More patient protection with new safety system for pharmaceuticals


Frankfurt/Main, 5 February 2019 – On 9 February, the new safety system for pharmaceuticals entitled “securPharm” will go live. The eponymous German organisation securPharm e. V., which was initiated by the pharmaceutical industry, wholesalers and pharmacists, has developed this system based on the requirements of the EU Falsified Medicines Directive. This marks the beginning of a longer conversion process in the entire legal pharmaceutical distribution, which will further improve the protection from falsified pharmaceuticals every single day.

Packages of prescription drugs that are newly launched by manufacturers will be provided with two additional safety features, which are verified immediately before packs are dispensed to patients. For patients, this means even better protection from falsified pharmaceuticals in pharmacies and hospitals.

These are the two safety features: An anti-tampering device based on which the integrity of a pack is recognizable and an individual package number that renders each pack unique. Through the securPharm system, pharmacists use these safety features to check for authenticity directly before the pack is dispensed to patients. Since the packages with the new protective measures will be released gradually after 9 February, there will be a transitional period during which some packages in pharmacies have the new safety features while others do not. The legislature has stipulated that packages already in the market can be sold until their expiry date.

Martin Bergen, managing director of securPharm e. V.: “Patient protection is a precious asset and indispensable for the partners in pharmaceutical care. With this new protective system, we will go even further in increasing the safety of pharmaceuticals.”

The securPharm system is embedded into a Europe-wide protective system of the legal supply chain against falsified pharmaceuticals. Initially, the safety systems in 26 EU member states as well as Norway, Iceland and Liechtenstein will become operational. By 2025, the systems in Italy and Greece will join.

The securPharm system was established by the partners in pharmaceutical distribution – the trade associations of the pharmaceutical industry, pharmaceutical wholesalers and pharmacists – in accordance with the requirements of the EU Falsified Medicines Directive and in coordination with the pharmaceutical authorities. The project is one of the largest infrastructure projects in terms of pharmaceutical care in Europe. In Germany alone, pharmaceutical companies had to convert their production of almost 60,000 different products to be able to apply the new safety features. Domestically, about 750 million packages of prescription drugs are dispensed in community pharmacies per year. Roughly 22,000 system users have been connected to the securPharm system. They have dedicated considerable financial and human resources to create the technical prerequisites for the introduction of the additional safety features.

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