securPharm – German contribution to the upcoming extended EU Falsified Medicines Directive

Falsified medicines represent a risk for the user even if there have only been individual cases of smuggling into regular pharmaceutical distribution so far. The distribution system is already being protected by a number of measures against falsified products. However, to provide an even better level of protection against this risk in the legal supply chain, an IT-based verification system is currently being implemented across the EU in which prescription medicines need to be checked for authenticity again, directly before the handover to the patient. The German part of this system is being set up by securPharm e.V., an alliance of associations in the pharmaceutical industry (vfa, BPI, BAH), pharmaceutical wholesalers (PHAGRO) and pharmacists (ABDA).
The securPharm system is already being used by some manufacturers, wholesalers and pharmacists in their daily work. From 9 February 2019, it will be in nationwide use connected with the corresponding systems in other EU states. This EU-wide “protective shield” will then help to ensure that patients will have a safe source for their medicines at regular pharmacies in the future too.

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The EU verification system gives every pack a unique identifier by equipping it with an individual number (a randomized serial number). This will appear on the pack in both human-readable form and as a square data matrix code. All the numbers issued will be sent by the manufacturers to a joint manufacturer database (operated in Germany by ACS PharmaProtect GmbH). Later in the pharmacy, the code of every pack will be scanned immediately before handover to the patient and the serial number on the pack will be automatically checked in the manufacturer database. If the serial number is correct and is being scanned for the first time, the system gives the “green light” for the handover of the pack. In case of discrepancies (serial number not issued or has already been scanned on another pack), the patient will receive another pack of the same medicine; the rejected pack will then be retained and the suspected counterfeit will be investigated.

The EU-wide system will not only include all the manufacturers and pharmacies but also the wholesalers and parallel distributors (who transfer medicines from one EU country to another).

EU guidelines as basis

Fiktive Arzneimittelpackung mit DataMatrix-CodePack with data matrix code (DMC) coming off the production line The basis for the counterfeit defense system is the EU Directive on falsified medicines from 2011 and an associated delegated regulation from 2016. They need to be fully implemented by 9 February 2019. Besides the verification system described above, the regulations also require that prescription medicines (and also certain non-prescription stomach medicines) are equipped with safety features to ensure any attempt to open and reseal a pack is not overlooked (anti-tampering device). This can be effected by means of a sealed flap or a pack with micro-perforation.

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