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Laws & Orders for international clinical trials in Ukraine

Title of DocumentVersion/Date
State Laws
On Prevention of CorruptionNo. 1700-VII dated Oct. 14, 2014
On Protection of Personal DataNo. 2297-VI dated Jun. 1, 2010
On Copyright and Related RightsNo. 3792-XII dated Dec. 23, 1993
On Access to Public InformationNo. 2939-VI dated Jan. 13, 2011
On InsuranceNo. 86/96-ВР dated Apr. 7, 1996
On MedicinesNo. 124/96-ВР dated Apr. 4, 1996
On Circulation of Drugs, Psychotropic Substances and PrecursorsNo. 61/95-ВР dated Feb. 15, 1995
in redaction of
No. 863-XIV dated Jul. 08, 1999;
No. 530-V dated Dec. 22, 2006
Orders of the MoH of Ukraine / Resolution of the CoM of Ukraine
On approving the Procedure of conducting clinical trials and expertizing clinical trial materials, and the Model provision of ethics committeesNo. 690 dated Sep. 23, 2009
in redaction of
No. 523 dated Jul. 12, 2012
On approving the Procedure for importing into Ukraine unregistered Medicines, standard samples, reagentsNo. 237 dated Apr. 26, 2011
On approving the Procedure of conducting clinical trials of tissue and cell transplants and expertizing clinical trial materialsNo. 630 dated Oct.10, 2007
On amending the Regulation on compliance of Medicines with the requirements to the Good Manufacturing PracticesNo. 452 dated Jul. 22, 2015
On approving the Procedure of managing the State Register of Medicines of UkraineNo. 314 dated May 8, 2014
On approving the Rules for utilization and destruction of MedicinesNo. 242 dated Apr. 24, 2015