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World Class Folding Boxes

Tamper Evident Folding Box

The easiest solution in compliance with Directive 2011/62/EU.

tamper evident

Astuccio anti manomissioni per medicinali prodotto da IGB

From February 9th, 2019, pharmaceutical products in Europe require tamper evident cartons or tamper - resistant cartons.

Compliance with the Directive 2011/62 / EU IGB produce and sell 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 provides “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.

Since many years already, glue is not accepted as an anticounterfeiting solution for pharmaceutical cartons in US and Australia.

Since many years already, 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 anticounterfeits features that make them expensive compared to standard seals.

Do you want to find out more? click here

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."

You can find more information by clicking here

In conclusion, labels and glue add up costs and complexity on the production process of pharmaceutical tamper evident cartons.

Tamper Evident solutions guide

tabella tamper evident

Igb Tamper Evident folding box:

  • No glue
  • No labels
  • No additional space required in packaging department
  • No slow-downs to production line
  • No investments in additional packaging machinery
  • Easy solution to FMD - Falsified Medicines Directive, Dir. 2011/62/EU and FDA and TGA requirements
  • Environmental friendly
  • Blind friendly
  • Has 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
  • Guarantees that graphics and texts keep intact and readable beacause it has no stickers that damage the cardboard when peeled off
  • Has been awarded by the most important trade shows in the business

* Patent n° 1425110

Are you looking for pharmaceutical tamper evident folding boxes? Have a look at our products!

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FAQ - Frequently Asked Questions

How it works on packaging lines

If you can close a standard folding box on your machine, you will be able to close ours too. They practically work in the same way and are based on the same principles. We have successfully tested our folding boxes on machines from most manufacturers. Watch the video:

Manual Packaging

Supplies and T&Cs

We don’t set a moq. The perfect quantity we aim at, depends on the customer’s needs: once the customer let us know the required quantity and product specifications, we will work it out together.

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Where to find us...

Address
via Varese 115
21059 Viggiù (VA) Italy
+39 0332 487372
+39 0332 487768
info@igbressan.it
02921590960

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