Mikhailyuk, Sorokolat & Partners

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Registration of medicinal products in Georgia | MSP

STATE REGISTRATION OF MEDICINAL PRODUCTS IN GEORGIA

Issues associated with the state registration of medicinal products in Georgia are regulated by the Ministry of Labour, Health and Social Affairs of Georgia. In accordance with the law of Georgia "On medicinal products and pharmaceutical activity", medicinal products are allowed for use in Georgia only after addition thereof to the State departmental register.


Possible ways of registration of medicinal products

The Georgian regulatory legislation stipulates two possible ways of inclusion of a medicinal product into 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 medicinal product within the frame of conducting the separate registration procedure.

What is required for recognition of the state registration

The procedure of recognition of the state registration is conducted at the first import of a medicinal product. In order to conduct said procedure it is necessary to provide the following 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 together with its certified translation to Georgian;
  • legalized copy of registration certificate issued by a competent authority of an importing country, where the medicinal product is registered;
  • legalized copy of certificate of a pharmaceutical product (CPP) or Free Sale Certificate;
  • proposed mockups in Georgian and/or Russian and/or English;
  • specification(s) and methods of control of the medicinal product;

2) Samples of the medicinal product and standard samples in an amount required for the double test.


WHAT IS REQUIRED FOR NATIONAL STATE REGISTRATION

In case of national state registration of a medicinal product within the separate registration procedure it is necessary to provide the following to the State Regulation Agency for Medical Activities:

1) Application with the attached administrative documents:

  • legalized Power of Attorney from the applicant to the representative;
  • legalized copy of certificate of a pharmaceutical product (CPP) and/or legalized copies of GMP Certificates for all manufacturing sites involved in manufacturing process issued by the competent authorities of countries-manufacturers and/or legalized copies of the Manufacturer's Authorizations for all manufacturing sites involved in manufacturing process issued by the competent authorities of countries-manufacturers;
  • 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 together 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 1 batch in an amount required for the double test (additionally it is necessary to provide 2 packages of the medicinal product with appropriate certificate of analysis).


Duration of registration process

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

The procedure of national state registration of a medicinal product should be conducted within not more than 3 months without consideration of the time for preparation of responses to requests.


Validity term and renewal

The validity term of the conclusion on recognition of the state registration of a medicinal product in Georgia may not exceed the term of the recognized Registration Certificate issued by the competent authority of importing country.

The Certificate about the national state registration of a medicinal product in Georgia is valid for 5 years and after that it is necessary to renew it each 5 years. The procedure of renewal of the registration must be initiated no later than 2 months before expiration of the previous registration. The renewal procedure does not require checking the scientific and technical documentation. The usual renewal procedure lasts for not more than 2 months without consideration of the time for preparation of responses to requests.

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


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