The process of placing hygiene and pharmaceutical products on the Georgian market involves a structured regulatory framework that varies depending on the nature and classification of the product. Understanding these requirements is essential for both domestic manufacturers and foreign companies seeking to introduce their products into Georgia.
The primary legislation governing this area includes the Law of Georgia on Product Safety and Free Movement Code (the Product Safety Code), the Law of Georgia on Medicines and Pharmaceutical Activities (the Pharmaceutical Law), the Law of Georgia on Licenses and Permits, and the Tax Code of Georgia, supplemented by various government decrees and ministerial orders. Together, these instruments establish the conditions under which hygiene products and pharmaceutical products may lawfully be placed on the Georgian market.
This article examines the legal criteria for marketability of hygiene and pharmaceutical products under Georgian legislation, the applicable conformity and labelling requirements, the distinction between the two product categories, and the practical implications for manufacturers, importers, and distributors.
Hygiene Products
Conformity of Foreign-Made Products
As a general principle under the Product Safety Code, a product within a regulated area that is manufactured in a country with appropriate product safety standards and a developed quality infrastructure, and which complies with the domestic legislation of that country, shall be placed on the Georgian market without restriction. Properly issued conformity documents are recognised without additional procedures. Such documents must be provided in English or accompanied by a notarised Georgian translation. Where required, conformity assessment should be performed by an accredited conformity assessment body or another body directly defined by law.
Safety Assessment Criteria
When assessing the safety of a product, the authorities consider the following factors: product characteristics, including composition, packaging, assembly, and installation and repair instructions; the impact on another product when it is likely to be used together with the product in question; product presentation, labelling, warnings, and instructions for use and disposal; and age categories of consumers for whom it might be harmful to use the product. A safe product may not be regarded as an unsafe product solely because a higher level of safety has been achieved in the respective field or because a safer alternative product exists.
Mandatory Product Information to the Consumer
The manufacturer or distributor must provide the consumer with the following information, which must be presented in the Georgian language: the name and type of the product; the brand name and address of the manufacturer and the country of manufacture; where applicable, the product’s expiry or best-before date, or the date of manufacture and shelf life where the product’s consumer appeal tends to deteriorate over time; where applicable, the net weight and/or volume; where applicable, the list of basic consumer characteristics of the product; where applicable, the terms and conditions for effective and safe use of the product, as well as special storage conditions; in cases of reservations made by the manufacturer or distributor, the warranty term and/or other obligations; and the actions to be taken by the consumer after expiry of the product’s consumption date and the expected results of failure to take such actions.
Product Marking (GE/CE)
Product marking under Georgian law is the declaration by a responsible person that the product conforms to the applicable new approach technical regulations and poses no threat to human life, health, or property, and that the conformity assessment procedures have been completed. The mark must be clearly affixed on the product, be easily readable, and must not be easily erasable.
Products manufactured in Georgia for the Georgian market that are regulated by the new approach technical regulations must bear the GE mark. Products bearing the CE mark, which certifies conformity with the requirements effective in the European Union, are admitted into Georgia without additional conformity assessment procedures, provided that the relevant documentation is in order and available.
Manufacturer’s General Responsibility
A manufacturer is liable for the damage caused by defective products placed on the market. Liability applies even where the damage is caused concurrently by a defective product and the action of a third party. However, a manufacturer is not liable for placing a defective product on the market if that product has not caused any damage.
Both the manufacturer and the distributor must, within their respective spheres of competence, cooperate with the competent authorities on the safety of products placed on the market or intended to be placed on the market.
Pharmaceutical Products
Classification
Under the Pharmaceutical Law, a pharmaceutical product (therapeutic agent) is defined as a medicine or a physiologically active substance derived naturally or by synthesis, or a combination of such substances, whose effect on the human body is achieved through pharmacological, immunological, or metabolic action, and which is authorised for medical use. The Pharmaceutical Law also extends its application, on a voluntary basis, to complementary medicinal products, biologically active additives, and paratherapeutic products, if an interested person performs their voluntary registration under the national regime of state registration of pharmaceutical products.
Registration of Pharmaceutical Products
The Legal Entity of Public Law (LEPL) Agency for Regulation of Medical and Pharmaceutical Activities within the Ministry of Health (the Agency) is the competent authority for registering medicinal products and maintaining the official list of admitted products, the Departmental Registry. Entry of a pharmaceutical product into the Departmental Registry constitutes the granting of marketing authorisation in Georgia.
Marketing authorisation may be granted under two regimes. The first is the recognition regime, under which Georgia unilaterally recognises the marketing authorisation granted by a state body regulating pharmaceutical products in a foreign country or internationally, as defined by the Government of Georgia. Under this regime, an interested person submits homology identification documents, and the Agency performs an administrative review, entering the pharmaceutical product into the Departmental Registry within seven working days. The second is the national regime, which involves a comprehensive administrative and scientific-technical review of registration documents, including the product’s quality, safety, and therapeutic efficacy, and a decision is typically rendered within two to three months.
Mandatory registration applies to medicinal products. Registration is voluntary for complementary medicines, biologically active supplements, and paratherapeutic products. Hygiene products are not included in the registration regime.
Licensing
A state permit (license) is required for pharmaceutical manufacturing in Georgia. The Agency issues permits for the manufacturing of pharmaceutical products, clinical trials, authorised pharmacies, and the export and import of pharmaceutical products under special control. This licensing requirement does not extend to hygiene products.
Practical Considerations
Early attention to the regulatory classification of the product is critical for companies seeking to place hygiene or pharmaceutical products on the Georgian market. Hygiene products, including baby diapers, wet wipes, and baby shampoos, move under the general product safety and specific technical regulations regime, supplemented by Georgian-language labelling and conformity requirements, and do not require pharmaceutical licensing or registration. Pharmaceutical products, by contrast, are subject to a more rigorous regime involving state registration, customs declarations, and, where applicable, manufacturing licenses.
For hygiene products, three elements are essential for marketability and risk control. First, conformity documentation must be available as described in the Conformity of Foreign-Made Products section above. Second, correct marking and traceability must be ensured, including proper use of the CE or GE mark, as applicable, and accurate manufacturer and importer details aligned with the technical file. Third, complete product information must be provided, including full composition, intended use, warnings, shelf life, and batch or series traceability.
Contractual arrangements between foreign manufacturers and local importers may allocate responsibility to the local party for ensuring compliance with Georgian requirements, such as Georgian-language labelling and marking, customs procedures, and engagement with regulators. However, Georgian law still imposes a baseline manufacturer responsibility for product safety.
Under Georgian legislation, the marketability of hygiene and pharmaceutical products is determined by the regulatory classification of the product and the applicable legal regime. Hygiene products such as baby diapers, wet wipes, and shampoos are governed by the general product safety framework, with emphasis on recognised conformity documentation, Georgian-language labelling, and proper product marking. Pharmaceutical products, by contrast, require formal state registration with the competent Agency and are subject to additional customs and accounting obligations.
By clearly distinguishing between these two categories and complying with the applicable requirements, foreign manufacturers and local importers can ensure the lawful and efficient placement of their products on the Georgian market. Companies are advised to pay close attention to conformity documentation, labelling in the Georgian language, and proper allocation of regulatory responsibilities between the parties in any import or distribution arrangement.