27.03.2017

Legal developments in the regulation of control over medicines circulation in Russia

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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. 



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Contacts:

Yana Dianova

Director of the Corporate and Commercial Law Department, GRATA International (Moscow)

Tel: +7 (495) 660 11 84

E-mail: ydianova@gratanet.com