Legal developments in the
regulation of control over
medicines circulation in Russia
In March and April 2017 the following regulatory acts entered into force:
--the Administrative Regulations of the Federal Service for Surveillance in the Health Care Sector (Roszdravnadzor) on Performance of Federal State Surveillance in the Area of Medicines Circulation through the Organisation and Conduct of Inspection for Compliance by Medicines Circulation Entities with the Requirements for Pre-Clinical Trials, Clinical Trials of Medicines, Storage, Transportation, Release, Sale of Medicines, Application and Destruction of Medicines';
--the Administrative Regulations of Roszdravnadzor on Performance of Federal State Surveillance in the Area of Medicines Circulation through the Organisation and Conduct of Inspection for Conformance of Medicines for Medical Use being in Civil Circulation with the Established Quality Requirements';
--the Pharmacovigilance Procedure.
Moscow