Lebanon

The primary regulatory authority for health products in Lebanon is the Ministry of Public Health (MOPH), operating through its Directorate of Pharmaceutical Affairs and Chemical Substances. The principal governing legislation includes the Pharmacy and Pharmaceutical Establishments Law (Law No. 367 of 1994) and subsequent ministerial decrees that extend oversight to pharmaceuticals, medical devices, diagnostics, and increasingly to digital health solutions. All health products intended for the Lebanese market must obtain MOPH registration or approval prior to commercialization, with the review process involving technical dossier evaluation, pricing assessment, and in some cases local laboratory testing or inspection requirements. The MOPH also coordinates with the Higher Committee for Drug Pricing to set and control the prices of registered pharmaceutical and health products.

Submission requirements for health product registration in Lebanon generally follow adapted international standards, with the Common Technical Document (CTD) format widely accepted for pharmaceutical dossiers. Foreign manufacturers are typically required to appoint a locally registered representative or authorized agent who assumes legal and regulatory responsibility within the country. Supporting documentation commonly includes a Certificate of Free Sale or Certificate of Pharmaceutical Product (CPP) issued by the country of origin, Good Manufacturing Practice (GMP) certificates, and relevant clinical or technical data. For medical devices, classification and conformity documentation aligned with CE marking or equivalent international standards are increasingly referenced. In recent years, the MOPH has pursued incremental reforms to streamline registration procedures and enhance pharmacovigilance frameworks, though implementation has been complicated by Lebanon's broader economic and institutional challenges, including currency instability and public sector resource constraints.

Public procurement of health products in Lebanon is primarily managed through the Ministry of Public Health, which oversees the Central Drug Store (CDS) responsible for warehousing and distributing medicines, medical supplies, and diagnostics to public hospitals and government health centers. National tenders are conducted by the MOPH in coordination with government procurement rules, with the Central Tender Board (CTB) playing a formal oversight role for public contracts above defined thresholds. Public hospital procurement, including institutions such as the governmental Rafik Hariri University Hospital, follows MOPH-directed processes. The severe economic crisis that began in 2019 has significantly constrained the public procurement budget, leading to reduced centralized purchasing capacity and increased dependence on external financing for essential health commodities.

The private sector dominates health product distribution in Lebanon, accounting for the majority of pharmaceutical and device sales through an established network of licensed importers, distributors, and pharmacies. This private channel has grown in relative importance as public sector procurement capacity has weakened. Donor-funded procurement plays a critical and expanding role: organizations including UNICEF, the United Nations Relief and Works Agency (UNRWA), the World Health Organization (WHO), and USAID-funded implementing partners procure and supply significant volumes of medicines, diagnostics, and medical supplies, particularly for vulnerable and refugee populations. The World Bank has also channeled emergency health sector financing through Lebanon. Local manufacturing capacity is limited, and there are no substantial local manufacturing preference policies enforced in procurement; product selection is primarily driven by price competitiveness, registration status, and compliance with international quality standards.