GMP conformity assessment 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 with 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 or Armenia).

Documents required for GMP conformity assessment

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;
• 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 for veterinary use or pharmaceutical substances for human or veterinary use 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 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;
• 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.

Procedure

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 for veterinary use or pharmaceutical substances for human or veterinary use.

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 submitting the documents for conducting the state procedure of GMP conformity assessment for all manufacturing sites involved in manufacturing process.

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 or a pharmaceutical substance with the departure to the plant.

Timeframe

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.

Validity term

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 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 and list of documents required from your side, as well as a sample of the Power of Attorney for execution, etc. please contact our specialists.