The Legal Foundations of Pharmaceutical Regulations
Georgian legislation on medicines and pharmaceutical activity rests on the Constitution of Georgia, international treaties and agreements, the law governing this sphere, and other legislative and subordinate normative acts. The declared purpose of the law is to promote increased public access to reliable pharmaceutical products; to that end, it establishes the legal foundations for regulating the circulation of pharmaceutical products and defines the rights and obligations of natural and legal persons operating in this field. State regulation mechanisms extend to complementary medicinal products, biologically active additives and paramedical products only when an interested person voluntarily registers them under the national regime of state registration of pharmaceutical products, while a non-invasive contraceptive mechanical product is entirely free from the state regulation envisaged by the law.
Pharmaceutical Market Control and Supervision
Control and supervision over the pharmaceutical market are exercised by the Agency, which applies risk-assessment-based selective control through two mechanisms: laboratory control and administrative control of the distribution chain. For products already present on the Georgian market, the Agency relies mainly on the administrative control mechanism of the distribution chain. Laboratory control is engaged when a pharmaceutical product admitted under the national or recognition regimes of state registration faces a high risk of falsification or deterioration, and the criteria for that risk are approved by the Minister. In exceptional cases the Agency holds a discretionary power to disregard the formal risk-determining criteria and apply the laboratory control mechanism, but for no more than 10 percent of the inspection frequency over the period of one year.
Market Admission Regimes for Pharmaceutical Products
Admission of a pharmaceutical product to the Georgian market proceeds under one of two regimes: the recognition regime or the national regime of state registration. The basis for applying the recognition regime is the differentiation of the regulatory body of another country or an interstate regulator according to its reliability and its ability to admit only high-quality pharmaceutical products on its own markets. Where that basis exists, Georgia unilaterally recognises the safety, efficacy and quality requirements applied by the reference regulator for admission to the markets under its control and conducts no repeated expertise for the same or a similar product. A decision by a trusted foreign regulator is thus accepted in Georgia without duplicated testing.
Manufacture and Sale of Pharmaceutical Products
The manufacture of pharmaceutical products is subject to a licensing regime, and the licence is issued by the Agency. The manufacture in Georgia of an unregistered pharmaceutical product is allowed only for its registration, for preclinical and clinical research, or for export. The state selectively recognises a list of international, regional and national good manufacturing practice standards, and the list itself is recognised by the Government of Georgia. An authorised pharmacy that prepares a product according to a magistral or officinal formula, and the pharmacy of a medical institution that dispenses products in the quantities needed for use within that institution, are not regarded as manufacture and need no licence. The person manufacturing a series bears responsibility for the safety, quality and efficacy of the product produced.
Retail sale is carried out by an authorised pharmacy, a pharmacy as a specialised trade object, a retail trade object, and in cases established by the legislation of Georgia by personnel holding pharmaceutical education or a natural person who is a subject of independent medical activity. An authorised pharmacy, which is itself subject to licensing control, may sell products assigned to the first, second and third groups and may also prepare products by officinal or magistral prescription. A pharmacy operating as a specialised trade object may sell only second- and third-group products, while an ordinary retail trade object may sell third-group products only. Personnel with pharmaceutical education or an independent medical activity subject may sell pharmaceutical products, except those subject to special control, in settlements of village and daba type. The start and completion of wholesale and retail sale are subject to mandatory notification to the Agency. The law prohibits sale at markets and bazaars, from open-type trade objects and from non-stationary trade places, the sale of first- and second-group products to minors, the over-the-counter sale of first- and second-group products, and wholesale or retail sale at a price above the reference price, except operations connected with import, export or re-export.
Illegal Pharmaceutical Activity and Fines
The law treats as illegal pharmaceutical activity the carrying on of pharmaceutical manufacture, the export or import of pharmaceutical products subject to special control, the operation of an authorised pharmacy, and the clinical research of a pharmacological product without the required permit. Such conduct triggers a fine of 4,000 lari, and the same act committed repeatedly triggers a fine of 8,000 lari. The sanction scales with the persistence of the violation.
Frequently Asked Questions
How can laboratory control be applied without formal criteria?
The Agency may disregard the formal risk criteria and apply the laboratory control mechanism, but only up to 10 percent of the inspection frequency during one year.
What is the difference between the recognition and national regimes?
Under the recognition regime Georgia accepts a trusted foreign regulator’s requirements without repeated expertise; the national regime involves full administrative and scientific-technical examination in Georgia.
Can third-group products be sold in an ordinary shop?
Yes. A retail trade object sells only third-group products, a specialised pharmacy sells second- and third-group products, and an authorised pharmacy sells all three groups.
How severe is the fine for operating without a permit?
Manufacture, import or export of specially controlled products, an authorised pharmacy and clinical research without a permit are fined 4,000 lari, or 8,000 lari when committed repeatedly.
How We Help on Legal.ge
The Legal.ge team supports pharmaceutical companies and individuals in applying these regulations: we assess the legal perspective of your case, explain licensing requirements, assist in communication with the Agency and help challenge fine decisions. Send us a request and receive a qualified consultation.