Liability for circulation of unregistered, substandard or falsified medicines, biologically active supplements and medical devices

20.01.2015

Legal update No 491

Goltsblat BLP advises that Federal Law No. 532-FZ of 31 December 2014 has amended the Criminal Code and the Code of Administrative Offences, as well as other regulatory acts. The purpose of the amendments is to increase liability for circulation of unregistered, substandard or falsified (information about) medicines, biologically active supplements and medical devices. The federal law introduces the following concepts: “falsified biologically active supplements”, “falsified medical devices”, “substandard medical devices” and “infringing medical devices” (i.e., contravening the Russian legislation). It also establishes a number of prohibitions on circulation of such products, for which purpose relevant amendments are to be introduced into the federal laws “On the Quality and Safety of Foodstuffs” and “On the Fundamentals of Public Health in the Russian Federation”.

The amendments to the Russian Criminal Code criminalise the following:

  • manufacture of medicines or medical devices without a special permit, if required;
  • manufacture of fake (forged) medicines, medical devices and biologically active supplements or their circulation, including their sale or import into the Russian Federation;
  • sale or import into the Russian Federation of substandard medicines or medical devices;
  • illegal manufacture, sale or import into the Russian Federation of unregistered medicines for resale;
  • manufacture, import or sale of falsified biologically active supplements containing pharmaceutical substances not declared at the time of state registration.

The penalties for these crimes vary from a fine to deprivation of liberty, depending on the qualifying features of the actions involved. It should be noted that, for the purposes of applying new Criminal Code articles 235.1 and 238.1, large scale is defined as relating to medicines, medical devices or biological active supplements worth over RUB 100,000.
 
Similar actions not displaying indicia of a crime, as below, may be classed as administrative offences:

  • manufacture, sale or import into the Russian Federation of falsified medicines or medical devices;
  • sale or import into the Russian Federation of infringing medicines or medical devices;
  • circulation of falsified biologically active supplements;
  • sale or import into the Russian Federation of substandard medicines or medical devices;
  • sale or import into the Russian Federation of unregistered medicines;

Such actions might entail a fine on legal entities of RUB 1 to 5 m or suspension of activities for up to 90 days.

The given amendments come into effect on 23 January 2015, their purpose being to harmonise the Russian legislation with the Council of Europe Convention on the counterfeiting of medical devices and similar crimes involving threats to public health, which the Russian Federation has already signed.

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