Iraq

The primary regulatory authority for health products in Iraq is the Central Device and Drug Control Department (CDCCD), operating under the Ministry of Health and Environment (MoHE). The principal legal framework governing registration and market authorization of health products is grounded in the Pharmacy and Medicines Law No. 40 of 1970 and subsequent ministerial directives and circulars that have been issued to modernize the system. All pharmaceuticals, medical devices, in-vitro diagnostics, and related health products must be registered with the CDCCD prior to importation, distribution, or sale. The registration process involves submission of a product dossier, review by technical committees, and issuance of a formal marketing authorization certificate. The review timeline is highly variable and can range from 12 to 24 months or longer, depending on product classification, workload, and completeness of the submission.

Key submission requirements include the appointment of a local authorized representative or licensed importer who must hold a valid license from the MoHE, as foreign manufacturers cannot register products directly without a local agent. Iraq does not formally mandate the Common Technical Document (CTD) format, but submissions referencing international dossier standards such as CTD or documentation accepted by stringent regulatory authorities (US FDA, EMA, WHO prequalification) are generally viewed favorably and can support faster review. Required documentation typically includes certificates of free sale from the country of origin, GMP certificates, product specifications, clinical and safety data, labeling in Arabic, and proof of the local representative's legal standing. Notable recent developments include efforts by the MoHE to digitize elements of the registration process and increasing alignment with WHO guidelines, although implementation remains uneven. The Kurdistan Region of Iraq (KRI) maintains a degree of administrative autonomy through the Kurdistan Regional Government Ministry of Health, and products may require separate approvals or registration steps to be marketed within that region.

Public procurement of health products in Iraq is primarily managed through the Ministry of Health and Environment at the federal level, which conducts centralized national tenders for pharmaceuticals, medical devices, diagnostics, and other health commodities. The General Directorate of Contracting and Procurement within the MoHE oversees the tendering process, which follows the Public Contracts Law No. 87 of 1977 and subsequent amendments, along with guidelines issued by the Board of Supreme Audit. Federal procurement decisions are typically made annually based on ministry needs assessments and budget allocations approved through the national budget cycle. Provincial health directorates also conduct some local-level procurement for specific needs, and the Kurdistan Regional Government operates its own parallel procurement system through the KRG Ministry of Health, conducting independent tenders for the Kurdistan Region. Participation in public tenders generally requires registration of the product with the CDCCD, a licensed local agent, a valid commercial registration in Iraq, and compliance with tender technical specifications.

The private sector constitutes a significant parallel channel for health product distribution, particularly in major urban centers such as Baghdad, Erbil, Sulaymaniyah, and Basra, where private hospitals, pharmacies, and clinics source products directly from licensed importers and distributors. Given the historical fragility of the public health system and periods of conflict, international donor and humanitarian organizations have played a substantial role in health product procurement and supply chain support. Organizations such as UNICEF, WHO, UNFPA, and various NGOs have procured and supplied health commodities outside the standard MoHE tender process, particularly during humanitarian response phases. USAID-funded programs have also supported health system strengthening and commodity supply in certain periods. While Iraq does not currently have an explicit statutory local manufacturing preference policy equivalent to some other markets, the MoHE has expressed strategic interest in supporting domestic pharmaceutical production capacity, and locally manufactured products may receive preferential consideration in certain tender evaluations as the government seeks to reduce import dependency.