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  5. Breach of the quality and safety rules for human organs, tissues and cells (Art. 46¹⁰)

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Health, Child Protection & Social Sector

Breach of the quality and safety rules for human organs, tissues and cells (Art. 46¹⁰)

What fine is provided for breaching the quality and safety rules for organs, tissues and cells?

Under the first part of Article 46¹⁰ — a fine of GEL 10,000 with confiscation of the object of the offence; for a repeated violation — a fine of GEL 20,000 with confiscation.

Which material does this article cover?

Human organs, tissues and cells, except for reproductive tissues and cells — the latter remain outside the frame of this norm.

What does confiscation of the object mean here?

It means that alongside the fine the confiscation of the object of the relevant offence is also provided for; the procedure for applying confiscation is determined by the general norms of the Code.

Who examines the case and how is it appealed?

These matters are not regulated by this article — the procedure, the time limits and the appeal process are determined by other provisions of the Code.

4 min·22 Aug 2026

Article 46¹⁰ and its purpose

Article 46¹⁰ of the Code of Administrative Offences of Georgia establishes administrative liability for breaching the appropriate rules, standards and requirements established by Georgian legislation for protecting the quality and safety of human organs, tissues and cells. The norm serves the protection of patients: human organs, tissues and cells used for medical purposes must meet strict quality and safety standards, because the health and life of the recipient depend directly on the quality of this material.

The scope of the article is defined as follows: it concerns human organs, tissues and cells, with the exception of reproductive tissues and cells — material of the reproductive direction therefore remains outside the frame of this norm. The object of the offence is compliance with the appropriate rules, standards and requirements established for the protection of quality and safety.

Updated: 14 Oct 2026