Legacy Pharmaceuticals has announced that preparations to meet the new Russian track-and-trace regulation, Federal Law No. 425-FZ, are well advanced. Headquartered in Birsfelden, Switzerland, Legacy is a global contract manufacturer of sterile/aseptic pharmaceutical products in ampoules and vials.
The track-and-trace regulations in Russia are due to be introduced in January 2020. The legal framework sets a new bar for serialisation, compliance reporting and data management.
“The Russian regulations are even more stringent than the newly implemented serialisation systems Legacy recently installed to meet the EU Falsified Medicines Directive in 2018," said Legacy CEO Mike Danzi. "The addition of cryptographic coding in particular, which adds another layer to security, is a significant technical challenge,” he commented.
“However, Russia has always been one of our key markets and we are committed to ensuring our longstanding customers can continue to rely on our products. We are preparing to install new inspection cameras with higher resolution to ensure readability of more complex codes demanded by the Russian mandated crypto coding."
Danzi said a new Bosch serialisation and aggregation equipment has been installed and certified on three packaging lines. "Complex labelling containing a wide range of readable/variable data and DMC-codes is now possible," he explained
"Two types of tamper-evident labels are available for different packaging materials including cartons, styrofoam boxes and bottles," Danzi concluded.
