Today – February 9, 2019 – the Falsified Medicines Directive 2011/62/EU has come into effect. It requires pharmaceutical manufacturers to provide secondary packaging of prescription medicines with an individual serial number as a 2D code for identification, plus a tamper-evident feature proving that the packaging is intact. This requirement is intended to stop illegal trading of falsified medicines.

Incidents of medicine counterfeiting increasingly often make the headlines – particularly when customs authorities achieve a major coup. In September 2017, German customs confiscated 950 parcels with 68,000 falsified pills and vials at only three parcel centers within a single week. An anonymized survey revealed that one in eight physicians has at one time or another held a counterfeit in his/her hand, and even six in 500 pharmacists have. One in seven counterfeits comes from a pharmacy in another EU country.

Mid-October, some 500 tons of fake medicines were confiscated in international raids. They included ineffective potency-enhancing drugs, pain killers and dietary supplements as well as counterfeit cancer drugs. According to Interpol, 116 countries were involved in the operation and 850 suspects arrested. This again shows the importance of tamper-proof packaging. An EU Directive-compliant closure seal provides an effective solution.

Treatment by self-medication with autoinjectors: a growing trend. For patients, the ease and safety of handling are particularly important. For pharmaceutical manufacturers, the protection of patients against fake medicines and security of the supply chain are crucial. The EU FMD, besides serialization, requires tamper protection of secondary packaging, however without considering first-opening indication for injection devices. That is exactly what the NFC-Label for autoinjectors is offering.

Often the less conspicuous a closure seal appears on medicinal packaging the more sophisticated the security technology it contains. Effects that are both conspicuous and unequivocal will only emerge when an informed expert authenticates the seal, like in the case of LumiSecure: Illumination by a special light makes colors on the label visible that can be clearly verified and thus indicate the authenticity of the packaged medicine.

Trade in counterfeit medicines is booming. The reasons: High profit margins, low risk of detection and relatively low penalties in some countries that prosecute the production of fake medicines as a patent infringement instead of what it really is: the endangerment of human life. Thus, for highly counterfeit-prone medicines, covert features such as microparticles provide particularly reliable proof of authenticity.

In September 2017, “Operation PANGEA” was run for the tenth time – an annual activity coordinated by Interpol to combat the sale of counterfeit and illegal medicines on the internet in which more than 100 countries participated. 25 million illegal and counterfeit medicines worth more than 50 million U.S. dollars were confiscated: a record number that shows how important fast and reliable authentication of an original product is. For customs officials, physicians, pharmacists and consumers.

Product pirates often use a simple but perilous method to put falsified medicines on the market: They open the product pack and exchange the contents. If the medicine pack is sealed with a conventional label, product counterfeiters simply cut through it and reapply the seal – this will often go unnoticed by patients. The Cut-Through-Indicator Seal, however, thwarts such tampering attempts.

There’s a dark side dormant in all of us… Pharmapack visitors will be able to test their criminal skills at Schreiner MediPharm’s booth (M31) in Hall 4 this year. The challenge: Everyone will be invited to try to open Schreiner MediPharm’s closure seals for pharmaceutical packaging without their tampering attempts being detected. This special activity will take place in the light of EU Regulation 2016/161 supplementing the Falsified Medicine Directive, which all pharmaceutical manufacturers of

A great product introduced in Tokyo: Our Schreiner MediPharm business unit together with its Japanese sales representative, Asahi Printing, is one of the 1,080 exhibitors represented at Interphex Japan. The product highlight is the new Flexi-Cap Protect for oncology applications. It is a further development of the proven Flexi-Cap security concept for first-opening indication.