** Bähren Druck presents 16679-Labels: A material portfolio of reliable tamper-evident labels to comply with the EU Falsified Medicines Directive 2011/62.
Serialization dominates the discussion about how to implement the Falsified Medicines Directive (2011/62/EU). But to meet the February 2019 deadline, companies must also pay attention to the second required safety feature: the anti-tampering device. The use of tamper-evident labels is widespread. But beware! There are many challenges and risks associated with these popular tamper-evident devices.
The sample kit offers a range of reliable tamper-evident samples in order to get a first impression of the individual behavior. Just in case you might be wondering why you find so many different samples, applications are very diverse. These range from varnish-free cartons with printing or no printing areas, and different kinds of carton types, to cartons that have been fully varnished with a UV coating, matt varnish or water-based varnish. This complex set-up requires an individual test. Sometimes prime materials are enough, sometimes premium materials are required. These are important aspects which influence production costs.
"The main challenge is the varnish on the folding box. These coatings can weaken the bond between the glue and the carton surface. Standard permanent glue reaches its limits."
Product Manager - Serialization & Tamper Verification
Bähren Druck - Der Pharma Spezialist
"The EU regulation does not specify how to implement an anti-tampering device. Both the directive 2011/62/EU and delegated regulation 2016/161 stipulate the safety feature but do not define any details. For this reason stakeholders prepared the CEN standard EN 16679 entitled „Tamper-verification features for medical product packaging,“ which will be upgraded to ISO 21296."