MIKHAILYUK SOROKOLAT & PARTNERS

Patent and Trademark Attorneys

Registration of medicinal products in the Eurasian Economic Union

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August 28, 2019

Mikhailyuk, Sorokolat and Partners would like to inform you that the procedure for submitting applications for registration of medicinal products according to the new regulations of the Eurasian Economic Union has been launched in Russia.

According to Decision No. 78 "On Rules for Registration and Examination Medicinal Products" determined by the Council of the Eurasian Economic Commission of November 03, 2016 the state registration of medicinal product conducted according to the said legislation 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 registration certificate for a medicinal product is issued for an unlimited period of time. However, for medicinal products that are first registered in Russia within 5 years it is necessary to renew the registration.

Upon your request we will be pleased to provide you with the detailed information about the associated costs as well as the list of required documents and the Power of Attorney form for execution. For any additional information please contact our specialists from the Regulatory Affairs Department.