What Article 46⁸ regulates
Article 46⁸ of the Code of Georgia on Administrative Offences establishes administrative liability for failing to draw up a document on activity carried out in accordance with the Law of Georgia on the Transplantation of Human Organs and/or the Law of Georgia on the Use of Human Tissues and Cells, for failing to fulfil the duty to maintain the corresponding record, and for breaching other traceability rules provided for by those same laws. The norm thus combines two directions: the duty to draw up documentation and keep records, and compliance with the other rules of traceability.
This page explains in detail which acts are treated as offences, how the sanctions are distributed across the four parts of the article, who is regarded as the liable person, and what the norm itself leaves unregulated. Every explanation is anchored in the text of the article: the fine amounts are given separately for each part, and no amounts have been compressed into a single range.
The material is useful for the management of medical institutions, for specialised departments and for those in charge of documentation within an institution. Knowing the structure of the article makes it possible to plan internal processes so that both the drawing up of documents and the other traceability requirements are satisfied at the same time rather than one at the cost of the other.
Failure to draw up a document or to keep records
The first part of the article treats as an administrative offence the failure by the appropriate person to draw up a document on activity carried out in accordance with the Law of Georgia on the Transplantation of Human Organs and/or the Law of Georgia on the Use of Human Tissues and Cells, or the non-fulfilment of the duty to maintain the corresponding record. This means that activity conducted within the framework of those laws must be reflected in documentation, and that leaving it undocumented or failing to keep the record entails a fine.
The practical significance of this part lies in the fact that documentation is the basis on which the processes connected with transplantation can be reconstructed and verified. Where a document is not drawn up or a record is not kept, the whole analytical chain is lost — and this does not release the offender from liability.
Breach of other traceability rules
The third part of the article defines as a separate offence the breach by the appropriate person of other traceability rules provided for by the same laws. The wording “other” rules makes it clear that the documentation and record-keeping duties protected by the first part are only one component of the traceability system, and that breaches of such other rules are assessed separately. It is therefore practically important to verify all traceability requirements together rather than one by one. An institution that knows exactly which requirements exist, how they interrelate and who verifies their fulfilment is considerably better protected against an accidental breach.
Fines under all four parts of the article
Article 46⁸ contains four sanctions, which are applied separately according to the relevant part:
- the act provided for by the first part — a fine of 10,000 GEL;
- the act provided for by the first part, committed repeatedly — a fine of 20,000 GEL;
- breach of the other traceability rules covered by the third part — a fine of 10,000 GEL;
- the act provided for by the third part, committed repeatedly — a fine of 20,000 GEL.
Understanding this structure matters: the first and the third parts govern different acts, while the second and the fourth parts increase the sanction in the event of repeat commission. When a case is examined, it must be established under which part the act is qualified and whether the person committed it repeatedly. The criteria of repeat commission are determined by other provisions of the Code.
What the article does not regulate
Article 46⁸ contains no rules on how a concrete document or record is to be formatted — that content is determined by the special laws and by acts adopted on their basis. Nor does the article regulate who draws up the administrative offence report, which body examines the case and how a fine may be appealed — these matters are governed by other provisions of the Code. If a fine has already been imposed, the practical first steps are to study the case materials, verify the qualification of the act within the framework of all four parts and prepare a reasoned position.
History of the provision and how Legal.ge can help
The text of the article refers to the Law of Georgia No. 3622 of 1 November 2023 and the Law of Georgia No. 130 of 13 December 2024. The Legal.ge team assists medical institutions in matters connected with Article 46⁸: we audit the compliance of documentation and traceability processes, assess the qualification of an alleged breach and prepare positions for the examination of a case and for appeal. An early assessment costs far less than the fine.