Data Protection and Exclusivity Periods
The approval process begins with the rule on data protection: the scientific-technical information about a registered product may not be used for a registration decision on the same or a similar product without the consent of the market admission right holder. An applicant under the national regime may likewise not rely on the tests and research data submitted for a same or similar product first admitted in a European Union member country or Georgia without the holder’s consent. These rules operate for 6 years from the first admission of the pharmaceutical product to the market of a European Union member country or of Georgia. The term may extend to 7 years if within the first 6 years the basic authorization holder obtains authorization for one or more new therapeutic indications considered to possess significant clinical advantage over the existing treatment.
Admission Regimes and the Application
Admission proceeds under the recognition or the national regime of state registration. The recognition regime rests on differentiating a foreign or interstate regulator by reliability: Georgia unilaterally recognises its safety, efficacy and quality requirements and conducts no repeated expertise. Under the national regime, the interested person — the manufacturer or the trade licence holder — submits an application with documents to the Agency, satisfying the requirements of the General Administrative Code of Georgia. The registration documents consist of an administrative and a scientific-technical part: the former in Georgian in material form with the Georgian translation of the instruction as an electronic file and a packaging-marking sample, the latter in Georgian, Russian or English in 3 identical copies, their identity being the applicant’s responsibility. The administrative part includes the application, the power of attorney, a certificate in the form recommended by the World Health Organization or a good manufacturing practice certificate or manufacturing licence, the standard packaging with marking, an instruction in Georgian or its certified translation, and confirmation of the fee payment. The scientific-technical part includes the chemical composition with ingredients per dose unit, monographs and analysis methods, the technological scheme, a sample of 2 standard packages sufficient for 2 analyses, stability data, preclinical and clinical data and, for generics, bioequivalence or therapeutic equivalence data with publications and bibliography.