Italy-based, serialisation software provider SEA Vision has expanded its operations in Moscow following the signing of Russia’s track and trace law
SEA Vision, which has more than 20 customers in Russia and has installed more than 800 full track and trace systems globally, is expanding its presence in Russia to offer local sales and technical support for its clients across the country.
Russia’s track and trace law, which has been in the State Duma for most of 2017, sets the official legal basis for coding, serialisation and compliance reporting. The law amended and passed through final voting the week of 18 December before being signed by President Putin on 28 December.
Federico Finotti, Sales Area Manager who manages the Moscow team, said: “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 its 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 1 January 2019. A final implementation deadline has been set for 1 January 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, has stated that he wants implementation for certain ‘essential’ drug classes by the end of 2018, though a specific deadline has not yet been set.
Federico Finotti said: “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 serialisation 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 analyse the overall equipment effectiveness (OEE) of pharmaceutical manufacturing lines, alongside performing serialisation.