On October 8, the video conference "Medicines: quality issues, measures to counteract counterfeit and forged products" was held.
The event was organized by the Ministry of Industrial Policy of the Kirov region as part of the Six-party agreement on detection, prevention and suppression of illegal commercialization of industrial products.
Alexey Pavlov, Head of the Quality Management Department at NANOLEK, and Andrey Kolupaev, a leading expert in IT support, delivered a report on the hands-on experience in implementation of drug labelling requirements at NANOLEK biomedical complex.
They met the experts from Rospotrebnadzor (Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing), Roszdravnadzor (Federal Service for Surveillance in Healthcare) and other representatives of pharmaceutical providers in the Kirov region.
Statutory requirements on labelling of medications have become mandatory on July 1, 2020 for all participants of the pharmaceutical industry – manufacturers, distributors, pharmacies and healthcare providers concurrently with the large-scale launch of the monitoring systems.
Our colleagues told us how and within which time limits the project for drug labelling in the MTM system (medication traffic monitoring) was implemented at NANOLEK biomedical complex.
Alexey Pavlov: "NANOLEK has managed to meet the deadline for launching the labelling project imposed by the regulatory authority. On November 21, 2019, NANOLEK biomedical complex in Kirov region manufactured a labelled commercial batch of Hunteraza® drug used to treat the mucopolysaccharidosis type 2 (MPS 2) included in the 14 Nosologies List.
In April 2020, we successfully performed a state contract on labelling of Darzalex® (Daratumumab) used in the treatment of multiple myeloma."
