/ Our Standards

Our Standards

Clinical Trial Logistic operates in compliance with following national and international regulations:

National regulations of the Russian Federation

Federal Laws
  • Federal Law «On Circulation of Medicines» No. 61-FZ, 12 April 2010
  • Federal Law On Public Health Protection in the Russian Federation, No. 323-FZ, 21 November 2011
Government Decrees
  • Government Order No. 771 of September 29, 2010 "On Procedure of Import of medicines for medical use into the Russian Federation"


Regulatory Orders
  • Order No. 200n dated April 01, 2016 of the Ministry of Health of the Russian Federation On Approval of Rules for Good Clinical Practice
  • Annex 13 to Order of the Ministry Ministry of Industry and Trade of the Russian Federation dated 14.06.2013 N 916 (as amended on 18.12.2015) On Approval of Rules for Guidelines for Good Manufacturing Practice for Medicinal Products for Clinical Use
National Standard
  • National Standard GOST R ISO 9001—2008 Quality Management Systems
  • National Standard of the Russian Federation GOST R 52379-2005 "Good Clinical Practice"


International Standards and Regulations

  • ISO 9001-2008 Quality Management Systems
  • ICH Guideline for Good Clinical Practice E6
  • Guidelines on Good Distribution Practice of medicinal products for human use (2013/C 343/01)
  • WHO Guide to Good Storage Practices for pharmaceuticals
  • Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use