Violations of Pharmaceutical Activity Rules and Their Fines
The law attaches a precise sanction to each breach of the pharmaceutical activity rules. The preparation or sale of a pharmaceutical product by unauthorised personnel — staff without pharmaceutical education or a subject lacking the right of independent medical activity — draws a fine of 4,000 lari with confiscation of the subject of the offence. Violation of the preparation rules or of the storage conditions established by the instructions draws 2,000 lari with confiscation. Violation of the sale rules for a pharmaceutical product, other than a product assigned to the first group, draws a fine of 500 lari, and the same act committed repeatedly draws 1,000 lari. Breach of the dispensing rules for a first-group product is punished more severely: a fine of 6,000 lari, and 12,000 lari when committed repeatedly. The sale of a substandard, expired or defective pharmaceutical product draws 6,000 lari with confiscation, while the circulation of a falsified product on the Georgian market draws 20,000 lari with confiscation. Violation of the established rules of accounting, manufacture, standardisation, marking, transportation and shipment, import and export, re-export, serial registration and destruction of a medicinal product draws 1,600 lari with confiscation, and 4,000 lari with confiscation when repeated. Each of these tiers stands separately and must not be merged into a single span when the sanction is being assessed.
How the Case Is Heard and Enforced
As a general rule, the protocol on an administrative offence envisaged by this law is drawn up by the Agency, and the case is considered by the court. For administrative offences envisaged by separate articles of the law, protocols are drawn up by the Agency and by authorised officials of the Revenue Service, the public law legal entity within the governance sphere of the Ministry of Finance; these officials consider the cases on the spot and impose the administrative penalty on the offender directly at the place of the violation. In defined instances the penalty may even be imposed electronically, in the cases and by the procedure determined by the Minister's order. For these purposes the Agency and the Revenue Service exchange information and, when necessary, plan and carry out joint measures. Individual administrative-legal acts imposing fines for this category of offences become immediately enforceable, and an appeal does not suspend their execution — a point of critical practical importance for anyone deciding whether to pay first and litigate later.
Grounds of Responsibility Among Circulation Participants
The law distributes responsibility among the participants in the circulation of a pharmaceutical product. For the safety, quality and efficacy of a product admitted to the market under the national regime, the market authorisation holder and the state are responsible; for a product admitted under the recognition regime, the state is responsible. Compliance of a product with the documentation submitted at registration under the national regime is the responsibility of the manufacturer of the series. If the qualities of an imported product admitted to the market changed after its release into the sales network, so that it no longer meets the safety and quality standard, the importer and the relevant link of the sales network are responsible, their guilt being established under the procedure set by Georgian legislation. For violation of the conditions of wholesale and retail sale, which covers all operations connected with purchase, storage, supply and sale, the seller of the pharmaceutical product answers. This classification allows the court and the parties to identify the correct defendant quickly and to avoid diffuse claims against the entire chain.
Illegal Activity, Marking Changes and Sales to Minors
Carrying on pharmaceutical manufacture, the export or import of a product subject to special control, the operation of an authorised pharmacy, or the clinical research of a pharmacological product without a permit constitutes illegal pharmaceutical activity and draws a fine of 4,000 lari, or 8,000 lari when the same act is repeated. A change of the packaging and marking of a pharmaceutical product without registration or without the mandatory notification to the Agency draws a fine of 1,000 lari, accompanied by suspension of the sale until the offence is eliminated. The sale of a first- or second-group product to a minor draws a fine of 500 lari. Together these sanctions form a layered system of protection in which every type of violation meets a defined and proportionate reaction of the state.
Frequently Asked Questions
Who draws up the protocol and who hears the case?
As a general rule the Agency draws up the protocol and the court hears the case, but for offences envisaged by separate articles the authorised officials of the Agency and the Revenue Service consider the cases and impose the penalty on the spot.
Does an appeal suspend enforcement of the fine?
No. Fines imposed for the offences heard on the spot become immediately enforceable, and filing an appeal does not suspend their execution.
Who answers for a falsified product?
Circulating a falsified pharmaceutical product on the Georgian market draws a fine of 20,000 lari with confiscation, while responsibility among the participants of circulation is distributed according to the statutory grounds, from the authorisation holder to the seller.
What follows an unlawful change of marking?
A change of packaging and marking without registration or without the mandatory notification to the Agency draws a fine of 1,000 lari, and the sale of the product is suspended until the offence is eliminated.
How We Help on Legal.ge
The advocates of Legal.ge assist in pharmaceutical disputes: we assess the protocol and the decision, explain the grounds of the sanction, prepare a court claim or an appeal, and protect your interests in relations with the Agency and the Revenue Service. Write to us and receive a concrete legal assessment of your case.