Lebanon

The primary regulatory authority for health products in Lebanon is the Ministry of Public Health (MOPH), operating through its Directorate of Pharmaceuticals and Chemical Substances (DPCS). The DPCS oversees the registration and market authorization of pharmaceuticals, medical devices, diagnostics, and increasingly, digital health solutions. The legal framework is anchored in the Pharmacy and Pharmaceutical Professions Law (Decree-Law No. 367 of 1994) and subsequent ministerial decisions that have extended regulatory scope to medical devices and in-vitro diagnostics. All health products must undergo a formal registration process before commercialization, which includes technical dossier review, product classification, and in some cases, laboratory verification. The MOPH also coordinates with the Lebanese Standards Institution (LIBNOR) for conformity assessments relevant to medical devices.

Submission requirements vary by product category but generally align with internationally recognized standards. For pharmaceuticals, the DPCS accepts dossiers structured according to the Common Technical Document (CTD) format, and applicants are encouraged to reference approvals from stringent regulatory authorities such as the EMA, US FDA, or WHO prequalification to facilitate review. A local authorized representative or licensed pharmaceutical importer is mandatory for all foreign manufacturers seeking market authorization. Medical device registrations increasingly reference CE marking or FDA 510(k) clearance as supporting documentation. Lebanon has undertaken incremental regulatory modernization efforts, including digitizing submission portals and aligning post-market surveillance requirements more closely with international norms, though implementation remains uneven given ongoing socioeconomic pressures and the impact of the 2019-2020 financial crisis on institutional capacity.

Public procurement of health products in Lebanon is primarily managed through the Ministry of Public Health (MOPH), which oversees the Central Drug Store (Magasin Central) responsible for procuring and distributing medicines, vaccines, medical supplies, and diagnostics to public hospitals and primary healthcare centers nationwide. Procurement is governed by the Public Accounting Law and related tender regulations administered by the Central Inspection Board and the Court of Accounts. The MOPH issues periodic public tenders for essential medicines and medical supplies, with contracts typically awarded on the basis of lowest compliant price. Public hospitals, including government-run facilities and university hospitals operating under MOPH agreements, may also conduct their own supplementary procurement within established frameworks. The severe economic crisis since 2019 has significantly constrained the government's purchasing power, leading to chronic shortages and increased reliance on alternative funding mechanisms.

The private sector plays a dominant role in Lebanon's health system, with a large share of health products entering the market through licensed private importers and distributors serving private hospitals, pharmacies, and clinics. This channel operates largely outside centralized procurement structures and is driven by commercial negotiations between suppliers and private buyers. Given the collapse of state financing, international and donor-funded procurement has become critically important: organizations such as UNICEF, the World Health Organization (WHO), UNHCR, and various NGOs funded by donors including USAID and the European Union have stepped in to procure and supply essential medicines, vaccines, and medical commodities, particularly for vulnerable populations including Palestinian and Syrian refugees. The World Bank has also channeled emergency health sector support through MOPH-administered projects. Lebanon does not currently enforce a formal local manufacturing preference policy in public tenders, though a nascent domestic pharmaceutical manufacturing sector exists and MOPH has expressed interest in promoting local production capacity as part of longer-term resilience strategies.