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.