Yes, it is necessary, in accordance with the requirements of the Procedure for conducting expert evaluation of registration materials for medicinal products submitted for state registration (re-registration), as well as expert evaluation of materials on amendments to registration materials during the validity of the registration certificate, approved by MoH order No. 426 dated 26.08.2005 (as amended by MoH order No. 460 dated 23.07.2015), by declaring the relevant changes taking into account the data that became the basis for generating/updating the RMP.
