Legacy ramps up preparations for new Russian track and trace sterilisation regulations

18 Jul 2019

Company to install new inspection cameras with higher resolution to ensure readability of more complex codes demanded by the Russian mandated crypto coding.

Legacy Pharmaceuticals, a global contract manufacturer of sterile/aseptic pharmaceutical products in ampoules and vials, has announced that preparations to meet the new Russian track and trace regulation, Federal Law No. 425-FZ, are well advanced.

Legacy ramps up preparations for new Russian track and trace sterilisation regulations

Due to be introduced in January 2020, the regulation sets a new bar for serialization, compliance reporting and data management.

“The Russian regulations are even more stringent that the newly implemented serialization systems Legacy recently installed to meet the EU Falsified Medicines Directive in 2018. The addition of cryptographic coding in particular, which adds another layer to security, is a significant technical challenge,” says Legacy CEO Mike Danzi.

“However, Russia has always been one of our key markets and we are committed to ensure 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. New Bosch serialization and aggregation equipment has already been installed and certified on three packaging lines. Complex labelling containing a wide range of readable/variable data and DMC-codes is now possible.

Two types of tamper-evident labels are available for different packaging materials including cartons, styrofoam boxes, and bottles. Legacy is committed to the Russia market, and to leading the way to comply with the new serialization requirements.”

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