---
title: "Drug Approval Process"
url: "https://legal.ge/en/service/healthcare-and-pharmaceutical-law-en/drug-approval-process-en"
field: "Healthcare & Pharmaceutical Law"
description: "Drug approval in Georgia: national and recognition regimes, expertise stages, deadlines and 6-7 year data exclusivity. Legal.ge."
reviewed: "2026-02-13"
updated: "2026-10-23"
publisher: "legal.ge"
---

# Drug Approval Process

> Source: legal.ge, https://legal.ge/en/service/healthcare-and-pharmaceutical-law-en/drug-approval-process-en

## Data Protection and Exclusivity Periods

The approval process begins with the rule on data protection: the scientific-technical information about a registered product may not be used for a registration decision on the same or a similar product without the consent of the market admission right holder. An applicant under the national regime may likewise not rely on the tests and research data submitted for a same or similar product first admitted in a European Union member country or Georgia without the holder’s consent. These rules operate for 6 years from the first admission of the pharmaceutical product to the market of a European Union member country or of Georgia. The term may extend to 7 years if within the first 6 years the basic authorization holder obtains authorization for one or more new therapeutic indications considered to possess significant clinical advantage over the existing treatment.

The full text is available on legal.ge after signing in: https://legal.ge/en/service/healthcare-and-pharmaceutical-law-en/drug-approval-process-en

### Who is the interested person under the national regime?

The manufacturer of the pharmaceutical product or the holder of the trade licence, who submits the application and the documents to the Agency.

### How much time does the Agency have for a decision?

3 months for a first registration, 2 months for re-registration, 20 or 40 calendar days for I series changes, and 14 days for the administrative expertise.

### Which products do not require registration?

A pharmaceutical substance, non-priced and intermediate products, products prepared by magistral or officinal prescriptions, and an allergen intended for a specific person.

### How accessible are foreign research data?

For 6 years from the first admission they may be used only with the consent of the right holder, and in a special case the term extends to 7 years.