The March of Serialization Continues – Falsified Medicine Directive
It is common knowledge that governments move slowly, and in the case of the Falsified Medicine Directive (FMD) it will, in the end, take eight years before it even comes partially into effect. The final countries will be required to comply with the complete text of the regulations in 2025, although most other countries will need to be in compliance by February of next year.
The FMD has a simple goal: ensure the authenticity of a given drug using a unique identification number and a requirement for a tamper-evident device to seal the packaging. The goal is twofold: stop the sale of a counterfeit product (made evident by the presence or absence of a valid code) and stop the ability of a tampered product with the seal – i.e. swapping the contents of a valid carton out with something else. Retailers will be immediately able to identify counterfeit or tampered products. Not a bad plan.
One of the most important features of the FMD is that its requirements involve every entity along the supply chain, from manufacturer to pharmacists/healthcare facilities. The manufacturer creates the code and attaches the anti-tamper device (whatever form that may take). The repacker replicates these security features (or replaces them with an equivalent one), but does not alter the codes in any way. Distributors are charged with recording the arrival and departure of each package, and performing reviews of products which are at a high risk of counterfeiting – essentially ensuring that nothing happened to the products on their trip from repacker to distributor.
From there, pharmacists are charged with verifying the integrity of the tamper-evident device and marking the code as dispensed at the point of sale. This deactivates the code and marks it as no longer valid, so that it cannot be used again. The same process takes place in healthcare facilities – it is assumed here that there will be no subsequent sale of the drug, and the code, just as with pharmacists, must deactivate the code. As large quantities of product are stored in healthcare facilities, they are also required to perform regular checks of their stores to ensure no tampering takes place before use.
The first step in this whole process is the most important, which is why manufacturers have been largely responsible for getting ready for the full implementation of the FMD. It probably does not come as much of a surprise that METTLER TOLEDO has developed systems to help bring manufacturers into compliance with this upcoming regulation. The Datamatrix Station XMV-TE in particular not only prints and verifies the required codes on the carton surface, it also applies a tamper-evident seal on the carton, allowing for total compliance. With the first quarter of the year already gone, time is running out. Governments move slowly, but manufacturers might find themselves needing to move quickly if they aren’t careful.
Article composed by Aaron Poppleton, Marketing Technical Writer for Mettler-Toledo Inc.
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