Georgia

The primary regulatory authority for health products in Georgia is the National Agency for Pharmacy and Medical Technologies (NAPMТ), 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 Activities, along with subordinate ordinances covering medical devices, diagnostics, and related health technologies. The registration process generally requires submission of a complete dossier to NAPMТ, followed by technical and scientific review. Products that have received prior approval from recognized stringent regulatory authorities (SRAs), such as the EMA or the US FDA, may benefit from an expedited or simplified review pathway, significantly reducing the overall approval timeline.

Key submission requirements include the appointment of a local authorized representative or a registered entity in Georgia, who bears legal responsibility for the product on the market. Dossiers are generally accepted in Common Technical Document (CTD) format, aligned with ICH guidelines, and supporting documentation may be submitted in English or Georgian. Georgia has undertaken notable regulatory reforms as part of its European integration agenda under the EU-Georgia Association Agreement and the Deep and Comprehensive Free Trade Area (DCFTA), progressively harmonizing its pharmaceutical and medical device regulations with EU standards. Recent reforms have focused on strengthening post-market surveillance, pharmacovigilance obligations, and expanding recognition of SRA approvals to streamline market entry for internationally registered products.

Public procurement of health products in Georgia is centrally coordinated through the Ministry of Internally Displaced Persons from the Occupied Territories, Labour, Health and Social Affairs, with procurement procedures governed by the Law of Georgia on Public Procurement and administered through the State Procurement Agency. Tenders for pharmaceuticals, medical devices, diagnostics, and digital health solutions are published on the unified electronic procurement platform, known as the e-Procurement portal (ge-procurement.gov.ge), ensuring transparency and open competition. The Social Service Agency, operating under the Ministry, plays a key role in managing state healthcare programs and their associated procurement needs, particularly for medicines and services covered under the Universal Healthcare Program.

Beyond the public sector, Georgia engages with several international donor-funded and multilateral procurement channels. Organizations such as UNICEF, the Global Fund to Fight AIDS, Tuberculosis and Malaria, and USAID are active in the country, procuring health commodities for disease-specific programs, often through international competitive tender mechanisms or established supply agreements with prequalified suppliers. The Global Fund in particular supports HIV, TB, and malaria programs in Georgia, creating additional market access pathways for qualified manufacturers. While Georgia does not currently enforce a strict local manufacturing preference policy, the government has expressed strategic interest in developing domestic pharmaceutical production capacity as part of broader industrial and health security goals, and local sourcing considerations may informally influence program design in certain state-funded initiatives.