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.
How Registration Acts on the Packaging and Marking
Where the term of admission to the market of a product registered under the national regime expires or the admission is cancelled, the cancellation of the registration extends to every type of packaging and marking of the product admitted on the Georgian market, and where the registration is suspended, the suspension extends to every type of additionally added packaging and marking of the product. The circulation of a product is allowed for 5 years from registration, and after the expiry of the term the product already in circulation, together with versions released under a different packaging and marking, remains on the market until the expiry of its validity period. After a change has been implemented, the circulation of the pre-change product is allowed until its own validity expires. Each version of the marking is thus tied to a specific status of the registration, and breaking that link is itself an offence.
Responsibility for Breach of the Marking Rules
A change of the packaging and marking without registration or without the mandatory notification to the Agency is punished with a fine of 1,000 lari, accompanied by suspension of the sale until the offence is eliminated. This means that a formally small error — a new design or label introduced without notification — temporarily removes the right to remain on the market, which for an importer or distributor is more painful than the fine itself. The data protection rule should also be kept in mind: the use of the scientific-technical information about a registered product for the registration of another product is prohibited without the consent of the right holder, this rule operating for 6 years from the first admission of the product to the market of a European Union member country or of Georgia and extending to 7 years in the case of a new therapeutic indication possessing significant clinical advantage.
Frequently Asked Questions
May a label be changed without notification?
No. A change of the packaging and marking without registration or without the mandatory notification draws a fine of 1,000 lari, and the sale is suspended until the offence is eliminated.
How long may the old marking be sold?
Import and manufacture under the marking admitted before the change is allowed for 12 months from the change as a transitional period.
What are the Agency's requirements for the sample?
Before the launch into production an electronic version of the marking sample suffices, after the launch the Agency may demand the material form, and upon a change of the marking 2 new samples are submitted.
How does cancellation of the registration affect the marking?
Cancellation extends to every type of packaging and marking of the product admitted on the market, and suspension extends to every additionally added packaging and marking.
How We Help on Legal.ge
The Legal.ge team clarifies every question of labeling compliance: we check the label and the design against the registration requirements, determine the type of the change and the necessary procedure, help plan the transitional period correctly and challenge fine decisions. Write to us and protect your product's right to remain on the market.