Iraq

The primary regulatory authority for health products in Iraq is the Drug and Pharmacy Control Directorate (DPCD), operating under the Ministry of Health and Environment (MoHE). The principal governing legislation includes the Pharmacy and Medications Law No. 40 of 1970 and its subsequent amendments, which establish the legal framework for the registration, importation, distribution, and control of pharmaceuticals, medical devices, diagnostics, and related health products. All health products must undergo a formal registration and approval process administered by the DPCD before they may be legally marketed or procured in Iraq. This process involves technical review by specialized committees within the DPCD, and approval is required from both federal and, in the case of the Kurdistan Region, the Kurdistan Regional Government (KRG) Ministry of Health, which maintains a partially autonomous regulatory process through its own directorate in Erbil.

Key submission requirements for product registration include the appointment of a local authorized agent or representative, who must be a licensed Iraqi entity registered with the MoHE and is legally responsible for the product within the country. Dossier submissions are generally expected to follow the Common Technical Document (CTD) format, though full adherence to international standards can be inconsistently enforced in practice. Supporting documentation typically includes a Certificate of Pharmaceutical Product (CPP) issued by the country of origin, Good Manufacturing Practice (GMP) certification, product samples, labeling in Arabic, and proof of registration in the country of manufacture. Iraq has been undertaking incremental modernization efforts within the DPCD, including moves toward digitizing submission workflows and aligning more closely with World Health Organization (WHO) prequalification standards, though implementation remains ongoing and regulatory capacity continues to develop.

Public procurement of health products in Iraq is predominantly centralized through the Ministry of Health and Environment at the federal level, which conducts national tenders for pharmaceuticals, medical devices, diagnostics, and consumables. The Central Contracts and Procurement Department within the MoHE oversees the tendering process, which is governed by the Public Contracts Law No. 87 of 1977 and related financial and administrative instructions. Federal budget allocations for health procurement are managed through annual Ministry budgets, with tenders published through official Iraqi government channels and the Government Contracts Committee. Provincial health directorates may conduct supplementary local procurement within approved budget limits, while the Kurdistan Regional Government operates its own parallel procurement system through the KRG Ministry of Health, with independent tendering and budget authority. Lengthy tender cycles, bureaucratic complexity, payment delays, and security considerations have historically created challenges for suppliers, requiring strong local representation and distributor relationships to navigate the process effectively.

Beyond the public sector, Iraq's private health market plays a significant and growing role in the distribution and sale of health products, particularly in urban centers such as Baghdad, Basra, Erbil, and Sulaymaniyah. Private hospitals, clinics, and pharmacies procure directly from licensed local distributors and importers, offering a more commercially accessible channel for many international manufacturers. Donor-funded procurement also represents an important segment, particularly for specific disease areas and health system strengthening initiatives. Organizations including UNICEF, the World Health Organization (WHO), the United Nations Population Fund (UNFPA), and various bilateral donors such as USAID have historically supported health commodity procurement and supply chain strengthening in Iraq, especially during and following periods of humanitarian crisis. While Iraq is not a Global Fund recipient country, international NGOs and humanitarian organizations remain active in procurement for displaced populations and underserved communities. Local manufacturing is limited but supported in principle through preferential pricing policies in public tenders, and the government has expressed strategic interest in expanding domestic pharmaceutical production capacity as part of broader economic diversification goals.