Lebanon

In Lebanon, the primary regulatory authority responsible for health products is the Ministry of Public Health (MoPH), specifically through its Directorate of Pharmaceutical Affairs and Chemical Substances (DPACS). The main governing legislation includes Law No. 367/1994 on the practice of pharmacy and pharmaceutical products, supplemented by various ministerial decisions covering registration, pricing, and post-market surveillance. All health products, including pharmaceuticals, medical devices, diagnostics, and increasingly digital health solutions, must undergo a formal registration process before being placed on the Lebanese market. The general approval pathway involves submission of a dossier to the MoPH, technical review by specialized committees, and issuance of a registration certificate prior to importation and commercialization.

Submission requirements in Lebanon mandate the appointment of a local authorized representative or registered pharmaceutical agent who bears legal responsibility for the product on the market. Dossiers are generally expected to follow the Common Technical Document (CTD) format for pharmaceuticals, while medical device submissions typically require evidence of conformity with internationally recognized standards such as CE marking (EU MDR/IVDR) or FDA clearance, which can facilitate a more streamlined review. Lebanon has historically accepted reference country approvals from stringent regulatory authorities including the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), and others as supporting documentation. In recent years, the MoPH has attempted incremental reforms to modernize its registration processes and strengthen pharmacovigilance frameworks, though significant capacity constraints, fiscal instability, and the broader socioeconomic crisis have slowed implementation of comprehensive regulatory reforms.

Public procurement of health products in Lebanon is primarily managed through the Ministry of Public Health (MoPH), which oversees purchasing for the public hospital network, primary healthcare centers, and national health programs. The MoPH conducts centralized tender processes for essential medicines, vaccines, and medical supplies distributed to public facilities, with procurement decisions subject to review by the Higher Tender Council (HTC), Lebanon's central public tendering authority. Public health budgets have faced severe constraints since the onset of Lebanon's financial crisis in 2019, and the collapse of the Lebanese pound has dramatically disrupted supply chains, reduced import capacity, and increased dependence on external financing. Procurement processes in the public sector are governed by the Public Procurement Law (Law No. 244/2021), which introduced reforms to improve transparency and accountability across all government purchasing, including health commodities.

Given the depth of Lebanon's economic crisis, international donor-funded channels have become critically important in sustaining the health system and often represent a significant share of health product procurement. Key partners include the World Health Organization (WHO), UNICEF, UNHCR, the United States Agency for International Development (USAID), the World Bank, and the European Union, all of which have channeled emergency health commodities and technical assistance through both the MoPH and non-governmental organizations. The private sector remains substantial in Lebanon, with a well-developed network of private hospitals, clinics, and pharmacies that procure products through licensed importers and distributors independently of public tender processes. Lebanon does not have a significant local pharmaceutical manufacturing base relative to its import dependency, and there are currently no strong formal local manufacturing preference policies in procurement; however, donor agencies typically follow their own procurement rules and may apply specific sourcing requirements aligned with international standards such as WHO prequalification.