The Laws & Orders for international clinical trials in Ukraine

Title of Document Version/Date
The State Laws
On Prevention of Corruption No. 1700-VII dated Oct. 14, 2014
On Protection of Personal Data No. 2297-VI dated Jun. 1, 2010
On Copyright and Related Rights No. 3792-XII dated Dec. 23, 1993
On Access to Public Information No. 2939-VI dated Jan. 13, 2011
On Insurance No. 86/96-ВР dated Apr. 7, 1996
On Medicines No. 124/96-ВР dated Apr. 4, 1996
On Circulation of Drugs, Psychotropic Substances, and Precursors No. 61/95-ВР dated Feb. 15, 1995
in redaction of
No. 863-XIV dated Jul. 08, 1999;
No. 530-V dated Dec. 22, 2006
The Orders of the MoH /The Resolutions of the CoM of Ukraine
On approving the Procedure of conducting clinical trials and expertizing clinical trial materials, and the Model provision of ethics committees No. 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, reagents No. 237 dated Apr. 26, 2011
On approving the Procedure of conducting clinical trials of tissue and cell transplants and expertizing clinical trial materials No. 630 dated Oct.10, 2007
On amending the Regulation on compliance of Medicines with the requirements to the Good Manufacturing Practices No. 452 dated Jul. 22, 2015
On approving the Procedure of managing the State Register of Medicines of Ukraine No. 314 dated May 8, 2014
On approving the Rules for utilization and destruction of Medicines No. 242 dated Apr. 24, 2015