Iraq

The primary regulatory authority for health products in Iraq is the Central Device and Drug Control Directorate (CDCD), operating under the Ministry of Health and Environment (MoHE). The legal framework is anchored in the Public Health Law No. 89 of 1981 and its subsequent amendments, supplemented by ministerial circulars and directives that govern the registration, importation, and distribution of pharmaceuticals, medical devices, diagnostics, and increasingly digital health solutions. All health products must undergo a formal registration process with the CDCD before they may be legally marketed or procured in Iraq. The review process involves technical evaluation of product dossiers, safety and efficacy data, labeling compliance, and, for devices, conformity documentation. Products approved by stringent regulatory authorities such as the US FDA, EMA, or Health Canada may benefit from an expedited review pathway, though full local registration remains mandatory.

Applicants are required to appoint a locally registered authorized representative or distributor who acts as the legal liaison with the CDCD and assumes responsibility for post-market obligations. Dossiers are generally expected to follow the Common Technical Document (CTD) format for pharmaceuticals, while medical devices require technical files that include ISO 13485 certification, CE marking or equivalent approval from a recognized authority, and a Declaration of Conformity. Labeling must be provided in Arabic. Iraq has undertaken intermittent reform efforts to streamline its registration processes, including digitization initiatives for submission tracking and efforts to harmonize requirements with regional standards. However, implementation remains uneven and timelines can extend significantly due to administrative capacity constraints, security considerations, and bureaucratic complexity. Companies are advised to engage experienced local partners early in the market entry process.

Public procurement of health products in Iraq is primarily managed through the Ministry of Health and Environment at the federal level, with the Central Pharmacy Company (CPC) serving as the principal state entity responsible for bulk purchasing, warehousing, and distribution of pharmaceuticals and medical supplies to public health facilities. Procurement is conducted through a formal national tendering process governed by the Public Contracting Law and overseen by the Government Contracts Execution Department. The Kurdistan Regional Government (KRG) operates a semi-autonomous procurement system through its own Ministry of Health, conducting separate tenders and maintaining independent supply chains, which means suppliers seeking comprehensive national coverage must engage both federal and KRG procurement channels. Budget cycles, payment delays, and currency controls have historically posed challenges for international suppliers, and Letters of Credit are the standard payment mechanism for imported goods.

Beyond the public sector, Iraq receives health commodities through several donor-funded and international channels, particularly in areas affected by humanitarian need. Organizations such as UNICEF, the World Health Organization (WHO), the United Nations Population Fund (UNFPA), and various NGOs procure and distribute health products outside the standard MoHE tendering framework, often following their own international procurement standards. USAID-funded programs have also supported health system strengthening and commodity supply in specific regions. The private sector represents a significant and growing channel, especially in urban centers such as Baghdad, Erbil, and Basra, where private hospitals and pharmacies source products directly through licensed importers and distributors. Iraq has articulated policy ambitions to promote local pharmaceutical manufacturing as part of its broader industrial development agenda, and preference mechanisms for locally manufactured products have been discussed in policy forums, though consistent and transparent enforcement of such preferences remains limited at present.