pharmaceutical regulation
Russian Laws

Federal Law 61
"On circulation of medicines"

The legal document below was translated into Russian by CEG or a translation company on behalf of CEG.
This translation may contain inaccuracies. For all issues related to law enforcement practice, please contact the authorities of Russia / the EAEU and CEG company.

Adopted by
the State Duma
on March 24, 2010

Approved by
the Federation Council
on March 31, 2010

(as amended by Federal Laws of July, 27 2010, No. 192-FZ;
of October 11, 2010, No. 271-FZ, of November 29, 2010 No. 313-FZ,
of December 06, 2011 No. 409-FZ, of June 25, 2012 No. 93-FZ,
of December 25, 2012 No. 262-FZ, of July 02, 2013 No. 185-FZ,
of November 25, 2013 No. 317-FZ, of March 12, 2014 No. 33-FZ,
of October 22, 2014 No. 313-FZ, of December 22, 2014 No. 429-FZ,
of March 08, 2015 No. 34-FZ, of June 29, 2015 No. 160-FZ,
of July 13, 2015 No233-FZ, of July 13,2015 №241-FZ,
of July 13, 2015 No262-FZ, of December 14, 2015 No 374-FZ,
of December 29, 2015 No389-FZ, of June 02, 2016 No163-FZ,
of July 03, 2016 No 261-FZ, of July 03, 2016 No305-FZ,
of July 03, 2016 No350-FZ, of July 29, 2017 No242-FZ,
of July 29, 2017 No278-FZ, of December 28, 2017 No425-FZ, of June 04, 2018 No140-FZ)
Chapter 1. General provisions
Chapter 2. Powers of Federal Executive Bodies and Executive Bodies of Constituent Entities of Russian Federation with Respect to Circulation of Medicines
Chapter 3. State Pharmacopeia
Chapter 4. State Control over Circulation of Medicines
Chapter 5. Development, Preclinical Trials of Medicines and Clinical Trials of Medicinal Products for Veterinary Use
Chapter 6. Performance of State Registration of Medicinal Products
Chapter 7. Clinical Trials of Medicinal Products for Medical Use, Clinical Trial Contract, Rights of Patients Involved in Clinical Trials
Chapter 8. Manufacture and Marking of Medicines
Chapter 9. Import of Medicines into the Russian Federation and Export of Medicines from the Russian Federation
(as amended by Federal Law of December 06, 2011 No. 409-FZ)
Chapter 10. Pharmaceutical Activity
Chapter 11. Destruction of Medicines
Chapter 12. State Regulation of Prices for Medicinal Products for Medical Use
Chapter 13. Efficacy and Safety Monitoring of Medicinal Products Being in Circulation in the Russian Federation
(as amended by Federal Law of December 22, 2014 No. 429-FZ)
Chapter 14. Information on medicinal products. System for monitoring logistics of medicinal products for medical use
Chapter 14.1. Limitations imposed on organizations performing activities in circulation of medicines
Chapter 15. Liability fo Violation of Legislation of the Russian Federation in Circulation of Medicines and Compensation for Harm to Human Health Caused by Administration of Medicinal Products
Chapter 16. Final Provisions
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