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.
Grounds of Responsibility and the Hearing Procedure
The law distributes responsibility among the participants in circulation: for the safety, quality and efficacy of a product admitted under the national regime, the market authorisation holder and the state are responsible; for a product admitted under the recognition regime, the state; for compliance with the documentation submitted at registration, the manufacturer of the series; where the qualities of an imported product changed within the sales network, the importer or the relevant link of that network; and for all operations of purchase, storage, supply and sale, the seller. The responsibility of a person for violations revealed during pharmaceutical activity is determined by this law and the legislation of Georgia. The protocol on an administrative offence, save for the cases envisaged by separate articles, is drawn up by the Agency, and the case is considered by the court; cases under separate articles are considered on the spot by authorised officials of the Agency and the Revenue Service, the fine decisions take immediate effect, and an appeal does not suspend their execution.
Illegal Pharmaceutical Activity and the Sanction
Carrying on pharmaceutical manufacture, the export or import of a product subject to special control, the operation of an authorised pharmacy, or the clinical research of a pharmacological product without a permit constitutes illegal pharmaceutical activity and causes a fine of 4,000 lari, with the same act committed repeatedly causing a fine of 8,000 lari. The sanction is directly linked to the breach of the boundaries of licensed activity and aims to protect fair competition among market participants, which is why an early legal assessment of a business model against the licensing requirements pays for itself.
Frequently Asked Questions
What does state policy in the sphere of circulation provide for?
It provides for ensuring the availability of quality, safe and effective pharmaceutical products on the Georgian market, while the task of control is to protect the market from products dangerous to the consumer.
When is laboratory control applied?
Laboratory control is applied in the event of a high risk of falsification or deterioration of an admitted product; exceptionally the Agency may apply it regardless of the formal criteria, but for no more than 10 percent of the inspection frequency during one year.
Who answers for the quality of a product?
Responsibility is distributed: for products admitted under the national regime, the authorisation holder and the state; under the recognition regime, the state; for documentation compliance, the series manufacturer; and for sale operations, the seller.
What fine threatens activity without a permit?
Activity without the required permit is punished with a fine of 4,000 lari, and with 8,000 lari when the same act is committed repeatedly.
How We Help on Legal.ge
The Legal.ge team explains the practical questions of pharmaceutical law: we assess your situation against the requirements of the law, assist in communication with the Agency, and prepare a court claim or an appeal. Send us a request through the application form and receive a qualified legal consultation.