Marketing Authorization in the Russian Federation

Регистрация лекарственных средств в России 

     Megainpharm GmbH core activity is state registration (Marketing Authorization) of pharmaceutical products intended for medical use, i.e. medicinal products, medical devices and pharmaceutical substances within the territory of the Russian Federation and the Eurasian Economic Union (Belarus, Kazakhstan, Kirgizia, Armenia). State registration is performed in accordance with the requirements of current regulatory and reference documents, pharmaceutical product specifications (therapeutic use, pharmaceutical form, status etc.). Federal Law N 61-FZ dd.12.04.2020 On Medicinal Products Circulation outlines the fundamentals of marketing authorization procedure for pharmaceutical products for therapeutic use. According to the law, state registration is obtained in no later than 160 working days from the application date, and in no later than 80 working days for orphan drug products, first three generic products, for use in children. Although, registration timelines may vary due to the specificities of each individual case.

Megainpharm GmbH has ample experience in the field of state registration of pharmaceutical products in Russia and the EEU countries. Our specialists design the most effective projects of state registration for medicinal products, pharmaceutical substances and medical devices, that allows to complete the registration as soon as practicable without spending extra resources. Permit for accelerated procedure of state registration can be obtained under certain conditions. Upon successful completion of all registration stages, a registration certificate (Marketing Authorization) with a validity period of five years is granted to a pharmaceutical product to be registered for the first time, permanent certificate is granted after the repeated expert examination. This certificate enables commercial release of a pharmaceutical product in Russian and the EEU countries markets.

Регистрация лекарственных средств в России 

Our company offers the following services:

  • Preparation of Marketing Authorization Application;
  • Consultative support on state registration of pharmaceutical products in Russia;
  • Assistance with interactions with competent authorities;
  • Facilitation of registration procedure from the first steps to obtaining the certificate;
  • Management and monitoring of appropriate preclinical and clinical trials;
  • Consulting and other services in execution of scientific knowledge and documentation;
  • Risk management expertise.