Falsified Medicines Directive

UPM Raflatac has developed a range of pharmaceutical labelling products to support compliance with the Falsified Medicines Directive (2011/62/EU) on packaging for prescription drugs and high-risk, over-thecounter medicines. An estimated 30 billion such drug packs are sold and handled annually in Europe. Few solutions offer the same ease of adoption for meeting the February 2019 deadline.

The Falsified Medicines Directive makes it mandatory for prescription (white list) or high-risk OTC (black list) drug packs to carry a unique serial number to identify and authenticate individual products. In addition, packs should be sealed in a tamper-evident way which visibly exposes attempts to open them.

While the delegated regulation (EU) No 2016/161 stipulates that an anti-tampering device has to enable verification of package tampering, there is no elaboration on specifications. However, the European Commission Directorate-General for Health and Food Safety advises that guidance can be taken from the new CEN standard EN 16679:2014 “Tamper verification features for medicinal product packaging”. This CEN standard is the route UPM Raflatac pursued in the development of tamper-verification labelling products meeting an urgent market need for Directive-compliant solutions.

Irreparable tamper verification

UPM Raflatac’s tamper-verification products are based on the RP62EU adhesive, which exploits the properties of the cardboard with water-based varnish typically used for pharmaceutical packaging. RP62EU works by facilitating cardboard tear between the bleached chemical pulp and BCTMP layers in the cardboard construction; lifting or removing the label causes highly visible and irreversible damage as an indication of package tampering. The labels cannot be smoothed back down.

RP62EU is available with a range of clear film as well as paper-based label faces. Pharmaclear PP Seal visibly stretches on removal, and Pharmaclear PP Tear TC displays the surface torn from tampered packs. Pharmatight paper label face is relatively fragile and suffers irreversible damage or break when tampered with. Attempted removal of the Pharmatight label will also cause surface damage to cardboard pharmaceutical packs. An RP62EUL adhesive variant enables
missing label detection by luminescent detector.

Inherent ease of adoption

For many pharmaceutical product lines, these self-adhesive label solutions are the preferred option due to their simplicity of implementation. Ease of adoption is particularly a strong point when the tamper-evident functionality of the RP62EU is combined with a clear, filmic label face, which has little effect on the graphic design of the package. Pharmaceutical manufacturers achieve the tamper-evidence required by the Falsified Medicines Directive, while continuing with their existing package layouts and packaging stocks.

--Issue 27--