MoH-specific requirements (patient information, packaging), mock-up preparation, and compliance support.
Support for local agent/representative requirements, MoH liaison, regulatory follow-up, and ongoing compliance management in Iraq.
Strategic market entry planning, MoH pathway guidance, regulatory intelligence on Iraq’s requirements, and risk mitigation support.
Partner with Medwisdom for expert, reliable, and compliant regulatory support in Iraq — from MoH product registration and import permits to pharmacovigilance, Arabic labelling, and sustained market access.
Contact Our Iraq Regulatory Experts