Counterfeit medicines endanger health – and not least also the reputations of the pharmaceutical manufacturers. They are a chronic problem for both patients and the pharmaceutical industry itself, which has to contend with immense revenue losses and liability problems. And the figures are frightening: 10% of medication sold globally and 50% of medication traded online are counterfeit – and the figures are still rising. By now, the fakes are so perfect that visual and safety checks in pharmacies are no longer sufficient alone. Additional security features on the packaging are imperative.
Patient protection by law
In order to ensure the protection of patients, EU Directive 2011/62/EU calls for two security labels for all prescription and some non-prescription medications by February 2019 at the latest. While the security feature is used to verify the authenticity of a medication, the tamper-evident seal shows whether the package has already been opened. In addition, serial numbers are mandatory for prescription drugs throughout the EU to keep track of medication along the entire supply chain.
Rely on the pioneer in drug safety
As a specialist for high-security packaging, K+D AG in St. Gallen has focused for many years on the implementation of the "Falsified Medicines Directive" and plays a pioneering role in this field. With our pharmaceutical competence and state-of-the-art technology, we develop and produce packaging that reliably protects medicines against counterfeiting and guarantee compliance with the EU Directive, thus avoiding revenue losses due to counterfeiters. The observance of hygiene regulations and outstanding print quality are a matter of course for us.
- Defining your requirements
- Analysis of the available options
- Creating a customer-specific concept with concept studies and pilot production, e.g., with a combination of various properties
- Individual consultancy through K+D AG
- Reliable protection against medication counterfeiting
- Reliable compliance with Directive 2011/62/EU
- Tamper-evident seal
- Security features
Tamper-evident seal - initial opening guarantee with low one-off costs
According to the EU Directive, each medication package must have a feature that allows tampering to be immediately identified. K+D has developed four different seal variants for this purpose that guarantee effective protection with minor design changes simple graphical elements.
Our four opening variants have been tested for machine capability. This means that you can modify your packaging line accordingly with at low one-off costs without the additional operating costs of, e.g., a labelling solution. The seal variants achieve a combination of tamper evident closure and resealability, and thus impress with their simplicity and convenience. In addition, we offer various decoration options such as finishing with cold foil elements.
- Tamper-proof, resealable tamper-evident closure
- Support in practical implementation
- Delivery of small batches for testing on the line
Security features – Originality verification duty in 2019
From February 2019 only prescriptive medicines with the new security features on the packaging are allowed to be trades in the EU. This EU Directive give wholesalers, and persons authorised or entitled to supply medicinal products to the public, the ability to verify the authenticity of the medication.
Avoid the risk of not being able to deliver on the due date and start the implementation as early as possible.
K+D warrants an effective, efficient and punctual realisation of the new legislation. Thanks to our close cooperation with high-security specialists, we can offer a variety of authentication methods and approaches. You can choose between three different levels and 17 different security features.
- Level 1 (visible, apparent without tools):
Die cutting, all kinds of embossing, special foils, cold foils, graphical elements such as security lines or special blank numeration, additional labelling (sequential numbering, e.g. Bollini) 2D matrix code with serialisation, Rolling Optics
- Level 2 (hidden, only visible with tools):
Graphical elements (microfonts, etc.), coin reactive ink, spot inks and lacquers, fluorescent fibres/markings, thermoreactive colours
- Level 3 (invisible/«forensic»)::
Nano particles in the glue, Unica Scrypto Trace (smartphone)
Serialisation – unmistakable with Data Matrix Code
In introducing serialisation, the EU specifications seek to ensure the authenticity of the medication along the supply chain. Each individual medicine package is given a one-off number that makes it unique, thus offering all stakeholders reliable security.
During serialisation, with an end-to-end control system, such as securPharm, every single package is given an individual identification number, which is printed in machine-readable form as a square Data Matrix code. In parallel, each number is stored in a central database by the manufacturer. At the pharmacy, the information can be read using a scanner and checked online in the database. If the data match, the medication is genuine and can be passed on to the customer. In case of discrepancies (serial number not assigned or already scanned for a different package), the patient is given a different package of the same drug; the offending package is then retained, and suspicion of fraud is investigated. We are happy to advise you on code placement on the carton or, if so desired, can implement coding on your behalf through one of our partners.
- Unique identification of the medication as per Directive 2011/62/EU.
- Effective protection against counterfeiting along the entire supply chain
- Machine-readable Data Matrix Code
- Text codes for verification of layout and legibility
- Small series as a blank samples for text on the line
- Upon request, provision of special codes