The Time-Frames are Regulated
The order by the Ministry of Industry and Trade of the Russian Federation of 26.05.2016 No 1714 “On Approval of Administrative Regulation of the Ministry of Industry and Trade of the Russian Federation on Rendering of Public Service on Issue of Conclusions on Compliance of Medicinal Drug Manufacturers with Good Manufacturing Practice” has been registered with the Ministry of Justice of the Russian Federation on 09.08.2016 No 43175. The order has been published at the official web-portal of legal information
The document establishes the time-frames for the Ministry to take a decision on issue / refusal to issue a conclusion: NMT 10 business days from the date of signing the inspection report or from the date of its submission from the authorized institution.
The cost of the public service has also been defined: 7500 rubles for Russian manufacturers, while for international manufacturers the cost is determined individually.
The time frames for inspection and valid dates of conclusions issued have also been established.