Pharmacovigilance in Georgia in 2026: MAH Requirements

Pharmacovigilance in Georgia in 2026: Requirements for Marketing Authorisation Holders

Updated 16 July 2026.

Pharmacovigilance in Georgia is governed by national legislation. The principal statute is the Law of Georgia on Medicines and Pharmaceutical Activities. Georgia is not a member of the Eurasian Economic Union, so EAEU pharmacovigilance rules do not apply automatically. EU Good Pharmacovigilance Practices and EMA guidance may be useful reference points, but they do not replace binding Georgian requirements.

Regulatory basis

Medicinal product circulation is supervised by the competent authorities within Georgia’s healthcare system. When planning registration and post-authorisation activities, a marketing authorisation holder (MAH) should check the current consolidated law, applicable secondary legislation, product-specific approval conditions and formal requests from the authority.

Core responsibilities of an MAH

• Safety-report intake. Information on adverse reactions and other safety issues should be captured, triaged and transferred to responsible pharmacovigilance personnel without delay.
• Individual case assessment. Reports should be validated, medically reviewed and followed up, with submission under the applicable national timelines.
• Local regulatory intelligence. The company should monitor changes in legislation, authority requirements and obligations imposed for the medicinal product.
• Literature and partner oversight. Search frequency should be justified by the product risk profile and company procedures. Agreements with distributors and other partners should define safety-data exchange.
• Aggregate safety evaluation. Requirements for periodic safety reports, risk management plans, signal evaluation and additional risk-minimisation measures should be confirmed for each product under national rules and approval conditions.
• Inspection readiness. Procedures, training, roles, compliance controls and record retention should be documented.

Practical compliance checklist

1. Appoint responsible pharmacovigilance personnel and a back-up contact.
2. Establish channels for receiving safety reports in Georgian and other languages used in the market.
3. Maintain written procedures and safety-data exchange agreements with partners.
4. Confirm product-specific obligations for case reporting, periodic reports, risk management and risk-minimisation measures.
5. Monitor official regulatory changes and retain evidence of compliance.

Official source

See the Law of Georgia on Medicines and Pharmaceutical Activities in the Legislative Herald of Georgia. Before making a regulatory decision, consult the current consolidated version and relevant secondary legislation.

How PharmExpert can help

PharmExpert supports companies operating in Georgia with regulatory gap assessments, adverse-reaction case processing, local procedures and agreements, compliance tracking and inspection readiness.

This article is for general information and does not constitute legal advice. Requirements should be confirmed for the specific product and registration pathway.