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.