The Ministry has put up for public discussion the method of determining the amount of payment for the provision of services for the inspection of drug manufacturers, the production of which is carried out outside the Russian Federation, for compliance with GMP regulations in order to issue opinions on the conformity of the pharmaceutical manufacturer to the requirements of these rules.
The document provides a list of procedures (operations) performed in the course of providing services, the calculation of the maximum amount of payment for its provision, as well as model names of the works carried out in the provision of services with indication of the actual complexity of their implementation.
Fee for the provision of services is determined for each applicant individually, taking into account the necessary work, in accordance with the list of standard items of works undertaken in the provision of services, with the actual complexity of their implementation and economically reasonable material and labor costs.
Conduct inspections of foreign pharmaceutical manufacturers are authorized FBU “State Institute of drugs and good practices” (FBU “GILLS and NP”).
Public discussion of the draft document on the website regulation.gov.ru will last till 17 Aug 2018