Georgia

The primary regulatory authority for health products in Georgia is the National Agency for Pharmacy and Medical Products (NAPM), operating under the Ministry of Internally Displaced Persons from the Occupied Territories, Labour, Health and Social Affairs of Georgia. The principal governing legislation includes the Law of Georgia on Medicines and Pharmaceutical Activity, as well as the Law of Georgia on Medical Devices, which together establish the legal framework for registration, market authorization, and post-market surveillance of pharmaceuticals, medical devices, diagnostics, and digital health solutions. The general approval process requires applicants to submit a registration dossier to NAPM, which undertakes scientific and technical review before granting a marketing authorization. Products already approved by recognized stringent regulatory authorities, such as the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), or equivalent bodies, may benefit from an abbreviated or expedited review pathway.

Applicants must designate a local authorized representative or a registered legal entity in Georgia to act as the responsible party for the product on the local market. Dossiers are generally accepted in Common Technical Document (CTD) format, aligned with International Council for Harmonisation (ICH) guidelines, and supporting documentation may be submitted in Georgian or English with certified translations required where specified. Georgia has undertaken significant regulatory reforms since the early 2010s as part of its broader association with the European Union under the EU-Georgia Association Agreement and the Deep and Comprehensive Free Trade Area (DCFTA), progressively harmonizing its regulatory standards with EU norms. Recent reforms have focused on strengthening post-market surveillance, pharmacovigilance requirements, and the regulation of medical devices in line with EU Medical Device Regulation (MDR) principles, reducing administrative burdens for products with prior approval from recognized stringent regulatory authorities.

Public procurement of health products in Georgia is primarily coordinated through the Ministry of Internally Displaced Persons from the Occupied Territories, Labour, Health and Social Affairs, with centralized tendering processes managed in accordance with the Law of Georgia on Public Procurement. The State Procurement Agency (SPA) administers public tenders via the electronic procurement platform, which mandates transparent, competitive bidding for government-funded health product purchases. The Social Service Agency (SSA), operating under the Ministry of Health, plays a key role in administering state health programs and financing, including the Universal Healthcare Programme, which drives a significant volume of pharmaceutical and medical device procurement. Centralized or framework agreements are used for high-volume or strategically important health commodities, and procurement criteria generally emphasize price competitiveness, product quality, and compliance with registration requirements.

The private sector constitutes a substantial portion of the Georgian health market, with a competitive pharmaceutical retail and distribution network operating across the country, including major pharmacy chains and private hospital groups that procure products independently through direct commercial agreements with local distributors or manufacturers. Georgia also benefits from donor-funded health programs, with organizations such as the Global Fund to Fight AIDS, Tuberculosis and Malaria, USAID, UNICEF, and the World Health Organization (WHO) supporting procurement of specific commodities including antiretrovirals, tuberculosis medicines, vaccines, and diagnostics through parallel supply channels that often operate under their own procurement frameworks and quality assurance standards. While there is no formal local manufacturing preference policy that explicitly disadvantages imported products, the government has expressed strategic interest in developing domestic pharmaceutical manufacturing capacity, and public procurement regulations encourage participation by locally registered entities, which can provide an indirect advantage to products with established local representation or manufacturing partnerships.