‘It is a major step for anti-counterfeiting’ | Parag Kothari

‘It is a major step for anti-counterfeiting’ | Parag Kothari, Chairman & Managing Director, Jay Instruments & Systems

A new era for the European Economic Area will begin on February 9, 2019. Marketing Authorisation Holders (MAHs) will be required to upload their products serialisation codes to the European Medicines Verification Organisation (EMVO) hub, while pharmacists will be able to scan them at the point of sale for verification. This will apply to almost all prescription medicines. All stakeholders that supply pharmaceutical RX-products to European Countries will be impacted including originators and generics manufacturers, traders, re-packagers and CMOs. Anti-tampering devices on packages will also become mandatory, although no preferred feature is specified.

First of all the serialisation has created an unprecedented push for the life science companies to update their manufacturing processes. New equipment for serialisation at line level are required to perform the code printing and verification of individual packages; standalone units can integrate labelling functions, tamper-evident seal application and check-weighing functionalities, while printing and verification can also be integrated on any existing packaging line. The IT architecture must then be upgraded at plant level, to manage work orders with serialised data across multiple lines, as well as at corporate levels where data are exchanged across multiple stakeholders – including distributors – and ultimately notified to governmental authorities.

Aggregation, the process of serialising all logistic units within the packaging line establishing a hierarchy between packs, bundles, cases and pallets, is not in the current scope of EU-FMD regulatory requirements, yet it is becoming mandatory for several other countries.

This new, global approach requires the support of a comprehensive and scalable software and hardware platform that can be implemented to cope with different regulations on the same production lines and to efficiently manage the communications across the supply chain, enabling full product traceability. It is a major step forward for anti-counterfeiting, which will ultimately add value to supply chain management for manufacturers. But the current investment from manufacturers is set to generate further advantages for their businesses. Welcome to EU-FMD. New responsibilities in the approach to a huge market, as well as a big step in a new supply chain efficiency paradigm.

Next article – ‘Serialisation can analyse business value’ | Shashikant Joag