From its adoption on 9 February 2019, and until Brexit was passed 31 December 2020, the European Union’s Falsified Medicines Directive (EU FMD) helped secure the pharmaceutical supply chain by requiring that all products be verified and decommissioned at dispensing.
The EU FMD was designed to identify any serialised code on a pack that is not in the system or with a status that indicates it should not be dispensed.
There will be no obligation for supply chain stakeholders in Great Britain to affix safety features or to scan packs of medicines; however, packs that already have EU FMD safety features will continue to be accepted, provided they are in line with other GB packaging requirements.
The MHRA is encouraging companies to retain the tamper-evidence device on packs supplied to the United Kingdom.
In short, the pharmaceutical supply chain is not as secure as it once was, and Great Britain may soon see an increase in falsified medicines unless an alternative to the EU FMD is developed.
Implementing OPTEL’s Verify Platform
Full track-and-trace history with visual timelines and maps
Track-and-trace solutions can help you identify any weak links in your supply chain, authenticate individual products and their components, track conditions to help prevent product damage, diversion or waste, and even take control of your products’ carbon footprint.
The insights you gain empower you to make immediate, informed decisions to help optimize your day-to-day operations, protect your brand and increase proximity and real-time contact with partners and end users.
Step one: Each product/unit is identified with a serial number that acts as the item’s unique identifier (UID) and individualizes it within the supply chain.
Step two: Once entered into your database, this serial number starts being monitored, creating real-time visibility at every stage of your supply chain.
Step three: The traceability platform collects data from each product, which can be used to make decisions in real time. You alone own the data and determine which data is most relevant to your operations.
Step four: Once they receive your product, your consumers will be able to view its history, its authenticity and any other information of your choosing, simply by scanning the barcode.
Identify issues with counterfeiting and market diversion
Track authentication failures
Provide a geographical heat map of authentication activity
Discover how Galderma gained higher productivity and plans on going beyond compliance, after successfully implementing aggregation and serialisation.
Bayshore Pharmaceuticals, which works with contract manufacturing organizations (CMOs) to supply the generic drug market, needed to comply with serialization regulations. The growing New Jersey-based company achieved that — and more — thanks to OPTEL’s serialization software.
Our client is an international pharmaceutical manufacturer that collects and fractionates blood plasma to produce and distribute plasma-derived therapeutic products for use in treating serious diseases, disorders and conditions. Find out why they chose OPTEL’s Verify Platform and SWIFT implementation framework to achieve regulatory compliance and gain operational efficiencies.