Georgia

The circulation and safety control of medicinal products in Georgia are overseen by the competent agency under the Ministry of Health in accordance with the Law of Georgia on Medicines and Pharmaceutical Activities. The Georgian consolidated law establishes state control of pharmaceutical-product safety and the Agency's regulatory functions. However, current publicly accessible official sources do not clearly establish EU-style mandatory QPPV, PSMF, PSUR/PBRER or RMP obligations for all MAHs. Accordingly, they are not established as universal Georgian obligations without a current national implementing rule or written authority confirmation. A suitable pharmacovigilance system and safety-reporting arrangements should be confirmed for the specific product and registration route. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.