---
title: "Pharmaceutical Labeling Compliance"
url: "https://legal.ge/en/service/healthcare-and-pharmaceutical-law-en/pharmaceutical-labeling-compliance-en"
field: "Healthcare & Pharmaceutical Law"
description: "Pharmaceutical labeling compliance in Georgia: marking changes, 2 samples, 12-month transition and a 1,000 lari fine. Legal.ge."
reviewed: "2026-06-27"
updated: "2026-10-20"
publisher: "legal.ge"
---

# Pharmaceutical Labeling Compliance

> Source: legal.ge, https://legal.ge/en/service/healthcare-and-pharmaceutical-law-en/pharmaceutical-labeling-compliance-en

## Marking Requirements at Registration

The label and marking of a pharmaceutical product are an integral part of its state registration. The administrative part of the registration documents is submitted in material form in Georgian and is accompanied by a Georgian translation of the instruction as an electronic file on a disc and by a sample of the packaging and marking. The electronic version submitted to the Agency must indicate the trade name of the product, the manufacturer, the trade licence holder, the form and dose of the medicine, the quantity contained in the package, the registration regime and the dates of submission of both parts of the documents. If the product has not yet been launched into production, the Agency is obliged to accept an electronic version of the marking sample, while after the launch it may demand its replacement in material form. The trade packaging is submitted with standard marking, and for an imported product the instruction is submitted as an authorized Georgian translation together with the original. The administrative expertise, which checks compliance with these requirements, is completed no later than within 14 days, so any defect of the label or the sample surfaces early in the procedure rather than at the end.

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

### What fine is provided for an unlawful change of marking?

A change of the packaging and marking without registration or notification draws a fine of 1,000 lari, with suspension of the sale until the offence is eliminated.

### How many samples are submitted on a change of marking?

On a change of the primary and secondary packaging marking and of the design, 2 new samples are submitted.

### How does the market term change after a change?

Import and manufacture under the previous marking is allowed for 12 months from the change.

### Which changes require separate registration?

Changes of the active substances, the form, the strength and those connected with manufacture are II series changes requiring separate registration.