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.