On 9 February 2019, the EU Falsified Medicines Directive (FMD) will be applied, meaning that all pharmaceutical companies providing medicines for human consumption must include both a unique identifier and an anti-tampering device on all their packaging
Essentra serialisation solutions
This requirement was added to existing legislation last year in an effort to counter the growing issue of counterfeit medicines — which has increased exponentially in recent years because of increasingly complex supply chains, the expansion of e-commerce and a lack of enforcement capacity.
Falsified medicines are an industry wide issue and are not only extremely dangerous to patients, but can also cause significant harm to the brands that manufacture legitimate products — as patients are likely to lose confidence in a brand if it is widely counterfeited.
It is essential that pharmaceutical companies respond expeditiously to ensure that their products are well protected and comply with the upcoming legislation.
As a global supplier of pharmaceutical packaging, Essentra advocates the use of multiple layer solutions — not only to comply with legislation, but to ensure products are wholly protected.
First, tamper verification solutions should be used to assure patients that their products have not been interfered with.
These should be paired with authentication technologies to prove that the items are genuine, as well as using serialisation solutions to certify that the products have come from the original manufacturer.
The first two elements, tamper verification and authentication, are often combined. One of the most popular types of tamper verification solution is labels, such as void labels. These labels provide overt verification; patients can clearly see if the seal has been broken owing to the void image residue.
To add a higher level of security, further covert authentication solutions can be added, such as UV, colourshift inks or taggants. These print techniques guarantee that the labels are authentic and make it more difficult for counterfeiters to recreate genuine-looking products.
The third — and possibly the most difficult element to execute — is track and trace. Systems are currently being implemented in countries all around the world (see infographic). The creation of the required serial codes can be a challenging task: from creation to data management and from quality to control.
To use the finalised serial code, a uniform system must be put in place that meets the requirements to read the code at each level of the supply chain. This may lead to existing suppliers and companies within the supply chain having to integrate new IT systems, databases and business structures, adding further infrastructure and administrative costs.
To successfully implement a three-step, multilayer solution, companies must act now — whether this means creating new serialisation systems in-house or outsourcing serialisation solutions to packaging companies.
Two years may seem like a long time; but, companies have a lot to accomplish within that short window. Not only do they need to evaluate potential serialisation solutions for their larger main product lines; it is essential that even the bespoke, specialist and short-run cartons have the correct serialisation codes too.
Click here to see how different countries are responding to the threat of counterfeiting.