The easiest solution in compliance with Directive 2011/62/EU.
IGB Tamper Evident: the lean solution to the FMD
300.000.000 boxes sold in 2019 IGB Tamper Evident folding boxes do not change the packaging process of pharma companies.
They are a lean solution to the 2011/62/EU: they allow to keep working at the same speed as non-tamper evident boxes and achieve the same performance:
- Easy solution to face the FMD - Falsified Medicines Directive, Dir. 2011/62/EU and FDA and TGA requirements
- The boxes irreversibly show if they have been opened
- They have a Tamper Evident seal built inside therefore it does not interfere with the Braille text, which, instead, can happen with other solutions that have perforations on the outside
- Graphics, texts and variable data will be kept intact and readable because no stickers are required, that could damage the cardboard when peeled off
- Environment friendly because entirely made of cardboard
- Awarded by the major trade shows worldwide
Patent n° 1425110
Since February 9th, 2019, pharmaceutical products in Europe require tamper evident cartons or tamper - resistant cartons.
In compliance with the Directive 2011/62 / EU, IGB produces and sells tamper evident medical boxes Certified for Europe and USA
The new European FMD - Falsified Medicines Directive - Dir. 2011/62/EU states that “…outer packaging...” must 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.”: a device, that could be removed to open the pack without detectable signs that it had been removed, would not fulfill the definition of anti-tampering device.
Glue is not accepted as an anticounterfeiting solution for pharmaceutical cartons in US and Australia.
FDA: “Paperboard cartons sealed by gluing the end flaps are not capable of meeting the TRP requirements.”
TGA: “Sealed paperboard cartons as currently available in the marketplace (e.g., cartons sealed by gluing the end flaps together) are unacceptable”.
FDA regulates the use of seals as well. According to the US agency, standard seals do not meet TRP (tamper resistant packaging) requirements.
FDA: " Tape seals relying on an adhesive to bond them to the package are not capable of meeting the TRP requirements because they can be removed and reapplied with no visible evidence of entry. However, the Agency recognizes that technological innovations may produce adhesives which do not permit the removal and reapplication of tape seals. In addition, tape seals may contain a feature that makes it readily apparent if the seals have been removed and reapplied. Tape seals must employ an identifying characteristic that cannot be readily duplicated.”
As a result, to adhere to the high security protocols on tamper evidence, seals must have sophisticated anti-counterfeiting features that make them expensive compared to standard seals.
TGA: "Tape seals are acceptable only if they contain a unique feature that makes it apparent if the seals have been removed and reapplied, e.g., a permanent adhesive."
In conclusion, labels and glue add up costs and complexity to the production process of pharmaceutical tamper evident cartons.