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.
Stages of Expertise and Decision Periods
The Agency carries out the administrative expertise — checking compliance — no later than within 14 days, and on a positive conclusion the documents undergo scientific-technical expertise establishing standardisation, quality, safety and therapeutic efficacy. To eliminate a revealed defect the interested person receives up to 2 months, with one notification by the Agency; if the defect reappears, the Agency notifies once more in writing and, if the defect is not fully eliminated, refuses the registration. Where necessary, the Agency may involve additional experts responsible for the objectivity of their conclusions. The registration decision is taken within 3 months for a first registration or a II series change, 2 months for re-registration or registration-recording, 20 calendar days for a I series change of type a and 40 calendar days for type b, counted from the full submission of the documents. On refusal the Agency must immediately communicate a substantiated refusal in writing; if the decision is not communicated in time, the product is considered registered, and the Agency must issue the market admission document within 10 days from the administrative act, equivalent to it.
Changes, Re-registration and Circulation Terms
Changes of active substances, form, strength, method of use and those connected with manufacture are II series changes of special significance requiring registration, while I series changes of relatively minor significance require only information to the Agency and pass into the II series if their conditions are not satisfied. A change registration does not alter the registration term. For re-registration, documents are submitted no later than 2 months before expiry, otherwise the first registration regime applies; data on side effects covering no less than 4 years of the last 5-year admission period, publications, bibliography and the current specification must be submitted. The circulation of a product on the territory of Georgia is allowed for 5 years from registration and after the expiry of the term, for products already in circulation, until the expiry of their validity period, though import is no longer allowed. After a change of packaging marking and design, import and manufacture under the previous marking is allowed for 12 months. A pharmaceutical substance, non-priced and intermediate products, magistral and officinal preparations and an individual allergen do not require registration.
Frequently Asked Questions
How long does the registration procedure take?
A first registration and a II series change take 3 months, re-registration and registration-recording 2 months, I series changes 20 or 40 calendar days; the administrative expertise is completed within 14 days.
How does the law protect research data?
For 6 years from the first admission, reliance on another person's data without consent is prohibited, and the term rises to 7 years where a new therapeutic indication with significant clinical advantage is authorised within the first 6 years.
Which changes require registration?
Changes of the active substances, the form, the strength, the method of use and the site of manufacture are II series changes and require separate registration.
What happens after the registration term expires?
After 5 years from registration, a product already in circulation may be sold until its validity period expires, but its import is no longer allowed.
How We Help on Legal.ge
The Legal.ge team stands beside you at every stage of drug approval: we check registration documentation, assess the type of a change and the procedure, and protect your interests when appealing a refusal. Send us a request and receive a concrete plan for your product’s registration.