Georgia

In Georgia, the primary regulatory authority overseeing health products, including pharmaceuticals, medical devices, diagnostics, and digital health tools, is the National Agency for Pharmacy and Medical Technologies (NAPM), operating under the Ministry of Internally Displaced Persons from the Occupied Territories, Labour, Health and Social Affairs of Georgia. The principal legislative framework governing market authorization is the Law of Georgia on Medicines and Pharmaceutical Activities, supplemented by relevant decrees and technical regulations issued by the Ministry. The general approval process requires applicants to submit a registration dossier for evaluation, following which NAPM conducts a scientific and technical assessment before granting a marketing authorization certificate. The process varies in complexity depending on product category, with pharmaceuticals subject to more rigorous clinical and quality scrutiny than certain lower-risk medical devices.

Georgia broadly aligns its dossier requirements with internationally recognized standards, accepting Common Technical Document (CTD) format submissions for pharmaceutical products, which facilitates applications from companies that have already registered in reference jurisdictions such as the EU, USA, or other ICH member countries. A local representative or legal entity registered in Georgia is typically required to act as the marketing authorization holder or local contact. Georgia has pursued progressive regulatory modernization as part of its broader EU integration agenda following the signing of the EU-Georgia Association Agreement and the Deep and Comprehensive Free Trade Area (DCFTA) in 2014. Ongoing reforms have focused on harmonizing technical standards with EU directives, streamlining electronic submission processes, and strengthening post-market surveillance mechanisms, with NAPM increasingly referencing European Medicines Agency (EMA) guidelines as benchmarks for assessment.

Public procurement of health products in Georgia is centrally coordinated through the State Procurement Agency (SPA), which administers competitive tender procedures in accordance with the Law of Georgia on Public Procurement. The Ministry of Internally Displaced Persons from the Occupied Territories, Labour, Health and Social Affairs serves as the primary contracting authority for nationally funded health programs, including the Universal Healthcare Program (UHC), which has significantly expanded access to publicly financed medical services since its introduction in 2013. State-funded procurement is conducted primarily through electronic tender platforms, and suppliers must meet registration and compliance requirements set by NAPM to be eligible to participate. There is no formal federal-state split in procurement, as Georgia operates as a unitary state, though certain regional health facilities may manage smaller-scale local purchases.

The private sector plays a substantial role in Georgia's health product market, with a well-developed network of private pharmacies, hospitals, and diagnostic centers procuring products through commercial distributors and direct manufacturer agreements. International donor and multilateral channels also contribute to health commodity supply, particularly for disease-specific programs. Organizations such as the Global Fund to Fight AIDS, Tuberculosis and Malaria support procurement of HIV and tuberculosis-related medicines and diagnostics, while UNICEF and USAID have historically provided technical and financial assistance for immunization and maternal and child health commodities. Georgia does not currently maintain formal local manufacturing preference policies in its public procurement framework, though broader industrial and trade policies under the DCFTA encourage compliance with EU-aligned standards that may indirectly shape market access conditions for international suppliers.