In accordance with the Decision of the Council of the Eurasian Economic Commission of November 3, 2016, No. 78 until December 31, 2020 two possible ways of state registration of medicinal products are stipulated in the member states of the Eurasian Economic Union (Russia, Belarus, Kazakhstan, Kyrgyzstan and Armenia), namely:
1. State registration within the frame of the national registration procedure conducted according to the local legislation of each country of registration. However, in case of submitting the Application for registration according to said demands it is possible to register medicinal product until December 31, 2020 only, after that till December 31, 2025 it will require obligatory conducting the procedure of bringing the registration dossier into compliance with the demands of Eurasian Economic Union together with obligatory conducting GMP inspection of all manufacturing sites involved in manufacturing process of medicinal product according to the demands of Eurasian Economic Union.
Also please note that for all medicinal products that were registered in the member-states of the Eurasian Economic Union according to the local legislation until the Decision of the Council of the Eurasian Economic Commission of November 3, 2016, No. 78 come into force till December 31, 2025 it is necessary to conduct the procedure of bringing the registration dossier into compliance with the demands of Eurasian Economic Union together with obligatory conducting GMP inspection of all manufacturing sites involved in manufacturing process of medicinal product according to the demands of Eurasian Economic Union. Otherwise, the registration of said medicinal products will be cancelled from January 01, 2026.
2. State registration within the frame of the procedure conducted according to the demands of Eurasian Economic Union. In case of submitting the Application for registration according to said demands till December 31, 2018 GMP inspection of all manufacturing sites involved in manufacturing process of medicinal product will be conducted by reference member state of the Eurasian Economic Union in parallel to the procedure of registration after submitting the Application. Please note that till said date it is not possible to conduct GMP inspection in accordance with the demands of Eurasian Economic Union separately from the registration procedure. However, till said date it is allowed to submit the Application for registration with GMP Certificates issued separately in accordance with the national legislation of one of the member-states of the Eurasian Economic Union. Meanwhile, in case of absence of said GMP Certificates and the inspection according to the demands of Eurasian Economic Union cannot be put in the inspection plan of the Authority during conduction of the registration procedure it will be included into the inspection plan in the first 3 years upon receipt of registration status.
Additionally please kindly note that to register any medicinal product according to the demands of Eurasian Economic Union it is necessary partially or completely to conduct clinical or bioequivalence studies (depending on the type of medicinal product) in the territory of one of the member states of the Eurasian Economic Union and provide their reports in the registration dossier. In case of presence of reports on clinical or bioequivalence 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 during the registration procedure to conducting unscheduled inspection of one of the clinical centers where the clinical or bioequivalence studies were conducted.
The last but not least, we would like to draw attention to the fact that the registration of medicinal product issued according to the demands of the Eurasian Economic Union by its member-state selected as a reference state allows conducting the simplified state registration of said medicinal product in other member states of the Eurasian Economic Union by the procedure of recognition of the state registration after issuing the Eurasian Registration Certificate. It is also possible to apply for simplified state registration of the medicinal product in other member states of the Eurasian Economic Union not waiting approval of registration in the reference member state, however, in this case the application for state registration in another member state has to be filed to the competent Authority of that member state within 14 workdays from the date of filing the application to the Authority of the reference state.
So due to starting conduction of the registration procedures this year according to the demands of the Eurasian Economic Union we recommend to register medicinal products in its member states according to said demands with the purpose to avoid the procedure of bringing the registration dossier into compliance with said demands and further additional expenses.
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