Protect patients and original manufacturers from counterfeit medicines: tesa scribos® offers counterfeit-proof product identification for reliable authentication and traceability of medicines.

Counterfeit medicines – a worldwide problem

The World Health Organisation WHO strongly warns against counterfeit medicines. These cheap imitations are made by criminal organisations, who sell them at a huge profit. Almost any medicine is fair game for counterfeiters. OTC (over the counter) medicines, "lifestyle" medicines such as protein powders, vitamin tablets, diet pills, dietary supplements and medicinal mineral compounds are all counterfeited on a mass scale. There are also dangerous copies of prescription medicines such as antibiotics, impotence drugs, cancer medicines, vaccines and medications for diabetes, HIV and heart conditions. And this problem certainly does not just affect developing countries. On the contrary, massive increases in counterfeit medicines have been recorded in Europe and North America. The reasons for this development include easy sale of these counterfeit products in online shops and a lack of globally applicable regulations and protective measures to effectively combat counterfeit products.

Counterfeit medicines endanger human lives

tesa PrioSpot® - On a blister packaging for high-level product protection

The counterfeit pills, vials, capsules and powders are usually produced in unhygienic conditions which means that the products are frequently contaminated with bacteria. Harmful substances such as road paint or tar are often used in their manufacture. Counterfeit medicines frequently contain too much or too little of the active ingredients, or indeed none at all. Taking cancer medicine as an example, it is clear how high the health risks are for patients.

Moreover, manufacturers of authentic medicines suffer financial losses when people buy counterfeit medicines or grey market goods instead of genuine, high-quality medicines. The research carried out does not pay off and cannot be used to cure diseases. If people mistake counterfeits for authentic medicines, the image of the manufacturer suffers lasting damage.

Serialisation and counterfeit protection in the pharmaceutical industry

Secure sealing of medication packaging through tesa® HighPerSealFX Etiketten

Implementing legal regulations​ (EU: 2016/161/EU; USA: DSCSA)

Regulations of the EU and USA aim to combat this dangerous trend. The European Union directive 2016/161/EU ("Falsified Medicines Directive") stipulates certain labelling standards for pharmaceutical manufacturers. By 2019, every prescription medicine must have a unique distinguishing feature, such as a serial number, and provide individual production data via a DataMatrix code. These printed codes alone, however, do not offer reliable counterfeit protection, because they can be easily copied. With the tesa PrioSpot® and tesa VeoMark® security labels, each medicine packet and blister pack is individually marked with a unique product code, which is protected with additional security features and can be linked to the labelling standard of the pharmaceutical industry. 
Only counterfeit-proof protection of the standard pharmaceutical labelling allows reliable tracing of a product throughout the whole supply chain from manufacturer to dealer to sale. The tesa® connect & check online verification platform allows end consumers, as well as dealers and customs authorities, to check the authenticity of their medicines easily online. This forces counterfeit products out of the market, which protects patients, reduces warranty claims and prevents manufacturers from suffering damage to their reputations and losing sales.

A further EU requirement is tamper protection. The semi-transparent sealing labels from tesa scribos® reliably seal medicine packaging. If the package is tampered with or opened, irreversible visual evidence (VOID effect) clearly shows whether a package is intact or not. The semi-transparency of the security label leaves important legal information on the packaging uncovered and the packaging design unaffected.

The security solutions from tesa scribos® enable the new EU and USA regulations for counterfeit protection and serialisation in the pharmaceutical industry to be reliably and effectively implemented.

Find out more about the tesa PrioSpot® and tesa VeoMark® security labels, the tesa® SecuritySealing security labels and the tesa® connect & check online verification platform.

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