Winning a Dispute over the Importation of Special Devices with the FCS

RussianLegal had a landmark win in an unprecedented dispute between U.S.-based IQVIA Inc. (a Fortune 500 company) with the Sheremetyevo Customs Office.

Our client was conducting clinical studies of a drug in Russia when it was suddenly subjected to an administrative prosecution by the Sheremetyevo Customs Office for the importation of ball pens with an audio recording capability without a licence from the Federal Security Service (FSS) of Russia. The pens were intended for physicians to simplify the management of patients with mental disorders.

The Federal Customs Service (FCS) of Russia considered the pens as clandestine data collection devices (CDCDs) and seized the cargo. That breached the applicable Clinical Study Protocol approved by the Health Ministry of Russia and endangered the registrability of the drug.

Despite the fact that the trial court found the FCS’s actions to be lawful, RussianLegal managed to reverse the proceedings and to cause the FCS’ order to be cancelled in full during five appellate hearings.

The case created a unique precedent not only for the pharmaceutical sector but for all suppliers of complex equipment. The judgment reflected the CDCD importation peculiarities and certification process and assessed the FCS’ conduct.