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.”
