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.
The National-Regime Procedure
Under the national regime, the interested person may be the manufacturer or the holder of the trade licence. The application, satisfying the relevant requirements of the General Administrative Code, and the accompanying documents are submitted to the agency. The registration documents consist of an administrative and a scientific-technical part, each undergoing its own expertise.
The language requirements are precise. The administrative part is submitted in material form in Georgian, with an electronic Georgian translation of the instruction and the packaging-labelling sample; the scientific-technical part — in Georgian, Russian or English, in three identical copies with an electronic version. The agency checks compliance within no later than 14 days — the administrative expertise — and, on a positive conclusion, the documents undergo the scientific-technical expertise establishing standardization, quality, safety and efficacy. Up to 2 additional months are granted to eliminate defects, and the agency may involve further experts.
Variations and Deadlines
Changes to an admitted product are classified: changes to active substances, the form, the strength, the method of use and those connected with production are class II changes of special significance and require registration; lesser class I changes require only informing the agency, and where the conditions are not met a change passes into the class II regime. Registration of a change does not alter the validity of the registration.
The deadlines are clearly divided. A first-time registration or class II change is decided within 3 months; re-registration or registration-recording within 2 months; certain class I changes within 20 or 40 calendar days. A refusal must be communicated immediately in writing with reasons; where no decision arrives in time, the product is considered registered and the confirmation document is issued within 10 days of the administrative act. Re-registration documents must be filed no later than 2 months before expiry, failing which the first-time regime applies. Circulation is permitted for 5 years from registration and afterwards until the shelf life runs out.
Frequently Asked Questions on Drug Registration
Under how many regimes is a drug admitted to the market?
Under two — the recognition regime and the national regime of state registration. The first relies on a foreign regulator, the second on a full expertise conducted in Georgia.
Who may be the interested person?
Under the recognition regime — any person; under the national regime — the manufacturer or the holder of the trade licence.
Within what period does the agency decide?
A first-time or class II registration — within 3 months; re-registration — within 2 months; certain class I changes — within 20 or 40 calendar days. If no refusal is communicated in time, the product is considered registered.
What is the administrative-expertise deadline?
The agency checks the registration documents against the requirements within no later than 14 days; up to 2 additional months are granted to eliminate identified defects.
What happens when the registration term expires?
Circulation is permitted for 5 years from registration and afterwards until the shelf life expires; re-registration documents must be filed no later than 2 months before expiry.
How We Help on Legal.ge
Drug registration demands the right choice of regime, precise documentation and tight deadline control. The Legal.ge team will help you choose between the regimes, prepare the dossier, classify variations and plan re-registration. Contact us — we will assess your product and build a complete plan.