Documents

№ 61-FZ On Circulation of Medicines

№ 61-FZ - On Circulation of Medicines.

Government Decree No. 771 of September 29, 2010 “On Procedure of Import of medicines for medical use into the Russian Federation”

Government Decree No. 771 of September 29, 2010

“Procedure of Import of medicines for medical use into the Russian Federation”

Government Decree No. 673 of September 3, 2010 “Approval of Rules for Import and Export of Biological Materials Obtained in Clinical Trials of a medicinal product for medical use into and from the Russian Federation”

Government Decree No. 673 “Approval of Rules for Import and Export of Biological Materials Obtained in Clinical Trials of a medicinal product for medical use into and from the Russian Federation”

Customs Code of the Customs Union

Customs Code of the Customs Union.

Full text is available at http://www.russian-customs-code.com/

Manufacture of Ivestigational Medical Products

EU Guide “Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use”,full text is available at http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm. (National Standard GOST R 52249-2009 is a translation of the EU Guide to Good Manufacturing Practice,except for Annex 20).

National Standard GOST R 52379-2005 «Good Clinical Practice»

National Standard GOST R 52379-2005 «Good Clinical Practice».

№ 61-FZ On Circulation of Medicines
  • IATA Transport Of Biological Samples: Air Transport View.
  • more IATA Air Cargo Transport Regulations are available at http://www.iata.org/publications/Pages/standards-manuals.aspx