Iraq

Health product regulation in Iraq is governed primarily by the Iraqi Drug and Medical Devices Control Center (IDMDCC), operating under the Ministry of Health and Environment (MoHE). The principal legislative framework includes the Pharmacy and Pharmaceutical Products Law No. 40 of 1970 and subsequent ministerial orders and directives that have been issued to address medical devices, diagnostics, and digital health tools. All health products intended for the Iraqi market must undergo a registration process administered by the IDMDCC, which evaluates product safety, efficacy, and quality. The process typically involves pre-submission review, technical dossier evaluation, and formal registration committee approval before a product license is granted. Registration certificates are generally valid for five years and are subject to renewal.

Submission requirements mandate the appointment of a local authorized representative or agent, who acts as the legal liaison between the foreign manufacturer and the IDMDCC. Dossiers are generally expected to follow a Common Technical Document (CTD) format or an equivalent internationally recognized structure, and supporting documentation must typically be attested and legalized through relevant diplomatic channels. Certificates of Pharmaceutical Product (CPP) from the country of origin are commonly required, along with GMP certificates, free sale certificates, and technical data sheets for devices and diagnostics. Iraq has been undertaking incremental regulatory modernization efforts, including greater alignment with WHO prequalification standards and increased engagement with Gulf region regulatory harmonization initiatives, though the system still faces capacity constraints and procedural delays that can extend review timelines considerably.

Public procurement of health products in Iraq is centralized primarily through the Ministry of Health and Environment, with the Central Pharmacy and Medical Supplies Company (CPMSC) playing a key operational role in aggregating demand, tendering, and distributing pharmaceuticals, medical devices, and diagnostics to public health facilities nationwide. National tenders are issued through the MoHE procurement directorate and are governed by the Iraqi Government Financial Management Law and associated public contracting regulations. The Kurdistan Regional Government (KRG) maintains a degree of autonomous procurement authority through its own Ministry of Health, conducting separate tenders for the Kurdistan Region, which creates a de facto dual-track public procurement environment. Provincial health directorates may also initiate smaller local procurements within budget allocations approved at the federal or regional level, though large-scale strategic purchases remain centrally coordinated.

The private sector represents a significant and growing channel for health product market access in Iraq, with a network of private importers, distributors, and retail pharmacies operating across major urban centers including Baghdad, Basra, Erbil, and Sulaymaniyah. Private hospitals and clinics procure independently through licensed local agents and distributors, often enabling faster market entry compared to the public tender cycle. Donor-funded procurement is an important supplementary channel, with organizations such as UNICEF, the World Health Organization (WHO), and USAID historically supporting health commodity supply during humanitarian and reconstruction phases, particularly for vaccines, essential medicines, and diagnostic supplies. While Iraq does not operate a formal local manufacturing preference policy comparable to some neighboring markets, there is growing government interest in supporting domestic pharmaceutical production capacity, and locally manufactured products may benefit from informal competitive advantages in public tenders, including reduced import-related costs and shorter lead times.