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.
Changes of Marking and the Transitional Period
A change of the primary packaging marking, of the secondary packaging marking and of the design is a I series change of relatively minor significance, conditioned upon the submission of 2 new samples. On a change of the name, the new name must not cause confusion with the international non-proprietary name or with the name of a registered product, and where a generally accepted name exists the change must be directed towards the pharmacopoeial or non-proprietary name. A change of the inscription on tablets, of the coating, of other marking or engraving, and of the inscription on capsules is allowed provided the new inscription does not cause confusion with other tablets and capsules. A change of the quantity of the product in the package is allowed only on condition that the packaging material is not changed. Changes of the active substances, the form, the strength and those connected with manufacture are II series changes and require separate registration. Upon a change of the marking and design, the import of the product and its manufacture in Georgia under the packaging and marking admitted before the change is allowed for 12 months from the implementation of the change as a transitional period, and upon each subsequent change the market may admit both the product corresponding to the new marking and the product with the marking last admitted before it.