MIKHAILYUK SOROKOLAT & PARTNERS

Patent and Trademark Attorneys

STATE REGISTRATION OF MEDICINAL PRODUCTS IN GEORGIA

Issues associated with the state registration of medicinal products are regulated by the Ministry of Labor, Health and Social Protection 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 including into the State departmental register. According to the same law two ways of inclusion of medicinal product into the State departmental register are stipulated, namely:

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

. The procedure of recognition of the state registration is conducted at the first import of medicinal product. In order to conduct said procedure it is necessary to provide the following to the Agency of State Regulation of Medical Activity of Georgia:

1) Administrative documents:

  • legalized Power of Attorney from the applicant to the representative;
  • legalized copy of instruction for medical use approved in importing country together with its certified translation to Georgian;
  • legalized copy of registration certificate issued by the competent authority of importing country, where 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 medicinal product;

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

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

. In case of national state registration of medicinal product within the frame of conducting the separate registration procedure it is necessary to provide the following to the Agency of State Regulation of Medical Activity of Georgia:

1) Application form 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 instruction for medical use approved in 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 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 medicinal product with appropriate certificate of analysis).

According to the Georgian legislation the procedure of national state registration of medicinal product should be conducted not more than 3 months without considering the time for preparation of responses to the remarks.

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

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

In order we could provide you with the information on costs associated with the registration of medicinal products in Georgia together with the detailed information and list of documents required from your side, sample of the Power of Attorney for execution, etc. please contact our specialists.

Tbilisi

49/51/51 a, Cereteli Ave.

Suite 7, Tbilisi, 0159

Georgia

Fax: +995 (32) 272 22 28

Email: office@msp.ge

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