Drug Registration in Georgia

Drug Registration

Under which two regimes is a drug admitted?

State-registration recognition and national regimes — the first recognizes a foreign regulator, the second requires a full expertise.

What is the sectoral registry?

A public document whose entry means market admission; it must be accessible to the public through the internet.

Who may file the application?

Under recognition — any person; under the national regime — the manufacturer or the trade-licence holder.

How long does a decision take?

First registration — 3 months, re-registration — 2 months; where no refusal is communicated in time, the product is considered registered.

5 min·8 Feb 2026

The Two Market-Admission Regimes

The admission of a pharmaceutical product to the Georgian market operates under two regimes: the recognition regime and the national regime of state registration. The routes rest on different logics — one builds on a foreign regulator's decision, the other on a full expertise in Georgia, and choosing correctly is a matter of time and cost.

The recognition regime rests on the differentiation of a foreign or international regulator by its reliability and its ability to admit only high-quality products to its own markets. Georgia unilaterally recognizes the safety, efficacy and quality requirements such an authority applies to the markets under its control and does not repeat the expertise — a product already admitted by a trusted regulator is not examined anew.