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.