On December 31, 2014 Federal Law No. 532-FZ was enacted on amending certain Legislative Acts of the Russian Federation in Connection with Interdiction of Falsified, Counterfeit, Poor-Quality and Unregistered Medicines, Medical Devices and fabricated Dietary Supplements” (“Law”) was enacted.
The Law establishes the following three new types of crimes with respect to medicines and medical devices:
- Illegal production of medicines and medical devices, i.e., production or manufacturing of medicines or medical devices without all required licenses and approvals;
- Importation or sale of counterfeit, substandard or unregistered medicines and medical devices and counterfeit dietary supplements; and
- Falsification of documents and/or packaging of medicines and medical devices.
Some offences may also result in the offender’s debarment of three or five years. If the commission of the offence has resulted in the death of two or more persons, then the maximum prison term, fine and/or debarment periods discussed above can be increased substantially.
The substandard, falsified or counterfeit medicines and medical devices are to be confiscated and either destroyed or exported from Russia at the expense of the offender.
Previously the manufacture, sale and distribution of counterfeit, substandard or unregistered medicines and medical devices carried only light fines in addition to confiscation and, typically, destruction of such products.
The Law came into force on January 23, 2015.
Squire Patton Boggs lawyers have significant experience assisting clients to navigate and comply with regulations affecting their operations. For more information on how we can help you, please contact your Squire Patton Boggs lawyer or one of the individuals listed in this publication.