Italy-based serialization software provider SEA Vision says it has more than 20 customers in Russia, widening its presence in Russia to offer local sales and technical support for its clients across the country.
According to the company, Russia’s track-and-trace law, which had been in the State Duma for most of 2017, sets the official legal basis for coding, serialization and compliance reporting. The law amended and passed through final voting the week of December 18 before being signed by President Putin 10 days later.
Federico Finotti, Sales Area Manager who manages the Moscow team, says, “Russia’s track-and-trace law is likely to be one of the most complex regulations of its kind. This has created the need for more expertise in the market to ensure the successful implementation of compliant solutions. To meet this demand, SEA Vision has invested in its technical resources in Russia to ensure that we can support our current and prospective customers during the entire life of their track-and-trace projects.”
Marketing Authorisation Holders (MAH) are required to file registration information for the track-and-trace system with the governing body by Jan. 1, 2019. A final implementation deadline has been set for Jan. 1, 2020, however the legislation allows the government to establish intermediate deadlines for certain groups of drugs.
Mikhail Murashko, who heads Roszdravnadzor, the government regulatory function for healthcare and medical devices, says he wants implementation for certain “essential” drug classes by the end of 2018, though a specific deadline has not yet been set, says SEA Vision.
Finotti adds, “The likelihood for intermediary deadlines has created significant time pressures for pharmaceutical manufacturers operating in and selling products in Russia. Companies need to act quickly to ensure they can access the resources and expertise they will need to implement a proper solution in good time.”
SEA Vision will work collaboratively with its strategic packaging machine manufacturer partner Marchesini Group to meet the hardware and software requirements for serialization across clients’ sites.
The companies recently launched a data collection plug-in designed to improve efficiencies during pharmaceutical manufacturing and achieve broader business benefits beyond compliance.
Using the data collection plug-in, it is possible to analyze the Overall Equipment Effectiveness (OEE) of pharmaceutical manufacturing lines, alongside performing serialisation.
SEA Vision says it has installed more than 800 full track-and-trace systems globally.
