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ISO 9001 CERTIFIED


State registration of medicinal products in Russia

In accordance with the Decision of the Council of the Eurasian Economic Commission of November 3, 2016, No. 78 medicinal products are allowed for use in the member state of the Eurasian Economic Union (Russia, Belarus, Kazakhstan, Kyrgyzstan and Armenia) only after state registration. According to the same Decision two possible ways of state registration of medicinal products are stipulated in Russia, namely:

  • State registration of medicinal product within the frame of the procedure according to the Decision of the Council of the Eurasian Economic Commission of November 03, 2016, No. 78;
  • State registration of medicinal product within the frame of conducting the national procedure according to the law of the Russian Federation On circulation of medicinal products. However in this case it is possible to register medicinal product until December 31, 2020 only, after that till December 31, 2025 it will require obligatory conducting of the procedure of bringing the registration dossier into compliance with the demands of Eurasian Economic Union.

. In order to register medicinal product according to the demands of the Eurasian Economic Union it is necessary to provide the following documents to the Ministry of Health Protection and Social Development of the Russian Federation:

1) Application form with the attached 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;
  • legalized copies of Conclusions of Compliance to the GMP requirements for all manufacturing sites involved in manufacturing process issued by one of the competent Authorities of the member state of the Eurasian Economic Union: Russia, Belarus, Kazakhstan, Kyrgyzstan or Armenia (the procedure of issuance of these documents is conducted before submitting the Application for registration) or legalized copies of the Eurasian GMP Certificates for all manufacturing sites involved in manufacturing process issued by one of the competent Authorities of the member state of the Eurasian Economic Union: Russia, Belarus, Kazakhstan, Kyrgyzstan or Armenia (the procedure of issuance of these documents is conducted in parallel to the procedure of registration after submitting the Application for registration);
  • legalized copy of registration certificate issued by the authorized body of applicant and/or manufacturers country or justification of its absence;
  • certified list of the countries where the medicinal product is registered/re-registered/cancelled with indication of dates, numbers and validity of the registration certificates/dates and reasons of cancelling;
  • proposed mockups for the market of the Russian Federation;
  • legalized copy of Certificate of Pharmaceutical Product or Free Sale Certificate (if available), etc.

2) Registration dossier in the format of the common technical document (CTD);

3) Samples of medicinal product and standard samples.

Please note that in case of registration of medicinal product according to the demands of the Eurasian Economic Union it is necessary partially or completely to conduct clinical trials (depending on the type of the medicinal product) in the territory of one of the member state of the Eurasian Economic Union (Russia, Belarus, Kazakhstan, Kyrgyzstan or Armenia) and provide their reports in the registration dossier. In the presence of reports on clinical studies conducted partially or completely in the territories of the countries of the region of the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) conducting the studies in the territory of one of the member state of the Eurasian Economic Union can be replaced to conducting unscheduled inspection of one of the clinical centres where the clinical study was conducted during the registration procedure.

Also we would like to draw your attention to the fact that according to the demands of the Eurasian Economic Union a foreign applicant must have a contact person of qualified person responsible for pharmacovigilance with location in Russia and provide this information in the registration dossier.

Besides, please note that the Ministry may request additional information and/or documents. This is individually for each instance.

According to the demands of the Eurasian Economic Union the procedure of state registration of medicinal product should be conducted within 210 days without considering the time required for preparation of responses to remarks. However in accordance with usual practice depending upon the completion of the provided materials and scope of documentation, number of requests of the Ministry of Health Protection and Social Development and other factors the procedure of registration may last from 12 to 18 months without considering the time required for preparation of responses to remarks.

. In order to register medicinal product according to the national procedure it is necessary to provide the following documents to the Ministry of Health Protection and Social Development of the Russian Federation:

1) Application form with the attached 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 Conclusions of Compliance to the GMP requirements for all manufacturing sites involved in manufacturing process issued by the competent Authority of the Russian Federation (the procedure of issuance of these documents is conducted before submitting the Application for registration);
  • legalized copy of registration certificate issued by the authorized organ of applicant and/or manufacturers country or justification of its absence;
  • list of the countries where the medicinal product is registered with indication of dates and numbers of the registration certificates;
  • proposed mockups for the market of the Russian Federation;
  • legalized copy of Certificate of Pharmaceutical Product or Free Sale Certificate (if available).

2) Registration dossier in the format of the common technical document (CTD);

3) Samples of medicinal product and standard samples.

Please note that in case of registration of medicinal product according to the national procedure it is necessary partially or completely to conduct clinical trials (depending on the type of the medicinal product) in the territory of the Russian Federation and provide their reports in the registration dossier.

According to the Russian legislation the procedure of state registration of medicinal product should be conducted within 160 workdays without considering the time required for conducting the clinical trials and preparation of responses to remarks. However in accordance with usual practice depending upon the completion of the provided materials and scope of documentation, number of requests of the Ministry of Health Protection and Social Development and other factors the national procedure of registration may last from 12 to 18 months without considering the time required for conducting the clinical trials and preparation of responses to remarks.

The Eurasian Certificate about the state registration of medicinal product in the Russian Federation issued according to the demands of the Eurasian Economic Union is valid on the permanent basis, however, for the medicinal products that are first registered in Russia within 5 years it is necessary to renew the registration. The procedure of the renewal of the registration may be initiated before expiration date of previous registration, but not earlier than 210 days. The usual renewal procedure lasts about 6 months without considering the time for preparation of responses to the remarks. The renewal procedure does not require checking the quality, pre-clinical and clinical data, however, it will be necessary to provide reports made by the independent experts in the form of Module 2 of the common technical document (CTD on quality and the current benefit/risk balance for the product on the basis of the safety/efficacy data accumulated since the first registration, making reference to relevant new information in the public domain.

Also please note that the procedure of the state registration of medicinal product conducted according to the demands of the Eurasian Economic Union allows conducting the simplified state registration of said medicinal product in other member states of the Eurasian Economic Union by the centralized procedure of recognition of the state registration in another member states of the Eurasian Economic Union after issuing the Eurasian Certificate. It is also possible to apply for simplified state registration of the medicinal product in another member states of the Eurasian Economic Union not waiting registration in the first country, however in this case the application for state registration in another member has to be filed in the competent Authority of that member state of the Eurasian Economic Union within 14 workdays from the date of filing the first application for state registration.

The Certificate about the state registration of medicinal product in the Russian Federation issued by the national procedure is valid within 5 years, but not more than till December 31, 2025, however this Certificate can be replaced to the Eurasian Certificate by means of conducting the procedure of bringing registration dossier into compliance with the demands of Eurasian Economic Union.

In order we could provide you with the information on costs associated with the registration of medicinal products in Russia 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.

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