Anti-Counterfeiting - Box safety up!
Directive 62/11/EU guarantees the maximum security to the end user when buying medicines.
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 pharmaceutical 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 for IGB’s customers, therefore for IGB itself, is to guarantee the authenticity of the packaging.
IGB R&D provides technologies to protect products against counterfeiting.
IGB provides an identification service through serialization.
IGB created and patented the “Tamper Evident folding box”. 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.