Goltsblat BLP advises that in November - December 2017, the Federal Service for Surveillance in Healthcare (Roszdravnadzor) issued a number of orders (the “Orders”) approving the scheduled inspection check lists in the following areas:
circulation of medicines (Roszdravnadzor Order No. 9438 dated 9 November 2017);
circulation of medical devices (Roszdravnadzor Order No. 10449 dated 20 December 2017); and
control over the quality and safety of medical activities (Roszdravnadzor Order No. 10450 dated 20 December 2017).
According to Government Resolution No. 840 dated 14 July 2017, Roszdravnadzor officials must use and confine themselves to the check lists during scheduled inspections in the above areas.
The clauses permitting scheduled inspection mandatory check lists are introduced by amendments to article 9 of Federal Law No. 294-FZ dated 26 December 2008 “On Protecting the Rights of Companies and Individual Entrepreneurs during Inspections by State (Supervisory) or Municipal Authorities”.
In furtherance of the above provision, Government Resolutions No. 1043 dated 15 October 2012 (On Supervision over Circulation of Medicines), No. 970 dated 25 September 2012 (On Control over Circulation of Medical Devices) and No. 1152 (On Government Control over the Quality and Safety of Medical Activities) require the check lists to be used from 1 January 2018.
Please note that the Orders are currently pending registration with the Russian Ministry of Justice and will not formally take effect until the procedure is completed.
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