Lebanon is a strategically located market in the Levant region with ongoing demand for pharmaceuticals, medical devices, and essential health products, supported by a resilient healthcare sector despite regional challenges.
The Ministry of Public Health (MoPH – وزارة الصحة العامة), through its Directorate of Pharmacy and Drug Administration, is the primary regulatory authority responsible for the registration, importation, distribution, quality control, and post-market oversight of medicines, medical devices, and related health products in Lebanon. The MoPH requires product registration, import permits, quality certificates (e.g., CPP, GMP), local agent representation, and alignment with WHO guidelines and regional standards. Foreign manufacturers face documentation requirements, procedural timelines, and import licensing processes. MedWisdom LifeScience provides expert regulatory affairs support to help global companies navigate Lebanon’s requirements, prepare compliant dossiers, secure MoPH approvals and import authorizations, and achieve successful market entry and compliance in this important regional market.
Get Lebanon Compliance Support
Preparation of regulatory dossiers, supporting documents (stability, preclinical/clinical data, GMP/CPP certificates), and quality review for MoPH submissions.
End-to-end support for MoPH registration of medicines, medical devices, and health products in Lebanon.
Assistance with MoPH import/export authorizations, batch release certificates, customs documentation, and special import permits.
Guidance on GMP documentation, quality assurance requirements, certificate support, and preparation for MoPH quality inspections.
Setup of pharmacovigilance systems, adverse event reporting to MoPH, periodic safety reporting, and basic risk management in Lebanon.
Support for post-market monitoring, vigilance reporting, field safety corrective actions, and compliance with MoPH post-registration requirements.
Arabic/French/English labelling review, MoPH-specific requirements (patient information, packaging), mock-up preparation, and compliance support.
Support for local agent/representative requirements, MoPH liaison, regulatory follow-up, and ongoing compliance management in Lebanon.
Strategic market entry planning, MoPH pathway guidance, regulatory intelligence on Lebanon’s requirements, and risk mitigation support.
Partner with Medwisdom for expert, reliable, and compliant regulatory support in Lebanon — from MoPH product registration and import permits to pharmacovigilance, Arabic labelling, and sustained market access.
Contact Our Lebanon Regulatory Experts