Medicinal Products Registration in Georgia

The state registration of medicinal products in Georgia is regulated by the Ministry of Labor, Health, and Social Affairs of Georgia. In accordance with the Law of Georgia “On Medicinal Products and Pharmaceutical Activity,” medicinal products may be placed on the market in Georgia only after their inclusion in the State Departmental Register.

Key registration facts

7 / 90

Working / Calendar days

Official timeframe for simplified recognition (7 working days) and national procedure (up to 3 months)

5

Years

Validity period for both national registration and recognition certificates (linked to the reference country)

2

Months

Deadline to initiate the renewal process before the current registration certificate expires

GMP

Compliance

Mandatory GMP certificates for all manufacturing sites from EMA, FDA, WHO, PIC/S, or Georgian authorities

Procedures for registration of medicinal products in Georgia

Georgian legislation provides two procedures for including a medicinal product in the State Departmental Register:

• Recognition of the state registration by conducting the simplified procedure (used only for medicinal products that have been registered in countries, wherein regulatory authorities apply high quality standards, particularly EU Member States, Switzerland, UK, USA, Canada, Japan, Australia, Korea, etc.);
• National state registration of a medicinal product within the frame of conducting the separate registration procedure.

Requirements for recognition of the state registration

The recognition procedure is applied at the stage of the first import of a medicinal product into Georgia. To initiate this procedure, the applicant must submit the following documents to the State Regulation Agency for Medical Activities:

1. Administrative documents:
   • Legalized Power of Attorney from the applicant to the representative;
   • Legalized copy of an instruction for medical use approved in an importing country along with its certified translation to Georgian;
   • Legalized copy of a Registration Certificate issued by a competent authority of an importing country, where the medicinal product is registered;
   • Legalized copy of a certificate of a pharmaceutical product (CPP) or a Free Sale Certificate;
   • Legalized copies of GMP Certificates for all manufacturing sites involved in the manufacturing process (including the API) issued by the competent authorities of EMA, EU, FDA, WHO, WHO-Listed Authorities, PIC/S members or Georgia;
   • Proposed mockups in Georgian and/or Russian and/or English;
   • Specification(s) and methods of control of a medicinal product.
2. Samples of a medicinal product and standard samples of one batch with the appropriate Certificates of Analysis in an amount required for the double test.

Requirements for national registration of a medicinal product in Georgia

In case of national state registration of a medicinal product within the separate registration procedure, the applicant must submit a full registration dossier to the State Regulation Agency for Medical Activities, including the following documents:

1. Application with the attached administrative documents:
   • Legalized Power of Attorney from the applicant to the representative;
   • Legalized copy of the certificate of a pharmaceutical product (CPP);
   • Legalized copies of the Manufacturer’s Authorizations for all manufacturing sites involved in the manufacturing process issued by the competent authorities of the countries-manufacturers;
   • Legalized copies of the GMP Certificates for all manufacturing sites involved in the manufacturing process (including the API) issued by the competent authorities of EMA, EU, FDA, WHO, WHO-Listed Authorities, PIC/S members or Georgia;
   • Proposed mockups in Georgian and/or Russian and/or English;
   • Legalized copy of an instruction for medical use approved in a country of the applicant along with its certified translation to Georgian.
2. Scientific and technical documentation according to the demands of the Law of Georgia “On Medicinal Products and Pharmaceutical Activity” (including chemical, pharmaceutical, biological, pharmacological, and clinical documentation).
3. Samples of the medicinal product and standard samples of one batch in an amount required for the double test (additionally, it is necessary to provide two packages of the medicinal product with the appropriate Certificate of Analysis).

Duration of the registration process

According to Georgian legislation, the procedure for recognition of the state registration of a medicinal product should be conducted within 7 working days.

The procedure for national state registration of a medicinal product should be conducted within up to 3 months, not including the time for preparation of responses to official requests (if any).

Validity term and renewal

The validity of the recognition of a medicinal product registration in Georgia is linked to the validity of the original Registration Certificate issued by the reference country and may not exceed five years.

A certificate of national state registration of a medicinal product in Georgia is valid for five years and must be renewed every five years thereafter. The renewal procedure must be initiated no later than two months before the expiration of the current registration. The renewal process does not involve re-evaluation of the scientific and technical documentation. In practice, the renewal procedure is completed within approximately two months, excluding the time required to prepare responses to official requests, if any.

For more detailed information, including on the costs associated with registration of medicinal products in Georgia, list of documents required for submission, etc. please contact our specialists.