In the US, the Drug Supply Chain and Security Act of 2013 (DSCSA) outlines guidelines for manufacturers, re-packagers, wholesale distributors, dispensers, and third-party logistics providers. In the EU the Falsified Medicines Directive (FMD) requires serialization and regulations similar to the US.
Per the regulations, registration information filing for track and trace systems is required by Marketing Authorization Holders (MAH) by January 1st 2019 for the US.
In the EU, the Falsified Medicines Directive (FMD) details similar serialization requirements to prevent entry of falsified medicines into the pharmaceutical supply chain. The FMD became active in 2018 for the EU.
Russia, one of pharmaceuticals emerging markets, is in the process of a full serialization and track and trace system. It is said to resemble the European system of serialization and regulation.
Matt Dent, a representative of the pharmaceutical inspection and serialization systems company SEA Vision told us, “It [Russia] is one of the most complex regulations of its kind and has created the need for more expertise in the market to ensure the successful implementation of compliant solutions.”
Dent furthered, “Russia’s track and trace law sets the official legal basis for coding, serialization and compliance reporting in the country…companies are required to manage serialization and traceability of medicines from manufacturer to patient, and report product and transaction events to the central government system.”
The new offices in the US, Germany and Russia will enable SEA Vision to provide commercial and technical support from a local office – project management, and after-sales services will be established in the new offices as well.
Emerging markets have “unique” characteristics for compliance, Dent explained, noting that establishing more offices in emerging markets will enable consistent compliance to track and trace in all offices.
Currently, SEA Vision is recruiting local experts and building larger infrastructure near targeted markets. Dent said, “It is essential to have on-site, efficient, mother tongue sales and technical services experts.”
Germany, a growing market for original equipment manufacturer (OEM), is also part of SEA Vision’s expansion plan. “One of SEA Vision’s core services, installation and validation testing, is often provided at the OEM’s site or customer’s plant,” said Dent. Expanding services to Germany will allow SEA Vision to partner with OEM’s and provide software design to meet client needs.
Offices also will be opened in the US to assist clients with serialization requirements.