The Two Market-Admission Regimes
The admission of a pharmaceutical product to the Georgian market operates under two regimes: the recognition regime and the national regime of state registration. The routes rest on different logics — one builds on a foreign regulator's decision, the other on a full expertise in Georgia, and choosing correctly is a matter of time and cost.
The recognition regime rests on the differentiation of a foreign or international regulator by its reliability and its ability to admit only high-quality products to its own markets. Georgia unilaterally recognizes the safety, efficacy and quality requirements such an authority applies to the markets under its control and does not repeat the expertise — a product already admitted by a trusted regulator is not examined anew.
The Sectoral Registry and the Routes of Entry
Entry into the sectoral registry means admission to the Georgian market: the registry is the public document recording admitted products. It indicates the registration number, interested person, manufacturing country, trade name, international nonproprietary name, form, dose and, where necessary, concentration, registration date, validity and an electronic packaging-labelling sample. It must be produced electronically and be accessible through the internet.
Under the recognition regime, entry is possible in three ways: proactively by the agency, based on information about a product admitted by a foreign or international regulator; after an administrative expertise of the homogeneous identification documentation submitted by an interested person; or after the notification procedure for a first import of an already admitted product with different packaging and labelling. Entry under the national regime follows the procedure set by a separate article of the law.
The Recognition-Regime Procedure and Documentation
The recognition regime applies to a product admitted to the corresponding market by a foreign or international regulator. The Government of Georgia establishes the list of such authorities, and the interested person may be any person — the procedure runs regardless of the purpose of import. Medicinal products of progressive therapy, too, are admitted under this regime.
For a first import, homogeneous identification documentation is submitted: the authorized Georgian translation of the instruction and the original; the form, dosing and labelling sample as an original or electronically (for a product not yet in production the electronic version must be accepted); a reference standard sufficient for 2 analyses or an active substance instead; the validity of admission on the corresponding market; the unique authorization number; a certificate of the regulator or an equivalent document, acceptable as certified copies; and a document confirming production under the good manufacturing practice standard.