FMD - Falsified Medicines Directive - Dir. 2011/62/EU
- has extended the concept of “counterfeit medicine”
- has extended it not only to the product inside the package, but also to the packaging itself, including labeling.
The aim is to guarantee the maximum security to the end user when buying medicines.
The importance of packaging
This directive requires pharmaceutical companies to rely more heavily on packaging manufacturers because it requires the outer packaging to provide “safety features enabling wholesale distributors and persons authorized or entitled to supply medicinal products to the public to verify the authenticity of the medicinal product and identify individual packs, as well as a device allowing verification of whether the outer packaging has been tampered with.”
According to the directive, therefore, there are three essential and complementary requirements:
- The outer packaging must be original (Authentication)
- The outer packaging must be identified (Serialization)
- The content must be the one originally inserted (Evidence of Tampering)
If one of these three elements is missing, it will weaken the anti-counterfeiting action of the outer packaging.
The outer packaging is the “first line of defense” against counterfeiting, so it is essential to make it hard to be copied.
The top priority of Igb’s customers, and so of Igb itself, is to guarantee the authenticity of the packaging.
Igb R&D provides technologies to protect products against counterfeiting.
They are very similar to the authentication technologies used in banknotes production.
In the old days, banknotes molds were physical and kept safe by Governments.
Nowadays, in the digital age, electronic molds need to be protected too.
The cutting-edge software of Igb makes its folding boxes unique and hard to counterfeit, by using graphic elements that:
- Cannot be scanned and reproduced
- Cannot be replicated without the source software and the algorithm used for their production.
Among these graphic elements, Igb offers guilloche, micro text, latent image, embossing, hidden patterns.
UA set of special inks:
- UV responsive inks: they are visible only when exposed to specific UV lamps.
- Shift Inks: they change color according to the viewing angle.
- Thermo Chromatic inks: they look different at different temperatures.
- Metameric Inks: they change color depending on the light they are exposed to.
- Coin-Reactive Inks: invisible, they become visible when rubbed with a coin.
Inks interacting with electronic devices:
- IR Invisible Black Security Ink: black ink that only an infrared videocamera can reveal.
- Infra Red (IR) Responsive Inks: their authenticity can be verified only by a special infrared pen.
- UV Responsive Inks: they combine both the effects of inks reacting to UV ray and the reactive effects of IR.
Digital technologies – Box Check App System
Inspired by forensic ballistics, it reads the “imprints” left by the folding box production process.
The system acquires such imprints and converts them into an algorithm stored on Igb servers. The imprints on the folding boxes can be read through a smartphone app and can be compared with the ones kept in the server. If the imprints match, the app gives the ok.
Igb provides an identification service through serialization.
Igb created the “tamper evident folding box”, for which patent pending proceedings have started. It’s the easiest, safest and less expensive solution in compliance with the requirements of FMD - Falsified Medicines Directive - Dir. 2011/62/EU, FDA and TGA.