Essence, Scope and State Policy of Pharmaceutical Law
The legislation of Georgia on medicines and pharmaceutical activity comprises the Constitution of Georgia, international treaties and agreements, the law governing this sphere and other legislative and subordinate normative acts. The purpose of the law is to promote increased public access to reliable pharmaceutical products; to achieve this, 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 the field. State policy in the sphere of circulation of pharmaceutical products provides for ensuring the availability of quality, safe and effective pharmaceutical products on the Georgian market. State regulation mechanisms apply to complementary medicinal products, biologically active additives and paramedical products only in the event of their voluntary registration, while a non-invasive contraceptive mechanical product remains free from such regulation. Together these provisions define the outer boundary of pharmaceutical law: where the state guarantees quality and safety, and where private autonomy governs.
The Task of State Control of Product Safety
The task of state control over the safety of pharmaceutical products is to protect the Georgian market from falsified, defective, unsuitable, expired products and from products lacking the right of admission to the market, all of which are dangerous to the consumer. This formulation places the protection of the consumer at the centre of the state's duty. Control is not a mere administrative formality but an instrument for protecting public health, ensuring that every product entering circulation meets the requirements of admission and that dangerous products are identified and removed before they can cause harm.
Mechanisms of Pharmaceutical Market Control
For selective control based on risk assessment of a pharmaceutical product, the Agency uses the mechanisms of laboratory control and administrative control of the distribution chain, while for supervision of products already present on the market it relies mainly on administrative control of the distribution chain. Laboratory control is applied where a high risk of falsification or deterioration exists for a product admitted under the national or recognition regimes, and the criteria of that risk are approved by the Minister. In exceptional cases the Agency may set aside the formal risk-determining criteria and apply the laboratory control mechanism regardless, but for no more than 10 percent of the inspection frequency over the period of one year. This balance prevents both the formal dilution of control and excessive pressure on business, and it gives the regulator a measured tool for responding to unexpected threats.