Lebanon

The primary regulatory authority in Lebanon is the Ministry of Public Health (MOPH), operating through its Directorate of Pharmaceutical Affairs and Chemical Substances (DPASC). The principal legislative framework is governed by the Pharmacy and Pharmaceutical Establishments Law (Legislative Decree No. 367 of 1994) and its subsequent amendments, alongside ministerial decisions that regulate the registration, importation, and marketing of health products including pharmaceuticals, medical devices, and in-vitro diagnostics. The approval process requires submission of a registration dossier to the DPASC, followed by technical review covering safety, efficacy, and quality. Medical devices and diagnostics are subject to classification-based scrutiny, while digital health products remain in an emerging regulatory phase with no fully codified framework yet in place. Approved products are listed in the official Lebanese registry maintained by the MOPH.

Submission requirements mandate that all applicants designate a locally registered pharmaceutical or medical representative or agent who assumes legal responsibility for the product in Lebanon. Dossiers are generally expected to follow the Common Technical Document (CTD) format for pharmaceuticals, while medical device submissions often reference CE marking, FDA clearance, or equivalent recognized international approvals as supporting documentation. Local Arabic labeling is required for all registered health products. In recent years, the MOPH has attempted incremental reforms to streamline registration timelines and adopt risk-based classification for devices, partly driven by pressures from the severe economic crisis that began in 2019, which has disrupted supply chains and prompted emergency procurement exemptions. The Lebanese government has also explored greater reliance on reference country approvals to expedite access for critical health products.

Public procurement of health products in Lebanon is centralized primarily through the Ministry of Public Health, which manages tenders for pharmaceuticals, medical supplies, and equipment distributed to public hospitals and primary healthcare centers under its network. The MOPH's Central Drug Store (CDS) serves as the main warehousing and distribution arm for publicly procured medicines and supplies. Tenders are governed by the general public procurement law and overseen by relevant government audit bodies. However, Lebanon's protracted economic and financial crisis, combined with institutional fragility, has severely constrained the public health budget and disrupted regular tender cycles, leading to chronic shortages in public facilities and heavy reliance on emergency or donor-funded procurement mechanisms.

The private sector accounts for the dominant share of health product distribution in Lebanon, operating through a network of licensed importers, distributors, and approximately 3,000 community pharmacies. Given the collapse of public financing, international and humanitarian organizations have played an increasingly critical role in health commodity procurement. Organizations such as UNICEF, the World Health Organization (WHO), the United Nations Relief and Works Agency (UNRWA) for Palestinian refugees, and USAID implementing partners procure and supply essential medicines, vaccines, diagnostics, and medical devices directly to healthcare facilities and vulnerable populations. The Global Fund supports procurement for HIV, tuberculosis, and malaria-related commodities. Lebanon does not maintain a formal local manufacturing preference policy in public tenders; however, a small domestic pharmaceutical manufacturing sector exists and locally produced products registered with the MOPH may compete in tenders. Donor-funded procurement typically follows the standards and prequalification requirements of the respective international agency rather than solely MOPH registration criteria.