MIKHAILYUK, SOROKOLAT & PARTNERS Patent and Trademark Attorneys ISO 9001 CERTIFIED
MIKHAILYUK, SOROKOLAT & PARTNERS Patent and Trademark Attorneys
ISO 9001 CERTIFIED


GMP conformity assessment for the State registration of medicinal products for human or veterinary use and pharmaceutical substances used for sale in Russia

In accordance with the Decision of the Council of the Eurasian Economic Commission of November 3, 2016, No. 78, the state registration of medicinal product for human use produced outside of the Russian Federation is possible only after conducting GMP conformity assessment for all manufacturing sites involved in manufacturing process conducted by one of the member state of the Eurasian Economic Union (Russia, Belarus, Kazakhstan, Kyrgyzstan and Armenia). According to the same Decision two possible ways of GMP conformity assessment of medicinal products for human use are stipulated in Russia, namely:

  • GMP conformity assessment within the frame of the procedure conducted according to the Decision of the Council of the Eurasian Economic Commission of November 3, 2016, No. 78 (this procedure can be conducted before submitting the Application for registration as well as in parallel to the procedure of registration after submitting the Application);
  • GMP conformity assessment within the frame of conducting the national procedure according to the law of the Russian Federation On circulation of medicinal products (this procedure is conducted before submitting the Application for registration).

According to the law of the Russian Federation On circulation of medicinal products the application for including pharmaceutical substance used for sale into the State Register in respect of products for human or veterinary use produced outside of the Russian Federation as well as the application for registration of medicinal product for veterinary use are accepted only after conducting GMP conformity assessment for all manufacturing sites involved in manufacturing process issued by the competent Authority of the Russian Federation.

Also we would like to draw your attention that registration of veterinary medicinal product in contrast to registration of medicinal product for human use also requires conducting GMP conformity assessment for API manufacturing site.

The GMP conformity assessment is conducted by the Ministry of Industry and Trade of the Russian Federation for medicinal products and pharmaceutical substances for human use and by the Federal Service for Veterinary and Phytosanitary Surveillance (Rosselkhoznadzor) on the basis of decision of the Federal State Institution Russian State Center for Quality Control and Standardization of Veterinary Drugs and Feeds (Institution) for medicinal products and pharmaceutical substances for veterinary use by examination of provided documents and mandatory inspection of all manufacturing sites involved in manufacturing process of a finished medicinal product and/or a pharmaceutical substance with the departure to the plant.

. In order to conduct GMP conformity assessment of medicinal products for human use according to the demands of the Eurasian Economic Union it is necessary to provide Application for issuance of the GMP Certificate together with the following documents:

  • legalized Power of Attorney from the applicant to the representative;
  • legalized copies of the Manufacturer's Authorizations for all manufacturing sites involved in manufacturing process issued by the competent authorities of countries-manufacturers;
  • legalized copies of GMP Certificates for all manufacturing sites involved in manufacturing process issued by the competent Authorities of countries-manufacturers (if available);
  • certified copies of last reports on inspections of the manufacturing sites by the competent authorities of countries-manufacturers or other competent authority that were conducted not earlier than 3 years before submitting the Application;
  • certified copies of dossiers of the manufacturing sites involved in manufacturing process (Site Master Files);
  • information on the revealed inconsistencies in the quality of medicinal products with the established requirements including the withdrawal of medicinal products from civil circulation for a period of at least 3 years prior to application;
  • list of medicinal products produced (or planned to be produced) at the manufacturing site for which inspection is carried out;
  • letter on the consent of the manufacturer for inspection.

. In order to conduct GMP conformity assessment of medicinal products or pharmaceutical substances for human or veterinary use according to the national procedure it is necessary to provide Application for issuance of the conclusion of compliance together with the following documents:

  • legalized Power of Attorney from the applicant to the representative;
  • legalized copies of the Manufacturer's Authorizations for all manufacturing sites involved in manufacturing process (including manufacturing site for API in respect of veterinary medicinal product) issued by the competent authorities of countries-manufacturers;
  • legalized copies of GMP Certificates for all manufacturing sites involved in manufacturing process issued by the competent Authorities of countries-manufacturers;
  • legalized copies of GMP Certificates for all manufacturing sites involved in manufacturing process (including manufacturing site for API in respect of veterinary medicinal product) issued by the competent Authorities of countries-manufacturers (if available);
  • certified copies of dossiers of the manufacturing sites involved in manufacturing process (Site Master Files);
  • information on the revealed inconsistencies in the quality of medicinal products/pharmaceutical substances with the established requirements including the withdrawal of medicinal products/pharmaceutical substances from civil circulation for a period of at least 2 years prior to application;
  • list of medicinal products/pharmaceutical substances produced at the manufacturing site for which inspection is carried out;
  • letter on the consent of the manufacturer for inspection.

GMP conformity assessment procedure includes the following steps:

  • submission of the application form and documents to obtain a certificate or conclusion;
  • inspection of manufacturing site;
  • receipt of the Eurasian GMP Certificate and/or report of compliance or non-compliance to the GMP requirements for medicinal products for human use in case of conducting the procedure according to the demands of the Eurasian Economic Union or receipt of the Conclusion of compliance to the GMP requirements and/or report of compliance or non-compliance to the GMP requirements for medicinal products or pharmaceutical substances for human or veterinary use in case of conducting GMP conformity assessment according to the national procedure.

According to the demands of the Eurasian Economic Union and Russian legislation inspection of manufacturing site should be conducted within 160 workdays from the date of submission of the application and the inspection period cannot exceed 10 workdays. However, in accordance with the usual practice depending upon the completion of the provided materials, scope of documentation, and other factors the procedure of GMP conformity assessment in the Russian Federation may constitute about 6-10 months.

For manufacturing sites of medicinal products for human use the validity term of the GMP Certificate issued according to the demands of the Eurasian Economic Union as well the validity term of the Conclusion of GMP Compliance issued according to the national procedure is three years from the date of the end of the inspection, however the latter can be accepted for the state registration of medicinal product for human use conducted according to the demands of the Eurasian Economic Union until December 31, 2018 and for the state registration of medicinal product for human use conducted according to the national procedure until December 31, 2020.

For manufacturing sites of pharmaceutical substances for human use and medicinal products and pharmaceutical substances for veterinary use the validity term of the Conclusion of GMP Compliance is three years from the date of the end of the inspection.

In order we could provide you with the information on costs associated with GMP conformity assessment in Russia together with the detailed information required from your side, sample of the Power of Attorney for execution, etc. please contact our specialists.

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