MIKHAILYUK SOROKOLAT & PARTNERS

Patent and Trademark Attorneys

State registration of veterinary medicinal products in Georgia

Issues associated with the state registration of veterinary medicinal products are regulated by the Ministry of Environmental Protection and Agriculture of Georgia. In accordance with the Resolution of July 7, 2015 No. 327 veterinary medicinal products are allowed for use only after including into the State departmental register. According to the same law two ways of inclusion of veterinary 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 veterinary 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 veterinary 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 veterinary medicinal product. In order to conduct said procedure it is necessary to provide the following to the National Food Agency of Ministry of Agriculture of Georgia:

1) Administrative documents:

  • legalized Power of Attorney from the applicant to the representative;
  • legalized copy of instruction for 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 veterinary 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 veterinary medicinal product;

2) 2 packages of veterinary medicinal product with appropriate certificate of analysis.

. In case of national state registration of veterinary medicinal product within the frame of conducting the separate registration procedure it is necessary to provide the following to the National Food Agency of Ministry of Agriculture 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 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 Resolution of July 7, 2015 No. 327 (including qualitative and quantitative composition, specification(s) and methods of control of veterinary medicinal product, texts of relevant international or state pharmacopoeia articles and studies results that confirms safety, efficiency for each declared species of animals).

3) 2 packages of veterinary medicinal product with appropriate certificate of analysis.

The validity term of the conclusion on recognition of the state registration of veterinary medicinal product in Georgia may not exceed the term of recognized registration certificate issued by the competent authority of importing country. After expiration of registration it is necessary to conduct the renewal procedure of recognition of the state registration. The usual renewal procedure lasts within not more than 5 working days.

The Certificate about the national state registration of veterinary 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 not earlier than 5 months before expiration of previous registration and no later than 2 months after expiration thereof. The renewal procedure does not require checking the scientific and technical documentation. The usual renewal procedure lasts within not more than 20 working days 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 veterinary 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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